Registration and Marketing Authorisation (MA)
What this domain tests
This domain separates two things candidates often merge: registration of a person (pharmacist) and authorisation of a product (marketing authorisation). Questions test the legal basis under the Pharmacy and Poisons Act, the evidence required, and the holder’s post-approval duties.
Core rules and concepts
- Pharmacist registration requires a recognised pharmacy degree, supervised pre-registration training, good character, and passing the PPB pre-registration examination. Retention depends on fees and CPD.
- A medicine needs an MA before marketing. The application is assessed for quality, safety and efficacy, usually in CTD format.
- Evidence includes manufacturing-site GMP status, specifications and test methods, stability data, labels and package insert, and a local technical representative.
- Changes after approval are variations; major changes may need prior approval. MAs have a validity period and renewal requirements.
Worked example
A company wants to import a new antihypertensive. It supplies a Certificate of Pharmaceutical Product and a GMP certificate. Reasoning: these support the file but do not replace the full MA dossier. PPB still evaluates the CTD, stability, labelling and site GMP. The importer must hold the MA and the appropriate import/wholesale licence before supply. If the manufacturer changes the tablet coating, that is a variation, not automatically a new MA.
Traps that cost marks
Confusing “registered pharmacist” with “registered product”. Assuming foreign approval automatically authorises Kenyan marketing. Forgetting that labelling must meet PPB requirements. Treating the MA as a one-off approval rather than a lifecycle with variations, renewal and post-market obligations.