Regulatory procedures in Morocco are under the control of the Directorate of Medicines and Pharmacy under the Ministry of Health. The latter is divided into three sub-directions: firstly, the Division of Pharmacy which is responsible for inter alia of clinical drug evaluation, registration and pricing where appropriate; secondly, the Pharmaceutical sector monitoring department in charge of activities like scheduling inspections in order to establish GMP certificate and finally, the LNCM which is responsible of the quality review of pharmaceutical documentations as well as of lab-testing.

To proceed with the registration of medical equipment, the MOH (Ministry of Health) requires the following: authorization of the manufacturer to permit a local company to register and market the products, EC Certificate, FSC (Free Sales Certificate), ISO 13485 certificate or equivalent, EC Declaration of Conformity of Equipment with components and accessories, labels or nameplates photos (equipment and its accessories), signed & stamped, user manuals and a technical file: Product Data, Maintenance Manual, Technical Specifications, Qualifications, Tests of controls, Final Test Report, Flow Chart, Manufacturing Processes Description.

Regarding the registration procedures for medicines, the marketing authorization request files are submitted to the Directorate of Medicine and Pharmacy. The assessment of the administrative file is made at the Pharmacy division while the assessment of the technical file is made at the National Laboratory for medicines control.
The results are then submitted to the national commission of MAs, composed of experts and medicine professors, who give their opinion on the therapeutic relevance of the medicine. If they are in favor, an agreement in principle is delivered to import or manufacture the medicine and submit samples to the National Laboratory for medicines control for an analytic expertise. The MA is then accepted if the results of the analysis comply with the regulations. In other cases (postponed or refused files, non-compliant analysis), further information or changes are required to re-examine the MA request files.

The regulatory authority has a website for sharing information, however, the website was not accessible. The MoH has a working website - https://www.sante.gov.ma/Pages/Accueil.aspx from which they share the necessary information to the citizens. The site is linked to other ministries’ sites. There is no sign of any linkage to a regional harmonization system though.