Imported Medicines: New Regulatory Framework

While the debate over the Competition Council’s opinion on opening up pharmacy ownership to the private sector remains unresolved, the Government Council has adopted two decrees concerning medicines. The first one aims to establish the conditions and procedures for submitting and reviewing applications for sanitary visas specifically for medicines intended for human use.
The same applies to the conditions for granting, suspending, or revoking such approval, in accordance with the provisions of the Law on the Code of Medicines and Pharmacy. This law established the principle of drug approval as a document issued by the administration upon the importation of medicines by industrial pharmaceutical companies.
This decree is also part of the effort to modernize the national pharmaceutical system and simplify administrative procedures. The aim is to adapt the regulatory framework governing the importation of medicines to the new responsibilities entrusted to the Moroccan Agency for Medicines and Health Products (AMMPS), in its capacity as the competent body for the organization and oversight of the pharmaceutical sector.
Specifically, the decree specifies the documents required to complete a health visa application and outlines the procedure for submitting and processing applications with the Agency. The piece of legislation provides for a 30-day processing period for submitted applications, which may be reduced to 7 days in urgent cases.
It also introduces a fee for the services provided by the Agency, based on a schedule to be set by a decision of its board of directors, in accordance with applicable legal provisions. Furthermore, it specifies the cases in which the health authorization may be suspended or revoked, particularly in the event of non-compliance with the obligations set forth in the decree, or when the marketing authorization for the drug in question is itself suspended or revoked.
Enhancing Transparency
Another significant change is the requirement to obtain a new health visa in the event of changes to certain essential elements relating to the drug, its manufacturing site, or the manufacturing facility. The piece of legislation also includes transitional provisions to ensure the validity of health permits already issued prior to its entry into force. This involves establishing a health permit for the importation of medicines in their commercial form as well as active pharmaceutical ingredients intended exclusively for pharmaceutical use.
Through this reform, the authorities aim to strengthen national drug safety, improve oversight of imported medicines, and increase the transparency and efficiency of administrative procedures in the pharmaceutical sector.
M.C.