The Pharma Legal Handbook: Algeria

Drugs, biologicals and medical devices authorization fees are fixed as part of Finance Law in Algeria. Fees are payable by the person who makes the application or submits variations, in local currency for locally-manufactured products, and in convertible foreign currencies for imported ones.

 

The supplementary Finance Law for 2020 has just been published in the Official Gazette. Its Article 61 has modified authorization fee due for a new application related to imported and non-essential drugs and biologics.

 

As at June 2020, the current authorization fees are:

• For each new application related to imported and non essential drug or biological: 2.000.000 to 20.000.000 DZD (approx. 16.700 to 167.000 USD);
• For each new application related to imported and essential drug or biological: 600.000 DZD (approx. 5.000 USD)
• For each new application related to locally-manufactured and non essential drug or biological: 150.000 DZD (approx. 1.250 USD);
• For each new application related to locally manufactured and essential drug or biological: 100.000 DZD (approx. 835 USD)
• For each new application related to imported medical device: 300.000 DZD (approx. 2.500 USD);
• For each new application related to locally-manufactured medical device: 150.000 DZD (approx. 1.250 USD);
• For each product assessed: 30.000 DZD (approx. 250 USD);
• For each API batch controlled in laboratory: 15.000 DZD (approx. 125 USD);
• For each finished product batch controlled in laboratory: 12.000 DZD (approx. 100 USD);
• For each market authorization renewal application: 300.000 DZD (approx. 2.500 USD);
• For each variation(s) submission: 150.000 DZD (approx. 1.250 USD);
• For each application related to clinical trial authorization: 300.000 DZD (approx. 2.500 USD).

Also from this Legal Handbook

In Algeria, the supplementary Finance Law for 2020 has just been published in the Official Gazette. This law materializes the authorities’ will to significantly ease the control of foreign investments in order to boost Foreign Direct Investment (FDI) and to accelerate the diversification of the national economy.

 

Despite several competitive advantages, including low cost of energy, skilled and inexpensive workforce, and geographic location at the crossroads of Europe, Africa, and the Middle East, FDI flows into Algeria have remained very modest since the adoption of the 51/49 rule in 2009.

 

The so-called 51/49 rule, which has so far limited participation of foreign investors to 49 percent of share capital, has been relaxed and is now only applicable to Algerian companies engaged in trade of products, or in production of strategic goods and services.

 

According to amendments to the investment rules, manufacturing projects in the pharmaceutical sector will no more be regulated by the 51/49 rule if related to innovative products of high added-value, regardless of whether they are intended for the domestic market or for export.

 

While in-country pharmaceutical manufacturing is extremely developed for basic drugs and has demonstrated its resilience during the COVID-19 crisis, it is markedly less so for innovative products and biologicals such as many oncology drugs.

 

This recent amendment is aiming to boost foreign investments in biopharmaceutical plants alongside existing incentives that include customs duties and tax exemptions throughout the project life, and concession of land by mutual agreement (under provisions of Investment Law No 16-09).

 

Other major amendments include abrogation of the state’s preemptive right on shares transfers carried out by or for the benefit of foreign party replaced by a simple government prior authorization for strategic activities). The obligation to resort to local financing was also abolished.

 

Finally, pharmaceutical products, medical devices, detection equipment, accessories and spare parts for this equipment, used in the response to COVID-19 were temporarily exempted from value-added tax and customs duties (with retroactive effect from March 21^st, 2020).

Also from this Legal Handbook

The ongoing reform of pharmaceutical regulations in Algeria has been marked on January 2020 by publication in the Official Gazette of the long-awaited Decree No 19-379 dated of 31st December 2019. This Decree has laid down procedures for specific administrative, technical and safety control of substances and drugs with psychotropic properties (i.e. including Cannabinoids).

 

The Decree No 19-379 was initially planned to enter into force by 5th of April 2020 according to its Article 41, but considering COVID-19 pandemic context, the Algerian Prime Minister has executed an amendment to this article to postpone the effective date to 3rd of November 2020.

 

The main objective of the aforementioned Decree, whose legal anchorage is Article 245 within Health Law No 18-11 dated of 2nd July 2018, is to ensure traceability and adequate control of substances and drugs with psychotropic properties from reception of the raw materials until dispensation at the pharmacy level.

 

Under the Decree No 19-379, outpatient prescribing of substances and drugs with psychotropic properties is limited to three (03) months and must be written on a special prescription in three copies of different colours (white, yellow and pink): – White and yellow colour copies are given by the prescribing physician to the patient; – The pink copy is to be kept by the prescribing physician for a period of two (02) years; – The yellow copy is saved by the pharmacist after dispensing the drugs; – The white copy is returned to the patient after dispensation or directly sent to the payer.

 

Whereas, prescription of such substances and drugs for an urgent need in public and private hospitals have to be written on a weekly order form in double white and pink copies, with respect to the endowment, and referring to a nominative statement by substance/drug (templates were attached to the Decree 19-379).

 

Psychotropic drugs with a restricted prescription for exclusive hospital use must be prescribed by a specialized physician (psychiatrist) at the exercise hospital, and maximum duration of prescription is limited to one (01) month. The dispensing of these drugs is reserved for hospital pharmacies, and their list should be fixed soon through Ministerial Decree.

 

Besides that, every prescribing physician has to record prescriptions in a register opened for this purpose, marked and initialled by the Provential Health and Population Directorate (“DSPW” – “Direction de la Santé et de la Population de Wilaya”) for those practising in the private sector, and by the health structure director for those in the public sector. Importers, manufacturers, distributors and dispensing pharmacists must also record all moves related to substances and drugs with psychotropic properties on special registers to be kept for five (05) years.

 

Periodic and unannounced inspections to check compliance with provisions of the Decree No 19-379 will be carried out by the National Agency for Pharmaceutical Products (“ANPP” – “Agence Nationale des Produits Pharmaceutiques”) for pharmaceutical establishments, or by inspectors affiliated to the Ministry of Health for community pharmacies and public/private health structures.

 

Finally, both national and provential commissions for substances and drugs with psychotropic properties have been established by the Decree No 19-379 with the purpose of assessing the risk of abuse and pharmacodependency, and proposing all necessary measures for effective control of such substances and drugs. Composition, organization and functioning of these commissions will be fixed by Ministerial Decree of the Minister of health.

Also from this Legal Handbook

A brief overview of the situation regarding biosimilars and biologics. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.

 

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

The Health Law No 18-11, dated of 2 July 2018 and published in the Official Gazette, has made a clear distinction between similar biotherapeutic products and generic products, and introduced a legal anchorage for biosimilars specific regulations.

A generic product is defined in the Article 210 as any drug having the same qualitative and quantitative composition in active substance, the same pharmaceutical form, and that is interchangeable with the reference product because of its demonstrated bioequivalence by appropriate bioavailability studies, where a drug can only be classified as a reference product if it has been registered in the light of all the data necessary and sufficient on their own for its evaluation.

A similar biotherapeutic product (name used by World Health Organization) has been defined in the same article as any drug in which the active substance is produced from or extracted from a biological source, and that is similar in terms of quality, safety and efficacy to a reference biotherapeutic product. The latter can only be qualified as a reference biotherapeutic product if its registration was carried out in the light of all the data necessary and sufficient in themselves for its evaluation.

 

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

Under Patents Ordinance No 03-07, dated of 19 July 2003 and published in the Official Gazette, inventions related to a product or process, which are new, result from an inventive step and which are susceptible of industrial application, can be protected by a patent in Algeria.

An invention is considered as new if it is not included in the state of the art, which consists of everything made accessible to the public by a written or oral description, a use or any other means anywhere in the world before the day of filing the application for protection or the priority date validly claimed for it (for detailed information, refer to Patents and Trademarks).

Thus, all reference biotherapeutic products are patentable in Algeria, at the opposite of similar biotherapeutic products for which the same International Nonproprietary Name (INN) is attributed according to Algerian regulations, and that cannot be patentable, except for a proven new manufacturing process.

 

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?

There are neither specific regulations for similar biotherapeutic products in Algeria for the moment, nor this term is used in legal provisions prior to Article 210 of the Health Law No 18-11, dated of 2 July 2018 and published in the Official Gazette.

In practice, existing similar biotherapeutic products were approved according to the regulatory framework applicable to other drugs, on the basis of application including manufacturing and quality control data, and where mandatory, non-clinical and clinical comparative data with the reference biotherapeutic product (for detailed information, refer to answer to question 2 of Regulatory, Pricing, and Reimbursement Overview).

 

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 data package to obtain market authorization for a similar biotherapeutic product is not defined since there are not yet specific regulations, but non-clinical and clinical comparative data could be required by the regulatory authorities on case by case basis.

Regulatory authorities with jurisdiction over drugs, biologics and medical devices in Algeria do not confer exclusive right to benefit from the proprietary non clinical and clinical data for a set period of time (also called Regulatory Data Protection) to innovative companies at the moment of granting the market authorization, and similar biotherapeutic products manufacturers are allowed to rely partially upon those data to obtain approval of their abbreviated applications supported by comparative data.

 

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

There are no specific requirements for the choice of the reference biotherapeutic product, whereas according to previous experiences, it was required from the reference biotherapeutic product to be already approved in Algeria.

 

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

This possibility did not occur before (at the opposite of generic products), and there is no specific provision for within the existing regulatory framework.

 

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

Prices of similar biotherapeutic products are regulated like other drugs by the Pharmaceutical Products Pricing Committee established at Ministry of Health by Ministerial Decree No 66 dated of 11 July 2012 modified and completed, published in the Ministry of Health Official Bulletin (for detailed information, refer to answer to question 12 of Regulatory, Pricing, and Reimbursement Overview).

Price requirement for imported similar biotherapeutic products is the same as for imported generic products (i.e. list price to be lower by 30% compared to the reference product), but it occurred that at the end of list price negotiation the difference was only of 20% between similar and reference biotherapeutic products.

As an incentive given to local production, for a hypothetically first locally-manufactured similar biotherapeutic product of a previously imported reference biotherapeutic product, the ex-factory price could be aligned during the first 5 years of authorization to FOB list price of the reference biotherapeutic product (when the general rule requires a difference of 30% in list price).

After a period of 5 years, locally manufactured similar biotherapeutic products are required to be lower by 10% (if ex-factory price is below 200 DZD), by 15% (if ex-factory price is between 200 and 500 DZD), by 20% (if ex-factory price is between 500 and 1000 DZD), and by 30% (if ex-factory price is above 1.000 DZD) compared to the reference biotherapeutic product.

 

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

National health insurance (social security) is covering the costs of similar biotherapeutic products sold through community pharmacies as for other drugs on the reimbursement positive list fixed and updated by the Reimbursement Committee established at the Ministry of Labor, Employment and Social Security by Interministerial Decree, dated of 16 August 2003 and published in the Official Gazette.

When the reference biotherapeutic product is already on the reimbursement positive list, the similar biotherapeutic product having been attributed the same International Nonproprietary Name (INN) by the regulatory authorities, is automatically admitted to reimbursement without additional assessment (the same rule as for generic products).

Besides that, the Government is fully covering costs for all products dispensed through public hospital pharmacies. These products are purchased by the Hospitals Central Pharmacy (“PCH” – “Pharmacie Centrale des Hôpitaux”) during public tenders and are given free of charge to patients at public hospitals, including all approved similar and reference biotherapeutic products, indistinctively.

 

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

The similar biotherapeutic product competition does not impact the reimbursement policy of the reference biotherapeutic product (reimbursed on the basis of the list price), except the case in which the Reimbursement Committee decides to establish a reference tariff for reimbursement on the basis of the cheapest similar biotherapeutic product already on the market.

For hospital products, similar and reference biotherapeutic products enter in competition within the same public tender launched at the PCH. The market could be split between reference/similar or two similar biotherapeutic products to avoid shift of patients already under treatment for non-medical reasons. In this case, transaction price is negotiated with the tender second winner on the basis of the first winner price, and the volumes to be purchased.

 

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?

There is no legal framework for similar biotherapeutic products prescription (prescribed in trademark at the physician discretion). The only existing two exceptions are:

• With products containing glargine insulin (dispensed through community pharmacies), for which the regulatory authorities have released a position paper, in 2017, requiring from prescribers not to switch patients after initial prescription of the reference or a given similar biotherapeutic product;
• With products containing trastuzumab (dispensed through hospital pharmacies), for which the regulatory authorities have decided, in 2015, in concert with senior physicians to dispense the approved similar biotherapeutic product to all new patients and to continue the treatment with the same product.

As similar biotherapeutic products are not generics, the automatic substitution by the pharmacist (reference/similar, similar/reference, or between two different similar biotherapeutic products) is not allowed within the meaning of Article 145 of the Decree No 92-276, dated of 6 July 1992 and published in the Official Gazette, related to the code of medical ethics. Pharmacists are required only to dispense the reference or the similar biotherapeutic product prescribed in trademark by the physician.

