News Flash
-
Head Offices
Pharmacy and Poisons Board offices along Lenana Road in Nairobi. The building was officially opened in 2005 by the Minister of Health at the time, Hon. Charity Ngilu. -
PV Launch
Pharmacovigilance department came out to the Kenyan public on the 9th of June 2009 when a formal launch of the Pharmacovigilance System in Kenya took place at the Panafric Hotel in Nairobi. -
NQCL
National Quality Control Laboratory. The quality of a drug is one of the criteria for market approval. Quality assurance covers all activities aimed at ensuring that consumers and patients receive a product that meets established specifications and standards of quality, safety an efficacy. -
Ministry of Health HQ
Pharmacy and Poisons Board is under the Ministry of Health whose HQ are at Afya House, Bishop Road, Nairobi -
Guidelines
The Pharmacy and Poisons Board has various guidelines that explain how services are delivered. The guidelines can be downloaded from this site.
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 of 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