CONDITIONS FOR MANUFACTURER REGISTRATION
1. The manufacturer must comply with c GMP.
WHO MAY APPLY FOR REGISTRATION
The application to register a pharmaceutical product should be made by the manufacturer. This person may either perform all the manufacturing and packaging operations by himself or assign one or more of the operations to someone else. In the later instance, however, it is necessary for the applicant to have such influence over the subject as will enable him to bear full responsibility for the relevant information that is given in the application for registration.
A foreign manufacturer may be represented in Kenya by a domiciled agent who is empowered to plead the manufacturer’s cause before the Pharmacy and Poisons Board.
An agent for a foreign manufacturer must file a blanket power of attorney which authorizes him to speak for his principal in all matters relating to the latter specialties.
Ownership of the Certificate of Registration shall be vested with the manufacturer who is the owner of the registered product. In case of contract manufacture the contract giver will be deemed to be the owner.
The Board reserves the right to verify the Good Manufacturing Practices Compliance of the manufacturer at the applicant’s expense.
A separate application is required for each product. In this context a product means in the case of a drug or medicinal product, a dosage form in a specified strength.
The Certificate of Registration for a Pharmaceutical Product shall be valid for five years.