GUIDELINES FOR SUBMISSION OF POST-APPROVAL VARIATION MEDICINE APPLICATIONS 2015

The Food, Medicine and Health Care Administration and Control Authority (FMHACA) of Ethiopia was established to protect the public health from unsafe, inefficacious and poor quality medicines by insuring effective and efficient pre and post -marketing authorization of medicines systems in the country as described in Proclamation No. 661/2009. An applicant and/or medicine manufacturer must notify and got approval from the Authority for any changes to an approved application in accordance with Food, Medicines and Healthcare Administration and Control Regulation (Regulation No. 299/2013) article 15, sub-article 5. In the preceding two “Guidelines for Registration of Human Drugs”, requirements for variation applications were described as one section of the documents and the types of variations described were not exhaustive to handle the current day-to-day facing variation types received by the Authority. Therefore, this guideline includes the current international accepted trend of variations types and requirements for handling of these variations. This is, therefore, the first edition of guideline for handling variation applications to the registered medicines by Food, Medicines and Healthcare Administration and Control Authority of Ethiopia. It is prepared for the purpose of providing applicants/manufacturers with information concerning documentation to be submitted for approval variations to the previously registered medicine by the Authority. Once a medicine is registered by the EFMHACA for sale in Ethiopia, any changes to the original information submitted with the application or set as conditions for registration must be submitted for approval. Variations to details of a medicine may be made to alter or to improve the medicines, to introduce an additional safeguard due to new scientific knowledge or to meet market demands. The conditions of registration of a medicine are therefore considered dynamic taking into account that variation to the original registered dossier may become necessary during the lifetime of the medicine