Registration and Marketing Authorisation (MA)
Registration and Marketing Authorisation (MA) tests whether a candidate understands how the Pharmacy and Poisons Board (PPB) decides that a medicine may be legally marketed in Kenya, and how that authorisation is maintained.
Legal basis and scope
Under the Pharmacy and Poisons Act (Cap 244), a medicine for human or veterinary use may not be manufactured, imported, exported, distributed, sold or supplied unless it is registered or otherwise authorised by PPB. MA is product-specific and site-specific: the product, manufacturer, formulation, label and intended use are all assessed.
What the application contains
Applications are submitted through the PPB portal using a Common Technical Document (CTD)-style dossier: administrative information, quality/Chemistry, Manufacturing and Controls (CMC), nonclinical and clinical modules. Supporting documents normally include a GMP certificate or GMP clearance for the manufacturing site, a Certificate of Pharmaceutical Product (CPP) where relevant, product information and artwork, stability data supporting the shelf life, and samples for testing where requested. PPB assesses quality, safety and efficacy, issues deficiency letters, and grants an MA with a registration number. MAs are time-limited and must be renewed; changes to formula, site, shelf life, labelling or indications require a variation.
Worked example
A local manufacturer submits Module 3 with batch records but no stability data for the proposed 24-month shelf life, and the site has no PPB GMP clearance. The assessor cannot approve: the shelf life is unsupported and GMP status is unverified. A deficiency letter is issued. The applicant generates stability data and undergoes GMP inspection; approval follows only after both gaps are closed. The reasoning is that MA is not a paper exercise - it links the product to a demonstrated quality profile and an acceptable manufacturing site.
Traps that cost marks
- Treating a business permit, premises licence or foreign approval as a Kenyan MA.
- Assuming a CPP automatically authorises marketing in Kenya.
- Omitting local product information, labels or artwork.
- Making post-approval changes without a variation.
- Allowing the MA to lapse before renewal.