The government is preparing to strengthen control over medications and penalties.
The Moroccan government is continuing its reform of the pharmaceutical sector through a new bill aimed at strengthening drug control, modernizing the pharmacovigilance system, and tightening sanctions related to violations affecting the quality and safety of healthcare products.
A Reform to Modernize the Pharmaceutical System
Presented before the Social Sector Committee in the House of Representatives by Amine Tahraoui, this bill amends and supplements the Code of Medicines and Pharmacy.
The minister explained that this reform aims to align Morocco’s regulatory framework with international standards and reinforce the Kingdom’s health sovereignty.
Objective: Achieving WHO Standards
Specifically, the government aims to achieve level 3 regulatory maturity for the Moroccan Medicines Agency as defined by the World Health Organization, considered an international recognition of the reliability of the national pharmaceutical regulatory system.
This development would further establish Morocco as a key regional player in the field of pharmaceuticals.
Extended Control Post-Market
The legislation provides for an expansion of the scope of pharmaceutical control. Monitoring will no longer be limited to the marketing of drugs but will also cover the quality tracking post-market, traceability, and storage conditions in clinics and healthcare establishments.
The project also strengthens mechanisms to combat counterfeit or substandard medications.
A New Pharmacovigilance System
The reform also introduces a national integrated pharmacovigilance system designed to ensure better monitoring of adverse drug reactions.
Pharmaceutical establishments will be required to appoint a person responsible for following up on alerts and reports, while healthcare professionals will face strengthened obligations to report side effects.
Support for the National Pharmaceutical Industry
The bill also outlines new authorization mechanisms to support the Moroccan pharmaceutical industry and facilitate access to certain innovative treatments.
New measures include authorizations intended exclusively for export, as well as conditional or exceptional authorizations to expedite access to certain medications in cases of shortages or health emergencies.
Tougher Penalties
One of the key aspects of the reform involves tightening penalties for violations related to quality, safety, and good manufacturing practices for drugs.
The government plans a comprehensive revision of the punitive framework, with increased financial fines to enhance trust in the national drug system and ensure better public health safety.
