Dear Nr Fara,
Thank you for your question.
Both the prescribed and un-prescribed drugs should be registered by the Ethiopian Food, Medicine, and Health Care Administration and Control Authority (FMHCAC) to be eligible for export into Ethiopia. The authority undertakes various tests to check the drugs for safety, quality and efficacy. The registration process is quite stringent and could take from 6 – 12 months. An applicant for registration should meet the following requirements (see attached Guidelines for the registration of human drugs to know the exact details):
Appoint at least one agent who could follow the registration process on behalf of the exporter. It is only through agents that the company could export into Ethiopia. The number of agents the company can appoint is also restricted by law to a maximum of three.
Check if the drug is already registered (included in the national drug list); please refer on the Authority website – www.fmhaca.gov.et , and submit further additional documents and samples as listed in the guideline.
New applicants are expected to submit Manufacturing Practice (GMP) certificates given by Stringent Regulatory Authorities (SRA), a complete dossier and a copy of Market Authorization issued by SRA, (see attached Market Authorization Guideline).
If the applicants have no Good Manufacturing Practice (GMP) certificates given by Stringent Regulatory Authorities (SRA), the Authority would undertake physical visits to their manufacturing facilities to determine if the factories meet its requirements.
If the drug meets all the requirements of FMHCAC, it will give 4 years market authorization for the drug to be imported into Ethiopia.
Purchase order and import permits are always required for every consignment of drugs to be exported into Ethiopia.
Posted on behalf of Dessalegne Yigzaw - UKTI Ethiopia