Creation of the National Agency for Pharmaceutical Products
By law n°18-11 of July 2, 2018 relating to health, in article 223.
The agency is a public establishment with specific management with legal personality and financial autonomy, placed under the supervision of the Ministry of Health (Art 224 of Law No. 18-11).
This supervision was transferred to the Ministry of the Pharmaceutical Industry by Ordinance No. 20-02 of August 30, 2020 modifying and supplementing Law N 18-11 of 18 of July 2, 2018 relating to health, article 1.
Main missions
Registration of pharmaceutical products and granting of the decision of registration, its renewal, suspension, withdrawal, assignment and transfer, after advice from the pharmaceutical products registration commission.
Approval of medical devices and the granting of the approval decision, its renewal, suspension, withdrawal, assignment and transfer, after advice from the medical devices approval commission.
Quality control and expertise of pharmaceutical products and medical devices and the maintenance of standard substances and reference products at the national level.
Carry out on-site audit and inspection missions carried out by inspectors from the agency, particularly regarding monitoring the application of good pharmaceutical practice rules and medical device standards, in accordance with current legislation and regulations.
Contribute to the development of pharmaceutical sector development strategies.
Refer the matter to the competent authorities in order to take the necessary measures to protect public health when a pharmaceutical product or medical device presents or is suspected of presenting a danger to human health.
Issue an opinion on temporary authorizations for use (ATU) of unregistered medicines.
Contribute to the definition of good practice rules for the manufacturing, storage, distribution and dispensing of pharmaceutical products.
Carry out the scientific evaluation of the benefits, risks and therapeutic value of pharmaceutical products and medical devices, as well as their medico-economic evaluation.
To contribute to the establishment of nomenclatures of pharmaceutical products and medical devices and their updating.
To contribute to the development of the list of essential pharmaceutical products and medical devices.
To contribute to the development of the national drug formulary and pharmacopoeia.
To issue the certificate of drug prices upon registration, once set by the intersectoral economic committee for drugs.
To participate in the development of the list of medicines reimbursed by social security organizations.
To issue prior authorizations for the promotion and advertising of registered pharmaceutical products to healthcare professionals.
To issue an opinion on requests for the conduct of clinical studies and bioequivalence studies.
To issue an opinion on the standards, rules of good practice, procedures and methods applicable to clinical studies on pharmaceutical products and medical devices.
To undertake any study, research, training or information action in the areas of its competence and to contribute to the promotion of scientific research in the field of pharmaceutical products and medical devices and to constitute the related databases.
To organize seminars, conferences, study days and other events related to its missions.
To participate in the development of draft legislative and regulatory texts governing pharmaceutical products and medical devices.
To implement international cooperation actions, in accordance with current legislation and regulations.
To prepare an annual report on the activities which it sends to the Minister responsible for the pharmaceutical industry.