How to Register a Medicine or Pharmacy with PMRA in Malawi

Registering with PMRA in Malawi involves different procedures depending on whether you are registering as pharmacy personnel, a business premises, or a medicine product. All registration types require submitting completed application forms to PMRA and paying prescribed fees.²³⁶

Registering as pharmacy personnel

To register as a pharmacy assistant, pharmacy technician or pharmacist, you must have successfully completed a pharmacy course from an accredited college or university in Malawi or a recognized foreign institution.² After completing your course, you sit a registration examination.⁴ Registration eligibility is independent of nationality, race, creed or gender.²

Once you pass the examination and are registered, you must apply for a separate practicing licence from PMRA before you can work in pharmacy.⁴ Both new and old registrants need this licence to practice legally in Malawi.⁴

Registering a medicine

If your medicine has been recommended for registration by ZAZIBONA, you must submit your application to PMRA within one year of the recommendation.³ Your application must include the completed form, all queries raised by ZAZIBONA and their responses, medicine samples as required, a declaration of any changes made since ZAZIBONA’s recommendation, and evidence of payment of fast-track registration fees.³ If you made a major change after ZAZIBONA’s recommendation, your application will not be eligible for the ZAZIBONA pathway.³

Application forms and the fee schedule can be downloaded from www.pmra.mw.³

Registering a pharmacy premises

Section 41 of the PMRA Act requires that any premises used for manufacturing, supplying, storing or selling medicines and medical devices must be registered by PMRA.⁶ Your application must include a completed form, verification that the person running the business is registered with PMRA, and evidence of fee payment.⁶

Your premises must be constructed and maintained to protect medicines from weather, ground seepage, and pests.⁹¹¹ It should be a spacious, permanent structure in good repair, with an efficient working area that allows staff to move freely.¹¹ Completed applications are submitted to the office of the Director General and accepted once completeness is verified.⁶

Required documents and fees

All application forms and fee schedules can be downloaded from www.pmra.mw.³ Specific requirements vary by registration type; check the PMRA website for the forms relevant to your application.⁷