 

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

As mentioned in answer to question 10 above, the physician-led switching is at the discretion of the prescriber (except for glargine insulin and trastuzumab containing products), and any pharmacy-level substitution is not allowed.

 

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?

The market authorization holder is obliged to notify any identified event related to the product safety that occurred locally or abroad, and must report regularly or upon request to the National Center for Pharmacovigilance and Materiovigilance (“CNPM” – “Centre National de Pharmacovigilance et de Matériovigilance”), created by Decree No 98-192 dated of 3 June 1998 and published in the Official Gazette.

Post-authorization requirements are the same for reference and similar biotherapeutic products in Algeria.

 

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

The similar biotherapeutic product labelling materials are expected to clearly identify the product, in apparent font, easily legible, by a unique trade name which does not suggest the name of the reference biotherapeutic product or that of another similar biotherapeutic product.

When an International Non-Proprietary Name (INN) exists (the same attributed to similar and reference biotherapeutic products), it must be put on the internal and external packaging, the Summary of Product Characteristics (RCP) and the package leaflet too.

The mention of the lot number on all packaging elements is essential as it is an important part of the manufacturing information and is critical for traceability in the event of problems with the similar biotherapeutic product.

The information on prescription of the similar biotherapeutic product should be the same as that of the reference biotherapeutic product, with the exception of specific aspects of the product, such as those related to different excipients. This information should be regularly updated, taking into account the most recent information related to the reference biotherapeutic product.

The general labelling rules and requirements are the same as for other drugs (for details information, refer to answers to questions 14, 15 and 16 of Marketing, Manufacturing, Packaging & Labeling, Advertising).

 

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).

Guidelines on similar biotherapeutic products have been drafted on May 2017 by the General Directorate of Pharmacy and Health Equipment (“DGPES” – “Direction Générale de la Pharmacie et des Equipements de Santé”) at Ministry of Health, mainly to clarify important specific requirements, including without being limited to:

• The choice of the reference biotherapeutic product, with possibility to consider a comparator product sourced from another regulatory jurisdiction (members of International Conference on Harmonization);
• The conditions for Phase III safety and efficacy comparative clinical trials waiver;
• The criteria for safety and efficacy data extrapolation to indications of the reference biotherapeutic product other than those covered in clinical trials;
• The post-authorization requirements for risk management and safety monitoring;
• The labeling and information on prescription, in particular if the prescribing indications are fewer with the similar biotherapeutic product;
• The conditions for pharmacy-level substitution at the initiation of treatment, and for physician-led switch in treated patients.

 

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?

Legal anchorage for specific regulations related to similar biotherapeutic products has been introduced as part of the Health Law No. 18-11 dated of 2 July 2018 (Article 210).

The Decree No 19-190 dated of 3 July 2019, setting out missions, organization and operating of the National Agency for Pharmaceutical Products (“ANPP” – “Agence Nationale des Produits Pharmaceutiques”, a financially independent institution newly created to replace the former General Directorate of Pharmacy and Health Equipment (“DGPES” – “Direction Générale de la Pharmacie et des Equipements de Santé”), has been published in the Official Gazette No 43 dated of 7 July 2019.

The aforementioned guidelines on similar biotherapeutic products are expected to come into force during 2020 (for detailed information on reform steps and timelines, refer to Regulatory Reforms).

 

 

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

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reforms
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
9. Orphan Drugs and Rare Diseases
10. Localization
11. Biosimilars and Biologics

Also from this Legal Handbook

The ins and outs of localization in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.

 

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?

According to Article 206 of Health law No 18-11, dated of 2 July 2018 and published in the Official Gazette, the Government supports national production through incentives and encourages pharmaceutical research and development, in particular by promoting investment in this field.

The legal framework for localization rules and policies include:

• Law No 16-09, dated of 3 August 2016 and published in the Official Gazette, related to investment promotion;
• Finance Law for 2001, published in the Official Gazette, in particular its Article 39 on the exemption of imported ingredients and materials intended for the manufacturing of drugs from customs duties;
• Presidential Decree No 15-247, dated of 16 September 2015 and published in the Official Gazette, on the regulation of public contracts and public service delegations, in particular its Articles 83, 84, and 85 related to promotion of national production;
• Decree No 17-100, dated of 5 March 2017 and published in the Official Gazette, amending and completing the Decree No 06-356 dated of 9 October 2006 related to the duties, organization and functioning of the Investment Development National Agency (“ANDI” – “Agence Nationale de Développement de l’Investissement);
• Decree No 09-396, dated of 24 November 2009 and published in the Official Gazette, defining the standard agreement to be concluded between social security organizations and community pharmacies, in particular its Article 27 offering a bonus for locally manufactured products;
• Ministerial Decree, dated of 30 October 2008 and published in the Official Gazette, fixing technical conditions for import of drugs and medical devices for human use, in particular its Articles 30 and 31 conditioning import permit by local investment in pharmaceutical production.
• Ministerial Decree, dated of 9 July 2015 and published in the Official Gazette, related to import ban on drugs and medical devices intended for human use locally manufactured in Algeria.

 

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

As part of recent significant changes in relation to localization rules:

• Finance Law for 2018, published in the Official Gazette, has extended exemption from customs duties set for in Article 39 of Finance Law for 2001, to imported ingredients and materials entering in manufacturing of medical devices too;
• Finance Law for 2017, published in the Official Gazette, has modified and completed Article 103 of Finance Law for 2003 by fixing different authorization fees for drugs and medical devices upon their sourcing status (imported or locally manufactured).

 

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)?

The market authorization process is in favour of locally-manufactured products, both in terms of authorization fees (6 times lower for drugs, and equal to half for medical devices: refer to answer to question 4 of “Regulatory, Pricing, and Reimbursement Overview”), and authorization timelines (assessment priority is given for local products, with approval timeframe of 5-6 months).

 

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)?

Priority is also given to locally manufactured products during pricing process. Their list prices are fixed in local currency (ex-factory), whereas imported products prices are fixed in foreign currency (FOB incoterm, mainly in euro).

As an incentive given to the first locally-manufactured version of a previously imported product, its ex-factory price is aligned during the first 5 years of authorization to FOB price of the imported version, even if the latter is a reference product, and the local one is a generic product (when the general rule requires a difference of 30% between a generic and the reference product).

After a period of 5 years, locally manufactured generics are required to be lower by 10% (if ex-factory price is below 200 DZD), by 15% (if ex-factory price is between 200 and 500 DZD), by 20% (if ex-factory price is between 500 and 1000 DZD), and by 30% (if ex-factory price is above 1000 DZD) compared to the reference product.

 

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)?

Despite it is considered in the final reimbursement approval decision, there is no particular incentive given to locally-manufactured during the assessment process.

Nevertheless, according to Article 27 of Decree No 09-396, dated of 24 November 2009 and published in the Official Gazette, defining the standard agreement to be concluded between social security organizations and community pharmacies, a 10% bonus is offered to pharmacists on each prescription for which the prices of all the medicines sold are equal or lower than the reference tariff for reimbursement (cheapest generics) + 10% bonus if all medicines sold within the same prescription are locally manufactured.

 

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)?

Presidential Decree No 15-247, dated of 16 September 2015 and published in the Official Gazette, on the regulation of public contracts and public service delegations, encourages local purchase as an incentive to national production.

Under the Article 83 of the Presidential Decree No 15-247, a preference margin (bonus) at a rate of twenty-five per cent (25%) is granted to products of Algerian origin and/or companies incorporated under Algerian law whose capital is held mainly by domestic residents.

According to Article 84, the specifications for international call for tenders must require from foreign bidders the commitment to invest in partnership, in the case of projects whose list is set by decision of the authority of the public institution or of the minister concerned, for their projects and those of the public institutions which belong to them.

According to Article 85 within the same Presidential Decree, the public contracting service must launch a national call for tenders when the national production is able to meet the needs.

Since 2015, the Hospitals Central Pharmacy (“PCH” – “Pharmacie Centrale des Hôpitaux”), responsible for purchasing drugs and medical devices for all hospitals (public tenders), has started to launch national exclusive call for tenders for products locally manufactured in Algeria, before considering international call for tenders during which the 25% bonus for local products/companies is applicable.

 

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?

a) Import permit:

Under the Article 30 of the Ministerial Decree, dated of 30 October 2008 and published in the Official Gazette, fixing technical conditions for import of drugs and medical devices for human use, any new import authorization is conditioned by investment in pharmaceutical production, in particular by:

• The construction of pharmaceutical production plants, on behalf of or in partnership;
• The production in technical-scientific partnership within existing pharmaceutical production plants;
• The upgrade or extension of existing pharmaceutical production plants;
• The contribution through products technical dossiers representing the share of participation in an investment project.

In this case, the import permit is issued for a period of one (1) year. This permit may be renewed if the stage of completion in the realization of investment is deemed to be in conformity with the plan of execution of the commitments subscribed.

According to Article 31 of the same Ministerial Decree, the importer undertakes to make the production investment within a period of two (2) years, failing which he loses the benefit of a new import permit.

However, the Minister of Health may extend the time limit of two (2) years referred to above, according to the assessment of the project progress in relation to the implementation plan of the commitments entered into.

b) Import ban:

The Ministerial Decree, dated of 9 July 2015 and published in the Official Gazette, has fixed a list of 357 drugs and 11 medical devices intended for human use banned for import as an incentive to support their local manufacturing in Algeria.

c) Import tariffs:

Without conflicts with the free trade agreements Algeria is party to, regular customs duties are applicable to all imported finished products (drugs and medical devices).

Article 39 of Finance Law for 2001 has exempted imported ingredients and materials entering in manufacturing of drugs from customs duties, but conditioned that exemption by a prior visa granted by the Ministry of Health to authorized pharmaceutical production establishments.

Article 118 of Finance Law for 2018 has amended the aforementioned article to extend the customs duties exemption to ingredients and materials entering in manufacturing of medical devices too.

d) Value-added tax (VAT):

All authorized drugs and medical devices in Algeria are value-added tax free, indistinctly if imported of locally manufactured.

 

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

Under provisions of the Law No 16-09, dated of 3 August 2016 and published in the Official Gazette, related to investment promotion, several tax incentives are given to companies investing in pharmaceutical local manufacturing upon submission of investment dossier to the Investment Development National Agency (“ANDI” – “Agence Nationale de Développement de l’Investissement):

a) During realization phase:

• Exemption from customs duties for imported goods directly involved in the realization of the investment;
• Value-added tax (VAT) exemption for goods or services imported or acquired locally directly in the realization of the investment;
• Exemption from the value transfer tax and the land registration tax, for all real estate acquisitions made in connection with the investment concerned;
• Reduction on the amount of the annual rental fee fixed by the estate services for the grant of land:
  o by 90% during the period of realization of the investment for investment projects located in the provinces of the North,
  o to the symbolic Dinar the square meter (m2) for a period of ten (10) years for the investments established in the provinces of the High Plateaus and other areas of which development requires a special contribution from the government,
  o to the symbolic Dinar the square meter (m2) for a period of fifteen (15)
  years for investment projects located in the provinces of the Great South;
• Exemption from property tax on real estate properties within the scope of the investment, for a period of ten (10) years from the date of acquisition;
• Exemption from registration fees on corporate deeds and capital increases.

b) During operation phase:

For a period of three (3) years for projects creating up to 100 direct jobs, and for five (5) years for those creating more than 100 direct jobs in provinces of the North, and for a period of ten (10) years in provinces of the High Plateaus and the Great South, from the start of activity established by the tax departments at the investor’s diligence:

• Exemption from corporate income tax (IBS);
• Exemption from the tax on professional activity (TAP);
• Reduction by 50% on the amount of the annual rental fee set by the estate services for the grant of land.

 

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?

Localization policies are already in place in Algeria, and there are no plans for reform in the short-term.

 

 

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

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reforms
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
9. Orphan Drugs and Rare Diseases
10. Localization
11. Biosimilars and Biologics

Also from this Legal Handbook

A brief overview of the situation regarding orphan drugs and rare diseases in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.

 

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

Rare diseases are defined in Algeria as those listed in the Ministerial Decree, dated of 6 February 2013 and published in the Official Gazette, fixing lists of rare diseases and life-threatening conditions as well as pharmaceutical products intended for their treatment.

Their number is of twenty-eight (28) rare diseases:

• Cystinosis;
• Factor VII deficiency;
• Fibrinogen deficiency;
• Prothrombin deficiency;
• Growth Hormone deficiency;
• Dermatopolymyositis;
• Dy tonia;
• Glanzmann disease;
• Icthyosis;
• Fabry disease;
• Gaucher disease;
• Lobstein’s disease;
• Niemann Pick disease;
• Still disease;
• Willebrand disease;
• Wilson disease;
• Muccopolysaccharidoses;
• Myasthenia gravis;
• Phenylketonuria;
• Polyradiculoneuropathy;
• Pump disease;
• Psoriatic arthritis;
• Scleroderma;
• West syndrome;
• Sjogren syndrome;
• Antisynthesizing syndrome;
• Hereditary tyrosemia;
• Xeroderma pigmentosum.

