BURUNDI
BURUNDI
The Republic of Burundi is an in East African country. Since February 4, 2019, the population of Burundi is estimated at 12 million inhabitants whose official languages are Kirundi and French.
Medicines and other health products can only be imported after registration.
Medicines market in Burundi:
The African market in general is a high-volume import market, in Africa local production accounts for only 3% of world production, while the market is expanding, and demand is growing.
Burundi has only one drug manufacturing establishment.
Registration of medicines:
The Republic of Burundi is a member state of the East African Community (EAC) and therefore applies its guidelines on the registration of medicines. In addition, there are some national texts and specificities of the country to know.
The registration dossier must be in CTD format and in French language.
Drug Registration Authority: The Burundian Regulatory Authority for Medicines for Human Use and Food (ABREMA) created in 2021.
The registration of drugs depends on the level of compliance of the file and requires 9 to 18 months.
AREMA offers you total assistance for the registration of your medicines in Burundi.
We provide regulatory services from the regulatory intelligence, preparation and translation of your dossier, the deposit, follow-up and registration of your various products until the establishment of a system of pharmacovigilance and post-marketing monitoring.
In order to initiate any collaboration or for any consultation you can contact us by email: