Vetting of Medicines and allied substances adverts and promotional materials

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 prescribed fees. Authorization is granted if the application meets the required standards in the guidelines.

Registration of premises  for pharmacy business

Section 41(1) of the Pharmacy and Medicines Regulatory Authority Act restricts the manufacture, supply, storage and sale of medicines and medical devices unless the premises have been registered by PMRA.
REGISTRATION REQUIREMENTS
Completed application forms for registration are submitted to the office of the Director General and are accepted upon verification of its completeness, registration status of a person under the Act to run the business premise and evidence of payment of prescribed fee. (fee structure and application form attached below)

The Authority processes applications that comply with registration requirements as stipulated in Guidelines for registration of pharmacy practice premises. (Guide line attached below)

The Board of Directors approves the licensing and registration of pharmacy practice premises upon recommendation from the Pharmacy Committee. Upon approval, the registered pharmacy practice premise is required to renew their license annually.

Registration of medicines

Section 62 of the PMRA Act requires that both human and veterinary medicines on the Malawi market are issued with a marketing authorization/product license after the Board is satisfied that the product has met the required standards of quality, efficacy, and safety.

Administratively, dossiers are submitted to the office of the Director General and will be accepted upon verification of dossiers format, number of samples and evidence of payment of registration fee.

The Authority accepts dossiers which are in common technical document (CTD) format as per ICH M4Q or WHO TRS 970 annex 4. This application requires completion of PMRA new product registration form (8A) below.

There are three ways of submission of product registration namely, routine procedure where full assessment is done by PMRA assessors; WHO Collaborative Registration Procedure for products which are WHO prequalified; and ZAZIBONA collaborative registration procedure where SADC countries jointly share and discuss dossier assessment report

Assessment reports are approved by the board of Directors upon recommendations of the Medicines Committee of the PMRA. Upon approval, the product is licensed and incorporated into the List of Registered Products for Malawi.

Registration and regulation of clinical trials

Section 74 of the PMRA Act mandates the PMRA to authorize the conduct of clinical trials in accordance with the principles of Good Clinical Practice (GCP). This is done through the review of clinical trials applications (CTAs) and issuance of clinical trial certificates.

The PMRA receives CTAs through the office of the Director General. The applicant must submit evidence of ethical clearance from either the National Health Science Research Committee (NHSRC) of the National Commission for Science and Technology (NCST) or the College of Medicine Research Ethics Committee (COMREC).

The Board of Directors approves the licensing and registration of CTA upon recommendation from the Clinical Trial Review Committee (CTRC). The approval granted may be full or conditional depending on the nature of the findings of CTRC. Post authorization GCP inspection is done for selected implemented clinical trials depending on the risk profile of the study.

Quality control testing of Medicines

The National Medicines Quality Control Laboratory (NMQCL) is one of the five departments in the Pharmacy and Medicines Regulatory Authority directly reporting to the Director General. It derives its mandate from section 79 of the PMRA Act.

The laboratory informs and facilitates regulatory decision-making by generating scientific evidence and reports on the quality of regulated products. It performs quality control tests on the following:
• Human Medicines
• Veterinary Medicines
• Male Condoms
• Hand Sanitizers (Liquids & gels)

The minimum required quantities for testing can be obtained from the Sample requirement guideline:
Upon the completion of the sample analysis, the NMQCL issues certificate of analysis to clients.

Registration of Pharmacy personnel and medical representatives

The inspectorate and law enforcement department is responsible for registration of pharmacy personnel and medical representatives as provided for in Section 22(1) and 39 of the PMRA Act respectively.

Registration requirements
Administratively, completed application forms (personnel and medical representative) for registration are submitted to the office of the Director General and will be accepted upon verification of completeness of application form, academic qualifications and evidence of payment of registration fee.

The Authority processes applications that comply with registration requirements as stipulated in Guidelines for registration of pharmacy personnel and Guideline for registration of medical representatives

The Board of Directors approves the licensing and registration of pharmacy personnel and medical representatives upon recommendation from the Pharmacy Committee. Upon approval, the registered personnel are required to retain their names in appropriate registers

Pharmacovigilance

Section 72 of the PMRA Act mandates the Authority to establish and maintain a national pharmacovigilance (PV) system. PMRA is the 135th member of the WHO’s Program for International Drug Monitoring (PIDM) since March 2019.

Under the PV system the Authority;

• Receive individual case safety reports (ICSR) from health care workers and the public using the forms below
• Conduct causality assessment of ICSR
• Coordinates the implementation of risk management plans

The authority undertakes both passive and active safety surveillance implemented through public and CHAM hospitals as well as public health programs. In this regard the Authority is involved in training of healthcare professionals in reporting of Adverse Events Following Immunization and Adverse Drug Reactions.

Issuance of import and export permits, narcotic licenses and authorization of donations

Section 58 and 59 of PMRA Act mandates the Authority to issue import and export permits respectively to registered pharmaceutical wholesalers who intend to import or export products.

In order to qualify for importation or exportation of products a registered pharmaceutical wholesaler needs to have an annual import permit. Thereafter the applicant is required to submit a consignment specific import permit request accompanied by an invoice.  

Regulatory requirements for importation of registered and unregistered products are detailed under  guidelines on importation and exportation of products.

All donations of medicines and allied substances should comply with the provisions of the Act and associated Regulations.