Evaluation and Reg. Human

APPLICATION FOR REGISTRATION OF A DRUG

REQUIREMENTS FOR OPENING OF A NEW MANUFACTURERS FILE

The following are the requirements for a new manufacturer to open a file with the Pharmacy and Poisons Board (PPB) in Kenya:

Letter of appointment of a local agent by the manufacturer. The local agent must be a registered whole seller of drugs in Kenya.
Payment of Good Manufacturing Practice (GMP) inspection fee from 4,000 USD.
At least one new product for registration accompanied by 1,000 USD registration fee for every product application.
Dossier to be submitted as one original hard-copy and one electronic copy (in pdf on a CD-Rom) including Modules 1 and 2 in MS-Word).
All applications to be submitted using the following format: New Application Form

The guidelines to assist you in filling the application form are: Guidelines for Submission

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