Medicine: A reform to secure the supply
Morocco has taken a further step in consolidating its health sovereignty. The draft bill amending Law 17.04 on Medicines and Pharmacy, now open for public consultation, goes far beyond a simple technical update of the regulatory framework.
The reform also aims to strengthen compliance with good manufacturing practices, the conformity of which could be certified by the Administration.
It reconfigures the sector’s regulatory architecture around three now central priorities: securing supplies, strengthening market surveillance, and aligning with World Health Organization standards.
The ambition is to establish the Moroccan Agency for Medicines and Health Products as a leading regulatory authority in the region. To this end, the legislation introduces, among other things, the obligation for pharmaceutical companies to maintain safety stocks of the medicines they manufacture, import, or distribute. The goal is to ensure the continuity of supply to the domestic market. The availability of medicines would thus become a regulatory responsibility fully enforceable against operators. In any case, fines ranging from 100,000 (USD 10,671) to 1 million dirhams (USD 106,713) are provided for violations related to manufacturing and supply.
Another change is the possibility of withdrawing marketing authorization if a product is not commercialized within the regulatory timeframe. This provision aims to limit the retention of unused authorizations, which could hinder market fluidity and delay effective access to treatments.
The legislation also strengthens the national pharmacovigilance system. It formalizes the requirement for responsible pharmacists to report adverse drug reactions and enhances post-marketing surveillance. The aim is to move toward continuous regulation of the drug lifecycle and no longer focus solely on the initial authorization phase.
Similarly, the inspection powers of the Moroccan Medicines Agency have been expanded. The scope of oversight now covers the entire distribution chain: from pharmaceutical establishments to healthcare facilities using medicines, including distribution centers and warehouses. This expansion of the scope of intervention accompanies the gradual strengthening of the national regulator’s role in market supervision.
Khadija MASMOUDI
