Compliance with Advanced Morocco Pharmacovigilance Regulations

The National pharmacovigilance system in Morocco consists of the National pharmacovigilance committee (CNP), National pharmacovigilance centre (CNPV), and National Technical centre (CTPV) at the Central Level. At the Regional level, it consists of a pharmacovigilance representative (CRPV) and lastly, it consists of all other members such as health professionals, pharmaceutical and healthcare products companies, and patients/consumers. CNP plays an advisory role regarding the decisions to be submitted to the Ministry of Health, CNPV oversees all the processing and management of the adverse drug reactions (ADR) including collecting and evaluating the ADR reports, maintaining the national database of the ADR reports received, coordinating with CNP for any potential signals/alerts, and participating in the risk minimization measures. Furthermore, CTPV provides all the technical assistance regarding scientific issues to the CNPV, conducts pharmacovigilance investigations whenever necessary and reports to the CNPV. The role of CRPV is to develop pharmacovigilance activities on the regional level, collect ADRs and maintain the ADR database from the hospitals, patients, and physicians within this region and report them to CNPV. Adverse event reporting is voluntary for patients/consumers. However, it is mandatory for healthcare professionals (HCP) and marketing Authorization holders (MAHs) to report all adverse events related to the products. All ADRs can be submitted through the yellow notification form which is available in both paper and online (website) format. Alternatively, adverse event reporting can be done via email, post, fax, and telephone.

Why Choose DDReg for Pharmacovigilance in Morocco?

As a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in Morocco that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.