Import and Export Control
Importation & exportation of Medicines and Biocidals
Section 73 of the Tanzania Medicines and Medical Devices Act Cap.219 gives mandate to TMDA to regulate importation and exportation of medicines, medical devices, invitro diagnostics and biocidals
Categories of importers:Government & Non-Government Institutions
- Wholesalers: pharmaceuticals, biocidals
- Manufacturers: pharmaceuticals, biocidals
- Clinical trial sponsors and Principal investigators
- Recipients of donations
When to apply for an import or export permit?
- At least 6 weeks prior to loading the consignment:
- Avoid storage costs at Ports of Entry (PoE)
- Avoid disposal costs of unpermitted products
- For medicines (section 73 (4) of the Act):
- Remaining shelf-life of product should be at least 60% greater than 24 months
- Remaining shelf-life of product should be at least 80% for products with shelf-life less than 24 months
- Importers & exporters must register their premises at TMDA before applying for permits (To register a premise)
- Compliance to conditions prescribed under section 1.2 and section 2.3 of the Guidelines for Importation and Exportation of Pharmaceutical Products and Guidelines for Importation and Exportation of Medical Devices including Invitro Diagnostic Device and Laboratory Equipment
How to apply for an import or export permit?
- Controlled drugs:
- are medicines with potential for physical and mental dependence;
- may be abused and misused; and
- have imposed restrictions on their importation, distribution and sale.
- In Tanzania, controlled drugs include any narcotic drug, psychotropic substance or precursors as listed under Section 77 of the Act.
- The Medical Stores Department (MSD) is the only institution allowed to import narcotic.
- Other facilities that stock and use narcotics MUST seek permits from TMDA prior to purchasing narcotic drugs from MSD. Other government institutions responsible for management of wild animal and veterinary use may also be authorized to import narcotics.
- Psychotropic substances and precursors may be imported by Authorized importers
- Submit application online accompanied by a letter requesting for issuance of certificate of official approval of import of psychotropic.
- The list of controlled drugs can be found in the Tanzania Medicines and Medical Devices (Scheduling of Medicines) Regulations, 2015. For more information on handling of controlled drugs refer to the Guidelines on Controlled Drugs.
Special Permit Procedure
What is it?
A special permit is an importation permit issued under section 57 (1) of the Act to allow importation of an unregistered regulated products
Who can apply?
- Healthcare providers
- Government Institutions
- Clinical trial personnel
- General public (Personal use)