 

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

According to Ministerial Decree No 35/MSP/MIN, dated of 6 April 1997 and published in the Ministry of Health Official Bulletin, related to marketing of orphan drugs, the latter are defined as all drugs necessary for public health whose manufacture is no longer provided by producers for profitability reasons or withdrawal of a therapeutic scheme, or for the treatment of rare diseases.

 

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?)

Despite its designation as orphan drug in the country (designation granted outside Algeria is not automatically taken into account), a product cannot be marketed unless it has been granted authorization by Ministry of Health according to Article 230 of Health Law No 18-11, dated of 2 July 2018. This requirement extends to treatments intended for rare diseases as listed in the Ministerial Decree, dated of 6 February 2013.

There are currently no specific regulations for the authorization of orphan drugs in Algeria. The regulatory framework for the authorization, pricing, and reimbursement remains the same as for the other drugs (see answer to question 2 of “Regulatory, Pricing, and Reimbursement Overview”).

 

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

No, there are no provisions for relaxed clinical trial/scientific evidence requirements for orphan drugs.

 

5. Is there an expedited pathway for Orphan Drugs?

Orphan drugs may be marketed under the regimen a temporary authorization for use (“ATU” – “Autorisation Temporaire d’Utilisation”) to be granted by the Minister of Health according to provisions of Article 233 of the Health Law No 18-11, when they have proven their therapeutic benefit. Manufacturers can apply for regular authorization by filling a complete application dossier in cases where prevalence and economic profitability thresholds are met.

 

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

No, there are no foreign marketing authorizations recognized in Algeria for orphan drugs, but a valid authorization and effective marketing in the country of origin is a mandatory regulatory requirement.

 

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

The Algerian government is fully covering costs of orphan drugs as for all products dispensed free of charge through public hospital pharmacies.

 

8. How are the prices of Orphan Drugs regulated?

Prices of orphan drugs are regulated like other drugs by the Pharmaceutical Products Pricing Committee established at Ministry of Health by Ministerial Decree No 66 dated of 11 July 2012 modified and completed, published in the Ministry of Health Official Bulletin (see answer to question 12 of “Regulatory, Pricing, and Reimbursement Overview”).

A new product cannot be launched on the market without prior agreement on price. List price attestation is granted by Ministry of Health at the same time as the market authorization.

Orphan drugs marketed under the regimen of a temporary authorization for use (“ATU” – “Autorisation Temporaire d’Utilisation”) have not a list price. Therefore, negotiation is directly conducted between the manufacturer and the Hospitals Central Pharmacy (“PCH” – “Pharmacie Centrale des Hôpitaux”), responsible for purchasing orphan drugs, in order to determine the transaction price.

 

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

The Pharmaceutical Products Pricing Committee is benchmarking the prices in 8 foreign countries (France, Belgium, United Kingdom, Spain, Morocco, Tunisia, Greece, and Turkey), in addition to country of origin if different, to determine the maximum list price in Algeria.

 

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

No, there has not been any significant legal development for 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 is no short term plan for regulatory reform in relation with orphan drugs in Algeria.

 

 

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

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reforms
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
9. Orphan Drugs and Rare Diseases
10. Localization
11. Biosimilars and Biologics

Also from this Legal Handbook

Key legal info on cannabinoid drugs, medicinal cannabis and opioid drugs in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99. 

 

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

No, cannabinoid drugs can be prescribed by any physician according to answer to question 5 above.

 

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

No approvals or notifications are required. Authorized physicians can prescribe cannabinoid drugs to their patients in their own discretion, on regular prescription.

 

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

According to national regulations, all drugs (i.e. including cannabinoid drugs) are only dispensed to patients through hospital pharmacies or private community pharmacies (see answer to question 14 of “Regulatory, Pricing, and Reimbursement Overview”).

 

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

No, all hospital pharmacies (public/private) and private community pharmacies are authorized.

 

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

There is a new Decree underway that aims to lay down the procedures for specific administrative, technical and safety control of substances and drugs with psychotropic properties (i.e. including cannabinoid drugs) as introduced by Article 245 of Health Law No 18-11. The main objective of the ongoing reform is to insure traceability of these drugs from the reception of the raw materials until the dispensation at pharmacy level.

According to the draft of the aforementioned Decree, prescription of drugs with psychotropic properties will be limited to three (03) months, and must be written on a special prescription in three copies of different colors (white, yellow and pink):

• White and yellow color copies are given to the patient;
• The pink copy must be kept by the prescribing physician for a period of two years;
• The yellow copy is saved by the pharmacist after dispensing the drugs;
• The white copy is returned to the patient after dispensation or directly sent to the payer.

Every prescribing physician must record his prescriptions in a register opened for this purpose, marked and initialed by the Provential Health and Population Directorate (“DSPW” – “Direction de la Santé et de la Population de Wilaya”) for those practicing in the private sector, and by the health structure director for those in the public sector. The register must be kept for five years.

The prescription of psychotropic drugs for hospital use with a restricted prescription must be made by a specialized physician at the exercise hospital. The maximum duration of prescription will be limited to one (01) month. The dispensing of these drugs is reserved for hospital pharmacies, and the list of these psychotropic drugs will be fixed through Ministerial Decree.

 

11. When are they likely to come into force?

The aforementioned Decree is expected to be published in the Official Gazette by Q1 2020.

 

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

Medicinal cannabis can be authorised in Algeria in accordance with provisions of Decree No 07-228 dated 30 July 2007 and published in the Official Gazette, laying down the procedures for granting authorization to use narcotic and psychotropic substances for medical or scientific purposes.

According to Article 3, the authorization provided for by this Decree No 07-228 may be granted only if the use of the plants, substances and preparations is intended for medical or scientific purposes.

 

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

The Ministry of Health is the national regulatory authority with jurisdiction over medicinal cannabis.

 

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

The Decree No 07-228 dated 30 July 2007 and published in the Official Gazette, laying down the procedures for granting authorization to use narcotic and psychotropic substances for medical or scientific purposes, alongside with the Law No 04-18 dated of 25 December 2004 and published in the Official Gazette, on the prevention and repression of the illicit use and trafficking of narcotic and psychotropic substances, form together the regulatory framework for medicinal cannabis.

Plants, substances and preparations intended for “compassionate use” under the regimen of temporary authorization for use (“ATU” – “Autorisation Temporaire d’Utilisation”) are regulated under provisions of Article 233 within the Health Law No 18-11, when prescribed as part of the management of serious diseases in situations where there is no equivalent treatment in the national territory, and have proven their therapeutic benefit.

 

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

Production, manufacturing, holding, offer, sale, offer for sale, acquisition, purchase for sale, storage, extraction, preparation, distribution, delivery, brokerage, shipping, transit, transport, export or import of narcotics and/or psychotropic substances and their precursors, as well as cultivation of opium poppy, coca and cannabis plants, are subject to the issuance of an authorization granted by the Minister of Health according to provisions of the Decree No 07-228.

 

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

The application for authorization is to be addressed to the Minister of health and must mention:

• The identification and the quality of the applicant;
• The nature of the proposed transaction;
• The name of the product/substance;
• The quantity in figures and letters of the product;
• The mode of transport envisaged;
• The use that will be made of the product;
• The applicant’s signature;
• An extract from the applicant’s criminal record.

The authorization is issued after a social inquiry into the moral and professional qualities of the applicant, carried out by the services authorized for that purpose, at the request of the Ministry of Health. The applicant must enjoy his civil rights and not have been convicted for the offenses provided for by the Law No 04-18 on the prevention and repression of the illicit use and trafficking of narcotic and psychotropic substances. The validity of the export or import authorization for each operation is three (03) months from the date of delivery.

The pharmaceutical, health or scientific establishments authorized to import substances or preparations classified as narcotic or psychotropic have to report quarterly to the Minister of Health. Their declaration must specify, for each substance/product:

• The quantities of imported products;
• Dosage per unit of setting;
• The form and presentation;
• The name and address of the supplier.

Holders of production authorization are required to draw up an annual report indicating for each narcotic drug or psychotropic substance:

• The quantity received;
• The quantities used for manufacturing or processing, specifying the nature and quantity of the products obtained;
• The quantity sold and its destinations;
• The end-of-year stocks, including those under processing.

This report covering the past year is sent to the Minister of Health no later than February 15th.

 

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

There is not yet a specific regulatory framework for the marketing and distribution.

 

18. How can patients obtain Medicinal Cannabis?

The dispensing of medicinal cannabis is reserved for hospital pharmacies.

 

19. Who can prescribe Medicinal Cannabis?

Medicinal cannabis can be prescribed by any specialized physician providing healthcare services at the exercise hospital where the patient will receive the substance/preparation. The conditions for the prescribing physicians are that they have to be registered on official list of the Doctors Order National Council, not being involved in substances procurement, and not being under prescription ban.

 

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

No, they can be prescribed by any authorized physician according to answer to question 19 above.

 

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

No approvals or notifications are required. Authorized physicians can prescribe medicinal cannabis to their patients in their own discretion.

 

22. Where is Medicinal Cannabis available?

Medicinal cannabis can be only available at hospital pharmacies.

 

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

No.

 

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

There is a new Decree under way that aims to lay down the procedures for specific, administrative, technical and safety control of substances and drugs with psychotropic properties (i.e. including medicinal cannabis) as introduced by Article 245 of Health Law No 18-11 (see answer to question 10 above).

 

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Opioid drugs, i.e. drug products as defined in Article 208 of Health Law No 18-11, dated of 2 July 2018, where the active substance is derived from opium, are authorised in Algeria in accordance with the Health Law No 18-11 provisions related to drugs.

 

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

The National Agency for Pharmaceutical Products (“ANPP” – “Agence Nationale des Produits Pharmaceutiques”, a financially independent institu- tion newly created under Article 223 of Health Law No 18-11, dated of 2 July 2018, and placed under the administrative authority of the Ministry of Health, Population and Hospital Reform (“MSPRH” – “Ministère de la Santé, de la Population et de la Réforme Hospitalière”) is the national regulatory authority with jurisdiction over opioid drugs for human use in Algeria.

 

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

According to Article 245 of the Health Law No 18-11, opioid drugs are subject to a specific administrative, technical and security control that encompasses:

• The production, manufacture, packaging, processing, importing, exporting, offering, distribution, disposal, acquisition, holding of substances, drugs with narcotic and/or psychotropic properties;
• The use of plants or parts of plants with narcotic and/or psychotropic properties.

The overall regulatory framework for the authorization, pricing, and reimbursement remains the same as for the other drugs (see answer to question 2 of “Regulatory, Pricing, and Reimbursement Overview”).

The Prescription and dispensation of opioid drugs is regulated by Ministerial Decree, dated of 29 June 2013 and published in the Official Gazette, fixing conditions for prescribing and dispensing of prescription related to drugs containing substances classified as narcotics.

 

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

According to the national database of drugs for human published in August 2019 by the Ministry of Health, there are several opioid drugs that are already authorized for marketing in Algeria, including morphine (both oral and injectable), fentanyl (injectable), sufentanil (injectable), oxycodone (oral), codeine (oral), and buprenorphine (injectable).

 

29. Who can prescribe Opioid Drugs?

Authorized opioid drugs can be prescribed by any physician providing healthcare services and registered on official list of the Doctors Order National Council, excepting those involved in drugs procurement and those under prescription ban (punished by Article 419 of the Health Law No 18-11).

 

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

No, they can be prescribed by any authorized physician according to answer to question 29 above.

 

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

No approvals or notifications are required. Authorized physicians can prescribe opioid drugs to their patients in their own discretion. Prescribing of opioid drugs is limited to seven (07) days for injectables and to twenty-eight (28) days for oral preparations, and must be written on special prescription extracted from a notebook with stumps: one part must be kept by the prescribing physician, and the second is saved by the pharmacist after dispensing the drugs.

The prescribing physician of opioid drugs must mention in readable plain text the following:

• The identification of the public or private health facility to which the physician belongs;
• The identification of the prescriber: title, function, registration at the doctors ordinal section;
• The precise identification of the patient: name, sex, age, if any, height and weight;
• The identification of the opioid drug(s);
• The detailed formula, the number of units or the volume if it is a compounding preparation;
• The strength or concentrations of substances in case of pharmaceutical specialties.
• The pharmaceutical form, dosage, duration of treatment and route of administration;
• The number of therapeutic units per dose;
• The number of doses.

 

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

According to national regulations, authorized opioid drugs are only imported by public institutions and dispensed to patients through hospital pharmacies or authorized private community pharmacies (see answer to question 14 of “Regulatory, Pricing, and Reimbursement Overview”).

