P3.1 – Registration as an Importer of Medication for Human Use

Category Import
Picture P3.1 – Registration as an Importer of Medication for Human Use
Summary Registration as an importer of medication for human use (one off registration at commencement of activities).
Description

This requires registration as an importer before any imports can be carried out. The Ministry of Health requires that any company wishing to import medications be registered to ensure quality and safety of imports. Companies should submit to the Department of Pharmacy http://www.arm.co.mz/ the following: Copy of the license as a foreign trade operator [P1]; copy of the I.D. of the applicant and of the technical director; floorplan and description of the premises, company statutes (estatutos), Declaration of Commitment of the Technical Director [F3.1], copy of the diploma of the Technical Director, copy of the pharmaceutical practice card of the Technical Director, and a covering letter. Note that all copies must be authenticated and signatures recognized by a notary. Companies must also submit the names of all brands they wish to import.

Forms

The following form/s are used in this procedure

Title Description Category Agency
Importer Registration of Medicines Form to apply for registration as an importer of medicines (and some medical or cosmetic products). Import Ministry of Health - Department of Pharmacy