Ministry of Public Health
http://www.sante.gov.mg/ministere-sante-publique/
Yes
Traditional Medicines, Cosmetics in Madagascar
6-12 months
Not Mention
5 Years
Medicinal plants: These are accessory forest products used in medicine and the preparation of pharmaceutical or chemical products. Herbaceous plants (Drosera, Centella, Catharanthus, etc.), woody plants (Rauwolfia, Pygeum, Hazunta, Harungana, etc.), and medicinal plants of aquatic origin (Spirulina, red or brown algae or others). Note that the list of plants or parts of plants classified as narcotics is established by Order No. -14,571/2013 of July 5, 2013.
Finished TM/MC products: Preparations obtained from one or more plants containing active constituents from parts of plants or other organic or inorganic materials (animal or mineral materials) or a combination of both. Products may contain excipients. However, if chemically defined active ingredients are combined, these products are no longer considered plant-based medicines.
Semi-finished products or similar products: Substances or mixtures of substances that have undergone transformation treatments.
Traditional Remedies
Substances of plant, animal, or mineral origin presented as promoting the prevention or treatment of human diseases, traditionally used on socio-cultural and/or religious foundations. They are not intended for parenteral injection.
Improved traditional remedies (RTA)
Herbal remedies modified to increase acceptability, labeled with active ingredients originating exclusively from plants.
Cosmetic and personal hygiene products
Contain active ingredients from plants or other non-plant materials (animal and mineral materials) or a combination, intended for contact with the superficial parts of the human body.
Insecticides and acaricides
Contain active ingredients from plants or other non-plant materials, intended to be applied to humans.
Dietetic products
Contain active ingredients from plants or other non-plant materials, intended for a specific diet, distinguished from commonly consumed foodstuffs.
AMM
Marketing Authorization, an authorization issued by the Ministry of Health before marketing health products.
Officinal Preparation
Medication prepared in a pharmacy according to pharmacopoeia indications or a recognized form, dispensed directly to patients.
Master Preparation
Medication prepared extemporaneously in a pharmacy or health establishment based on a prescription for a specific patient.
Preparations intended for the conduct of therapeutic trials
Drugs subjected to preclinical studies with conclusive in vivo or in vitro results on an animal model, indicating the absence of drug toxicity.
Finished TM/MC products of any category must adhere to national ethical standards, the ethical standards of the Malagasy pharmacopoeia, or other pharmacopoeias recognized by the Malagasy State. Before public sale, finished TM/MC products of any category require a Marketing Authorization (AMM) issued by the Madagascar Medicines Agency of the Ministry of Health for a five-year period.
Medicinal preparations, compounded preparations, and preparations intended for the conduct of therapeutic trials are exempt from Marketing Authorization.
The MA application addressed to the Director of the DPLMT must include:
The Marketing Authorization must be renewed six (06) months before its expiry date.
The application file for the renewal of the registration of finished products and assimilated products of MT/MC must include the following documents:
Addressed to the Director of Pharmacy, Laboratories, and Traditional Medicine specifying that no modification has been made to the elements produced in support of the request apart from the authorized modifications. This letter must include:
Any modification made to one or more elements of the finished product, excluding the price, must be the subject of a new application for the registration of the Marketing Authorization. Variations in the Marketing Authorization may concern the following elements:
In the case of the first five modifications, six (06) samples of the finished product, presented in the packaging method of the sales model of the same batch, must be attached, accompanied by the analysis report of the corresponding batch duly completed and signed.
The following modifications must be justified:
It must include the following sections:
New Application for Marketing Authorization (MA)
The renewal application for marketing authorization must include the following:
Any modification of one or more elements of the MA dossier of the drug must be subjected to assessment by Madagascar Drug’s Agency.
The Marketing Authorization modification may cover the following:
Ownership of Assessed Files:
Application Acceptance Limit:
Deadline Extensions:
Terms and Conditions of Payment:
As part of the verification of the implementation of Good Manufacturing Practices (GMP), pharmaceutical industries are required to facilitate access to their manufacturing facilities for representatives of the Madagascar Drug’s Agency.
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
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