According to the Ministerial Decree dated of 29 June 2013, a prescription related to opioid drugs may be dispensed in its entirety or for the entire fraction of the treatment, only if it is presented to the pharmacist in forty-eight (48) hours from the date of its establishment, or after the end of the previous fraction. If it is submitted after this period, it can only be executed for the duration of the prescription, or the fraction of treatment remaining to be covered.

In addition, it is forbidden to prescribe and to deliver substances classified as narcotics when they are not contained in a pharmaceutical specialty or a compounding preparation.

 

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

All hospital pharmacies are authorized, and any private community pharmacy is eligible for authorization.

 

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

No, there is no plan for reform in relation with opioid drugs regulation.

 

35. When are they likely to come into force?

Not applicable.

 

 

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

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reforms
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
9. Orphan Drugs and Rare Diseases
10. Localization
11. Biosimilars and Biologics

Also from this Legal Handbook

Regulatory reforms in Algerian Pharma – a comprehensive legal overview. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.

 

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

Yes, there is an important reform that is ongoing and which concerns the authority in charge of regulating drugs, biologicals and medical devices for human use at the level of the Ministry of Health, Population and Hospital Reform (“MSPRH” – “Ministère de la Santé, de la Population et de la Réforme Hospitalière”).

According to provisions of Article 223 within the Health Law No. 18-11 dat- ed of 2 July 2018, a National Agency for Pharmaceutical Products (“ANPP” – “Agence Nationale des Produits Pharmaceutiques”) is established. It possesses a specific public institution status, with legal personality and financial autonomy, and is placed under the administrative authority of the Minister of Health.

ANPP ensures public service missions in the matter of:

• Evaluation of the benefits, risks and therapeutic value of drugs, biologicals and medical devices and their medico-economic assessment;
• Authorization of drugs and biologicals by granting of a registration decision, its renewal, and where appropriate, its suspension, withdrawal, or transfer, after the positive opinion of the Pharmaceutical Products Registration Commission;
• Authorization of medical devices by granting a homologation decision, its renewal, and where appropriate, its suspension, withdrawal, or transfer, following the positive opinion of the Medical Devices Homologation Commission;
• Issuance of an opinion on temporary use authorizations (ATU) for non-registered products;
• Definition of the rules of good practices of manufacture, storage, distribution and dispensing of pharmaceutical products;
• Carrying out on-site audits and inspections, in particular on the monitoring of compliance with the rules of good pharmaceutical practices and medical devices standards;
• Quality control of drugs, biologicals and medical devices, as well as the maintenance of standard substances and reference products at the national level;
• Specific control of substances and drugs with narcotic and/or psychotropic properties;
• Taking the necessary measures to safeguard public health when a drug or a medical device is, or is suspected, to present a danger to human health;
• Issuance of prior authorizations for the scientific information, promotion and advertising of authorized pharmaceutical products to health professionals;
• Issuance of an opinion on the standards, rules of good practice, procedures and methods applicable to clinical studies on drugs, biologicals and medical devices;
• Issuance of the price certificates of drugs and medical devices, after fixation by the Pharmaceutical Products Pricing Committee;
• Participation in drawing up the list of reimbursable medicines by Pharmaceutical Products Reimbursement Committee;
• Participation in the drafting of legislative and regulatory texts governing the drugs, biologicals and medical devices;
• Participation in international cooperation actions, in accordance with the legislation and the current regulations;
• Undertaking any study, research, training or information action in the fields of its competence and to contribute to the promotion of scientific research in the field of pharmaceutical products;
• Contribution to the establishment of updated nomenclatures, the development of the lists of essential drugs and medical devices, the national formulary and the national pharmacopoeia;
• Contribution to strategic plan for the development of national pharmaceutical sector.

The financial resources of the ANPP come in particular from:

• Subsidies included in the Government budget;
• Revenues related to the activity of the agency, including fees paid by pharmaceutical companies for the registration, homologation and advertising of drugs and medical devices;
• Income from the services provided;
• Donations and legacies;
• Any other income related to its activity.

Structures in charge of the missions devolved to ANPP under provisions of the Health Law No 18-11, including the General Directorate of Pharmacy and Health Equipment (“DGPES” – “Direction Générale de la Pharmacie et des Equipements de Santé”) and the Pharmaceutical Products National Control Laboratory (“LNCPP” – “Laboratoire National de Contrôle des Produits Pharmaceutiques”) continue to assume these missions until the full establishment of the Agency.

 

2. When are they likely to come into force?

Ongoing regulatory reform related to the establishment of the ANPP is likely to enter in application during the 2020-2021 biennium. The transfer process is gradual and follows a stepwise approach.
The Decree No 19-190 dated of 3 July 2019, setting out missions, organization and operating of the National Agency for Pharmaceutical Products (ANPP), has been published in the Official Gazette No 43 dated of 7 July 2019.

The headquarters of the ANPP was set in Algiers, while regional annexes of the agency may be created by order of the Minister of Health. Furthermore, activities related to products assessment, registration of drugs, and homologation of medical devices, have already been transferred from DGPES to ANPP.
The LNCPP was dissolved and all its building, laboratories, means, personnel and rights will be transferred to the ANPP. This transfer operation must be carried out, at the latest, within one (1) year from the date of publication of the Decree No 19-190 in the Official Gazette.

In addition, important legislative texts are under way and should be released during the 2020-2021 biennium. This covers specific regulations that the ANPP is working on in relation with OTC products and Similar Biotherapeutic Products, whose legal anchorages have been introduced as part of the Health Law No. 18-11 dated of 2 July 2018.

At the same time, there is deadline fixed to, at the latest, two (2) years from the date of publication of the Health Law No 18-11 in the Official Gazette, to update the pharmaceutical regulations through the revision of existing legislative texts (detailed in the answer to question 1 of “Regulatory, Pricing, and Reimbursement Overview”).

 

 

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

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reforms
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
9. Orphan Drugs and Rare Diseases
10. Localization
11. Biosimilars and Biologics

Also from this Legal Handbook

Want to know more about patents & trademarks in Algerian Pharma? Read on! Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.

 

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

Patents Ordinance No 03-07 and Trademarks Ordinance No 03-06, both dated of 19 July 2003 and published in the Official Gazette, form the legislative framework for requirements related to patents and trademarks protection in Algeria.

a) Patents

Patent application shall be filed directly with the competent agency or sent by post with acknowledgment of receipt, or any other appropriate means indicating the confirmation of receipt.

The application must include the following documents:

• Request for grant in 4 examples, drawn up on a form provided by the competent agency;
• Description of the invention, claims, drawings, if the latter are necessary for the understanding of the description, and a descriptive abstract whose content does not exceed 250 words, provided in duplicate, both in Arabic and in French;
• Proxy to the legal representative, if the applicant is represented by an authorized agent;
• Priority document, where a priority according to the Paris Convention for Industrial Property is claimed, and a certified copy of the original application within 03 months from the application;
• Assignment of priority right, if the applicant is not the holder of the earlier application claimed;
• Declaration by which the applicant justify his right to the patent;
• Payment receipt or title of payment of the filing and publication fees: 7.500 and 5.000 DZD respectively (approx. 63 and 42 USD), in addition to priority claim fees, if applicable: 2.000 DZD (approx. 17 USD).

The patent validity is of twenty (20) years from the filing date of the application, but is subject to the payment of the registration and maintenance fees: from 5.000 to 18.000 DZD/year (approx. 42 to 151 USD/year).

b) Trademark:

The trademark right is acquired by registering it with the competent agency. The registration of a trademark has a validity of ten (10) years with retroactive effect to the date of filing of the application. Registration may be renewed for consecutive periods of ten (10) years starting on the day following the expiry date of the previous period.

Except for theft, the trademark belongs to the person who first fulfilled the conditions required for the application or who first validly invoked the earliest priority for his deposit within the meaning of the Paris Convention.

The application for registration of the trademark must include:

• Registration request in 3 examples, drawn up on a form provided by the competent agency;
• Reproduction of the trademark whose dimensions do not exceed the scope provided for this purpose in the official form. Where color is claimed as a distinctive and constitutes a feature of the trademark, the applicant must attach reproductions in color to the application;
• Clear and complete list of products and/or services covered;
• Proxy to the legal representative, if the applicant is represented by an authorized agent;
• Priority justification document, if applicable.
• Payment receipt or title of payment of the filing and publication fees: 14.000 to 15.000 DZD (approx. 118 to 126 USD) and 2.000 DZD per class of products and/or services covered (approx. 17 USD/class), in addition to priority claim fees, if applicable: 1.000 DZD (approx. 9 USD).

On 31 October 2015, Algeria has acceded to the Madrid Protocol for international trademark protection, which is now effective across the entire Madrid system. Therefore, trademark owners in Algeria benefit from a full access to the territories covered by the Madrid Protocol.

To achieve that, a request for extension of the trademark protection to designated countries is to be submitted with the national competent agency by paying a national fee of 4.000 DZD (approx. 34 USD). A simulation of the total amount to be paid is subsequently communicated to the applicant. If the latter decides to continue the procedure, he must express this to the national competent agency that will fill the appropriate form and send it to WIPO accompanied by the trademark registration or the basic application (national), containing reproduction of the trademark object of the request.

 

2. What agencies or bodies regulate patents and trademarks?

The nationally competent agency for patents and trademarks protection is the Algerian Industrial Property National Institute (“INAPI” – Institut National Algérien de la Propriété Industrielle), which is a Ministry of Industry and Mines institution.

INAPI examines the applications filed, proceeds to the grant of patents and trademark registration certificates when it finds that there are no grounds for refusal, keeps dedicated special registers where all acts are recorded, and publishes the Industrial Property Official Bulletin (“BOPI” – “Bulletin Officiel de la Propriété Intellectuelle”).

 

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

a) Patents:

Under Patents Ordinance No 03-07 dated of 19 July 2003, inventions related to a product or process, which are new, result from an inventive step and which are susceptible of industrial application, can be protected by a patent in Algeria.

An invention is considered as new if it is not included in the state of the art, which consists of everything made accessible to the public by a written or oral description, a use or any other means anywhere in the world before the day of filing the application for protection or the priority date validly claimed for it.
Are not considered as inventions:

• Scientific principles, theories and discoveries, as well as mathematical methods;
• Plans, principles or methods with a view to performing purely intellectual or playful actions;
• Methods and systems of teaching, organization, administration or management;
• Methods of treatment of the human or animal by surgery or therapy, and diagnostic methods;
• Simple presentations of information;
• Computer programs;
• Creations of exclusively ornamental character.

Patents cannot be obtained for:

• Plant or animal varieties and essentially biological processes for production of plants or animals;
• Inventions whose implementation would be contrary to public order or morality;
• Inventions whose exploitation would be detrimental to the health/life of persons and animals, or to the preservation of plants, or would seriously affect the environment protection.

b) Trademarks:

Under Trademarks Ordinance No 03-06 dated of 19 July 2003, are defined as a trademark, any signs susceptible of a graphic representation, in particular words, including names of persons, letters, figures, drawings or images, characteristic shapes of the products or their packaging, colors, alone or in combination between, intended and able to distinguish the products or services of a natural or legal person from those of others.

Are excluded from trademarks registration in Algeria:

• Signs that do not constitute trademarks within the meaning of the aforementioned definition;
• Signs belonging to the public domain or devoid of any distinctive character;
• Signs consisting of the shape of the products or their packaging, if that shape is imposed by the nature or function of those products or packaging;
• Signs contrary to public order or morality, and whose use is prohibited under national law or bilateral or multilateral conventions to which Algeria is a party;
• Signs which reproduce, imitate or contain among their elements coats of arms, flags or other emblems, the name, abbreviation or acronym or official sign or hallmark of control and guarantee of a State or an international organization, unless authorized by the competent authority;
• Signs likely to mislead the public or commercial places as to the nature, quality, provenance or other characteristics of the products or services;
• Signs which consist exclusively or partly of an indication which may give rise to confusion as to the geographical origin of the products or services in question or which, if registered as a trademark, would unduly hamper the use of the geographical indication by other persons entitled to use this indication;
• Signs identical or confusingly similar to a trademark or trade name that is notoriously known in Algeria for identical or similar products of another company, or signs that constitute a translation of that trademark or this trade name;
• Signs identical or similar to a trademark that has already been the subject of an application for protection, or registration for products or services identical or similar to those for which the trademark is registered in where such use would result in a likelihood of confusion.

 

4. How can patents and trademarks be revoked?

a) Patents:

The forfeiture of a patent occurs in the event of non-payment of the maintenance fees, on anniversary date of the application: from 5.000 to 18.000 DZD/ year (approx. 42 to 151 USD/year).

However, a grace period of six (6) months from that date is granted to the patent holder to pay the taxes due plus a late penalty of equal amount. Nevertheless, at the reasoned request of the holder, made at the latest six (6) months after the expiry of the grace period, the competent department can decide to restore the patent after payment of the taxes due and a restoration tax of 5000 DZD (approx. 42 USD).

