Guidelines on Medicines and Vaccines Renewals

The Board is empowered under Section 3A of the Pharmacy and Poisons Act, Cap 244 Laws of Kenya (“The Act”), to formulate guidelines for regulating the manufacture, distribution, sale and use of medical products. Further, the Board is empowered under the same section to grant or withdraw marketing authorization for medical products subject to appropriate conditions and revise such conditions for marketing as necessary. Section 3B of the Act, further mandates the Board to maintain a register of all authorized/registered medical products and health technologies.

Medical products and health technologies registered under the Act are issued with a certificate of registration, valid for a period of five (5) years as specified under Rule 7 of the Pharmacy and Poisons (Registration of Drugs) Rules. Such registered products, under Rule 9A, are to be retained in the register of medical products annually upon payment of a specified retention fee. It is therefore a requirement, under Rule 9, that certificates of registration are renewed every five (5) years upon satisfactory compliance with specified conditions.

These guidelines seek to provide for the framework for renewal of marketing authorizations/ certificates of registration issued under the Pharmacy and Poisons Act, Cap 244