Mozambique : Vaccines
Relevant Regulatory Harmonization Initiatives
Member of the African Medicines Regulatory Harmonization (AMRH) initiative through the Southern African Development Community (SADC)/Common Market for Eastern and Southern Africa (COMESA) Regional Economic Community (REC). As part of the African Union, Mozambique is implementing the Pharmaceutical Manufacturing Plan for Africa (PMPA) with the goal of increasing the ability to produce essential medicines.
Mozambique is a also a member of the African Vaccines Regulatory Forum (AVAREF).
Clinical Trial Data Requirements
Mozambique follows the South African Development Community's guidelines for regulating the conduct of clinical trials in human subjects and the World Health Organization (WHO)'s good clinical practice guidelines to assess and review clinical trial applications. At the moment Mozambique does not have any official law on clinical trials. SADC's guidelines are available here.
Clinical Trials Import Authorization
Only drugs included in the National Formulary can be imported. Unauthorized drugs can be imported with special permission from the Ministry of Health. This is stated in Article 22 of the Medicines Act 4/98: "When, against clinical justification, they are considered as being indispensable for the treatment or diagnosis of certain pathologies" or "exclusively aimed at clinical research and tests."
Precedent (Clinical Trials Approved/Denied in Last 2 Years)
2 clinical trials approved from June 2012 to June 2014.
Product Registration Data Requirements
There are two types of drug registrations:
-extraordinary: simplified process of medicines already in the market by licensed operators. This is valid for three years and not eligible for renewal or exclusivity.
-definite: regular drug registration process valid for five years and renewable.
There are both complete and simplified versions of registration. The primary components of registration include:
1-A: Summary of process administrative information.
1-B: Characteristics of medicine.
2: Chemical and pharmaceutical documentation.
3: Documentation on security.
4: Documentation on effectiveness.
More detail is available here.
Product Registration Estimated Timeline
According to the WHO, the average time from submission to registration in the Southern African Development Community is 6 months.
Product Registration Costs
US$800 for an originator product and US$600 for a generic product.
Post Registration Pharmacovigilance Requirements
CIMED (Information Center for Medicines) is in charge of collecting data, investigations, and reporting. A team of two doctors and one pharmacist (from the PD) are in charge of this. Inceidents are classified using WHO guidelines. This program is only present in 10 districts of the country. Participation is not required.
September 25, 2014.