Besides that, total or limited nullity to one or more claims of the patent could be pronounced by the competent court, at the request of any interested person:

• If the subject matter of the patent does not meet the conditions of
  patentability;
• If the description of the invention does not satisfy the disclosure requirements of the invention;
• If the claims of the patent do not define the expected protection;
• If the same invention was the subject of a patent in Algeria following a previous application or benefiting from an earlier priority.

When the decision of nullity has become final, the most diligent party shall notify it to the competent agency (“INAPI”) which proceeds to its recording in the patents register and its publication in the Industrial Property Official Bulletin (“BOPI”).

b) Trademarks:

The competent court could revoke the registration of a trademark:

• at the request of the competent department (“INAPI”) or an interested third party, if one of the grounds for exclusion arises after registration and still exists at the time of the revocation decision. However, the registration is not revoked when the trademark has acquired distinctiveness after registration;
• at the request of an interested third party, if the trademark has not been used.

The exercise of the right conferred by the registration of a trademark is subject to the genuine use of the trademark on the products or their packaging, or in relation to the services which the trademark serves to distinguish. Failure to use will result in the revocation, except in the following cases:

• When the defect of use does not last more than three (3) years uninterrupted;
• Where, before the expiry of that period, the holder furnishes proof that serious circumstances justify the lack of use; in this case, an extension of time not exceeding two (2) years is granted.
• If the conditions set out are only met for some of the products or services for which the trademark is registered, the revocation of the trademark extends only to those products or services.
• The final judicial decision pronouncing the revocation of the trademark registration is to be recorded by the competent agency (“INAPI”) on the trademarks register and is published in the Industrial Property Official Bulletin (“BOPI”).

 

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

a) Patents:

Algeria is a signatory to the Patent Cooperation Treaty (PCT) that entered into force in the territory on 8 March 2000. According to Patents Ordinance No 03-07 dated of 19 July 2003, a patent application to which an international filing date has been granted under the PCT, and which indicates Algeria as a designated State for the purpose of obtaining a patent, will be considered as a valid application as long as it has been filed with the competent agency (“INAPI”), and the relevant date for that application will be the international filing date.

Under provisions of Patents Ordinance No 03-07, applicants domiciled abroad have to be represented at the competent agency (“INAPI”) by a legal representative chosen among authorized agents whose names are published on the agency website.

b) Trademarks:

Algeria has signed the Madrid Agreement since 5 July 1972, and has acceded to the Madrid Protocol for international trademark protection on 31 October 2015. Therefore, trademarks registered through the international application are recognized in Algeria, and the validity of the registration for a period of ten (10) years applies with retroactive effect from the international filing date.

Under provisions of Patents Ordinance No 03-06, applicants domiciled abroad have to be represented at the competent agency (“INAPI”) by a legal representative chosen among authorized agents whose names are published on the agency website.

 

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

No, there is no any non-patent/trademark barrier to competition to protect drugs or medical devices.

Regulatory authorities with jurisdiction over drugs, biologics and medical devices in Algeria do not confer exclusive right to benefit from the proprietary pre-clinical and clinical data for a set period of time, also called Regulatory Data Protection (RDP), to innovative companies at the moment of granting the market authorization, and generic manufacturers are allowed to rely upon those data to obtain approval of their abbreviated applications.

 

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

No, there are no restrictions to any type of drugs or medical devices that can be granted patent and trademark protection, without compromising patentability conditions and trademark definition provided in Patents Ordinance No 03-07 and Trademarks Ordinance No 03-06, respectively.

However, a compulsory license may be granted at any time by the Minister of Industry and Mines (whose ministerial department is in charge of Industrial Property) to a State service or a third party designated by the Minister, for a patent application or for a patent, in one of the following cases:

• Where the public interest, in particular national security, nutrition, health or development of other sectors of the national economy so require, and in particular where for patented pharmaceutical products, excessive prices or discriminatory in relation to average market prices are fixed;
• When a judicial or administrative body judges that the manner in which the patent holder or his licensee exploits the invention is anticompetitive, and when the Minister of Industry and Mines is convinced that the exploitation of that invention through a compulsory license will remedy this practice.

 

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

a) Patents:

The clauses contained in the license agreements are deemed to be invalid insofar as they impose on the licensee at the industrial or commercial level, limitations constituting an abuse of the rights conferred by the patent having an effect detrimental to competition in the domestic market.

According to Patents Ordinance No 03-07 dated of 19 July 2003, valid patent licenses have to be duly recorded on patents register before the competent agency (“INAPI”).

b) Trademarks:

The license agreement must, on pain of nullity, contain the trademark, the duration of the license, the products or services for which the license has been granted and the territory for which the trademark may be affixed or the quality of the products manufactured or services provided by the licensee.

According to Trademarks Ordinance No 03-06 dated of 19 July 2003, valid trademark licenses have to be duly recorded on trademarks register before the competent agency (“INAPI”).

 

 

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

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reforms
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
9. Orphan Drugs and Rare Diseases
10. Localization
11. Biosimilars and Biologics

Also from this Legal Handbook

The key facts about product liability in Algerian Pharma. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.

 

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

In Algeria, any product intended for consumption and/or use, under normal or reasonably foreseeable conditions of use, including of duration, must present no risk or only reduced risks at a low level compatible with the use of the product, considered acceptable in respect of a high level of protection for the health and safety of persons (as per Article 3 of Consumer Protection and Fraud Repression Law No 09-03 dated of 25 February 2009, published in the Official Gazette).

When a product causes bodily, material and/or pecuniary damage to consumers, any person involved in all stages of the process of release for consumption (manufacturer, importer, wholesaler or retailer) to whom is attributable the event giving rise to such damage, is deemed responsible. The product liability covers any breach of the obligations provided for in Consumer Protection and Fraud Repression Law No 09-03 related to:

• hygiene and sanitation (Articles 6 and 7);
• product safety (Article 9);
• checking the conformity of the product before it is released for consumption (Article 12);
• testing the product (Article 15);
• information and labeling (respectively Articles 17 and 18).

Depending on the defect and the harm caused by the product to consumers, the person responsible of the bodily, material and/or pecuniary damage incurs:

• administrative penalties (Articles from 53 to 66 within Consumer Protection and Fraud Repression Law No 09-03);
• civil penalties (Article 140 bis of the Civil Code);
• penal sanctions (Articles from 68 to 95 within Consumer Protection and Fraud Repression Law No 09-03).

 

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

All of the above product liability types apply to drugs and medical devices manufacturers.
Administrative penalties as part of the product liability include:

• warning;
• fine;
• seizure of illegal earnings or property;
• order to stop manufacturing activities;
• suspension or withdrawal of licenses;
• administrative detention; and other administrative punishments as stipulated in Consumer Protection and Fraud Repression Law No 09-03 (Articles from 53 to 66).

According to Article 432 of the Penal Code, if a falsified pharmaceutical product resulted for the person who has consumed it or to which it has been administered, an illness or an incapacity for work, the author of the falsification as well as whoever has offered for sale or sold the said product knowingly falsified are punished by imprisonment of five (5) to ten (10) years, and a fine of 500.000 to 1.000.000 DZD (approx. 4.175 to 8.350 USD).

When the aforementioned falsified product causes either incurable disease, loss of use of an organ, or permanent disability, they are punishable by imprisonment for ten (10) to twenty (20) years and a fine of 1.000.000 to 2.000.000 DZD (approx. 8.350 to 16.700 USD), and when it causes the death of a person, the penalty is life imprisonment.

Under provisions of Health Law 18-11 Article 211, “falsified product” means any product with a false presentation of:

• its identity, including its packaging and labeling;
• its name or composition, including excipients and all components amount;
• its source, including its manufacturer, country of manufacture, or country of origin;
• its history, including authorizations, records and documents of the used distribution channels.

Besides that, Article 168 of Insurance Ordinance 95-07 dated of 25 January 1995 published in the Official Gazette, requires that any person who manufactures, imports or distributes pharmaceutical products for consumption or use shall take insurance for professional civil liability towards consumers or users and third parties (product liability insurance).

 

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

Claims could extend to corporate executives, employees, and representatives of the pharmaceutical company, who were deemed responsible of bodily, material and/or pecuniary damage to consumers as consequence of deliberate misconduct, falsification, forgery, fraud, or negligence.

The product liability is also extended to the pharmacist technical director under whose responsibility the technical management of any authorized pharmaceutical establishment (manufacturer, importer or distributer) is put to insure the satisfactory compliance with regulatory requirements.

Without prejudice to civil penalties and penal sanctions incurred, breaches of the obligations set out in the Health Law No 18-11, as well as the rules of medical ethics, expose the pharmacist technical director to disciplinary sanctions too.

 

4. How can a liability claim be brought?

A product liability claim can be brought by the aggrieved party as plaintiff in civil or criminal courts that have jurisdiction. In addition, administrative claim for investigation could be filled before:

• The Pharmaceutical Products National Agency “ANPP” – “Agence Nationale des Produits Pharmaceutiques”, that is gradually replacing former “DGPES” – “Direction Générale de la Pharmacie et des Equipements de Santé” at Ministry of Health.
• The National Center for Pharmacovigilance and Materiovigilance “CNPM” – “Centre National de Pharmacovigilance et de Matériovigilance”), which is a Ministry of Health institution.
• One of the 9 Regional Commerce Directorates “DRC” – “Directions Régionales du Commerce” or one of the 48 Provincial Commerce Directorates “DCW” – “Directions du Commerce de Wilaya”, which are attached to Ministry of Commerce.

 

5. What defenses are available?

There is no limit to defenses that could be used to demonstrate absence of legal obligations breach, or causation between the product / manufacturer responsibility and damage argued by the plaintiff. Defenses will depend on the case and the object of the claim.

 

 

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

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reforms
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
9. Orphan Drugs and Rare Diseases
10. Localization
11. Biosimilars and Biologics

Also from this Legal Handbook

All legal aspects surrounding traditional medicines and OTC products in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.

 

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

Traditional, herbal and complementary products are commonly regulated by Ministry of Commerce under provisions of Consumer Protection and Fraud Repression Law No 09-03 dated of 25 February 2009, published in the Official Gazette, along with the following regulations:

• Decree No 13-378 dated of 9 November 2013, published in the Official Gazette, laying down the terms and conditions related to consumer information;
• Decree No 12-203 dated of 6 May 2012, published in the Official Gazette, related to the rules applicable to product safety;
• Interministerial Decree dated of 19 October 2017, published in the Officiel Gazette, setting the terms and conditions applicable to labeling of products assimilated to foodstuffs.

However, products that contain non-food substances giving them curative or preventive properties are to be considered as drugs, and therefore are regulated as such by Ministry of Health under provisions of Health Law No 18-11 dated of 2 July 2018, published in the Official Gazette.

As per provisions of Article 210 within the Health Law No 18-11, products possessing properties useful for human health, and whose active substances are exclusively one or more herbal substances or preparations (excluding psychotropic and narcotic compounds), have an herbal-based drug status and are subject to a simplified authorization process. Exception to this rule occurs when active substances are isolated or chemically defined, in which situation chemical-based drug regulations are applicable.

Whereas presence of vitamins or minerals is not a criterion for considering a product as drug, the specified claimed indication and dietary daily reference intakes are determinant for the classification.

Besides that, monitoring of adverse reactions and/or incidents following the use of traditional, herbal or complementary products are under the scope of the National Center for Pharmacovigilance and Materiovigilance (“CNPM” – “Centre National de Pharmacovigilance et de Matériovigilance”), created by Decree No 98-192 dated of 3 June 1998 published in the Official Gazette, which is a Ministry of Health institution.

 

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

Marketing and advertising to the public for products regulated as drugs by Ministry of Health (under provisions of Health Law No 18-11) are prohibited regardless of the channel used, but such activities are tolerated for other traditional, herbal and complementary products regulated by Ministry of Commerce (under provisions of Consumer Protection and Fraud Repression Law No 09-03) without infringement of the terms and conditions related to consumer information set in Decree No 13-378 dated of 9 November 2013.

Traditional, herbal, complementary, and alternative products were included in the Ministerial Decree No 52 dated of 10 July 1995, published in the Ministry of Health Bulletin, fixing the list of goods authorized for sale in community pharmacies. Thus, these products can directly be sold to consumers at community pharmacies, and other shops authorized by Ministry of Commerce (excluding products having the drug status, exclusively sold through authorized community pharmacies).

 

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

The use of any health claim is subject to the prior agreement of the Ministry of Health competent services, according to Article 23 of the Interministerial Decree of 19 October 2017, setting the terms and conditions applicable to labeling of products assimilated to foodstuffs.

