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Marketing Authorization Marketing Authorization

SUMMARIZED STEPS FOR MARKETING AUTHORIZATION

Submission

Submit soft copies of the product dossier(s) with the required information to the lead country in Medicines Evaluation and Registration (MER) which is Tanzania Food and Drugs Authority. Submit soft copies of the Site Master File (SMF) with the required information to the lead country in Good Manufacturing Practice (GMP) which is National Drug Authority of Uganda.

If the dossier is complete upon screening, submit the product dossier(s) to the remaining EAC National

Medicines Regulatory Authorities (NMRAs).

Fees to be paid by the applicants to all EAC NMRAs shall continue to follow national Fees Regulations.

Evaluation

First evaluation will be done within one month from the date of acceptance of the application and second evaluation will be done within one week after the first evaluation. Incase additional data is required and response is submitted, evaluation will be done immediately after receipt of response.

Registration

Once satisfied with the evaluation and GMP inspection, a notification letter will be issued by the EAC Secretariat to the applicant/manufacturer.

National approval will be granted within three months from the date of joint acceptance as agreed by all EAC Partner States’ NMRAs.

The letter which confirms the final registration outcome will be communicated by the respective NMRAs.

Maintenance

Registered products shall be maintained in each NMRA’s list of registered products subject to continued compliance with registration requirements, National Health Policies and any other directive(s) issued from time to time.

Our Development Partners Our Development Partners

EAC Partner States NMRAs EAC Partner States NMRAs

Supported by: Trademark East Africa.