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(2015; 72 pages)
EFMHACA would like to acknowledge the United States Agency for International Development (USAID) and the U. S. Pharmacopeial Convention Promoting the Quality of Medicines (PQM) Program for the financial and technical support delivered in preparation of this Guidance.
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 get 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.
This guideline includes the current international accepted trend of variations types and requirements for handling of these variations. This is the first edition of guideline for handling variation applications to the registered medicines by EFMHACA. 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.
In order to facilitate the classification of the various types of variations, the following sections explicitly define the classification of variations:
SECTION I lists major variations. These are classified by the type of variation as such and the applicable conditions. Whenever the conditions are not kept, the variation may either become major variations or may even make a new application necessary.
SECTION II lists minor variations. The minor variations further classified as minor variation require prior approval and minor variations require notification only.
The above two classes (major and minor) of variations are classified by the type of variation as such and the applicable conditions & the required documentation. There may be a situation in which the variation to be made by the applicant/manufacturer do not listed in the above two classes of variations, in such situation the applicant need to consult Authority for proper categorization the variation type and the documentation needed to be submitted to the Authority.
SECTION III lists types of variation which make a new application necessary. SECTION IV lists stability requirements for variations to registered medicines. SECTION V describes the consideration of SRA procedure for variation application.
The guideline also contains three annexes: Annex I, describe the application form, Annex II, list types of variation applications that require laboratory testing of samples of actual product at EFMHACA laboratory and Annex III, outline the application payments requirement.