Section 58 of PMRA Act mandates the Authority to issue import permits to registered entities including donations of medicines into Malawi.

In order to qualify for a donation permit, the donated medicines;

• Must be of acceptable quality, safety and efficacy.
• Must be relevant to the local situation with respect to disease patterns complying with the Malawi National Medicines Policy and fit in the treatment guidelines.
• Must serve the needs of the recipients.
• Must be of acceptable shelf life (at least 1 year) and labelled in a language that can be understood by Malawians.

A duly signed and filled donation form (PMRA/D/01) together with an application letter, an invoice and declaration of donation shall be submitted to the authority for approval and issuance of import permit. This can be submitted by the applicant who is either the recipient of the donation or any other institution organizing the donation on behalf of the recipient. The authority shall do the approval of donation within ten (10) working days of receipt of the application after payment of applicable processing fees.

All donations should comply with the provisions of the Act and associated regulations.

The donation form and further guidance on donations can be accessed in the guidelines here: