The Pharma Legal Handbook: Egypt

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The Pharma Legal Handbook: Egypt answers essential questions about the legal and regulatory environment for pharmaceuticals in Egypt. It is a must-have for any company operating in the country or looking to enter the market.

Prepared in association with Youssry Saleh, a leading Egyptian law firm, it should answer any questions linked to regulation, pricing, clinical and preclinical trials, marketing, manufacturing, trademarks and patents.

If legal handbook content is updated, you will receive a free updated PDF for up to one year after purchase.

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June 2019

1. Biosimilars & Biologics: Egypt

Biosimilars & biologics in Egypt – a legal guide. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.

1. Are biosimilar medicines considered the same as generic medicines in your country?

In Egypt, Biosimilars are considered different from Generic Medicines but similar to biological products, where the “Biosimilar” definition according to the Guidelines for Registration of biosimilar products in Egypt, is the following: A similar biological medicinal product having the same active substances, dosage form, concentration and route of administration of a reference biological product and was proven through a comparability program that is quality, safety, and efficacy are highly similar to a reference product when prescribed on a claimed indication.

While the Generic is a copy of medicinal product with chemical, small molecule drug substance(s) that is/are structurally and therapeutically equivalent to that/those of and originator pharmaceutical product.

2. Are all biologic medicines, including biosimilar medicines patentable in your country?

Biological and biosimilar in Egypt are patentable in accordance with the Intellectual Property Law No.82 of the year 2002 in Egypt, the Patent was defined in Article 1 as follows: “A patent shall be granted, in accordance with the provisions of this Law, to any industrially applicable invention, which is new, involves an inventive step, whether connected with new industrial products, new industrial processes, or a new application of known industrial processes. The patent is also granted, independently, for any modification, improvement or addition to a previously patented invention, which meets the criteria of being new, inventive and industrially applicable, as stated in the preceding paragraph; in which case, the patent shall be granted, under the provisions of this Law, to the owner of the modification, improvement or addition.”

3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?

Yes, there is a specific guideline issued along with Ministerial Decree No.150 of the year 2015, in order to regulate the authorization of the biosimilar is at the Central Administration Planning Administration CAPA Registration, there are two approaches for the registration of a biosimilar product:

For the imported products: the finished product is manufactured and marketed in the country of origin and only evaluation of the final dossier is performed. The steps of registration are clarified below;
For locally manufactured products: they are finished products manufactured in factories licensed in Egypt and include the following categories:

Manufacturing finished product starting from developing active substances to the final finished product in local factory/factories;
Manufacturing finished product starting from manufacturing the final formation from an imported active substance;
Filling of an imported ready to fill final bulk.

The marketing phases of the biosimilar is as follows:

Phase 1: the applicant submits an application inquiry for box approval; box approval or disapproval is issued within 15 working days, if the box is opened, the following phases/steps have to be completed;
Phase 2: the applicant submits the pricing dossier within 30 working days of receiving box approval Pricing license issued within 60 W.D with 2 years validity period. During these 2 years:

the applicant is allowed to purchase (in case of imported active substance) or produce (in case of locally manufactured active substance) specified amount of active substance required for manufacturing specified batch sizes for development;
The applicant has to develop the biosimilar product, perform the quality and preclinical comparability studies along with preparation of clinical studies protocol. At the end, the results of quality and preclinical studies as well as the clinical studies protocol are submitted for evaluation.

Phase 3: An assessment of the submitted quality and preclinical comparability studies is performed by the regulatory authority and approval on clinical studies protocol is issued for the applicant to perform clinical studies with 2 years validity period. After completion of the clinical studies, the applicant completes the registration dossier to be submitted for validation and assessment.

Phase 4: An assessment of registration dossier is performed during this phase and the final assessment report is issued within 60 working days.
Phase 5: Reports collection for submission to Technical committee for drug control within 60 working days.

*After finishing the abovementioned registrations phases the next step will be the pricing, then reports collection & submission to technical committee for drug control and finally the last step will be the issuance of the license.

4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?

The packaging of the biosimilar will be similar to the biological, the packaging of the products differs from the finished products and the local manufactured product packaging and wrapping materials must include the type and specifications of the components of the packaging & wrapping materials, in addition to the suppliers’ names.

There are no differences in the packaging requirements of the biosimilar drug and the biological drug.

5. What are the requirements for the choice of the reference comparator product?

The drug substance of the reference biological product and that of the biosimilar product must be similar, as the reference biological product should be authorized on the basis of complete dossier (full Quality, Preclinical and Clinical data).

6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?

Yes, it is required that the reference biological product from another country be licensed and widely marketed in a reference country and with the same criteria that should be fulfilled on the reference product with the same standards in Egypt.

7. How are the prices of biosimilar medicines regulated? Is this any different to the requirements for the original Biologics drug?

No. there is no specific difference in the pricing requirements of both the biosimilar and the biological. The pricing regulatory framework in Egypt is regulated through Ministerial Decree No.314 of the year 1991, Decree No.373 of the year 2009 and Decree No. 499 of the year 2019.

The above-mentioned decrees clarify the pricing mechanism in Egypt, while the pricing requirements are regulated.

Pricing of the biosimilar medicines is regulated and follows the same rules and procedures of the biological and vaccines serums, which is promulgated in the Ministerial Decree No. 279 of the year 2009, after submitting the following documents:

Pricing application form clearly mentioning the proposed price & pack, printing on the company paper & sealed with company seal;
The approval on the query application;
Payment receipt of the pricing services fees;
Copy of free sales certificate in the country of origin notarized from the Egyptian Embassy abroad;
List of cost, import price & price of the country of origin (notarized from the Egyptian Embassy abroad) (Original & Copy);
Prices in other countries including Arab countries (Pricing form);
Copy of the product’s original pack & insert.

8. What is the reimbursement policy for biosimilar medicine? Is this any different to the requirements for the original Biologics drug?

The reimbursement policy is similar to the method that is applied to the other drugs; the Ministry of Health and Population “MOHP” issues the reimbursement policies and regulations, which is followed by the MOHP’s facilities and the Health Insurance Organizations. The procurement department is mainly responsible for setting the reimbursement price and the tender drug list, which is published and distributed to all the MOHP facilities.

9. Does biosimilar competition impact the reimbursement policy of the originator reference products?

Biosimilars commands a great attention due to the significant cost saving and potentially wider use for the patents and achieve their medications demands for its affordability, accordingly, biosimilars have committed a competition with the original biological drugs due to its low prices.

10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?

Up until now, there has been no legal framework regarding the prescription of the biosimilar specifically but the general rules of all drugs will be applied, physicians shall not recommend or prescribe medicines without applying appropriate examinations personally on the patient not according to an oral, written or visual data. For pharmacists they cannot dispense drugs without a medical prescription and the drugs shall be registered at the Ministry of Health, drugs that are not registered at the Ministry of Health shall not be distributed.

11. Is the system considering physician-led switching and/or pharmacy-level substitution (without involvement of the clinical decision maker)?

No, the pharmacists are not permitted to switch to patients from biologics to biosimilars, the biosimilar shall be prescribed by the physician, as the physician prescribes such medicine after examining and diagnosing the medical situation and also after being informed with the medical history of the patient and whether he is allergic to certain types of drugs.

12. What are the post-authorisation requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?

Yes, the requirements are different, as mainly, the biosimilars authorizations should cover two distinct but complementary aspects:

The molecular characteristics and quality attributes (QA) of the target product profile should be comparable of those of the reference medicine product;
The performance and consistency of the manufacturing process of the biosimilar should be achieved on its own.

The quality of target product profile (QTPP) of a biosimilar should be based on data collected on the chosen reference medicinal product, including publicly available information and data obtained from extensive characterization of the reference medicinal product.
The QTPP should be detailed at an early stage of development and form the basis for the development of the biosimilar end the manufacturing process. It is important to identify critical quality attributes that may impact the safety and efficiency of the product.
In case of developing recombinant products, it is expected that the expression construct for a proposed biosimilar product will encode the same primary amino acid sequence as its reference product.
The use of novel expression systems should be carefully considered, as they may introduce additional risk, such as atypical glycosylation pattern, higher variability or even a different impurity profile, as compared to the reference medicinal product.
The expression of the active substance of the biosimilar product in the same host cell type of the reference product is expected to produce a product that will encode the same primary amino acid sequence.
If the manufacturer used host cell type different from that of the reference biological product for development of a biosimilar product, more extensive comparability exercise should be employed top assure quality, efficiency and safety of the biosimilar product.
However, demonstration of comparability for glycoproteins will be difficult because glycosylation patterns vary significantly between different host cell types.

The following post- authorization shall be covered:
Comparability key elements:

A comparability quality, pre-clinical and clinical data between the biosimilar product and the reference biological product using the product manufactured with the final manufacturing process, if changes are introduced to the active substances and/or finished product development, comparability assessment for the biosimilar product before and after change should be performed as per the ICH guidelines Q5E – comparability of biotechnological/ biological product subject to changes in their manufacturing process.

Collecting data from publicly available information and data from extensive analytical characterization for different batches of the reference product will enable the applicant to:

Achieve the quality target product profile (QTPP) of the purpose biosimilar.
Detect batch-to-batch variation within the batches of the same reference product.
Specify the acceptance criteria for biosimilarity with justification.

Data from suitable number of batches, at least 3 pilot scale batches of the purposed biosimilar product at time of submission should be provided for proving similarity with the reference product.

Complete CMC should be submitted in CTD format according to ICH guidelines in addition to quality comparability exercise with the reference product.

Pre-clinical and clinical comparative studies with the same reference product used in the quality comparability exercise should be submitted. The extent of the preclinical and clinical data required depends mainly on the outcomes of the quality data.

Differences in quality pattern between the biosimilar and the reference product of unknown clinical relevance, particularly regarding safety should be addressed in additional studies pre-marketing.

Differences in quality pattern between the biosimilar and the reference product that is known to have potential impact on the clinical activity will influence the judgement whether to consider the product as the biosimilar or not.

Quality Aspects: level of comparability studies (drug substance and drug level product level)

Product characterization studies for both the proposed biosimilar and the reference biological medicinal product should be performed using state of the art analytical methods.
If the drug substance for the reference biological medicinal product is available, comparability exercise should be performed on both drug substance and drug product level but due to general unavailability of the drug substance of the reference biological product, comparability exercise is generally performed on the finished product.
It is the responsibility of the applicant to demonstrate that the selected methods used in the comparability exercise would be able to detect slight difference in all aspects pertinent to the evaluation of the quality.
Methods used in the characterization studies from an integral part of the quality data package and should be appropriately qualified for the purpose of the comparability. If the applicable standards and reference materials should be used for the method qualification and standardization.

A) Structural and confirmation characterization:

A comprehensive set and combination of analytical methods are used; generally, characterization tests include but not limited to:
Primary structures, such as amino acid sequence, N and C-terminal sequence
Higher order structures, including secondary, tertiary, and quaternary structure (including aggregation)
Enzymatic post-translational modification, such as glycosylation and phosphorylation.
other potential variants such as protein deamidation.
Intentional chemical modification such as pegylation sites and characteristics.

B) Specifications: Release of drug substance / drug product (DS / DP)

Appropriate analytical test methods should be selected based on the nature of the protein being characterized and knowledge regarding the structure and heterogeneity of the reference and the proposed biosimilar product (ICH guidelines: Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products have to be consulted)
Specifications for the proposed biosimilar product should be set based on the applicant’s own experimental results obtained for both the proposed biosimilar and the reference product, the specifications shall not be wider than the range of variability of the reference product unless justified.
Each acceptance criterion should be established and justified based on data obtained from lots used for the demonstration of manufacturing consistency, data from stability studies, relevant development data and data obtained from the comparability exercise.
Methods used for setting specifications may or may not be the same as analytical methods used for products characterizations and for establishing product comparability.

The comparability testing regarding the specifications includes:

Physicochemical Properties: they include but are not limited to molecular weight/size, isoform pattern, extinction coefficient, electrophoretic patterns, liquid chromatographic patterns, spectroscopic profiles.
Biological activity: Appropriate biological assays are required to characterize the activity and establish the product’s mechanism of action and clinical effects (in unit of the activity).
Immunochemical properties: they include but are not limited to binding assays of the antibody to antigen, affinity, avidity and immune-reactivity (including cross reactivity).
Purity and impurities:
-The purity and impurity profiles of the active substance and medicinal product should be compared both quantitatively by a combination of analytical procedures.
-Appropriate state of the art methods should be used to compare the product-related substances and impurities. This comparison should take into account specific degradation pathways of the biosimilar product and potentials post-translational modifications of the proteins.
-The age/shelf life of the reference medicinal products at the time of testing should be mentioned, and its potential effect on the quality profile should be discussed where appropriate.
-Comparison of the relevant quality attributes, tested at selected time of testing should be mentioned, and its potential effect on the quality profile should be discussed where appropriate.
-Comparison of the relevant quality attributes, tested at selected time points and storage conditions, could be used to further support the similarity of the degradation pathways of the reference medicinal product and of the biosimilar.
Final Formulation:
-The formulation of the biosimilar does not need to be identical to that of the reference medicinal products. The applicant should take into account state-of-the-art technology and, regardless of the formulation selected, the suitability of the proposed formulation with regards to stability, compatibility (interaction with excipients, diluents and packaging materials), integrity, activity and strength of the active substance should be demonstrated.
-The acceptability of the type, nature, and extent of any differences between the proposed finished biosimilar product and the finished reference product should be evaluated.
-Differences in formulation between the proposed biosimilar product and the reference product are among the factors that may affect whether subsequent clinical studies may take a selective and targeted approach.
Stability: Stability studies on both drug substance and drug product following “ICH guidelines “Quality of biotechnology products: stability testing of biotechnological/biological product QC5” should be consulted. At time of submission, stability data for 6 months as minimum on at least 3 pilot scale batches into the long-term stability program after approval. The quality of the pilot batches should be representative of the quality of the materials used in the pre-clinical and clinical studies and of the quality of the material made at production scale. Side by side accelerated and stressed studies comparing the biosimilar product to the reference product will be value in determining the similarity of the products showing comparable degradation profiles.

Pre-Clinical Aspects: The design of an appropriate pre-clinical study program requires a clear understanding of the product characteristics outcomes from the quality comparability data and depends on the product class. Generally, the spectrum of studies required to establish safety & efficacy of the biosimilar product may vary considerably & should be defined on a case-by-case basis. General considerations of the preclinical studies:

pre-clinical studies should be comparative in nature between the proposed biosimilar and the reference product;
More than one aspects of comparability can be addressed in one study depending on the study design (which considers the objective(s), Evaluation criteria, system used …)
performing preclinical studies should take into consideration

The pre-clinical studies required for evaluating a biosimilar product are:

In Vitro studies: (Pharmacodynamic Studies):
In Vitro studies: (Pharmacodynamic/Toxicological/Immunogenicity Studies)
Which are performed to address toxicity – pharmacodynamics – local tolerance – Immunogenicity)

Clinical Aspects: The scope and extent of the clinical studies will depend on the outcomes of the comparability quality and preclinical data.

In addition to the clinical study which addresses the following aspect: PK parameters, PD markers, safety, efficiency, immunogenicity)

A confirmatory efficacy study is required to demonstrate biosimilarity, this study can be waived if all the following conditions are met:

PK of reference product are well characterized and the relationship between dose/response and response/efficacy of the reference product as “concentration – response” curve is known (for example from literature).
Structural and functional comparability of biosimilar and reference can be characterized to a high degree of confidence by physicochemical and in vitro techniques.
The biosimilar product is comparable to the reference product in all preclinical and evaluations conducted.
PK/PD study has demonstrated comparability and has preferentially been done in an inpatient setting with safety measurement (including immunogenicity) for adequate period justified by the applicant and efficacy measurements.
A comprehensive post marketing risk management plan has been presented that will gather additional safety data with a specific emphasis on gathering immunogenicity data.
At least one PD marker is accepted as a surrogate marker for efficacy, and the relationship between dose/exposure to the product and this surrogate marker is well known.

Batches: Clinical studies should be conducted with the final formulation. Generally, it is required to generate the clinical data for comparability study with the biosimilar product as produced with the final manufacturing process and therefore representing the quality profile of the batches to be commercialized. If there was a manufacturing change during development, comparability should be evaluated in line with ICH Q5E Guideline, as necessary.

Extrapolation of indication could be possible if the following conditions are met:

A sensitive population criterion that is able to detect potential differences between biosimilar and reference product is used.
The clinically relevant mechanism of action and or involved receptor(s) are the same
Safety and immunogenicity of the biosimilar product have been investigated in the patient population that carries the highest risk of an immune response and immune-related adverse event, thus sufficiently characterized and there are no unique/additional safety issues expected for the extrapolated indication(s)
The efficacy trial used a non-inferiority study design and demonstrated acceptable safety and efficacy of the biosimilar compared to the reference product, the applicant should provide convincing arguments that this finding can be applied to the extrapolated indications.
If the above-mentioned conditions for extrapolation of the efficacy and safety data of the biosimilar to other indication(s) of the reference are not fulfilled, the applicant will need to submit its own clinical data to support the desired indication(s).

Pharmacovigilance Plan: Product pharmacovigilance plan according to the EPVC guidelines should be submitted, this plan should include protocol for post marketing immunogenicity study at the time of submission of the marketing authorization application.

Risk Management Plan: RMP should be presented to the EPVC and should include post marketing immunogenicity study at the time of submission of the market authorization application.

13. Are there specific policies and requirements in terms of biosimilar medicines labelling in the event of second medical use patents? Is this any different to the requirements for the original Biologics drug?

No, there are no specific requirements that differ from any other labelling requirements of pharmaceuticals, the labelling requirements are regulated under Ministry of Health Decree 425 of the year 2015 and the Guidelines for Outer Label of Pharmaceutical Products issued by CAPA, the labelling requirements are as follows:

Required Information:

The outer label must contain the following information:

Trade name as approved by CAPA;
Active ingredients under the trade name and on the side of the package;
Pharmaceutical form under the active ingredients;
Number of units per pack;
Route of administration;
Any other ingredients if they are not mentioned in the leaflet;
Storage conditions;
Special precautions;
Information on the manufacturer (name, address, city, country, phone, fax, website) and license holder (logo or trade mark);
Barcode of the product;
Batch number;
Production and expiry dates;
The dosage form or the product if it relates to a specific group (infant, children, adults, men, and women);
The approved price for each unit and the whole package;
All drugs must state “keep out of the reach of children”; and
Other contents in the package must be mentioned on the outer label (if any, for example, measuring cup, applicator, dropper, syringe, calibrating dropper, and so on).

All information on the outer label must be written in both Arabic and English. Further, the design and color of the outer label must differ from that of competitor products.

In case of dietary supplements, a ribbon (15% of the package size) must encircle the package. In this ribbon, the words “Dietary Supplement” must be written, in both English and Arabic.

14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product).

The regulatory framework of the Pharmaceutical’s IP is regulated through the Intellectual Property Right Law No.82 of year 2002 and it’s regulation. As per this law patents can be granted for an amendments, modifications, or addition to an invention already granted a patent, provided that the conditions of novelty, innovation and industrial applicability are met. The patent is valid for 20 years from the application filing date, and an annual maintenance fees shall be paid until the expiry date of the patent protection.

Under the aforementioned law, there is a patent infringement in the following cases:

counterfeits with the aim of commercial circulation;
unlawfully placing on products, adverts, trademarks, packaging materials or other materials information leading to the belief that the party has registered an invention patent or utility model patent.

In the pharmaceutical sector, Patent registration is lengthy (about three years), some pharmaceutical companies do not wait for the patient registration and they start selling their products, some others register their products with the MOH before even applying for patent registration.

The IPR Law stipulated that the patent infringement is a criminal offence punishable by a fine of at least EGP 20,000 up to EGP 100.000. In case of a recurring offence, imprisonment of no more than two years and a fine of at least EGP 40,000 up to EGP 200,000 will be applied.

In all cases, the court can order confiscation of the counterfeit products, the court judgment in case of patent infringement is published through internet and newspapers.

The owner can also claim damages or seizure of infringing products through a claim in the civil court.

The economic court has jurisdiction over IP matters. Further, Article 33 of the abovementioned Law stipulated that the owner could request from a court a precautionary measure against products or goods suspected to infringe a patent, to preserve the patent owner’s right. In that case, the court can issue a preliminary injunction before the main proceedings. The main preliminary injunction will expire if the main proceedings are not brought within eight days from the date of the injunction.

Competition is regulated under Law No. 3 of 2005 on the Protection of Competition and the Prohibition of Monopolistic Practices and its executive regulations (Competition Law). Article (5) provides that the Competition Law also applies to acts committed abroad if they result in the prevention, restriction or harm of/to freedom of competition in Egypt, and are offences under the Competition Law.

The Competition Authority enforces the Competition Law. It receives mergers and acquisitions notifications and reports of violations. Its board of directors can refer a case to prosecution on a written request of the chair if it obtains majority board approval. The Competition Authority can also opt for an out-of-court settlement.

Abuse of a dominant position is prohibited. The Competition Law considers an entity to be in a dominant market position if it holds over 25% of the relevant market share, can change the prices or volume of products offered in that market and competing parties cannot prevent this.

The Competition Law prohibits persons from entering into agreements that limit competition with their suppliers or clients. Competing persons in a relevant market cannot carry out price-fixing, market allocation, bid-rigging and output restrictions. However, there is an exception for horizontal agreements approved by the Competition Authority if the restrictive effect on competition is outweighed by the benefit to consumers.

The Competition Authority is very active. In 2016, it reviewed 28 complaints of anti-competitive practice, and issued a decision in 22 of them. However, there are not many cases concerning pharmaceuticals.

In 2015, the Competition Authority referred four drug distribution companies to prosecution for violating Article 6(a) and (d) of the Competition Law, by coordinating their marketing and selling terms for small and medium pharmacies and reducing the credit terms and cash discounts offered. In 2018, they were fined EGP500 million by the Egyptian courts. It is considered the largest fine in Egypt for competition violations.

In 2016, the Competition Authority challenged the Ministry of Health’s regulations on pricing and registration of drugs under Ministerial Decree No. 425 of the year 2016. The Competition Authority argued that this decree creates restrictions inhibiting the entry of new investors into the market, leading to a monopoly of big market player entities through their acquisition of other companies. The Competition Authority also challenged Decree No. 499 of 2012, arguing that the pricing mechanism breaches the principles of free competition and equal opportunities. These challenges did not lead to any changes in these laws.

15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?

No, up until now, there have been no proposals of applying any significant change to the regulation of biosimilars in Egypt.

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2. Localization: Egypt

The key facts about the localization in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.

1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?

Yes, the legal framework of localization is regulated through Ministerial Decree No. 425 of the year 2015 and Ministerial Decree No. 820 of the year 2016.

2. Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?

No, there have not been any significant changes involving localization rules.

3. Is the process of obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No, in Egypt, the marketing authorization process is not affected by localization polices.

4. Is the pricing process for pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No, the pricing process of pharmaceuticals is not impacted by localization policies. The pricing mechanism in Egypt is regulated through Ministerial Decrees No.314 of the year 1991, Decree No.373 of the year 2009 and Decree No. 499 of the year 2012. Egypt adopted pricing method of cost plus margin, which means that each company submits a study reflecting the cost for producing or importing pharmaceuticals in to the market and automatically apply the applicable margin for each stakeholder in the supply chain up the customer price. After issuing decree No. 373 of the year 2009 Egypt adopted a new pricing method based as it applies the least customer price available in any country where the pharmaceuticals is traded after applying a discount 10% , the same margins for distributor and pharmacist remains applicable even after the issuance of this decree.

Under decree No. 499 of the year 2012, the decree aimed to increase the margins for distributors and pharmacists, while maintain the same pricing method with slight variations.

Mainly, the prices of the pharmaceuticals are determined during the registrations phase, the pricing committee in the Central Administration of Pharmaceutical Affairs CAPA is responsible for reviewing the pricing application and documents.

5. Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No, the reimbursement policy is not impacted by localization policies.

6. Is the access to public or public tenders of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No, the access to public tenders of pharmaceutical products is not impacted by localization policies in Egypt.

7. Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country ? If yes, how so?

Neither Import tariffs, importation nor exportation permits nor taxation of pharmaceutical products are impacted by localization policies in Egypt.

8. Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?

The ministry of health “MOH” has adopted the Common Technical Document (CTD) system, which supports the Egyptian pharmaceutical companies to register their products and benefit from a number of incentives pertinent to pricing and supply of alternatives.

9. Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?

Currently, there have not been any discussions regarding implementing any new localization policies in Egypt, other than the rules, which are declared in the Ministerial Decree No. 425 of the year 2015, and Decree No. 820 of the year 2016.

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3. Orphan Drugs & Rare Diseases: Egypt

All legal aspects surrounding orphan drugs & rare diseases in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.

1. What is the definition of Rare Diseases in your country?

In Egypt, there is no definition of the “Rare Diseases” however, in accordance with the conclusion of medicine professors’ researches and studies a disease is considered a rare disease if it affects 1 in 2,000 or 2,500 individuals.

2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)

Currently, there is no designation in Egypt for Orphan Drugs.

3. What is the regulatory framework for the authorization of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)

There is no specific regulation that regulates the orphan drugs in Egypt separately; the regulatory framework of drugs authorization of the Ministerial Decree No. 415 of the year 2015 will be applied to the orphan drugs.

4. Does your country have provisions for relaxed clinical trial/scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?

No, up until now Egypt has not provided specific clinical requirements for orphan drugs; however, in accordance with the Egyptian Group for Orphan Renal Disease “EGORD”, they’ve referred that due to the rarity and diversity of rare diseases, research needs to be international to ensure that experts, researchers and clinicians are connected, that clinical trials are multinational and that patients can benefit from pooling of resources across borders.

5. Is there an expedited pathway for Orphan Drugs?

Until this day, there is no disclosure regarding the issuance of pathways of Orphan Drugs.

6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?

In Egypt, the Ministry of Health recognizes foreign marketing authorizations, which are issued by efficient foreign supervisory bodies such as the European Medicines Agency “EMA”, and the US Food and Drug administration “FDA”, the Japanese Ministry of Health, or the Australian Therapeutic Goods Administration, Labour and Welfare.

7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan drugs?

Until this day, there is no specific reimbursement policy considered for orphan drugs

8. How are the prices of Orphan Drugs regulated?

The prices of the orphan drugs are regulated through the same pricing mechanism of other drugs in Egypt, under the Ministerial Decrees No.314 of the year 1991, Decree No.373 of the year 2009 and Decree No. 499 of the year 2012. Egypt adopted pricing method of cost plus margin, which means that each company submits a study reflecting the cost for producing or importing pharmaceuticals into the market and automatically apply the applicable margin for each stakeholder in the supply chain up the customer price. After issuing Decree No. 373 of the year 2009, Egypt adopted a new pricing method based as it applies the least customer price available in any country where the pharmaceuticals is traded after applying a discount of 10%, the same margins for distributor and pharmacist remain applicable even after the issuance of this decree.

Under Decree No. 499 of the year 2012, the Decree aimed to increase the margins for distributors and pharmacists, while maintain the same pricing method with slight variations.

9. In case of reference price based on a basket of countries, what countries are included?

The recommended price is approved or reduced according to the lowest price-referenced country for the referenced product. The reference countries are Australia, Austria, Belgium, Canada, Denmark, Germany, Finland, France, Iceland, Ireland, Netherlands, Japan, Luxemburg, U.S.A, New Zealand, Norway, Sweden, Switzerland, United Kingdom, Italy, Portugal, and Spain.

10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?

No, until now in Egypt, there are no significant legal developments related to the orphan drugs

11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?

No, there are no proposals published stating any changes that may come into force.

Also from this Legal Handbook

4. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs: Egypt

Cannabinoid drugs, medicinal cannabis and opioid drugs in Egypt – an overview. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

No, Cannabinoid Drugs are not authorized in Egypt, however, they are regulated by Law No. 182 of the year 1960 concerning combating drugs and regulating their use and trafficking.

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

Ministry of Health and its departments, Addiction Control and Treatment Fund Organization and Egyptian Drug Authority.

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

With regards the Pricing:

Pricing of drugs is regulated through a pricing committee. Any price increases of the medicines and drug products are determined according to issued Ministerial Decrees.

Regarding the Reimbursement:

MOHP’s facilities and Health Insurance Organizations follow the reimbursement process provided by MOHP. There are other institutions or ministry-affiliated public facilities follow MOHP regulations but have their own budget and autonomy.

With regards the Authorization:

As per Article 4 of the said Law, the authorization of the drugs referred to above may be granted only to the following persons:

Managers of stores licensed to trade in narcotic drugs.
Administrators of pharmacies or shops intended for the manufacture of Pharmacopoeia preparations.
Managers of chemical or industrial analysis laboratories or scientific research.
Some of the Governmental entities and recognized scientific institutes.

The competent administrative authority may refuse the request for permission or reduce the required quantity.

The application shall indicate the name of the applicant, his work address, the full name of the substance, the nature of the drug, the quantity he wants to bring or export, along with the reasons that justify the import or export, as well as other data requested by the competent administrative authority.

Article 3 of the said Law, these drugs may not be brought or exported except under a written license from the competent administrative authority.

Moreover, Article 7 provides that the narcotic drugs may not be traded except after obtaining a license from the competent administrative authority in each of the two regions.

This license may not be granted to:

Person convicted of a felony.
Person convicted of one of the misdemeanours stipulated in this Law.
Person convicted of stealing or concealing stolen items, dishonesty, monument, giving a check without credit, falsifying or using forged papers, perjury or indecent assault, corrupting morals, homelessness or suspicion, as well as the convict for attempting to provide for one of these crimes.
Persons previously disciplined from public office for reasons of moral turpitude, unless three years have elapsed from the date of the final dismissal.

As per Article 8, it is not permitted to trade in narcotic drugs except in stores or warehouses in the cities of the governorates, the capitals of the districts and the rules of the regions and centres therein, except the governorates and the border centres. In such places, the conditions stipulated by a decision of the competent minister shall be met.

The warehouse shall not have a common entrance door with a dwelling, a medical clinic, an analytical laboratory, a commercial or industrial shop or any other place, nor shall it have any outlets related to any such thing. However, trafficking in narcotic drugs may be combined with trafficking in toxic substances in a single warehouse or warehouses.

Moreover, Article 9 stated that the applicant for the license shall submit to the competent administrative authority an application containing the data to be issued by a decision of the competent minister, accompanied by the papers and drawings concerned in that decision.

With regards the authorization for manufacturing:

It shall not be permissible in the pharmaceutical industry to make preparations containing narcotic drugs, except after obtaining the license provided for in Article 7 mentioned above. These factories shall not use its narcotic substances except in manufacturing its formulations which it produce and it shall follow the provisions of Articles 12 and 13 with regard to what it receives from the narcotic substances and the provisions of Articles 11, 12 and 13 with regard to what it produce from medical formulations which interfere in its composition one of the narcotic substances in any ratio.

With regards the pricing and reimbursement:

As per Articles 2 and 3 of Law N.499 for year 2012, the manufacturer apply to the competent administrative authority with the Medicinal product, and this Medicinal product will be discussed by the specialized panel.

4. Which are the cannabinoid drugs that have received market approval to date?

According to Table No. 2 of the Law No. 182 of the year 1960, the medicinal products based on cannabis extract or tincture that are for the outside use only have market approvals. Unlike all the drugs mentioned in Table No. 1, of the Law No. 182 of the year 1960, which are forbidden to produce, extract, or isolate any of the components mentioned in Table No. 1, including without limitation to the following:

a. Cannabis

All kinds and names such as kanmuja, banjo, marijuana, or any other names that may be called, produced, prepared or extracted from fruits, leaves, stems, roots or resin of the cannabis plant, its flowers or leaves, galenic lotions for cannabis (extract or dye).
Preparations based on cannabis extract or tincture.
Cannabis resin preparations (all preparations containing the active cannabis element, resin in any proportion).
Plant extract or any part of it such as cannabis oil.
Powders consisting of all or some parts of cannabis plants such as cannabis powder or in any other mixture.
Tunges resulting from the plant, whether in the form of pure or in the form of a mixture of any kind.

b. Classical cannabinoids. Dibenzopyran.

5. Who can prescribe Cannabinoid Drugs?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

Managers of authorized stores in this trade.
Directors of pharmacies and pharmaceutical factories;
The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

Doctors designated by hospitals, clinics and dispensaries without pharmacists.
Managers of chemical and industrial analysis laboratories and scientific research.
The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

Managers of authorized stores in this trade.
Directors of pharmacies and pharmaceutical factories;
The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

Doctors designated by hospitals, clinics and dispensaries without pharmacists.
Managers of chemical and industrial analysis laboratories and scientific research.
The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

Articles 14 and 15 specifically provided that the pharmacists shall not disburse the narcotic substances except by a medical prescription from a doctor or dentist who holds a diploma or bachelor or by license card in accordance with the following provisions:

Prohibited for those to disbursed narcotic substances by a medical tickets if the quantity recorded in it is more than the quantity prescribed in Table (4), however if the patient’s condition necessitated the increase of such quantities so the doctor shall request a license card for these quantities for this purpose.

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

Managers of authorized stores in this trade.
Directors of pharmacies and pharmaceutical factories;
The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

Doctors designated by hospitals, clinics and dispensaries without pharmacists.
Managers of chemical and industrial analysis laboratories and scientific research.
The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

Managers of authorized stores in this trade.
Directors of pharmacies and pharmaceutical factories;
The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

Doctors designated by hospitals, clinics and dispensaries without pharmacists.
Managers of chemical and industrial analysis laboratories and scientific research.
The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

No.

11. When are they likely to come into force?

N/A.

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

No, Medicinal Cannabis is not authorized in Egypt, however, they are regulated by Law No. 182 of the year 1960 concerning combating drugs and regulating their use and trafficking.

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

Ministry of Health and its departments, Addiction Control and Treatment Fund Organization and Egyptian Drug Authority.

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

With regards the Authorization:

As per Article 4 of the said Law, the authorization of the drugs referred to above may be granted only to the following persons:

Managers of stores licensed to trade in narcotic drugs.
Administrators of pharmacies or shops intended for the manufacture of Pharmacopoeia preparations.
Managers of chemical or industrial analysis laboratories or scientific research.
Some of the Governmental entities and recognized scientific institutes.

The competent administrative authority may refuse the request for permission or reduce the required quantity.

Article 3 of the said Law, these drugs may not be brought or exported except under a written license from the competent administrative authority.

Moreover, Article 7 provided that the narcotic drugs may not be traded except after obtaining a license from the competent administrative authority in each of the two regions.

This license may not be granted to:

Person convicted of a felony.
Person convicted of one of the misdemeanours stipulated in this Law.
Person convicted of stealing or concealing stolen items, dishonesty, monument, giving a check without credit, falsifying or using forged papers, perjury or indecent assault, corrupting morals, homelessness or suspicion, as well as the convict for attempting to provide for one of these crimes.
Persons previously disciplined from public office for reasons of moral turpitude, unless three years have elapsed from the date of the final dismissal.

With regards the authorization for manufacturing:

With regards the pricing and reimbursement:

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

With regards importing:

As per Article 4 of the said Law, the authorization of the drugs referred to above may be granted only to the following persons:

Managers of stores licensed to trade in narcotic drugs.
Administrators of pharmacies or shops intended for the manufacture of Pharmacopoeia preparations.
Managers of chemical or industrial analysis laboratories or scientific research.
Some of the Governmental entities and recognized scientific institutes.

The competent administrative authority may refuse the request for permission or reduce the required quantity.

Article 3 of the said Law; these drugs may not be brought or exported except under a written license from the competent administrative authority.

With regards production:

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

With regards importing and trading, Article 3 provided that it is prohibited to bring narcotic substances or export it except by a written license from the competent administrative party. Prohibited to bring narcotic substances or export it except by a written license from the competent administrative party.

Article 7 provided that the narcotic substances may not be traded except after obtaining a license from the competent administrative authority in each of the two regions.

Moreover, it is mentioned in Articles 5 and 6 that the narcotic substances, which reach to the customs, shall not be delivered except by written permission to withdraw given by the competent administrative party to the licensee to bring or to the one who replaces him in his work. The customs department in the cases of bringing or exporting shall receive the permission to withdraw from the stakeholders and return it to the competent administrative party. It is not permitted to bring narcotic substances or export it or transport it in packages containing other substances and it shall be delivered (even as a sample) in insured packages, and shown on it the full name of the narcotic substances and its nature, quantity and ratio.

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

Managers of authorized stores in this trade.
Directors of pharmacies and pharmaceutical factories;
The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

Doctors designated by hospitals, clinics and dispensaries without pharmacists.
Managers of chemical and industrial analysis laboratories and scientific research.
The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for to the following persons:

Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

18. How can patients obtain Medicinal Cannabis?

Articles 14, 15, 16 and 17 specifically provided that the pharmacists shall not disburse the narcotic substances except by a medical prescription from a doctor or dentist who holds a diploma or bachelor or by license card in accordance with the following provisions:

Moreover, Pharmacists shall not disburse medical tickets, which contain narcotic substances after five days from editing it. The competent minister shall issue a decision by the data and conditions needed to be provided in editing the medical tickets by means of which the narcotic substances are being disbursed by it from the pharmacies with the exception of the pharmacies of the hospitals and clinics and dispensaries and the tickets which are disbursed from the books stamped by the stamp of the competent administrative party delivered with the prices determined by that party and its price shall not exceed two hundred penny. The competent minister may determine the quantities, which cannot be exceeded in disbursing for each patient per month. The medical tickets which contains narcotic substances shall not be replayed to its holder and prohibited to use more than once and it must be kept in the pharmacy and shows on it the date of disbursing the medicine and its registration number in the book of registering the medical tickets and its holder may request from the pharmacy to deliver him a copy of the ticket stamped by its seal and its prohibited to use the copy in obtaining narcotic substances or medicines that contains these substances.

19. Who can prescribe Medicinal Cannabis?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

Managers of authorized stores in this trade.
Directors of pharmacies and pharmaceutical factories;
The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

Doctors designated by hospitals, clinics and dispensaries without pharmacists.
Managers of chemical and industrial analysis laboratories and scientific research.
The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

Managers of authorized stores in this trade.
Directors of pharmacies and pharmaceutical factories;
The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

Doctors designated by hospitals, clinics and dispensaries without pharmacists.
Managers of chemical and industrial analysis laboratories and scientific research.
The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

22. Where is Medicinal Cannabis available?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

Managers of authorized stores in this trade.
Directors of pharmacies and pharmaceutical factories;
The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

Doctors designated by hospitals, clinics and dispensaries without pharmacists.
Managers of chemical and industrial analysis laboratories and scientific research.
The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for to the following persons:

Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

Managers of authorized stores in this trade.
Directors of pharmacies and pharmaceutical factories;
The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

Doctors designated by hospitals, clinics and dispensaries without pharmacists.
Managers of chemical and industrial analysis laboratories and scientific research.
The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

No.

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

No, Opioid Drugs are not authorized in Egypt, however, they are regulated by Law No. 182 of the year 1960 concerning combating drugs and regulating their use and trafficking.

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

Ministry of Health and its departments, Addiction Control and Treatment Fund Organization and Egyptian Drug Authority.

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

With regards the Pricing:

Pricing of drugs is regulated through a pricing committee. Any price increases of the medicines and drug products are determined according to issued Ministerial Decrees.

Regarding the Reimbursement:

With regards the Authorization:

As per Article 4 of the said Law, the authorization of the drugs referred to above may be granted only to the following persons:

Managers of stores licensed to trade in narcotic drugs.
Administrators of pharmacies or shops intended for the manufacture of Pharmacopoeia preparations.
Managers of chemical or industrial analysis laboratories or scientific research.
Some of the Governmental entities and recognized scientific institutes.

The competent administrative authority may refuse the request for permission or reduce the required quantity.

Article 3 of the said Law, these drugs may not be brought or exported except under a written license from the competent administrative authority.

Moreover, Article 7 provided that the narcotic drugs may not be traded except after obtaining a license from the competent administrative authority in each of the two regions.

This license may not be granted to:

Person convicted of a felony.
Person convicted of one of the misdemeanours stipulated in this Law.
Person convicted of stealing or concealing stolen items, dishonesty, monument, giving a check without credit, falsifying or using forged papers, perjury or indecent assault, corrupting morals, homelessness or suspicion, as well as the convict for attempting to provide for one of these crimes.
Persons previously disciplined from public office for reasons of moral turpitude, unless three years have elapsed from the date of the final dismissal.

With regards the authorization for manufacturing:

28. Which are the Opioid drugs that have received market approval to date?

According to Table No. 2 of law No. 182 for year 1960, the medicinal products based on cannabis extract or tincture that are for the outside use only.

29. Who can prescribe Opioid Drugs?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

Managers of authorized stores in this trade.
Directors of pharmacies and pharmaceutical factories;
The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

Doctors designated by hospitals, clinics and dispensaries without pharmacists.
Managers of chemical and industrial analysis laboratories and scientific research.
The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

Managers of authorized stores in this trade.
Directors of pharmacies and pharmaceutical factories;
The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

Doctors designated by hospitals, clinics and dispensaries without pharmacists.
Managers of chemical and industrial analysis laboratories and scientific research.
The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

31. What approvals or notifications are required to prescribe Opioid Drugs?

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

Managers of authorized stores in this trade.
Directors of pharmacies and pharmaceutical factories;
The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

Doctors designated by hospitals, clinics and dispensaries without pharmacists.
Managers of chemical and industrial analysis laboratories and scientific research.
The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for in the following articles to the following persons:

Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

Managers of authorized stores in this trade.
Directors of pharmacies and pharmaceutical factories;
The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

Doctors designated by hospitals, clinics and dispensaries without pharmacists.
Managers of chemical and industrial analysis laboratories and scientific research.
The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

No.

35. When are they likely to come into force?

N/A.

Also from this Legal Handbook

5. Regulatory Reform: Egypt

An intro to the legal situation for regulatory reforms in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.

1. Are there proposals for reform or significant change to the healthcare system?

No, but the Comprehensive Health Insurance Scheme Law No. 2 of the year 2018 was issued on 11th of January 2018 and its Executive Regulations issued by virtue of the Prime Minister’s Decree No. 909 of the year 2018, which was issued on 8th of May 2018.

2. When are they likely to come into force?

N/A.

Click the following links to read more legal articles from Egypt:

Also from this Legal Handbook

6. Patents & Trademarks: Egypt

Patents and trademarks in Egypt – a comprehensive legal overview. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.

1. What are the basic requirements to obtain patent and trademark protection?

In accordance to the Executive Regulations provided in the Decree No. 1366 of the year 2003, the requirements to obtain patents are as follows:

Fill the application for patents at the Patent office; the patent application shall be accompanied by…

A fully detailed description, in Arabic, of the invention or utility model, prepared in a clear manner, using correct technical terms, including a statement on prior art and shortcomings therein, the novel element in the invention or utility model and the best way known by the inventor, to enable a person of expertise to execute it, showing also, in a precise and clear manner, the new elements for which protection is sought, and indicating any chemical equations or formulae or illustrative drawings.
The applicant shall furnish, on the form established to that effect, full data and information on applications filed abroad for the same invention or utility model or any relevant information, the fate of such applications, and resulting decisions.
An abstract describing the invention or utility model in the Arabic and English languages, with chemical formulae, if any, using the form established to that effect.
Where the application relates to an invention or utility model involving plant or animal biological material, traditional medicinal, agricultural, industrial or handicraft knowledge, or cultural or environmental heritage, it shall be accompanied by documentation proving that the inventor has accessed the source from which the material was obtained in a legitimate manner, according to the legislation applicable in the Arab Republic of Egypt.
Where the invention involves microorganisms, the applicant shall disclose such organisms according to conventional scientific rules, including all necessary information for the identification of the nature, characteristics and uses of such organisms, shall deposit a live culture thereof with a laboratory authorized by decision of the competent minister for scientific research affairs, and shall furnish a certificate to the effect that such deposit was made.
Where the applicant is a legal entity, an extract from the commercial register or an official copy of the constitution act or decision shall be furnished.
Documentation establishing the quality of the applicant.
Documentation establishing, where applicable, the assignment by the right holder of the invention or utility model.
Certificate of temporary protection for the invention or utility model, if any.
Receipt of payment of the application fees.

The applications shall be recorded in the patent registry, which shall contain the following data:

Serial number of the application.
Date and time of receipt of the application.
Name of the inventor
Name, surname and address of the applicant, or, if the applicant is a legal entity, name and address of that entity, and an address for service.
Name and surname of the agent, if any.
Where the application for a patent or utility model was filed according to the provisions of Article 38 of the Law, name of the foreign entity or country with which the application was filed and the filing date of the application.
Acts relating to the patent application.
Date at which the decision granting the patent for the invention or utility model, was issued, the patent number, and the name of the right holder.
Acts and procedures relating to the ownership or right of exploitation, of the patent.
Actions of seizure carried out in relation with the patent.

The office may require that the applicant for a patent an invention or utility model for chemical products relating to foodstuff, pharmaceuticals and agriculture furnish two samples of such products.

The applicant shall establish a list of the samples and their nature, which shall be included in or attached to, the detailed description.

The applicant shall indicate, at the top of the detailed description of the invention or utility model, that such samples are furnished. The Office shall include such indication in the publication of the acceptance of the application, in the Gazette.”

2. What agencies or bodies regulate patents and trademarks?

The competent authority for Trademarks registrations is “The Department of Trade Registry”, while the competent authority for Patents registrations is “The Patent Office”.

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

According to Law No. 82 of the year 2002 which defined Patents in Article 1 as follows: “A patent shall be granted, in accordance with the provisions of this Law, to any industrially applicable invention, which is new, involves an inventive step, whether connected with new industrial products, new industrial processes, or a new application of known industrial processes. The patent is also granted, independently, for any modification, improvement or addition to a previously patented invention, which meets the criteria of being new, inventive and industrially applicable, as stated in the preceding paragraph; in which case the patent shall be granted, under the provisions of this Law, to the owner of the modification, improvement or addition.”

According to Law No. 82 of the year 2002 which defined the trademarks in Article 63 as follows:

“trademark is any sign distinguishing goods, whether products or services, and include in particular names represented in a distinctive manner, signatures, words, letters, numerals, designs, symbols, signposts, stamps, seals, drawings, engravings, a combination of distinctly formed colors and any other combination of these elements if used, or meant to be used, to distinguish the products of a particular industry, agricultural, forest or mining venture or any goods, or to indicate the origin of products or goods, or their quality, category, guarantee, preparation process, or to indicate the provision of any service. In all cases, a trademark shall be a sign that is recognizable by sight.”

Types of Patents that cannot be protected in accordance to the IPR Law No. 82 of the year 2002 are as follows:

Inventions whose exploitation is likely to be contrary to public order or morality, or prejudicial to the environment, human, animal or plant life and health.
Discoveries, scientific theories, mathematical methods, programs and schemes.
Diagnostic, therapeutic and surgical methods for humans and animals.
Plants and animals, regardless of their rarity or peculiarity, and essentially biological processes for the production of plants or animals, other than microorganisms, non-biological and microbiological processes for the production of plants or animals.
Organs, tissues, live cells, natural biological substances, nuclear acid and genome.

Types of trademarks that cannot be protected in accordance to the IPR Law No. 82 of the year 2002 are as follows:

The following shall not be registered as trademarks or components thereof:

Marks devoid of any distinctive character, or composed of signs or statements which only usage grants to the products, or which are the normal picture or image thereof.
Any mark which is contrary to public order or morality.
Public armorial bearings, flags and other emblems pertaining to the State or any other state, regional or international organizations, as well as any imitations thereof.
Marks, which are identical with, or similar to, symbols of religious character.
Symbols of the Red Cross or Red Crescent, or any other emblem of the same character, as well as any imitations thereof.
The portrait of an individual or his armorial bearings, except with his consent.
Designations of honorary degrees which the applicant is unable to prove his right thereto.
Marks and geographical indications which are likely to mislead or confuse the public or which contain false descriptions as to the origin of products, whether goods or services, or their other qualities, as well as the signs that contain an indication of a fictitious, imitated or forged trade name.

4. How can patents and trademarks be revoked?

Patents:

The rights conferred by a patent shall lapse and fall into the public domain under the following conditions:

Expiration of the protection period according to Article 9.
Relinquishment by the patent holder of his rights without prejudice to the rights of third parties.
Final decision taken revoking the patent.
Failure to pay, within one year from the due date, the annual fees or the overdue penalty of 7% of the annual fees, after notification of payment according to the procedure prescribed by the Regulations.
Where the invention is not exploited in Egypt within two years following the grant of a non-voluntary license and upon a request by any interested party submitted to the Patent Office.
Abuse by the patent owner of his rights, where the non-voluntary license is insufficient to remedy that abuse.

Reference to patents whose owners’ rights are terminated according to the previous provisions shall be published in the Patent Gazette, in the manner prescribed by the Regulations

Trademarks:

The competent court may, upon request by any interested party, issue an enforceable decision to cancel the registration if it appears to the court that the mark has not been seriously used for a period of five consecutive years.

A cancelled mark may be re-registered — in favor of its owner exclusively — within three years from the date of the cancellation, according to the prescribed conditions and same procedure of registration and against payment of a fee prescribed by the Regulations not exceeding 1,000 pounds. After the lapse of the said period, a mark may be re-registered for the benefit of its owner or a third party, in connection with the same products, under the same conditions, procedures and fees of the initial application for registration. However, where the cancellation is in response to an enforceable court order invalidating the registration of a mark, such a mark may be registered in favor of a third party soon after the cancellation.

5. Are foreign patents and trademarks recognized and under what circumstances?

Patents:

Without prejudice to the international conventions in force in Egypt, any natural person or legal entity, Egyptian or foreign, belonging to, domiciled or active in a country or an entity that is a member of the World Trade Organization or that applies reciprocity to Egypt, shall have the right to apply for a patent at the Egyptian Patent Office, and enjoy whatever rights derived therefrom, in conformity with the provisions of this Law. Nationals of all member countries of the World Trade Organization shall benefit from any advantage, preference, privilege or immunity granted by any other law to nationals of any state in connection with the rights provided in the IPR Law 82 of the year 2002, unless such advantage, preference or immunity derives from: (One) agreements on judicial assistance or agreement on law enforcement of general nature; (Two) agreements in connection with the protection of intellectual property rights which came into force prior to the 1st of January 1995.”

Trademarks:

Without prejudice to the provisions of international conventions in force in Egypt, any natural person or legal entity, Egyptian or foreign, belonging to or having the center of his or its effective activity in a country or entity member in the World Trade Organization or who applies reciprocity to Egypt, shall have the right to apply for the registration of a trademark with the Department of Trade Registry in Egypt, with all attendant rights in conformity with the provisions of the IPR Law 82 of the year 2002.

Nationals of all member countries of the World Trade Organization shall benefit from any advantage, preference, privilege or immunity granted by any other law to nationals of any state in connection with the rights provided for in this Chapter, unless such advantage, preference or immunity derives from: (One) agreements on judicial assistance or agreements on law enforcement of general nature; (Two) agreements in connection with the protection of intellectual property rights which came into force prior to 1st January 1995.

6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?

In Egypt, there is not yet specific data and marketing exclusivity protection periods for medicines.
Nowadays, Egypt has applied the fast-track registration method for medicines that has already obtained the approval from foreign authorities such as FDA, EMA, etc.… Such method has been productive as it gives medicines the marketing exclusivity periods against any generic product not approved by the foreign authorities. New Therapeutic indications does not have extensions of the patent term. However, it can be registered as a new patent as long as it satisfies the conditions of patentability.

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

The IPR Law No. 82 of the year 2002, has set some list of what cannot be registered as trademarks, which are as follows:

Marks devoid of any distinctive character, or composed of signs or statements which only usage grants to the products, or which are the normal picture or image thereof;
Any mark which is contrary to public order or morality;
Public armorial bearings, flags and other emblems pertaining to the State or any other state, regional or international organizations, as well as any imitations thereof;
Marks, which are identical with, or similar to, symbols of religious character;
Symbols of the Red Cross or Red Crescent, or any other emblem of the same character, as well as any imitations thereof;
The portrait of an individual or his armorial bearings, except with his consent;
Designations of honorary degrees which the applicant is unable to prove his right thereto; or
Marks and geographical indications which are likely to mislead or confuse the public or which contain false descriptions as to the origin of products, whether goods or services, or their other qualities, as well as the signs that contain an indication of a fictitious, imitated or forged trade name.

