Missions Principales
Registration of pharmaceutical products and granting of the registration decision, its renewal, suspension, withdrawal, assignment, and transfer, following the opinion of the Pharmaceutical Products Registration Committee.
Approval of medical devices and granting of the approval decision, its renewal, suspension, withdrawal, assignment, and transfer, following the opinion of the Medical Devices Approval Committee.
Quality control and expertise of pharmaceutical products and medical devices, and maintenance of reference substances and standard products at the national level.
Conducting audit and inspection missions on-site, carried out by agency inspectors, particularly to verify the implementation of good pharmaceutical practices and medical device standards, in accordance with the applicable legislation and regulations.
Contributing to the development strategies of the pharmaceutical sector.
Referring matters 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 risk to human health.
Issuing opinions on Temporary Authorizations for Use (ATU) for unregistered medicines.
Contributing to the definition of Good Practices for the manufacturing, storage, distribution, and dispensing of pharmaceutical products.
Conducting scientific evaluations of the benefits, risks, and therapeutic value of pharmaceutical products and medical devices, as well as their health-economic assessment.
Contributing to the establishment and updating of nomenclatures for pharmaceutical products and medical devices.
Contributing to the development of the list of essential pharmaceutical products and medical devices.
Contributing to the preparation of the national medicines formulary and the pharmacopoeia.
Issuing price certificates for medicines at the time of registration, once prices are determined by the Intersectoral Economic Committee for Medicines.
Participating in the preparation of the list of medicines reimbursable by social security organizations.
Issuing prior authorizations for the promotion and advertising of registered pharmaceutical products directed to health professionals.
Providing opinions on requests for conducting clinical trials and bioequivalence studies.
Providing opinions on standards, good practice rules, procedures, and methods applicable to clinical studies involving pharmaceutical products and medical devices.
Undertaking studies, research, training, and information activities within its fields of competence, contributing to the promotion of scientific research related to pharmaceutical products and medical devices, and establishing the relevant databases.
Organizing seminars, conferences, study days, and other events related to its missions.
Participating in the drafting of legislative and regulatory texts governing pharmaceutical products and medical devices.
Implementing international cooperation actions, in accordance with applicable legislation and regulations.
Preparing an annual activity report submitted to the Minister in charge of the Pharmaceutical Industry.