Under requirements of Decree No 13-378 dated of 9 November 2013, laying down the terms and conditions related to consumer information, any representation or advertising that states or suggests that a product has particular qualities related to its origin, properties, manufacturing, composition or any other quality, shall not be misrepresented, deceptive or likely to create an erroneous impression of its nature in such a way as to mislead the consumer, and as such should not:

• be inaccurate, ambiguous, or unjustified;
• raise doubts as to the safety and/or suitability of the product;
• encourage or tolerate excessive consumption of the product;
• suggest that a balanced and varied diet cannot provide all the nutrients in sufficient quantity;
• mention changes in body functions that may inspire fear to the consumer in the form of texts, pictures or symbolic representations.

 

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

Definition for over-the-counter (OTC) medications was introduced for the first time in the Health Law No 18-11 dated of 2 July 2018, published in the Official Gazette. They were defined as drugs that can be directly dispensed to consumers by pharmacists without prior medical prescription, and whose list is to be established by Ministry of Health.

There is no specific authorization process for OTC medications according to Health Law No 18-11, and they are assessed as drugs by Ministry of Health according to Article 230 within the same law.

 

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

OTC medications can be directly sold to consumers, but only at authorized community pharmacies under pharmacist advice. According to Algerian regulations, they cannot be sold or delivered via post or other unauthorized channels.

 

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

Under local regulations requirements, scientific information on OTC medications is mandatory (as for all authorized drugs). It must be accurate, verifiable, and in accordance with demonstrated medical data, especially for: therapeutic indications; dosage, adverse effects; contraindications; warnings, precautions for use, and drug interactions, if any. Scientific information provided is intended for health professionals and users in order to ensure the proper use of OTC medications.

Marketing and advertising of OTC medications are authorized for health professionals, but without being misleading or detrimental to the protection of public health. Advertising must present the product objectively and always promote its proper use, with respect to the provisions of the product market authorization and the therapeutic strategies recommended by the Ministry of Health.

International Nonproprietary Name (INN) has to be mentioned on internal and external packaging, as well as all scientific information, marketing and advertising supports. Each OTC product must be accompanied by a leaflet easily legible, written in Arabic and in French.

 

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

According to the Health Law No 18-11 provisions, marketing and advertising for drugs to the public are prohibited regardless of the channel used. Therefore, marketing and advertising of OTC medications (included in the drug definition) are only limited to health professionals with being subject to prior technical visa of Ministry of Health which sets the list of these products.

 

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

There is no provision within the Health Law No 18-11 for switch process of prescription-only drugs to OTC status. This mechanism shall be established in underlying regulations.

 

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

Authorized importers receive an annual import permit granted by Ministry of Health for a defined list of approved products that are regulated as drugs under Health Law No 18-11 provisions. Importation must comply with technical requirements for the import of drugs and medical devices for human use set by the Ministerial Decree of 30 October 2008, published in the Official Gazette.

For products regulated by Ministry of Commerce under provisions of Consumer Protection and Fraud Repression Law No 09-03, multiyear open import license for a group of products is granted to the authorized importers. Requirements of Decree No 05-467 dated of 10 December 2005 published in the Official Gazette, setting the conditions and procedures for border control of the imported products conformity, are applicable.

 

 

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

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reforms
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
9. Orphan Drugs and Rare Diseases
10. Localization
11. Biosimilars and Biologics

Also from this Legal Handbook

Marketing, manufacturing, packaging & labeling, advertising in Algerian Pharma – an overview. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.

 

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

To obtain market authorization for new drugs, biologics and medical devices in Algeria, submission of application to Ministry of Health is required, and must be accompanied by a submission dossier that includes clinical data. Authorization process is detailed in answer to question 3 of  “Regulatory, Pricing, and Reimbursement Overview”.

There is no specific authorization process for over-the counter (OTC) medications according to Article 230 of Health Law No 18-11, dated of 2 July 2018, defined within the same law as drugs that could be dispensed through authorized community pharmacies without prior physician prescription, and whose list is established by Ministry of Health.

Under Health Law No 18-11 provisions, some dietary supplements and herbal products could be considered as drugs, and are therefore assessed by Ministry of Health.

 

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

Market authorization process for generic products is the same as for brand-name products, except that generic products are in general exempted from submitting pharmacological, toxicological and clinical tests. The Ministry of Health could request that the in vivo bioequivalence of the generic product be demonstrated against the brand-name product already on the market.

 

3. What are the typical fees for marketing approval?

Marketing approval fees for new drugs, biologics, and medical devices are fixed as part of Finance Law. They depend of the product type, importance and origin (imported or locally manufactured). As at July 2019, the current authorization fees are ranging between 100.000 DZD and 1.000.000 DZD (approx. 835 to 8.350 USD). Fees amount is detailed in answer to question 4 of “Regulatory, Pricing, and Reimbursement Overview”.

 

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

Market authorization is granted for a period of five years. For renewal process details, see answer to question 5 of “Regulatory, Pricing, and Reimbursement Overview”.

 

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

The market authorization holder is obliged to notify any identified event related to the product safety that occurred locally or abroad, including those supposedly attributable to vaccination, and must report regularly or upon request to the National Center for Pharmacovigilance and Materiovigilance (“CNPM” – “Centre National de Pharmacovigilance et de Matériovigilance”), created by Decree No 98-192 dated of 3 June 1998 and published in the Official Gazette.

The CNPM missions include:

• Monitoring adverse reactions due to the use of drugs on the market and incidents or risks of incidents resulting from the use of medical devices.
• Carrying out any study or research related to the safety of use of drugs and medical devices during administrations and various uses to perform prophylactic, diagnostic and therapeutic acts.

 

6. Are foreign marketing authorizations recognized?

Yes. Foreign marketing authorizations are recognized and required for imported products under provisions of Decree No 92-284 dated of 6 July 1992, published in the Official Gazette, and related to registration of pharmaceutical products for human use. The foreign market authorization applicant in Algeria has to designate a reference market abroad (referred at as country of origin).

In addition, a valid Certificate of Pharmaceutical Product issued by the competent regulatory authorities of country of origin in the format recommended by the World Health Organization + copy of valid marketing authorization in country of origin and/or CE marking certificate (for medical devices) are required as part of initial submission dossier and for the 5-year renewal.

Nevertheless, imported drugs, biologicals and medical devices cannot be marketed in Algeria unless they have been granted authorization by Ministry of Health (“registration decision” for drugs and biological, “homologation decision” for medical devices, according to Article 230 of Health Law No 18-11, dated of 2 July 2018).

 

7. Are parallel imports of medicines or devices allowed?

No. All imported products must be authorized in Algeria before entering the national territory, and no entity, other than importers authorized by Ministry of Health, is allowed to import any drug or medical device in Algeria.

Authorized importers receive an annual permit for a defined list of products granted by Ministry of Health, and should comply with technical requirements for the import of drugs and medical devices for use in human medicine set by Ministerial Decree dated of 30 October 2008, published in the Official Gazette.

Products intended for “compassionate use” under the regimen of temporary authorization for use (“ATU” – “Autorisation Temporaire d’Utilisation”) require the prior authorization granted by Ministry of Health under provisions of Article 233 within Health Law No 18-11, when they are prescribed as part of the management of serious diseases in situations where there is no equivalent treatment in the national territory, and have proven their therapeutic benefit.

Non-registered products used locally as part of clinical trials approved protocols are also requiring special authorization for import, issued by Ministry of Health according to Article 389 of Health Law No 18-11.

 

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 Article 27 of Decree No 92-286 dated of 6 July 1992, related to scientific and medical information on pharmaceutical products for human use, and published in the Official Gazette, manufacturers, importers, promotion companies, medical representatives are prohibited from giving or allowing directly or indirectly to give bonuses, objects or products of any kind, or material benefits of any nature whatsoever to health professionals and practitioners. However, scientific activities as well as congresses, seminars and meetings can benefit from donations, or material and financial support, subject to a prior declaration to Ministry of Health.

Under provisions of Article 237 within Health Law No 18-11, free medical samples for advertising and promotion are now expressly prohibited from being offered to health professionals and practitioners.

 

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

Health Law No 18-11, dated of 2 July 2018, along with Decrees No 93-114 dated of 12 May 1993, and No 92-285 dated of 6 July 1992, related to authorization of pharmaceutical products manufacturing and distribution sites, published in the Official Gazette, form the legislative framework for manufacturing of drugs, biologicals and medical devices in Algeria.

Compliance of the activities carried out by manufacturers is monitored and evaluated by Ministry of Health, at which “ANPP” – “Agence Nationale des Produits Pharmaceutiques”, a financially independent agency newly created by Article 223 of Health Law No 18-11, dated of 2 July 2018, will gradually replace former “DGPES” – “Direction Générale de la Pharmacie et des Equipements de Santé”, upon its establishment.

 

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

Yes. Local manufacturing requirements refer to the GMPs as defined by the European Medicines Agency, and to those of U.S. Food & Drug Administration as guidance. Therefore, the requirements are compatible.

 

11. What is the inspection regime for manufacturing facilities?

Under Health Law No 18-11, all manufacturers have an obligation to accept GMP compliance inspection by the Algerian Ministry of Health, at the time of examination of market authorization, and within every five years thereafter. Inspections could also be conducted at any time, with or without prior notice, to inspect premises and verify compliance with the local regulatory requirements.

 

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

Despite the fact that there are no specific regulations on this matter, foreign inspectors (including US FDA/EMA) and third-party inspectors are performing inspections in local manufacturing facilities, especially for toll manufacturing contracting and in context of export.

 

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

Conducting of these activities is strictly limited to pharmaceutical establishments defined in the Health Law No 18-11 as companies organized according to the legal forms provided for by Commercial Code, and subject to the prior approval of Ministry of Health competent services.

Manufacturers and importers undertake to distribute the drugs and medical devices exclusively to wholesalers who are duly authorized, inspected and distributed throughout the national territory. At the same time, wholesalers commit to source the products only from authorized manufacturers or importers that are inspected by Ministry of Health.

Technical management of all authorized pharmaceutical establishments is put under the responsibility of a pharmacist technical director fulfilling the conditions of professional qualification and exercise set by regulation. His main duty is to insure the satisfactory compliance with the Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs) requirements.

 

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

a) For drugs:

The internal and external packaging must include the following mentions, easily legible, in apparent and indelible characters in Arabic and in French:

• trade name;
• International Nonproprietary Name (INN) printed in large print or, failing that, the usual name;
• registration decision number in Algeria;
• date of manufacture, by printing the first three letters of the month and the year;
• expiry date by printing the first three letters of the month and the year;
• pharmaceutical form;
• centesimal formula with precise indications of active substances;
• active ingredient content per unit and per package;
• lot number;
• manufacturing site and the country of origin;
• particular conditions of storage and conservation;
• special conditions of dispensation (registration on lists I or II);
• duration of stability in the case of a preparation to be reconstituted;
• name and address of the manufacturer;
• barcode.

b) For medical devices:

The internal and external packaging must comply with international standards in force and bear the following words, in Arabic and in French:

• name of the product;
• nature of the product, if any;
• method of use of the product, if any;
• technical characteristics;
• sterilization method;
• particular conditions of storage;
• dates of manufacture and expiry;
• lot number;
• particulars, especially for sterile medical devices (non-reusable);
• name and address of the manufacturer.

Each drug or medical device must be accompanied by a leaflet easily legible, written in Arabic and in French, and containing, in addition to the information required above, the following information:

• therapeutic indications;
• strength;
• adverse effects;
• contraindications;
• warnings, if any;
• precautions for use, if any;
• drug interactions, if any;
• duration of stability in the case of a preparation to be reconstituted;
• name and address of the manufacturer’s registered office;
• other particulars necessary for the proper use of the product, including oral form, chewable, diluted solution, etc.

 

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

Addition information is not specified in regulations, but false, exaggerated or misleading information is expressly prohibited to be included in labeling and packaging. In general, all relevant information that may help to a better understanding of the information (pictograms, icons, different colors and elements of design, etc…), and lead to the best possible use of the drug or medical device is accepted by Ministry of Health.

 

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

Are prohibited from being included in labeling and packaging all items that are not strictly concordant with the information submitted by the market authorization holder and approved by Ministry of Health, including all false, disguised, misleading, indirect, subliminal, or unfair information, as well as indication, usage, administration, or expiration information which are not approved in Algeria.

Besides that, tags cannot be affixed to the packaging to correct or add information except those related to authorized public price and reimbursement status that are attached by manufacturers or importers in accordance with regulatory requirements.

 

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

Under local regulations, scientific information on pharmaceutical products is considered as mandatory, and is defined as information that must be accurate, verifiable and in accordance with the latest data from medical and scientific research, at the time of its release. It is intended, in particular, for health professionals and users in order to ensure the proper use of pharmaceutical products.

Scientific information must necessarily mention the International Nonproprietary Name (INN) of the product that is the subject of this information, and can only be carried out for pharmaceutical products duly authorized by the Ministry of Health competent services.

Whereas advertising for pharmaceutical products to healthcare professionals is defined in regulations as any activity aiming to promote prescription and dispensing of the advertised products. Advertising must not be misleading or detrimental to the protection of public health. It must present the drug or product objectively and promote its proper use. It must respect the provisions of the market authorization as well as the therapeutic strategies recommended by Ministry of Health.