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

Patents:

If a patent application is filed in a country or by an entity member of the World Trade Organization or a country that applies reciprocity to Egypt, the applicant or the successor of his rights may, during the first year following the filing date of the application, file a similar application with the Patent Office in Egypt for the same subject matter and in conformity with terms and conditions provided for in this Law and its Regulations. In this case, for determining precedence, the date of the first application in the foreign country shall prevail.

Trademarks:

The owner of a well-known trademark, worldwide and in Egypt, shall have the right to enjoy the protection conferred by this Law even if such a mark is not registered in Egypt.

The Trade Registry Department shall, reject any application to register any mark which is identical with a well-known mark and is intended for products which are identical with those of the well-known mark, unless the application is submitted by the owner of the well-known mark.

The preceding paragraph shall apply to applications intended for products which are not identical with those of the well-known mark, where the well-known mark is registered in a country member of the World Trade Organization and in Egypt, and where the use of the mark in relation to those non-identical products is meant to lead people to believe that a connection exists between the owner of the well-known mark and those products, and that such a use may be prejudicial to the interests of the owner of the well-known mark.

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7. Product Liability: Egypt

The key facts about product liability in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.

1. What types of liability are recognized in your jurisdiction?

There are two types of liabilities in Egypt, Criminal Liability, in case the product caused any injury, permanent disability injury or wrongful death due to negligence or mistake occurred in the preparation process of the medicinal product.

Civil liability, in case the product caused any type of damage to the consumers.

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

The Manufacturers of the medicines and devices must notify the Consumer Protection Authority in case of discovering any defects that affects the safety and health of the consumers, this notification shall be within seven days from the date of discovering the defect. Manufacturers and suppliers in the aforementioned case shall publish an announcement to the public refrain them from using the defective products, warning them from the products causes and effects.

In accordance to the Pharmacy Law No. 127 of the year 1955, the MOH will issue a decree for banning the circulation of any substance, or any pharmaceutical preparation which is harmful to the public health, the registration of the preparation shall be deleted from the ledgers of the Ministry, if registered and the remaining quantities thereof shall be administratively confiscated wherever existent, without the owners thereof having the right to have recourse against the Ministry for any possible indemnification.
Either the manufacturer or supplier will face civil and criminal liability in case of the occurrence of any of the aforementioned.

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

The marketing authorization holder has control over the medicinal product, including determination of the manufacturer/importer and renewal of the medicinal product registration. Therefore, the marketing authorization holder is liable for the medicinal product, its technical specification and quality control.

However, in practice, the applicant for registration (which could be the scientific office of a foreign marketing authorization holder, or a local manufacturing/agency company) is the entity addressed by the Ministry of Health if any issues arise about the registered medicinal product in Egypt.

Further, under Article 67 of the Commercial Law, the claimant can bring an action against the manufacturer, the distributor, or both without joint liability. If the manufacturer or distributor do not have presence in Egypt, the claimant can bring his case before the Egyptian courts against the manufacturer or agent located in Egypt.

Any individual who intentionally or due to gross negligence causes a defect which results in product liability can be personally liable under both civil and criminal laws.

4. How can a liability claim be brought?

The limitation period for product liability claims is three years from the date the claimant became aware of the damage and the responsible person.

Class actions are not regulated under Egyptian law. A person must have capacity to bring a claim and the claim is limited to damage affecting the claimant. To raise a class action, the claimant must be a legal person representing a class of people affected by the claim.

5. What defenses are available?

The available defenses can only be based on:

Lack of fault by the manufacturer/supplier.
Challenging the existence of the damage to the relevant patient.
Negating the causality between the fault and the damage.

Supervision and approval by the Ministry of Health can be relied on as evidence for lack of fault where applicable.

Liability for defective medicinal products cannot be limited or waived, and any agreement to the contrary is void.

In practice, efforts to limit liability focus on setting out in detail in the medicinal product’s patient information leaflet any possible side effects and damage from using the product.

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8. Traditional Medicines and OTC Products: Egypt

A brief overview of the situation regarding traditional medicines and OTC products in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

The regulatory requirements for traditional and herbal products shall follow the regulations and standards:

WHO requirements and guidelines;
Good Manufacturing Practices;
Good Laboratory Practice;
Good Pharmacovigilance Practice;
Good Agricultural and Collection Practices;
Good Pharmacovigilance Practice for Arab countries; and
Ministry of Health’s regulations, instructions, laws and internal regulations.

Moreover, in order to obtain the registration of the Traditional and Herbal products, a separate application is required for each product. Applications shall be made by submitting a completely filled in application form which shall be accompanied with:

Complete documentation as per these guidelines. (All ingredients must comply with specification prescribed in Pharmacopoeias. In-house specification may be acceptable if justified by validation reports).
For under license products, original notarized Certificate of Pharmaceutical Product from the Drug Regulatory Authority of the country of origin of the product should be submitted. This shall be accompanied with approved product information.
Copy of license of the manufacturing site for local manufacturers and toll register for toll manufacturers.
Pilot samples of each package size being applied for registration (One commercial sample for re-registration if required in case of variation) to carry out quality control tests as declared in the dossier. The samples must be in the form and container in which they will be marketed.
Stability study should be done on pilot batch(es) on the finished product in its final container closure system as accelerated (6 months). (In case of re-registration, the stability study is done on at least one production batch in the final container closure system as accelerated stability study (6 months) or long-term stability study).
Pharmacovigilance requirements for herbal medicinal products.
Patient Information Leaflet draft and Artwork (Mock-ups)
An appropriate and complete index/ list of the various sections and documents of submission.

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

Advertising any pharmaceutical product whether herbal or complementary or alternative products shall be obtaining an approval of advertising the product and must approve on the pamphlet information of the product from technical committee in the Ministry of Health before publishing the products to the public.

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

N/A

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

Over the counter (non-prescription), medicines are regulated by Ministerial Decree No. 422 of the year 2014, which promulgates that non-prescription medicines are determined in a list, which is issued by the Ministry of Health to the public.

5. Are there any limitations on locations or channels through which OTC products may be sold?

N/A

6. What health, advertising, and marketing claims may be made for OTC products?

N/A

7. Can OTC products be marketed or advertised directly to the public?

N/A

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

N/A

9. What are the requirements for the importation of either traditional medicines or OTC products?

N/A

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9. Marketing, Manufacturing, Packaging & Labeling, Advertising: Egypt

All legal aspects surrounding marketing, manufacturing, packaging & labeling, and advertising in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products?

The authorization process of marketing new drugs and any medicinal products are as follows:

An application for obtaining a marketing authorization for pharmaceuticals is submitted to CAPA.
The Pharmacy Law No. 127 of the year 1955 provides that a marketing authorization for pharmaceuticals is limited to local manufacturing facilities, foreign manufacturing facilities, agents for foreign manufacturing facilities and individual medical professionals.

An application can only be accepted if there is availability in the relevant box of pharmaceuticals with similar specifications. Ministry of Health Decree 425 of the year 2015 stipulates that the maximum number of pharmaceuticals with similar active ingredients and specifications is 12, including the original (innovative) pharmaceutical. In general, only one imported product is allowed for each box. The number of imported products increases to five for pharmaceuticals requiring complex technology not commonly available in Egypt. Pharmaceuticals are registered in the country of origin or any of the recognized reference countries. In case of the non-recognized reference country, such a registration will be more complex and lengthier.

The applicant must submit an inquiry to CAPA on the availability of a place in the box of similar pharmaceuticals. If there is no space in this box, the request is registered on a waiting list. On confirming that there is a place in the box, the applicant must submit the required documents for determining the commercial name of the pharmaceutical and its price. After then, the application is reviewed by the different technical committees at CAPA.

The applicant must manufacture a pilot batch for testing purposes in respect of locally manufactured pharmaceuticals. For imported pharmaceuticals, random samples are tested by CAPA. CAPA can choose to inspect the local or foreign manufacturing facility before issuing the marketing authorization.
The standard timeframe for obtaining a marketing authorization is about two years. CAPA recently introduced a fast-track registration process.

The marketing authorization holder must notify CAPA with the names of its distributors and confirmation that the distributors apply good supply practices and good manufacturing practices rules. The marketing authorization holder must complete stability studies for the first three production batches in respect of locally manufactured products. The marketing authorization will be cancelled if the holder fails to start production or importing within 18 months from the date of issue of the marketing authorization. The marketing authorization will also be cancelled if the holder fails to produce or import the relevant pharmaceuticals for a continuous period of two years.

The authorization process of the biological products in accordance to Decree No. 297 of the year 2009 shall be as follows:

The applicant must submit a query application about the product concerning the group of alternative drugs to the CAPA. The query application shall include active ingredient, concentration, indications, dosage form & manufacturing company. This application will be recorded according to the date and the hour of presentation. The query applicant is notified with the product situation within fifteen working days of application receipt. After approving the query application, the requested documents will be declared for the pricing determination and will be submitted to the CAPA within thirty working days from the date of reply on the query application or else the query entry number is considered cancelled. The product will be priced – whether local or imported – in a period of maximum sixty working days from the date of receipt of the completion of the pricing file.

After pricing, the preparation is directed to scientific committees in the following cases:

If it contains a new active ingredient, a new formulation or doesn’t have scientific reference;
If it has a new indication, a new concentration or a new dosage form; or
If any international warnings were declared concerning the formula presented for registration.
In the above-mentioned cases the registration applicant is notified to present the scientific studies of the product within thirty working days from the pricing date. Submission is made to the scientific committees within sixty working days from the date of receipt of complete scientific file.

The procedures of product registrations are to be continued in case of approval from the scientific aspect. However, in the case of disapproval, submission is made to the technical committee of drug control to take the appropriate decision.

2. What is the authorization process for the marketing of generic versions of these products?

The authorization of Pharmaceuticals in Egypt follows the “Box” system whereby the box shall not exceed 12 products classified as 1 brand or innovator product and 11 generic products. If there is no space in the box, the request shall be registered on a waiting list.

Concerning products that need high manufacturing technology not available in Egyptian factories, the number of products included in the Box is 12 products including the brand or innovator product and 5 generic products.

After the confirmation of the Box, the applicant must submit the required documents for determining the trade name of the pharmaceutical and its price. Then the application will be reviewed by the Technical Committees at the CAPA. The imported pharmaceutical products (generic) random samples will be tested by the CAPA. The CAPA can choose the inspection of the local manufacture or the foreign before issuing the marketing authorizations.

The average timeframe for the marketing is two years. CAPA introduced recently a fast-track registration process.

The marketing authorization holder must submit to the CAPA the name of the distributors and a confirmation that the distributors apply the GMP rules.

3. What are the typical fees for marketing approval?

The typical fees for marketing approval that does not exceed 10,000 EGP upon each advertisement according to decree no 26 of the year 2009.

4. What is the period of authorization and the renewal process?

The period of authorization is 10 years and then it must be renewed at the CAPA within the last year of the 10 years.

Renewal Process:

Human pharmaceutical preparations shall be re-registered every ten years upon a request from the owner of the preparation to the General Directorate of Registration in the last year of the validity of the registration notice, provided that the re-registration applicant shall submit a preliminary file for re-registration containing the documents approved by the General Directorate for registration.

Meeting the requirements of the Egyptian Pharmacovigilance Center EPVC, and to fulfill all the requirements of the final file for re-registration, all within a period not exceeding three and a half years from:

The expiry date of the registration notification or the date of issuance of the approval of the procedure for re-registration or the date of the approval of the Technical Committee for Drug Control, whichever is newer, in the case of preparations that have a scientific reference.
The date of the approval of scientific committees or the technical committee for Drug Control on the product, whichever is newer, in the case of preparations that do not have a scientific reference. It is permitted to produce, import and trade the product with a temporary license from the General Administration for registration until the end of the three and a half years. At the end of this period and failure to meet the requirements of the final file for re-registration, the product shall be given an additional six months to complete the re-registration process. In addition, if the requirements of the final file for re-registration are not met during the additional six months, the registration of the product is canceled. The provisions of the preceding paragraph shall apply to the preparations already made or to be submitted for re-registration. The product shall be referred to the scientific committees. In the case of non-approval, the technical committee for drug control shall take the decision it deems appropriate, the re-registration procedures shall be completed, the internal publications shall be updated, and the stability study of the product shall be evaluated within 60 working days from the date of submission of the full stability study. Evaluations of availability, bioequivalence and melting rate studies shall be conducted within 30 working days from the date of submission of the completed study. In accordance with the rules and procedures governing the studies of bioavailability, bioequivalence and melting rate studies. The General Directorate of Pharmaceutical Inspection shall withdraw samples in the case of a bioequivalence study. The technical committee for drug control shall present it within 60 working days from the date of completing the re-registration file. In the case of approval, the registration shall be re-registered for a period of ten years with the same registration number in the event of no change of the active substances or of any kind. In case the company changed the activity substances whether in quantity or kind, then all kinds of measures are taken to register as a new product. If the registration period of the product has expired without submitting the re-registration file within the last year of the validity of the registration notice, the registration of the product will be expired.

