Drug Evaluation & Registration Department
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Human and Veterinary Drug Evaluation and Registration

Any pharmaceutical product before it is made available to the market needs evaluation and registration. Drug registration, which is equivalent to marketing authorization, is a process where drugs are evaluated for their safety, efficacy and quality. The data required for application of registration is indicated in the guideline for registration of each category.

The guidelines for registration are available upon request from the authority and it is 10 birr.

After referring to the registration guideline, manufacturers are required to submit their application for registration compiled according to the guideline accompanied with appropriate registration fee through their local agent.

Once the application is submitted the local agent should have to communicate with staff of the division regarding the status of the registration. Usually, the expert assigned for the evaluation of the application will report his findings after 15-21 days of submission of the application. The comments made by the expert will be communicated to the manufacturer in writing via his local agent in Ethiopia. The local agent should inform any missing elements or findings of the evaluation to the manufacturers. The manufacturers should supplement any missing elements in writing as soon as he receives the query. After sustentative screening of the application by the individual expert and completion of any missing elements the application will be submitted to committee for final approval.

After approval by the committee the manufacturer will be requested for the submission of actual samples of the product for quality control laboratory analysis. Therefore, applicants are strongly recommended not to submit samples of actual products at the time of submission of the application for registration. The quantity of samples required will be indicated in writing during sample request. The actual samples to be submitted should be the product that is manufactured under the conditions and procedures stated in the dossier and the labeling requirement should be the same as the one approved during evaluation.

Marketing Authorization will be issued when the laboratory findings comply with the information stated in the dossier. Once the marketing authorization is issued, it is valid for five years and re-registration is required after five years. However, if found guilty of fraud within the valid period of the marketing authorization, the authority has a right to suspend or chancel the registration certificate already issued.

Any variation made to the product should be notified to the authority. The possible kinds of variations and registration requirement for each variation type are stated in the guideline. If there is any variation, which is not mentioned in the guideline, the manufacturer can contact the staff of the division as to the contents of the data type required for his variation. Any variation, which needs certification, should be accompanied with the registration fee.

Pesticides Evaluation and Registration 

It includes evaluation and registration of public health and house hold pesticides.

The registration system is basically similar as that stated above for human and veterinary products. The requirements are given in the Guideline for Registration of Pesticide Products in Ethiopia.