Advertising can only be carried out for regularly authorized pharmaceutical products, and is prohibited when the drug is re-evaluated by Ministry of Health for the benefit-risk ratio.

 

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

Approved drugs and medical devices are solely sold to consumers at authorized community pharmacies or dispensed through hospital pharmacies, based on physician prescription (except for over-the-counter medications).

According to Algerian regulations, especially provisions of Article 16 of Decree No 92-286 dated of 6 July 1992, related to scientific and medical information on pharmaceutical products for human use, and published in the Official Gazette, no drug or medical device can be sold or delivered via post or other channels.

 

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

There are no specific regulations for advertising through electronic channels to health professionals. Requirements for those channels are the same as for conventional ones and prior technical visa of Ministry of Health is required.

 

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

Under the Health Law No 18-11 provisions, marketing and advertising for pharmaceutical products to the public are prohibited regardless of the channel used. Advertising of over-the-counter (OTC) medications is also limited to health professionals, and is subject to prior technical visa of Ministry of Health which sets the list of these products.

According to Article 179 within the same law, OTC medications can be directly sold to consumers, without prior medical prescription, but only via authorized community pharmacies channel.

 

21. How is compliance monitored?

Scientific information and advertising on pharmaceutical products are allowed to be conducted by pharmaceutical manufacturers directly, or through duly authorized companies specialized in medical promotion. Both must be established under Algerian law to conduct these activities.

May also be authorized to perform scientific information and advertising on pharmaceutical products for non-promotional purposes:

• Public institutions whose vocation is related to public health, training and scientific research in the field of health when the public health needs require it;
• Scientific associations for their training activities;
• Associations of social nature and in particular consumer protection associations for their health education activities.

In all cases, scientific information and advertising on pharmaceutical products are subject to prior authorization granted by Ministry of Health.

 

22. What are the potential penalties for noncompliance?

According Health Law No 18-11 provisions, anyone who contravenes the law provisions relating to scientific information and advertising on pharmaceutical products, is liable to a fine of 200.000 DZD to 500.000 DZD (approx. 1.670 to 4.175 USD). In the event of a second offense, the fine is doubled.

Any manufacturing, operating, import, export or distribution of pharmaceutical products by structures not approved by the competent services, is punishable by imprisonment of five (5) years to ten (10) years and a fine of 5.000.000 DZD to 10.000.000 DZD (approx. 41.750 to 83.500 USD).

Anyone who contravenes prohibition to the manufacture, brokerage, distribution, advertisement, offer for sale, sale, import, export or possession of falsified pharmaceutical products is punishable by imprisonment of five (5) years to ten (10) years and fine of 1.000.000 DZD to 5.000.000 DZD (approx. 8.350 to 41.750 USD).

 

 

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

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reforms
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
9. Orphan Drugs and Rare Diseases
10. Localization
11. Biosimilars and Biologics

Also from this Legal Handbook

The legal framework for preclinical and clinical trial requirements in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.

 

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

The Health Law No 18-11, dated of 2 July 2018, replacing Health Protection and Promotion Law No 85-05, dated of 16 February 1985, and that constitutes the regulatory framework for clinical trials, does not expressly provide such requirement in view of obtaining the market authorization.

Nevertheless, clinical trials are subject to the prior authorization of the Ministry of Health granted within a period of three (3) months after initial submission, on the basis of a medical and technical dossier, and a declaration of intent to engage a clinical trial on humans to be filed by the sponsor. Any modification in the clinical trials dossier, once the authorization granted, is subject to the agreement of the Ministry of Health.

Anyone who contravenes the requirements related to clinical trials authorization is punishable by imprisonment of two (2) years to five (5) years, and a fine of 5.000.000 DZD to 10.000.000 DZD (approx. 41.750 to 83.500 USD).

 

2. How are clinical trials funded?

According to Article 384 of Health Law No 18-11, clinical trials must be conducted by a sponsor defined as the natural or legal person who initiates the clinical trial. It may be a pharmaceutical company, a contract research organization (CRO) approved by the Ministry of Health, a healthcare structure, a scientific society, a research institution or a natural person with the required qualifications and skills.

 

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

According to the requirements stated in the Ministerial Decree No 388 dated of 31 July 2006, published in the Ministry of Health Bulletin, and related to clinical trials authorization process, the sponsor of a clinical trial must submit a written protocol, signed by the investigating physician(s) after he (they) has (have) expressed his (their) agreement, signifying his (their) acceptance of the protocol and his (their) commitment to respect the conditions of realization,

Clinical trials protocols must also be approved by the Medical Ethics Committee which is an independent body created at the level of the external healthcare services, and whose activities are supervised by the relevant departments of the Ministry of Health (“DGPES” – “Direction Générale de la Pharmacie et des Equipements de Santé” that will be gradually replaced by the “ANPP” – “Agence Nationale des Produits Pharmaceutiques”).

In addition, the clinical trials must be carried out in accordance with the rules of good practices in this area in approved and authorized structures, according to the requirements of the Ministerial Decree No 200 dated of 25 July 2009, published in the Ministry of Health Bulletin, and related to clinical trials good practices.

 

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

Clinical trials cannot be carried out in Algeria without the free, informed, and written consent of the persons to be included in the trial or their legal representatives. Prior information must be provided by the investigating physician or the physician who represents him, especially on:

• Objective;
• Methodology;
• Duration of the trial;
• Expected benefits;
• Constraints;
• Foreseeable risks;
• Possible medical alternatives;
• Right to refuse to participate in trial or withdraw consent at any time without incurring any liability and without prejudice to therapeutic care.

The consent of the participant in a clinical trial must be included in the study protocol. The consent of the person applies strictly and only to the trial for which he is asked, and no one can lend himself simultaneously to several clinical trials.

Any sponsor, who carried out a clinical trial without obtaining the consent of a participant in the clinical trial protocol, will be punished by imprisonment of two (2) years to five (5) years, and a fine of 100.000 DZD to 500.000 DZD (approx. 835 to 4.175 USD).

 

5. May participants in clinical trials be compensated?

Clinical trials, with the exception of those without direct individual benefit, do not give rise to any direct or indirect financial compensation for the persons who lend themselves to it, except the reimbursement of expenses incurred by these persons.

In the case of a clinical trial without direct individual benefit, the sponsor may pay the persons who lend themselves an indemnity compensation for the constraints.

However, clinical trials without direct individual benefit must not involve any foreseeable serious risk to the health of participants. They must be preceded by a medical examination of the persons concerned, and the results of this examination are communicated to them prior to the expression of their consent.

 

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

The sponsor is legally responsible for ongoing evaluation of the investigational drug safety, and must immediately notify any serious or unexpected adverse reaction, or any new safety fact, occurring during or after the end of the clinical trial, to the Ministry of Health, the Medical Ethics Committee for the clinical trial(s) concerned, and to all investigating physicians, at the latest, within seven (7) days.

There is also a requirement for the establishment of written, standardized operating procedures (SOPs) by the sponsor to meet the quality standards required for each stage of data collection, case documentation events and adverse effects, their validation, evaluation, archiving and reporting, as well as the guarantee of data protection. The sponsor must submit an annual safety report to the Ministry of Health and the Medical Ethics Committee for clinical trials.

For all interventional clinical trials, the sponsor must take out insurance covering his civil and professional liability for the activity he undertakes, whereas for those without direct individual benefit, the sponsor assumes, in all cases, even without fault, compensation for the trial harmful consequences for the person who lends itself to it and that of his successors.

 

 

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

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reforms
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
9. Orphan Drugs and Rare Diseases
10. Localization
11. Biosimilars and Biologics

Also from this Legal Handbook

An insight into regulatory, pricing and reimbursement in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99.

 

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

Ministry of Health, Population and Hospital Reform (“MSPRH” – “Ministère de la Santé, de la Population et de la Réforme Hospitalière”) is the national regulatory authority responsible for drugs, biologicals, and medical devices for human use in Algeria.

General Directorate of Pharmacy and Health Equipment (“DGPES” – “Direction Générale de la Pharmacie et des Equipements de Santé”) at MSPRH is the body responsible for reviewing, assessing, regulating and monitoring pharmaceutical products, since the MSPRH’s new organizational chart implementation in 2012.

National Agency for Pharmaceutical Products (“ANPP” – “Agence Nationale des Produits Pharmaceutiques”, a financially independent institution newly created under Article 223 of Health Law No 18-11, dated of 2 July 2018, will gradually replace DGPES upon its establishment. ANPP will remain under the administrative authority of MSPRH.

 

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

Health Law No 18-11, dated of 2 July 2018, published in the Official Gazette, replacing Health Protection and Promotion Law No 85-05, dated of 16 February 1985, forms the legislative framework for all activities related to drugs, biologicals and medical devices.

a) Authorization:

• Decree No 92-284 dated of 6 July 1992, published in the Official Gazette, related to registration of pharmaceutical products for human use;
• Decree No 93-114 dated of 12 May 1993, published in the Official Gazette, modifying and completing Decree No 92-285 dated of 6 July 1992, related to authorization of pharmaceutical products manufacturing and distribution sites;
• Ministerial Decree No 116/MSP/MIN dated of 5 December 1996, published in the Ministry of Health Bulletin, fixing registration conditions for generics products;
• Ministerial Decree No 18/MSP/MIN dated 13 February 1997, published in the Ministry of Health Bulletin, fixing template of registration decision and certificate of free sale related to pharmaceutical products for human use;
• Ministerial Decree No 138/MSPRH/MIN dated of 18 October 2005, published in the Ministry of Health Bulletin, fixing timelines for assessment of registration applications related to pharmaceutical products for human use;
• Ministerial Decree No 139/MSPRH/MIN dated of 18 October 2005, published in the Ministry of Health Bulletin, fixing template of registration application forms and composition of submission dossiers;
• Ministerial Decree No 12/MSPRH/MIN dated of 16 April 2012, published in the Ministry of Health Bulletin, modifying and completing Ministerial Decree No 2479 dated of 6 November 2007, fixing homologation conditions for medical devices.

b) Pricing:

• Decree No 98-44 dated of 1 February 1998, published in the Official Gazette, fixing the caps margins applicable for production, packaging and distribution of pharmaceutical products for human use.
• Ministerial Decree No 66 dated of 11 July 2012 modified and completed, published in the Ministry of Health Bulletin, related to organization and running of the Pharmaceutical Products Pricing Committee.

c) Reimbursement:

• Interministerial Decree dated of 16 August 2003, published in the Official Gazette, creating and fixing missions, organization and running of the Pharmaceutical Products Reimbursement Committee.
• Ministerial Decree dated of 6 March 2008 modified and completed, published in the Official Gazette, fixing the positive list of reimbursed products by social security.
• Ministerial Decree dated of 6 March 2008 modified and completed, published in the Official Gazette, fixing reference tariffs for products reimbursement by social security.

 

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

New drugs, biologicals and medical devices cannot be marketed unless they have been granted authorization by Ministry of Health (“registration decision” for drugs and biological, “homologation decision” for medical devices, according to article 230 of Health Law No 18-11, dated of 2 July 2018).

Applications for market authorization must be submitted to the Ministry of Health on a form specially prepared for that purpose (Form A: for generic products; Form B: for new drug products; Form D: for medical devices), accompanied by a submission dossier that includes:

• Certificate of Pharmaceutical Product issued by regulatory authorities of country of origin in the format recommended by the World Health Organization + copy of valid market authorization in country of origin (for imported products) and/or CE marking certificate (for medical devices);
• Attestation of different manufacturers and sites involved in the manufacturing, packaging, control and releasing of the product (including for Active Pharmaceutical Ingredient or API).
• Authenticated copy of GMP compliance certificate and manufacturing authorization for all sites involved in manufacturing of API(s) and finished product.
• Technical dossier in electronic format including manufacturing and quality control data, and where appropriate, non clinical and clinical data of the product + access letter to the Drug Master File restricted part;
• 05 samples of finished product (both for imported and locally-manufactured products), accompanied by original certificate of analysis + template of artworks intended to be used;
• Note for therapeutic and economic interest summarizing absolute and relative medical service, in addition to public health importance;
• FOB price attestation certified by Chamber of Commerce in country of origin (for imported products) / ex-factory price structure (for locally-manufactured products).
• Receipt of registration fees payment + change attestation (payment in convertible foreign currencies for imported products).

The authorization process generally involves:

• Preliminary examination (at the end of which, an application receipt is granted),
• Evaluation of application (including laboratory quality control tests),
• Approval or denial of application (on quality/safety/efficacy criteria + price negotiation),
• Granting of the market authorization + list price attestation.

Exceptions:

A temporary authorization for use (“ATU” – “Autorisation Temporaire d’Utilisation”) may be exceptionally issued by Ministry of Health for non-registered products, when the latter are prescribed as part of the management of serious diseases in situations where there is no equivalent treatment in the national territory, and have proven their therapeutic benefit.