5. What are the requirements, if any, for post-approval pharmacovigilance?

The marketing authorization holder must have a pharmacovigilance system in order to impose analysis and monitor the effects of medical drugs which have been licensed for human use, and the marketing authorization holder must inform CAPA of any adverse effect of their licensed drugs not later than 15 days from becoming aware of them.

6. Are foreign marketing authorizations recognized?

A separate marketing authorization is obtained from CAPA. The Ministry of Health recognizes foreign marketing authorizations issued by foreign competent authorities such as the European Medicines Agency, the US Food and Drug Administration, the Australian Therapeutic Goods Administration and the Japanese Ministry of Health, Labor and Welfare.

7. Are parallel imports of medicines or devices allowed?

Parallel import is not allowed in Egypt. An importer of any pharmaceutical must be registered in a special importers’ ledger at the Ministry of Health. Registration requires an appointment letter from the market authorization holder. This requirement grants marketing authorization holders control over parallel imports.

However, there is unauthorized parallel importation of pharmaceuticals into Egypt, especially from Gulf countries.

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

According to the Ministry of Health Decree No. 238 of the year 2003 stipulating Medical Profession Ethics prohibits medical professionals, it is impermissible to trade in the samples of the medicines and in the pharmaceutical preparations, made ready for publicity purposes, or put them down for sale. The possession thereof is also impermissible for any organizations other than pharmaceutical organizations, which are authorized to import or manufacture them. It is impermissible for the middlemen to keep the medicines samples in any place other than the depot where they have been authorized. Moreover, it is a must to have printed on the internet and external labels of the sample in a clear manner the phrase ‘free medical sample’.

Moreover, the Egyptian Penal Code criminalizes bribery, including facilitation payments. There is no legislation similar to the US Foreign Corrupt Practices Act or the UK Bribery Act, which covers auditing of corporation accounts, self-reporting and self-investigation anti-bribery obligations, nevertheless, the Egyptian Law regulated the bribery in limited cases such as penalizing public officials who committed or engaged in bribery acts committed in Egypt. However, the Egyptian Penal Code provided an exemption from punishment privilege for those who admits the bribery act before the issuance of the judgement, as it is considered a cooperation with the Administrative Prosecution for facilitating the conviction of the relevant public official.

9. How is the manufacturing of medicines and devices regulated and by which agencies?

The manufacturer must obtain a general manufacturing operational license from the Industrial Development Authority and the manufacturing facility must be registered in the industrial register. Then, the company must obtain a license from CAPA at the Ministry of Health.

Conditions of the CAPA license:

Due registration of the company with the competent Egyptian authority;
Valid possession of a manufacturing facility;
Valid operational license for the manufacturing facility from the Industrial Development Authority; and
Compliance of the manufacturing facility’s design with CAPA technical requirements.

Required documents to be submitted before the obtainment of the license:

Statement about the machinery to be used;
Statement about the laboratory equipment;
Staffing structure; and
Site master file.

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?

Yes, as Egypt applies the GMP guidelines issued by the World Health Organization “WHO” as per Article 1 of the MOH Ministerial Decree No. 539 of the year 2007. In case of the non-compliance of the WHO’s GMP, a grace period will be provided to the Company in order to reinstitute in accordance with the guidelines. In case the Company did not reinstitute, the Technical Committee will review the issue in order to take all the requisite procedures. However, in case of severe non-compliance in accordance to the non-compliance mentioned in the guidelines, the production will be suspended and cannot be resumed unless the Company complies with the GMP guidelines and the approval of the Technical Committee. In case of reoccurrence of the violation, the Technical Committee can cancel the production license.

11. What is the inspection regime for manufacturing facilities?

There is a department called manufacturing site inspection, which is responsible for ensuring that manufacturing companies are following regulations, legislations and GMP guidelines on their processes for manufacturing of medicines for human and veterinary use. The department ensures that all pharmaceutical products that are introduced to the Egyptian markets are safe, effective and have the best quality.

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

No, as per the internal regulations of the Central Administration of Pharmaceutical Affairs (CAPA) department at the Ministry of Health, such department forms a committee to inspect and evaluate the Manufacture in accordance to the GMP.

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

Storage of the Medicines and Devices:

In order to license the establishment of pharmaceutical institution, each of the following requirements shall be fulfilled:

The premises shall be established from modern nonflammable construction materials that comply with the Egyptian Standard Specifications, provided that the net height between the ground of the pharmaceutical institution and the bottom of the soffit shall not be less than 2.6 meters.
The premises ground shall be in the same level of its neighboring land with an exception to undertaking the sufficient necessary precautions to prevent water leakage to the pharmaceutical institution, including providing sewage network, on condition that it shall not violate the patient’s safety during entering and exiting from the pharmacy. In all circumstances, the pharmaceutical institution shall not be established in the basement.
Walls shall be covered with materials easy to be cleaned to prevent bacterial growth.
The pharmaceutical institution shall be supplied with a public clean water resource so that water can be withdrawn from upside through a tap that is installed inside the premises above the basin via filter.
The warehouse where the pharmaceutical products are stored shall fulfill the good storage practices in terms of:
a. Maintaining the temperature and humidity imposed by the specifications of drugs and pharmaceuticals in addition to installing indicators in a visible location in the institution to measure both of them and record the measurements on fixed periods during the working hours, on condition that temperature degrees shall not exceed 30 °C and the pharmacist shall record the measurement regularly.
b. Providing the warehouse with a refrigerator provided with freezer and a thermometer in order to maintain the pharmaceuticals that need a temperature lower than the room temperature in addition to recording the measurement regularly.
c. Allocating a safe and airtight place for psychotropic and narcotic drugs.
d. Allocating a separate place for storing the expired medical products away from the other utilized medical products until the elimination of such products or returning such products back to the producing company by virtue of approved documents taking into consideration the coordination with the competent health authority, provided that a sign, clearly indicating that such products are expired drugs that shall not be used, shall be put on such place.
e. Disposing of pharmaceutical waste in a safe and sound manner that does not constitute any danger to the environment or endanger society’s health.
Allocating a suitable place in the pharmacy to discuss secretly with the patient the matters related to the pharmacotherapy prescribed to the patient, in addition to making sure that the patient is fully aware of the sufficient information concerning the best use of the drug as well as the method of storing it, the side effects of the drug, and the safest way to dispose of the drug in case the patient did not complete the treatment schedule.
Providing an access to the internet and the usage of a special program on the computer to keep the records, prescriptions, and all the data of the pharmaceutical institution in order to obtain any of such information when requested, also to keep the receipts and documents evidencing the ingoing and outgoing drugs for five years at least.
Providing a permanent electricity current at the premises.
Hanging a fixed banner on the front of the pharmaceutical institution indicating the name of the pharmaceutical institution and the name of its owner.
Disposing of waste in public sewage according to the engineering drawing approved by the competent health authority, so if there is no public sewerage on 30 meters then the drainage shall be carried out in a separate tank that is built in a vacant land that belongs to the owner and outside the buildings pursuant to the approved engineering drawing.
Manholes and septic tanks shall be covered with tight iron lids, yet they shall be ventilated through a four-inch pipe that is at least two meters high from the surrounding and the corresponding surfaces, and its upper opening shall be covered with a narrow-weaved wire to prevent the entrance of insects.
Tanks shall have separate entrances so that scavenging a tank shall not necessitate passing through any of the rooms of the pharmaceutical establishment. They shall also be as far as two meters at least from the walls, unless the tank is not impervious, in such a case, the above-stated requirement of the distance between the tanks and the walls may be waived.
If the public sewer is approaching 30 meters or less from the pharmaceutical institution, the sewerage must be connected to it and the existing tanks should be filled and crushed.
The basins on gully trap and it should be drained over the public sewer and gullytrap and the inspection rooms should be located in a space outside the pharmaceutical establishment.
It is not permissible to find any tank or inspection room or a telescope under the eye’s surface, and no sewer dispensers, drains, or toilets can be found inside the storage, and drainage dispensers may be passed under the eye’s surface in cases of emergency approved by the competent health authority. In this case, all the safety procedures must be taken.
In case of establishing toilets, toilets must be established in a separate place and have a door that does not open onto places dealing with the public or the storage of the pharmaceutical products, it must have a window open on a street or a skylight, ventilation should be used and the toilet must be disposed on a private inspection room operated on public sewage.
No part of the property shall be rented to another person or used for any other purpose for which it is licensed.
Materials or tools other than the materials and tools necessary for the work licensed by the Pharmaceutical institutions shall not be found.
No animals or birds shall be present at the pharmaceutical institution.
Ensure that the pharmaceutical institution complies with the latest engineering chart approved by the competent authorities, and no modification is allowed before obtaining written approval from the competent health authority.
The space of public, private, governmental or commercial pharmacies and their proceeds shall not be less than 40 square meters (For warehouses or warehouses of pharmaceutical intermediaries must not be less than 500 square meters and may be divided on two levels and they shall be separated from any other activity, and pharmaceutical factories need to allocate sufficient space to meet the manufacturing requirements of the World Health Organization (WHO).
The original license and the copy of the approved engineering drawing and the register of the licensed workers must be kept at the institution including the license of practice the profession of the Egyptian director in charge and the Egyptian constitution of the medicines to be submitted if requested.
The warehouses of intermediaries, warehouses and shops of trafficking in medicinal plants and their proceeds shall be exempted from the requirements of the water supplier and drainage method stating that there are no watercourses inside.
Regarding the requirements conditions of pharmaceutical factories, Ministerial Decision No. 265 of 1981 is applicable regarding the conditions and technical requirements to be met in the pharmaceutical factories and Ministerial Decision No. 539 of 2007 regarding the adoption of the Egyptian Code for good manufacturing practice “GMP” methods for pharmaceuticals.

Packaging and Labelling of Medicines and Devices:

The Medicines must be sold from the storage in their own original packaging. If portioned, they shall have to be inside airtight packages, bearing thereupon labels in the name of the storage, its address, name of the manager, name of the substances, its strength and pharmacopeia by means of which they were prepared, amount thereof, factory from which they were imported or in which they were made as well as the expiry dates, if any. If they are prepared for veterinary use, that must be indicated on the card, as per Article 49 of the Pharmaceutical Profession Law No. 127 of the year 1955.

Moreover, Article 63 of the same law states that the special and pharmacopeial pharmaceutical preparations must be sold duly wrapped inside their original wrappings, with the exception of the ampoules or injections in case the name of the medicine, its quantity, and the name of the preparing factory will be printed thereupon in a fixed substance difficult to be removed. The information and details stated on the labels of the pharmaceutical preparations and in the pamphlets and advertisements related thereto must comply with the actual contents of those preparations in terms of substances, and with their therapeutically characteristics. They must avoid containing phrases which would conflict with public ethics, or which would misguide the public. It is necessary to obtain the approval of the technical committee for Medicine Control at the Ministry of Public Health as to the context of those items of information, or pamphlets or advertisements and their means prior to the publications.

Moreover, Ministry of Health Decree 425/2015 and the Guidelines for Outer Label of Pharmaceutical Products issued by CAPA regulates packaging and labelling. The competent regulatory authority is the naming committee at CAPA. Ministry of Health Decree no. 26/2016 requires all medicinal products to have the barcode for the Global Trade Item Number.

14. What information must be included in medicine and device labeling?

In case of medicines: Ministry of Health Decree 425 of the year 2015 and the Guidelines for Outer Label of Pharmaceutical Products issued by CAPA regulates packaging and labelling. The competent regulatory authority is the naming committee at CAPA. According to the regulations of the Ministry of Health, require all medicinal products to have the barcode for the Global Trade Item Number.

Required Information:

The outer label must contain the following information:

Trade name as approved by CAPA;
Active ingredients under the trade name and on the side of the package;
Pharmaceutical form under the active ingredients;
Number of units per pack;
Route of administration;
Any other ingredients if they are not mentioned in the leaflet;
Storage conditions;
Special precautions;
Information on the manufacturer (name, address, city, country, phone, fax, website) and license holder (logo or trade mark);
Barcode of the product;
Batch number;
Production and expiry dates;
The dosage form or the product if it relates to a specific group (infant, children, adults, men, and women);
The approved price for each unit and the whole package;
All drugs must state “keep out of the reach of children”; and
Other contents in the package must be mentioned on the outer label (if any, for example, measuring cup, applicator, dropper, syringe, calibrating dropper, and so on).

All information on the outer label must be written in both Arabic and English. Further, the design and color of the outer label must differ from that of competitor products.

In case of dietary supplements, a ribbon (15% of the package size) must encircle the package. In this ribbon, the words “Dietary Supplement” must be written, in both English and Arabic.

In case of Medical devices:

All medical devices must be labelled in accordance with the requirements of the legislation and related standards, e.g. ISO- 15223-1-2007: medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements. While the packaging should contain the CE, which means that the device satisfies the relevant essential requirements and is fit for its intended purpose as specified by the manufacturer. All medical devices, (except custom-made devices and those intended for clinical investigations) must bear a CE mark.

15. What additional information may be included in labeling and packaging?

According to Decree No. 76 of the year 2000, the information included in the packaging, labeling shall be clear and precise with no ambiguous words and can be easily recognized, and the information shall be kept at MOH in Arabic language and does not contradict with the information listed in the reference country.

