Legal & Regulatory > 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…

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…

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…

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…

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…

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…

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.    Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid 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 cannabinoids, can…

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…

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…

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…

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…

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…

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…

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…