Frequently asked questions

PMRA stands for Pharmacy and Medicines Regulatory Authority.

Pharmacy and Medicines Regulatory Authority (PMRA) is a statutory organization established by PMRA Act No. 9 of 2019 to replace the then Pharmacy, Medicines and Poisons Board (PMPB).

Ideally nutraceuticals are supposed to be registered as they are part of allied substances. However, the Authority has not yet started registration of nutraceuticals. 

Medicines registration fees depend on procedure the applicant has chosen. For fast track registration, applicable fee is USD3000 per product. Fast track registration procedures include WHO collaborative registration and SRA registration procedures. Fees for ordinary registration procedure is USD1,500 per product. As for variations, fees depend on type of a variation. For notification, fee is USD100, minor variation fee is USD140 and major variation fee is USD400.

Duration for registration depends on the pathway the applicant has applied for. For SRA and WHO CRP registration procedures, registration time is 90 days. For the other fast track registration procedure which involves full review of the application, registration time is 180 working days. The duration for ordinary registration procedure is 360 days.

The Authority is mandated to regulate and control sale of herbal medicines. Regulatory procedures for registration of medicines are however not finalized and registration of the same has not commenced. Due to public health concern and as provided for in the Authority’s Act, the Authority is regulating advertisement. According to the requirements, any advertisement of herbal medicines is supposed to be vetted and authorized by PMRA.

The Authority is mandated under Section 68 of the PMRA Act to screen and approve advertising materials for medicines and allied substances before they are broadcast or publicized.

The applicant is required to submit a completed application form (attached below) together with the advertising material and proof of payment of prescribed fees (Fee schedule is available at Authorization is granted within 14 working days if the application meets the required standards in the guidelines. Where the advertising material does not meet the requirements, the applicant is supposed to resubmit the amended material in line with communication on non-compliances observed.

“Allied Substances” include acaricides, cosmetics, disinfectants, food supplements, feed additives and supplements, traditional medicines, medical and surgical sundries, medical devices, reagents and condoms.

Traditional medicines include: Plant or herbal material, non-human animal material, vitamins, minerals including mineral salts and naturally occurring minerals, micro-organisms (whole or extracted) except vaccines.

Use any of the two account numbers to pay for any service at PMRA:
1. Bank Name: National Bank of Malawi
Account Number: 1007551955
Account Name: Pharmacy and Medicines Regulatory Authority
Branch: Capital City

2. Bank Name: Standard Bank
Account Number: 9100002325559
Account Name: Pharmacy and Medicines Regulatory Authority
Branch: Capital City