16. What items may not be included in labeling and packaging?

Any information included in labelling, packaging or even marketing/advertising must not contain any phrase, which would conflict with the public ethics or which would misguide the consumers as per Article 63 of the Pharmaceutical Profession Law No. 127 of the year 1955.

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

Advertising of medicinal products is regulated under Law no.206/2017 regulating the advertising of health products and services. The competent regulatory authority to review and approve advertising materials is a higher committee to be formed by the Prime Minister. This committee will issue advertising permits.

Advertising prescription pharmaceuticals is limited to licensed medical professionals. Addressing marketing or advertising of prescription pharmaceuticals to patients is not allowed. The technical committee at the Ministry of Health must approve the content of the advert or any marketing materials before its use.

While, in order to get a marketing authorization, the following shall be as follows:

A request for obtaining the marketing authorization shall be submitted to the CAPA according to the form, in addition to the annexes, documents, materials and samples. The application in question shall be delivered in return for a receipt acknowledging the quality of the attachments from the information provided in the documents and samples.

Further on, the request, its components and attachments will be reviewed by the Head of the CAPA, who refers the request to the competent entity that deals with it in all the stages necessary to complete the examination, evaluation and testing. It is not permitted for the non-employees to be present in various work sites, it is not permitted as well for them to trade, transfer, deliver the request or any of its contents, attachments or samples accompanying it to any of the competent authorities or any of its employees.

The Examination Committee shall be responsible of scrutinizing the application, attachments, and annexes thereto as well as the accompanying samples in order to ensure the availability of the basic requirements necessary for the validity of trading the pharmaceutical in the market. In the regard of evaluating the situation, the Committee uses the information available to it and the supportive information, data and studies provided by the concerned person on the pharmaceutical and the active ingredient thereof in terms of: medical classification, biological efficiency, drug/medical usage, indications and contraindications, the warnings that accompany usage, pharmaceutical’s known interactions (or the active ingredient thereof) with the other medicines (or with food), the potential side effects that accompany the normal usage and upon exceeding the defined dosage, acute and chronic toxicity, pharmaceuticals dosage forms, the strength (or concentration) of the active ingredient in the dosage, the dose recommended to be used in the different health conditions (or illness conditions), and the other characteristics of the pharmaceutical product (or the active ingredient thereof) in addition to determining the level of safety of use upon the normal usage of the pharmaceutical as well as mentioning the studies conducted for evidencing all of the aforementioned.

During presenting the aforementioned data and information, the applicant shall submit the supporting studies and reports, the applicant shall also determine whether such studies and reports as well as the data and information included therein are published in specialized scientific journals and shall determine its references, or published in general media platforms such as the internet, media and promotional leaflets and publications together with the data of bio-equivalence that the applicant wishes to submit.

The applicant shall as well submit the data of the pharmaceutical’s exclusivity in the field marketing (along with mentioning the dates) in the country of origin and the other countries as well as the official authorities that tested such pharmaceutical and licensed it in such countries, and the pharmaceutical dosage forms that have been already tested and traded within such markets.

The applicant shall also submit information concerning the cost and elements thereof required for evaluating the price of selling to consumer in Egypt as well as information concerning the price of selling to consumer (regarding the pharmaceutical dosage forms and its different concentrations) in the country of origin and the countries where the pharmaceutical is traded.

In carrying out its duties and evaluating the situation, the Examination Committee is further assisted with the Assistive Technical Bodies through the Drug Policy and Planning Center, including the Pharmacology Committee, the Specialized Scientific Advisers Group, and the Drug Pricing Committee.
According to what is decided by the Examination Committee, the concerned person shall, through the aforementioned office at the Central Administration for Pharmaceutical Affairs, submit the additional information and data in relation to the works carried out by the National Organization for Drug Control and Research and to submit as well the reference samples of the active ingredient and the other elements of the pharmaceutical product.

The Chairman of the CAPA may ask the applicant to submit the information relevant to the methods of analysis of the active ingredients and other ingredients of the pharmaceutical products if the National Organization for Control and Drug Research requests so. In the event that such information and additional data are undisclosed information pursuant to the definitions stated in Article No. (56) of Law No. 82 of the year 2002, hence, such information shall not be disclosed to any third party nor shall be used for any unfair commercial purposes.

The National Organization for Control and Drug Research;

The said organization shall be responsible for the examination and testing procedures as well as the qualitative and quantitative analyses of the pharmaceuticals’ active ingredients and other ingredients, additives, flavors, fillers, colorants, flavorings and odorant agents.

Pursuant to the studies and the works carried out at the laboratories of the NOCDR the organization may give a notice of the pharmaceuticals’ fulfillment/ non-fulfillment of the necessary requirements.

In addition, the organization may decide on its need for further information, data, samples or reference materials to resume its studies. In such a case, it shall notify the Chairman of the Central Administration for Pharmaceutical Affairs of its need, and then the latter informs the applicant thereof, through the afore-mentioned office in order to provide the specified requirements within a definite period. In the event that the NOCDR issues its decision of the non-conformity of the pharmaceutical with the Authority’s specifications, the said organization shall as well prepare its report including the Organization’s justifications so that the applicant shall be informed thereof through the afore-mentioned office. A liaison officer appointed by the organization shall be responsible for moving the application and the decisions issued thereon, between the National Organization for Control and Drug Research and the Central Administration for Pharmaceutical Affairs.

Moreover, the Drug Pricing Committee practices its work to reach a reasonable evaluation for the pharmaceutical’s price to be incurred by the customer. The said committee works through negotiation with the applicant; and relying on the correct information that is available concerning the cost elements. It may also bear into consideration the sale price to the customer that is used in other countries for the same pharmaceutical with the same concentration.

The Technical Committee for Drug Control:

The said committee takes the final decision based upon all the information given by the Examination Committee together with the issued decisions and the views reached by other concerned bodies. If the final decision approves of the trading of a pharmaceutical in the Egyptian market, the Technical Committee for Drug Control consequently approves issuing a registration number for the said pharmaceutical, which marks a sign of marketing approval together with a determination of the sale price for the customer. In case the final decision does not approve of the pharmaceutical, the applicant shall be informed thereof, through the afore-mentioned office, together with a statement of the reasons and justifications for the decision.

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

Medicines are sold from distributors and wholesale stores that are licensed and approved by the Ministry of Health or from the producing companies to licensed pharmacies, which sells the products to the patients. There is no Law or Regulation that mentions selling medical products online; however, Law prohibits the sale of prescription pharmaceuticals without a valid prescription by a licensed physician.

19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?

Internet advertising is not regulated by Ministry of Health decrees. A few companies have obtained CAPA consent to run internet webpages including marketing materials, without requiring the pre-approval of the technical committee. The position of CAPA on this matter is not consistent.

Pharmaceutical companies are currently required to obtain pre-approval of any marketing or advertising materials before publishing them on a webpage.

The authors expect CAPA to issue guidelines to address this subject in more detail.

20. May medicines and devices be advertised or sold directly to consumers?

Yes, medicines and devices can be advertised directly to the consumers according to the Code No. FM-PMA-01 issued by the Marketing materials and media monitoring. Promotional materials directed to the public must include:

The active ingredient(s) name(s).
The trade name.
Major indications for use.
Major precautions, contra indications & warnings, side effects (incidence> 1%).
Name and address of manufacturer or distributor.
Price information must be honest and accurate.
References to scientific literature as appropriate.
CAPA approval number and invalidation date of the promotional material.

Regarding selling medicines directly to the consumers, medicines cannot be sold directly to the consumers, as drugs cannot be sold unless by licensed pharmacies, which buys the medical products and devices from distributors and wholesale stores that are licensed and approved by the MOH or from any producing companies.

21. How is compliance monitored?

CAPA has an inspection department, which ensures the compliance of the factories with the WHO Guidelines on Good Manufacturing and local regulations.

22. What are the potential penalties for noncompliance?

In case the inspection department found the non-compliance of the factories with the GMP and local regulations, thereof the license will be cancelled or suspended.

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10. Preclinical and Clinical Trial Requirements: Egypt

Preclinical and clinical trial requirements in Egypt – an overview. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.

1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?

Yes, as there is an Authority “Central Directorate for Research and Health Development”, which is responsible for the registration and approvals of conducting such preclinical and clinical trials.

2. How are clinical trials funded?

Clinical Trials are funded in accordance with the financial support of the subordinate bodies or its own financial resources.

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

Concerning the preclinical requirements: Decree No. 734 of the year 2016 stipulated the Good Clinical Practicing (GCP), which provides that the sponsor who might be a pharmaceutical company or an individual initiate, funds and organizes the conduct of the protocol. If the sponsor is a foreign company or organization then it must have a local representative to fulfill the local responsibilities. The sponsor and the investigator might be severally or jointly responsible in obtaining all the required approvals and authorizations.

Moreover, the sponsor must provide an insurance for the trial subjects to cover trial-related injury or death and provide indemnity for the investigator, except for the claims resulting from a malpractice or negligence made by the investigators’ side.

National Organization for Drug Control & Research decides to issue an approval or rejection of the clinical trial in case of the acceptance to begin on the clinical trial the aforementioned Authority sends its decision to each of the following as per Article 3 of Decree No.189 of the year 2010:

Scientific Research Ethics Committee;
The basic researcher who will perform the clinical trial; and
The Central Administration of Pharmaceutical Affairs.

Concerning the trial’s requirements: The GCP provides that the trial must be concluded in accordance with the protocol concluded between the sponsor and the investigator. The trial protocol and any amendments to it, must be approved by the Institutional Review Board of the Independent Ethics Committee before any implementation occurs. Moreover, all and any consent must be pre-obtained even if new information becomes available, if relevant to the subject of the consent.

4. What are the requirements for consent by participants in clinical trials?

Information Pamphlets of the participants and their informed consent of the participants of the clinical trial. Such consent must include the following information as per the consent template provided by the Central Directorate for Research and Health Development:

Pamphlet Approval;
Subject of the research;
Brief of the study;
Main researcher;
Participant researchers;
Source of funds;
Information about the disease and the research;
Benefit;
Side effects;
Possibility of approving or rejecting the participation;
Persons who have knowledge of such research;
Other alternatives;
Any other inquiries;
Acknowledgment of all the above by the participant with his signature.

Moreover, such consent must comply the GCP and the ethical principles originated from the Declaration of Helsinki developed by the World Medical Association. Prior to the conclusion of the trial, the investigator must obtain the approval of the Independent Ethics Committee with regards to the trial and any other related subject or information.
The consent by the participants must be updated, if there is any new available information that is of relevance to the subject or the trial, which as well must be approved by the Independent Ethics Committee.

5. May participants in clinical trials be compensated?

Yes, the participants of the clinical trials are secured with payable insurance and will be compensated in the occurrence of any harm or side effect due to the clinical trial.

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

The National Organization for Drug Control & Research is imposed to inspect on the place where the clinical trial will take place on and that’s to ensure that it matches the Good Clinical Practice (GCP) and reviews the documents and the attached registrations and all the relevant sources that are related to the clinical trial and to protect the rights of the participants and to ensure that the clinical trial proceeds as follows:

The protocol that is applied for the clinical trial;
The scientific references that are internationally recognized; and
Standard operating procedures for clinical practice.

In case of the occurrence of lack of conformity, the aforementioned authority will classify it and will take the appropriate measures and the sort of the classification in accordance to the following:

1) Major non-compliance situations:

Trials that may possibly cause damages to the participants rights which provides the non-efficiency and non-accuracy of the information which is related to the clinical trial in this case the trial will be suspended until the proper solution to correct the situation is taken especially if there is any danger facing the participants’ life.

2) Minor non-compliance situations:

Trials, which does not cause any damages to the participants’ rights and safety and does not affect the proficiency and accuracy of the information and in this case the authority may suspend the trial or resume it.

In case the occurrence of any dangerous side effects on the participants of the clinical trial, the participant shall inform the National Organization for Drug Control & Research authority and the Scientific Research Ethics Committee within 24 hours from the occurrence of the side effects, and then will begin the analysis of the cause of the side effects and the trial will be suspended until the final results of the analysis appears if it appears that the causes of the side effects is not due to the Clinical Trial then the Trial will resume in case the trial is suspended the sponsor shall inform the authority with an explanation of the causes that led to such a suspension.

The authority shall make sure that the sponsor took all the necessary measures to ensure on the participants safety and insurance in case of the occurrence of any danger that may happen to the participants through the clinical trial.

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11. Regulatory, Pricing, and Reimbursement: Egypt

An insight into regulatory, pricing, and reimbursement of drugs in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

The pharmaceutical regulatory body in Egypt is the Egyptian Drug Authority (EDA) operating and working under supervision of the Ministry of Health (MOH) in Egypt.

The EDA comprises three independent organizations consisting of the following:

Central Administration for Pharmaceutical Affairs (CAPA): which is mainly responsible for the registration and pricing of medicines, and inspection of pharmacies and manufacturing facilities.
The CAPA hosts four departments for registration: Licensing and Pharmacists services, Inspection and Control, and Importation and Exportation department.
The CAPA includes a department (Egyptian Pharmacovigilance Center “EPVC”) that monitors the use of the drugs and medical devices after their registration.
The National Organization for Drug Control and Research (NODCR): which is responsible for quality control of pharmaceutical products, medicines, medical plants, cosmetics, raw materials, insecticides, and products from natural origin. The organization entails many laboratories for testing all the pharmaceutical products under registrations, which will be marketed in Egypt.
National Organization for Research & Control of Biologicals (NORCB): which is responsible for the marketing authorizations and licensing activities.

