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The Government through the MOPH regulates the pharmaceutical market through a set of policies and regulations. The MOPH impacts drug production and quality, licensing, importation, registration, pricing and inspection.The drug import/export department deals with the drug from its early stages until the delivery of market authorization or AMM. The drug registration follows a chain of links that are all submitted to the control of a Drug Registration Technical Committee (TC) at the MOPH. All pharmaceutical products must be registered at the MOPH whether being manufactured locally or imported. Any importation or distribution of drugs that is not submitted to the control of the MOPH is considered illegal and therefore subjects to confiscation. The following sections present the Technical Committee Activities (agenda, decisions, date of meetings), the Regulations governing the registration and the Guidelines that set the registration and pricing procedure.
- Drugs Technical Committee
- Manual for Administrative Procedures for Drugs & Pharmaceutical Products Registration
- Guides for the Drug Technical file submission: Module 3 (S and P Parts) and Module 5 (Bioequivalence Study) :
* Guide for the Quality Module 3- Part S - Drug Substance
* Guide for the Quality Module 3- Part P - Finished Product
* Guide for Bioequivalence - Module 5
* Guide for the Quality Module 3- Part P - Finished Product
* Guide for Bioequivalence - Module 5
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