 

4. What are the approximate fees for each authorization?

The drugs, biologicals and medical devices authorization fees are fixed as part of Finance Law. Fees are payable by the person who makes the application or submit variations to initial market authorization, in local currency for locally-manufactured products, and in convertible foreign currencies for imported ones.

As at December 2019, the current authorization fees are:

• For each new application related to imported and non essential drug or biological: 1.000.000 DZD (approx. 8.350 USD);
• For each new application related to imported and essential drug or biological: 600.000 DZD (approx. 5.000 USD);
• For each new application related to locally-manufactured and non essential drug or biological: 150.000 DZD (approx. 1.250 USD);
• For each new application related to locally manufactured and essential drug or biological: 100.000 DZD (approx. 835 USD);
• For each new application related to imported medical device: 300.000 DZD (approx. 2.500 USD);
• For each new application related to locally-manufactured medical device: 150.000 DZD (approx. 1.250 USD);
• For each product assessed: 30.000 DZD (approx. 250 USD);
• For each API batch controlled in laboratory: 15.000 DZD (approx. 125 USD);
• For each finished product batch controlled in laboratory: 12.000 DZD (approx. 100 USD);
• For each market authorization renewal application: 300.000 DZD (approx. 2.500 USD);
• For each variation(s) to market authorization application: 150.000 DZD (approx. 1.250 USD).

 

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

The market authorization is issued for a period of five years, renewable every five years. It may also be amended, suspended or withdrawn by the Minister for Health under certain conditions.

The market authorization is renewable at the request of its holder. This request must be submitted no later than ninety (90) days before the expiry date of the validity of the said decision.

It is renewed only if the decision holder certifies that no change has occurred in the evidence submitted in support of the initial application for registration/ homologation, especially regarding indications, composition, contraindications, precautions for use and adverse effects. If necessary, additional justifications may be requested.

For imported products, a recent Certificate of Pharmaceutical Product issued by regulatory authorities of country of origin in the format recommended by the World Health Organization + copy of valid market authorization in country of origin and/or CE marking certificate (for medical devices), are required.

 

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

Market authorization for generic products is subject to the same requirements as brand-name products, except that generic products are exempted from pharmacological, toxicological and clinical tests required for brand-name ones.

However, for products with a narrow therapeutic index, or with significant bioavailability problems or with particular pharmacokinetic characteristics, the Ministry of Health may request that the in vivo bioequivalence of the generic product, object of the application, be demonstrated against the brand-name product already on the market.

Excluding application submission dossier composition and currency of registration fees, there are no differences in regulatory requirements between locally manufactured products and imported ones, but in practice, and according to the government’s will to support local manufacturing and to promote investment (Article 206 of Health Law No 18-11, dated of 2 July 2018), assessment priority is given for locally manufactured products, including during pricing process (timelines of 5-6 months set in Ministerial Decree No 138/ MSPRH/MIN dated of 18 October 2005).

 

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

There are no specific regulations for combination products in Algeria, nor is this term used in legal provisions. In practice, if the main intended action of the combination product is achieved by the drug or biological (defined as drug by Article 210 of Health law No 18-11) or if they form a single integrated product with the medical device (e.g. pre-filled syringes and pens, patches for transdermal drug delivery and pre-filled inhalers), the entire product is regulated as a drug under provisions of Health Law No 18-11, dated of 2 July 2018 and other applicable drugs regulations.

Whereas, if the main action is achieved by the medical device (defined by Article 212 of Health law No 18-11, that mentioned possibility of being “used alone or in combination”), then medical devices regulations are applicable.

If drug/biologicals and medical devices are co-packaged (separate items contained in the same package) or obtained separately (independent manufacturing and control processes), relevant regulations for each item are applicable.

 

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

Compliance of authorized products on the market, and the activities carried out by manufacturers, importers, exporters, and distributors with regulations, is monitored and evaluated by Ministry of Health, at which “ANPP” – “Agence Nationale des Produits Pharmaceutiques”, a financially independent institution newly created by Article 223 of Health Law No 18-11, dated of 2 July 2018, will gradually replace “DGPES” – “Direction Générale de la Pharmacie et des Equipements de Santé”, upon its establishment.

Ministry of Health ensures the supervision and enforcement of the legal provisions through periodical inspections conducted by Ministry of Health inspectors at the authorized structures premises (Article 191 of Health Law No 18-11), quality and risk assessments on the authorized products, as well as audit and report- ing requirements, including adverse events under pharmacovigilance rules.

 

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

According Health Law No 18-11 provisions, any manufacturing, operating, import, export or distribution of pharmaceutical products by structures not approved by the competent services, is punishable by imprisonment of five (5) years to ten (10) years and a fine of 5.000.000 DZD to 10.000.000 DZD (41.750 to 83.500 USD).

Anyone who contravenes the prohibition related to the manufacture, brokerage, distribution, advertisement, offer for sale, sale, import, export or possession of falsified drugs (defined in Article 211 of the Health Law No 18-11) is punishable by imprisonment of five (5) years to ten (10) years and a fine of 1.000.000 DZD to 5.000.000 DZD (8.350 to 41.750 USD).

Every person who contravenes the provisions related to registration of pharmaceutical products and homologation of medical devices, will be punished by imprisonment of two (2) years to five (5) years, and a fine of 1.000.000 DZD to 5.000.000 DZD (8.350 to 41.750 USD).

 

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

Algeria has a national healthcare system characterized by near-universal coverage and free-of-charge treatment at the point of delivery. The Government provides funding for the public health sector, in accordance with the legislation and regulations in force, for the prevention, training, medical research, healthcare, in benefit of poor people and for those in difficulty.

Public expenditure on healthcare accounted for 70% of total health expenditure in 2018 (public hospitals budgets, social security, national health insurance and local collectives), and is expected to remain relatively stable over the next few years.

The Government ensures the financial equilibrium of the public sector in order to meet the national needs. The resources mobilized for funding the national healthcare system and the expenditures made on it have to be published annually in the form of accounts called “National Health Accounts”.

 

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

Organization of the national healthcare system is based in particular on:

• Health map and health organization plan;
• External structures of the health sector;
• Health public service provided by public and private institutions invested with this mission;
• Private health sector;
• Intersectorality in the implementation of the national health policy;
• Complementarity between the public and private sectors in health services;
• Diagnostic and therapeutic approaches based on factual consensus, regularly updated;
• Organization and promotion of training and research in the health sciences;
• Contribution of the associative and mutualist movement;
• Healthcare networks.

Creation of private health structures and institutions must meet the standards defined by the health map and the priorities set by the health organization plan. They have also to meet the technical installation and operating conditions set by Ministry of Health.

Expenditures on healthcare provided by private health structures and institutions with health public service missions are governed by agreements with the Ministry of Health. In all cases, they must comply with the regulations on public information and pricing inherent to the healthcare activity.

 

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

Prices of drugs and devices are regulated by the Pharmaceutical Products Pricing Committee established at Ministry of Health by Ministerial Decree No 66 dated of 11 July 2012 modified and completed, published in the Ministry of Health Bulletin.

The Pricing Committee is an interministerial committee chaired by Ministry of Health, Population and Hospital Reform (“MSPRH” – “Ministère de la Santé, de la Population et de la Réforme Hospitalière”).

Different governmental departments are represented within the Pricing Committee:

• Ministry of Labor, Employment & Social Security (responsible of reimbursement).
• Ministry of Finance (through Customs and Taxes Directorate representatives, since 2015).
• Ministry of Commerce (since 2015).
• Ministry of Industry (since 2015).

a) For locally-manufactured products:

Prices are fixed in local currency (ex-factory) by the Pricing Committee. Legal margins for wholesalers, and pharmacists (if the product is dispensed through private community pharmacies), should be added to calculate the public price (all authorized medicines are value added-tax free).

b) For imported products:

Prices are fixed in foreign currency (FOB incoterm, mainly in EUR) by the Pricing Committee. Prices are converted in local currency per each importation operation, transportation and insurance fees are added. Then, legal margins for wholesalers, and pharmacists (if the product is dispensed through private community pharmacies), should be added to calculate the public price (all authorized medicines are value added-tax free).

A new product cannot be launched on the market without prior agreement on price. List price attestation is granted by Ministry of Health at the same time as the market authorization.

There is a provision for the appeals within the Pricing Committee organizing Ministerial Decree No 66 dated of 11 July 2012. The timeline to introduce an appeal has now been fixed to 30 days from notification of the Committee initial decision, and final decision of the committee after appeal is irrevocable.

 

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

Government is fully covering costs for all products dispensed through public hospital pharmacies, in addition to mandatory vaccines offered free of charge at vaccination centers.

National health insurance (social security) is covering the costs of drugs and medical devices on the reimbursement positive list fixed and updated by the Reimbursement Committee established under Interministerial Decree dated of 16 August 2003, published in the Official Gazette.

Social security is covering 100% of costs for reimbursed products related to a fixed list of serious chronic diseases and/or in benefit of poor people and those in difficulty, and 80% of costs for other reimbursed products in profit of affiliated patients (about 90% of population), on the basis of the list prices, or the reference tariffs when they have been established by the Reimbursement Committee.

Private health insurance companies exist under the Health Law No 18-11 provisions. They are taken by patients themselves or their employers to cover the remaining 20% of costs for reimbursed products covered at 80% rate by social security, and costs of non reimbursed products.

Finally, patients without private health insurance pay out of their pocket for non reimbursed products and those directly purchased from private community pharmacies through self-medication (without physician prescription).

 

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

Drugs and medical devices are dispensed to patients by pharmacists at both hospital pharmacies and private community pharmacies. They have to dispense pharmaceutical products only on a physician prescription. However, community pharmacists may dispense without a medical prescription certain products whose list is fixed by the Minister of Health.

According to the Health Law No 18-11 provisions, pharmacists dispensing drugs and medical devices at hospitals (public and private ones) benefit from a special status and a compensatory regime, generally a fixed salary, in line with the specificities of the sector, whereas pharmacists who dispense pharmaceutical products at private community pharmacies are compensated differently.

In Algeria, the pharmacist is the sole owner and manager of the community pharmacy he holds. Decree No 98-44 dated of 1 February 1998, published in the Official Gazette, allows a degressive capped retail margin depending of the product CAF price (for imported products) or ex-factory price (for locally-manufactured products):

• 50% of wholesale price for products priced up to 70 DZD/box (0,60 USD/box);
• 33% of wholesale price for products priced between 70-110 DZD/box (0,60-0,90 USD/box);
• 25% of wholesale price for products priced between 110-150 DZD/box (0,90-1,25 USD/box);
• 20% of wholesale price for products priced more than 150 DZD/box (1,25 USD/box).

In addition, a fixed remuneration valued between 1,50-2,50 DZD (0,012-0,020 USD) for each box dispensed is allowed and integrated in the final public price. Pharmacists other than the holder and recruited for dispensing drugs and med- ical devices at community pharmacies perceive a fixed salary.

 

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?

Hospital pharmacists are responsible for:

• Ensuring management, supply, preparation, control, storage, detention and dispensation of drugs and medical devices used by the hospital;
• Conducting or participating in information campaign on drugs and medical devices, in actions aiming to promote their good use and contributing to their evaluation;
• Conducting or participating in actions likely to contribute to the quality and safety of the treatments and care;
• Applying rules of hospital pharmacy good practices set by Ministry of Health.

Community pharmacists are responsible for:

• Ensuring retail dispensation of drugs and medical devices after verifying prescriptions;
• Executing of magistral and officinal preparations;
• Providing health-related services, participating in information, counseling, follow-up and therapeutic education for patients, and encouraging the use of generic products;
• Calling without delay (under pain of the penalties) to the intervention of a physician when, during the exercise of their activities, they detect any risk for patient in relation with the expected treatments.

According to the Health Law No 18-11 provisions, any discharge, storage, display or dispensing of drugs or medical devices on the public area or in other places not authorized by Ministry of Health, carried out by any person even with a pharmacist degree, is considered an illegal practice of the pharmacist profession, and is punishable in accordance with Article 243 of Penal Code.

Under pain of the penalties, it is forbidden for any pharmacist dispensing drugs or medical devices to solicit or to accept directly, or through an intermediary, in the course of his duties, gifts, gratuities or any benefits of any kind.

Except for justified medical necessity, any pharmacist who, through negligence or proven professional misconduct in the exercise or on the occasion of his duties affects the physical integrity or health of a person causing permanent disability, endangering his life or causing his death, is punishable in accordance with Articles 288, 289 and 442 of Penal Code.

Failure to comply with the obligation of medical and professional secrecy exposes the pharmacist to the penalties provided for in Article 301 of Penal Code.

 

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

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labeling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reforms
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
9. Orphan Drugs and Rare Diseases
10. Localization
11. Biosimilars and Biologics