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

The authorization process is regulated by Decree 425 of the year 2015.

Pricing of drugs is regulated through a pricing committee. Any price increases of medicines and drug products are determined according to issued Ministerial Decrees.

The drug manufacturers recommend the prices of the new medicines, the pricing committee reviews the recommended prices, and the pricing committee then determines whether to approve or reduce the prices to the lowest price of the referenced countries.

The Ministry of Health is responsible for the registrations and approvals regarding medicines and medical devices in Egypt through the Drug Policy and Planning Center and the Central Administration for Pharmaceutical Affairs in Egypt.

Reimbursement of drugs, biologicals, and medical devices:

Regarding the private sector entities, they have to abide by the MOHP healthcare standards and regulations, as they do not have to follow the same reimbursement regulations at the MOHP. The procurement department is responsible for setting the tender drug list and reimbursement price, which is published and distributed to all MOHP facilities. Each hospital or primary care facility with a plausible budget can purchase their drugs directly from the drug manufacturers or wholesalers according to the price specified in the tender drug list (No negotiations).

3. What are the steps to obtain authorization to develop, test, and market a product?

A variation application details a proposed change to approved documentation, providing a formal means by which the approved license details held by the Competent Authorities for a given medicinal product can be updated.

Types of variation such as follows: Variation department approval (VDA): They need prior approval by the variation department (VDA) before implementation;

Variation committee approval (VCA): They need prior approval by the variation committee (VCA) before implementation;

Technical committee approval (TCA): They need to be approved by the technical committee (TCA) before implementation;

Requirements to be fulfilled according to the type of change in the guidelines:

A) NODCAR:

Notification (N);
Analysis inspection Department (AI);
Analysis registration Department (AR).

B) Stability:

None;
Ongoing;
Accelerated (6M);
6M + long-term stability.

C) Dissolution:

None (DN);
Comparative In-Vitro dissolution in most suitable medium (D1);
Comparative In-Vitro Dissolution at three different PH media (1.2/4.5/6.8) and most suitable medium (D3/4);
Bioequivalence study (BE).

D) Pricing (P)

N.B: In some cases, request within reporting category VDA can be issued to VCA if needed according to file case.

4. What are the approximate fees for each authorization?

The approximate fees for marketing application form is EGP 10,000.
The registration fee is EGP 1000 for each “Application Form”; the fee is non-refundable.

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

The registration is valid for 10 years starting from the day of obtaining the approval of the Technical Committee for Pharmaceutical Control, and the renewal procedures shall be renewed at the CAPA during the last year of its validity shall be applied at the beginning of the last year from the tens the applicant shall apply for renewing the registration to the General Authority for Registration. While the registration of the biological products, serums and vaccines are re-registered every 5 years according to a request submitted by the product owner to the CAPA as per Decree 297 of the year 2009.

6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?

According to Decree No. 425 of the year 2015, in order for a pharmaceutical company to market and sell drug products under a brand-name the company shall firstly obtain approval from the Food and Drug Administration (FDA) by submitting a new drug application and a documentation shall include all data to establish drug’s clinical safety and efficiency. Moreover, studies will be performed to determine the characteristics of the drug dosage form, including the manufacturing process, drug stability, purity, strength, and how it dissolves. Once the drug receives FDA approval, the innovator company can then exclusively market and sell this ‘brand-name’ product for as long as the company has patent protection.
The “Box” system in the authorization of Pharmaceuticals in Egypt must include 12 products, in which one of them must be a brand-name product and the rest (eleven) are generic products.

Yes, there are differences. The authorization process of the local manufacturers differs from the foreign owned manufacturers.

The locally manufacturers’ authorization procedures will be as follows:

In accordance with the standards of the World Health Organization, a minimum of 10% of the production of Pilot Batch volume shall be complied with in the presence of an inspector from the General Directorate of Inspection. This operation shall not be carried out in the local market at all. The registration procedures shall be completed according to the installation statement on which the production was based. For the next steps:

Take off samples through Pharmaceutical Inspection from the “Pilot Batch” for analysis at the National Organization for Drug Control and Research. The applicant shall submit the file of the analysis to the above-mentioned authority containing the required documents and attachments for the analysis file specified in Annex No.8, the committee is obliged to issue the analysis results within 60 working days form the date of the submitting of the file.
Provide the accelerated stability study for a period of six months on the Pilot batch for evaluation by the scientific committee to evaluate the stability studies. The evaluation shall be within 60 working days from the date of presenting the stability study file.
In cases where it is necessary to study availability, bioequivalence or solubility rate according to the rules and procedures for conducting studies of availability, bioequivalence and melting rate studies, samples are drawn by the General Administration for Pharmaceutical Inspection to be sent to the approved availability and bioequivalence centers of the administration and the evaluation of the study is conducted within 30 working days of the date of submission of the study.

For imported drugs, the procedures will be as follows:

Submission of the analysis file to the registration department of the National Organization for Drug Control and Research containing the required documents and attachments for the analysis file specified in Annex No.8, the committee is obliged to issue the analysis results within 60 working days form the date of submitting the file. For the Pharmaceutical products that have a certificate of registration and trading from one of the reference countries approved by the Technical Committee for Pharmaceutical Control, submit the file of the analysis to the National Organization for Drug Control and Research (Registration Department).

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug +biologic + device) regulated?

There are no regulations in Egypt that regulate the combination of biologicals separately. The general regulations and Laws of the pharmaceutical products and medical devices may apply. However, the combinations of drugs are registered at the CAPA unless the combinations of the product consists of pharmaceuticals and medical devices, then, in this case, each component will be registered separately depending on its nature.

8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

Yes, the regulatory regime is comparable with the US Food and Drug Administration or the European Medicines Agency as the Egyptian Drug Authority (EDA) consists of Central Administration of Pharmaceutical Affairs (CAPA), National Organization for Drug Control and Research (NODCAR) & National Organization for research & Control of Biologicals (NORCB), each department monitors and has its own functions.

CAPA has a department, which is specialized in the inspection of the pharmaceutical factories. Such department inspects factories in order to ensure the compliance of the factories with the GMP of the WHO and the local regulations.

9. What is the potential range of penalties for noncompliance?

In the case of the inspection department finding a violation or non-compliance, the department will cancel or suspend the license.

10. Is there a national healthcare system? If so, how is it administered and funded?

Yes, there is the General Organization for Comprehensive Health Insurance Scheme, which is regulated by the Law No. 2 of the year 2018.

It is administrated by the Board of Directors of the Organization according to Article 6 of the said Law. Whereas the BOD is the supreme governing body of the Organization, running its affairs, and formulating and implementing such policies necessary for achieving its purposes and goals. Moreover, it shall have the authority to take final decisions without the need for approval of any further entity.

The Organization’s resources consist of:

The Share of the insured and dependents;
The Share of Employers;
Co-payments;
Investment yield of the Organization’s funds;
Obligations of the public treasury for the poor;
Charges of other services delivered by the Organization as determined by the BOD, apart from the charges stipulated in this law;
External and domestic grants and loans contracted on by the government to the benefit of the organization pursuant to the rules established in this regard;
Donations, assistances, contributions, and bequests which the organization’s BOD may decide to accept pursuant to the rules established in this regard;
Other sources:
i. 75 piasters per a pack of cigarettes sold in the local market, whether the cigarettes were produced locally or abroad. Such amounts shall be increased every 3 years by 25 piasters until it reaches 150 piasters.
ii. 10% of the price of every sold unit of tobacco derivatives, apart from cigarettes.
iii. 1 EGP is collected for every vehicle passes on highways that are subject to these fees – collection system.
iv. 20 EGP for every year when issuing or renewing a driving license;
v. 50 EGP for every year when issuing or renewing license for vehicle for capacity of less than 1.6 liters;
vi. 150 EGP for every year when issuing or renewing a license for a vehicle of a capacity 1.6 liters and less than 2 liters;
vii. 300 EGP for every year when issuing or renewing license for a vehicle with a capacity of 2 liter or more;
viii. An amount ranging between 1000 and 15000 EGP when medical clinics, therapeutic centers, pharmacies and pharmaceutical companies, contract with the Scheme;
ix. 1000 EGP for every bed when licensing hospitals and medical centers;
x. Solidarity contributions of 0.0025% of gross annual revenues of sole proprietorships and companies, regardless of their type or legal systems governing them, as well as public economic authorities. In application of the Income Tax Law, Solidarity Contributions isn’t considered deductible costs;
xi. 50% of the revenues collected under self-resources development regulations for hospitals efficiency improvement, issued by Minister of Health Decree No. 239 of the Year 1997 and 200 of the year 2002;
xii. A stamp duty of 5 EGP in the name of the Scheme to be affixed to the application submitted to the Organization, the Care Organization and Accreditation and Control Authority.

11. How does the government (or public) healthcare system function with private sector healthcare?

The HIO covers the governmental employees and school-age children, was created decades ago in order to provide health care and insurance to the citizens. However, it was never implemented. Under the new universal health coverage, the plan is to reinstitute the role of HIO at the provider of insurance in care of all Egyptians. The increased premiums and co-payments for universal coverage consider the Employees salary range and the rise in health care services and prices. The CCO operates in specific governorates and contracts with other entities to provide care. Other public governmental entities – such as university hospitals and clinics, ministry – affiliated hospitals and clinics (e.g. military and railway hospitals), and institutions affiliated hospitals (e.g. EgyptAir hospitals and clinics) provide healthcare services for their members and population at large at a reduced fee. The Teaching Hospitals and Institute Organization (THIO) provides primary, secondary and tertiary services. Both of these entities have self-governance abiding by the MOHP regulations.

While the private sector includes several private insurance organizations as well as a network of outpatient clinics and hospitals. There are also health facilities run by religious entities and NGOs as a charity service. The private sector has its own set of regulations and standards. Some are the same as those for the public sector and some may differ. Private insurers and providers negotiate prices with drug manufacturers but are not involved in the drug evaluation process.

12. Are prices of drugs and devices regulated and, if so, how?

Yes, prices of drugs and devices are subjected to the compulsory pricing and determining the profits Law No.163 of the year 1950 and Law No. 113 of the year 1962 regarding the reorganization of the import, manufacture, and trade of medicines, supplies and medical chemicals.

The prices of pharmaceuticals are regulated through issued ministerial decrees issued by the Ministry of Health.

The Ministry of Health issued Decree No. 373 of the year 2009, which applies the lowest customer price available in any country where pharmaceuticals are traded with a 10% discount on the original price, years later, the Ministry of Health issued decree No.499 of the year 2012, the prices are determined during the registration process.

13. How are drugs and devices used by patients paid for? What roles do public and private payers play?

The drugs and devices used by patients are paid in accordance to the healthcare system and the pharmaceutical groups or medications that the specialized scientific committees and the organization have specified.

The General Organization for Comprehensive Health Insurance Scheme (GOCHIS) provides medical services and products to the public for nominal value at the governmental hospitals and pharmacies that are run by the MOH and the Ministry of Higher Education and Scientific Research. Such value covers a certain level of services and products. However, GOCHIS might approve certain medical services and products for free in certain cases. In case of private insurance, funds allow patients to receive free medical services and products from certain hospitals and pharmacies, which will be reimbursed by the funds.

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

Pharmacists registered at the Ministry of Health. The costs of the medical services or products will be reimbursed to the Pharmacists by the public or private insurance entities.

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

Pharmacists cannot dispense drugs without a medical prescription and shall not distribute drugs which are not registered at the Ministry of Health.

A fine penalty not less than twenty thousand pounds and not exceeding fifty thousand pounds will be imposed to those who brought in, or produced with the aim of trading, or sold, or offered for sale, any of the medicines or the medical preparations and requisites for which there was no decree from the Minister of Health to use or circulate as well as on each one who would sell or offer for sale any of the medical requisites of unilateral use, as determined by a Decree from the Minister of Health, despite their previous use.

If the crime has been committed by the owner of a pharmaceutical organization or by whoever has been entrusted its management, a further infliction of the penalty of closure for a period not less than three months and not more than one year shall be sanctioned in addition to the penalty referred to.

In case of recidivism, the two minimum and maximum limits of the fine and closure stipulated upon under this Article shall be doubled.

Regarding the data protection responsibility on the dispensers, recently Egypt has ratified a new Data Protection Law No.151 in of year 2020m it aims to safeguard the rights of individuals in Egypt in respect of their personal data and to place responsibilities on businesses in how they process personal data. However, the Code of Ethics means that Doctors cannot disclose a patients’ secrets that have been disclosed to him due to his profession unless certain cases are applied. Moreover, the Penal Code prohibits the disclosure of patients’ secrets by physicians, pharmacists, nurses and midwives.

Concerning the safety of the patients, as per the Code of Ethics, the Doctor must warn his patients to take all the precautionary means and to guide them of the consequences in case of non-compliance with his instructions. The Doctor may request the signatures of his patients.

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