The Pharma Legal Handbook: Algeria
Join industry executives in staying informed on pharmaceutical regulations in Algeria.
Regulation, Pricing, Clinical Trials, Marketing, Manufacturing, Trademarks, Patents, Orphan Drugs, Biosimilars and more!
Get your pharmaceutical legal and regulatory questions answered in The Pharma Legal Handbook– a must-have guide for any company operating in the country or looking to enter the market.
Prepared in association with SAARPE, a leading Algerian nonprofit legal consultancy.
If legal handbook content is updated, you will receive a free updated PDF for up to one year after purchase.
January 2020
1. Updates on Authorization Fees in 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).
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2. COVID-19: Algeria Moves to Boost Foreign Direct Investment
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 21st, 2020).
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3. Updates on Cannabinoid Regulation in Algeria
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.
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4. Biosimilars and Biologics: Algeria
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).
Click the following links to read more legal articles from Algeria:
- Regulatory Pricing and Reimbursement Overview
- Preclinical and Clinical Trial Requirements
- Marketing, Manufacturing, Packaging & Labeling, Advertising
- Traditional Medicines and OTC Products
- Product Liability
- Patents & Trademarks
- Regulatory Reforms
- Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
- Orphan Drugs and Rare Diseases
- Localization
- Biosimilars and Biologics
Also from this Legal Handbook
5. Localization: Algeria
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.
Click the following links to read more legal articles from Algeria:
- Regulatory Pricing and Reimbursement Overview
- Preclinical and Clinical Trial Requirements
- Marketing, Manufacturing, Packaging & Labeling, Advertising
- Traditional Medicines and OTC Products
- Product Liability
- Patents & Trademarks
- Regulatory Reforms
- Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
- Orphan Drugs and Rare Diseases
- Localization
- Biosimilars and Biologics