How to Register a Medicine or Pharmacy with PMRA in Malawi

The Pharmacy and Medicines Regulatory Authority (PMRA) regulates the registration of medicines, pharmacy personnel, and business premises in Malawi.²⁶ All persons seeking to practice pharmacy and all premises manufacturing, supplying, storing or selling medicines must be registered with PMRA before operating.²⁶

Registering as pharmacy personnel

To register as a pharmacy assistant, pharmacy technician, or pharmacist, you must have successfully completed a course in pharmacy from an accredited college or university in Malawi or from a recognized foreign university or college of pharmacy.² You must also satisfy all other requirements determined by PMRA at the time of application, regardless of nationality, race, creed or gender.² After passing your registration examination, you must collect your results letter from PMRA offices.⁴ Once registered, you must apply for a practicing licence issued by the Authority before you can practice pharmacy in Malawi.⁴

Registering pharmacy premises

All medicine shops and retail pharmacies must be registered with PMRA before they can operate.⁶ You need to submit a completed application form to the office of the Director General, along with verification of your registration status as pharmacy personnel, evidence of payment of the prescribed fee, and other required documents.⁶ Your premises must be constructed and maintained to protect medicines from weather, ground seepage, and pests, and kept in good repair.⁹¹¹ If you are establishing a dispensing premise (such as a clinic), you must also provide a letter from the medical or nurse’s council authorizing you to operate the clinic.¹¹

Registering a medicine

For a medicine recommended for registration by ZAZIBONA (the regional medicines registration body), you must submit your complete application to PMRA within one year of the recommendation.³ Your application must include all queries raised by ZAZIBONA and their responses, medicine samples as per guidelines, a declaration of any changes made after ZAZIBONA’s recommendation, and evidence of payment of fast-track registration fees according to PMRA’s fees schedule.³ If you have made a major change after ZAZIBONA’s recommendation, your application will not be eligible for registration through the ZAZIBONA pathway.³ You can download the application form and fee schedule from www.pmra.mw.³

Application documents and fees

Specific application forms are available from PMRA for different types of registrations, including forms for practicing licences, medicine store relocations, and pharmacy upgrades or downgrades.⁷ You must provide evidence of payment of the prescribed fee when submitting your application.⁶³ Contact PMRA offices for the current fee structure and to verify all requirements for your specific type of registration.