Regulations

1. The Tanzania Medicines and Medical Devices (Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials) Regulations, 2015.
2. The Tanzania Medicines and Medical Devices (Recall, Handling and Disposal of Unfit Medicines) Regulation, 2018.
3. The Tanzania Medicines and Medical Devices (Good manufacturing Practice Enforcement) Regulation, 2018.

Guidelines

1. Guidelines for Recall, Handling and Disposal of Unfit Medicines, 2020
2. Good Manufacturing Practice Guidelines for Veterinary Medicinal Products, 2020
3. Guidelines for Dealing in Controlled Drugs, 2020
4. Guidelines for Business Licensing and Good Storage and Distribution Practices of Medicines and Medical Devices, 2020
5. Guidelines for Production of Extemporaneous Formulations and Hospital Based Sterile Preparations, 2020
6. Guidelines for Importation and Exportation of Pharmaceutical Products and Raw Materials, 2020
7. Guidelines on Submission of Documentation for Establishment of Compliance to GMP through Desk Assessment, 1st Edn, June 2020

Application forms

1. Premises Registration and Business Permit Application Form
2. Quarterly Consumption Report for Narcotic Drugs/Psychotropic Substances /Precursor Chemicals Used in a Manufacturing Facility
3. Application for Procurement and use of Narcotic Drugs
4. Narcotics Drugs Ledger Book
5. Narcotics Drugs Ledger Book (Record of Used Narcotic Drugs in a Facility)
6. Quarterly Consumption Report for Narcotic Drugs /Psychotropic Substances/ Precursor Chemicals usage in a Health Institution
7. Annual Consumption Report for Narcotic Drugs /Psychotropic Substances/Precursor Chemicals used in a manufacturing Facility
8. Annual Consumption Report for Psychotropic Substance/Narcotic Drugs/ Precursor Chemicals usage in a Health Institution
9. GMP inspection Application Form
10. GMP Desk Review Application Form
11. Disposal Application Form
12. Sample collection Form
13. Observation Form
14. Confiscation Form
15. GMP Inspection Attendance Record
16. GMP Inspection Memorandum Form

IMPORT AND EXPORT CONTROL

Section 73 of the Tanzania Medicines and Medical Devices Act Cap.219 gives mandate to TMDA to regulate importation and exportation of medicines. Facilities which intends to import or export medicines for business purposes must register their premises at TMDA before they apply for import/export permits. The Medical Stores Department (MSD) is the only Institution allowed to import narcotic drugs as per the guidelines for controlled drugs. All other facilities that stock and use narcotics seek permits from TMDA for the purpose of purchasing narcotic drugs from MSD.

Only manufacturing facilities are allowed to apply for import permit of raw materials for products which have been authorized to be manufactured in Tanzania.

Importers of pharmaceuticals shall fall under the following categories:

Government and Non- Governmental institutions

1. Pharmaceutical wholesalers
2. Pharmaceutical Manufacturers
3. Clinical trial sponsors and Principal investigators
4. Recipients of donations

However, the following can be authorized in the special circumstance:

1. Persons authorized to import pharmaceuticals for personal use
2. Hospitals authorized to import pharmaceuticals for hospital use

Applications for import and export permits must be submitted to TMDA through the online trader portal. To submit an on online application, Click here.

The applicants will be able to log into the online trader portal after opening an account at TMDA. To open the account, one shall be required to fill an application form and submit to TMDA. The application form can be accessed here.

The General conditions for importation of pharmaceuticals are as indicated below;

1. All pharmaceutical products to be imported must be registered by TMDA unless given special approval by the Authority.
2. All importation of pharmaceutical products must be done by importers whose premises are dully registered by TMDA or relevant Government institution.
3. All importers must import pharmaceutical products through the authorized Port of Entry (POE).
4. In case of donations, importer must have a donation certificate and adhere to the Guidelines for Donations. The donated pharmaceutical products must be fit for human consumption, safe and of good quality and not prohibited in either the exporting or importing country.

According to Section 73 (4) of the Act, it is not allowed to import any pharmaceutical product with shelf life of more than twenty-four months whose remaining shelf life is less than 60% and a drug with shelf life of less or equal to twenty four months whose remaining shelf life is less than 80%.

Applications for import and export permits must be accompanied by scanned copy of an original proforma invoice from the marketing authorization holder of the product(s) or authorized supplier(s).

Applications for import and export permits must be accompanied by scanned copy of an original proforma invoice from the marketing authorization holder of the product(s) or authorized supplier(s).

The Proforma invoices shall state for each pharmaceutical to be imported, the following (s);

1. Profoma invoice number and date
2. Name of the supplier.
3. Name of the manufacturer.
4. Country of origin.
5. Trade or proprietary name.
6. The International Non Proprietary name (generic name) of the drug and its strength.
7. In the case of the product containing more than one active ingredient, the name and strength of each shall be stated.
8. The pharmacopoeial specification of the ingredient such as BP, USP.
9. The product registration number issued by the Tanzania Medicines and Medical Devices Authority.
10. The quantity to be imported for each drug, its unit value, total value and acceptance currency.
11. Batch number for each product
12. Manufacturing and expiring date
13. Currency
14. Mode of shipment (sea, air, road)
15. Destination port of entry
16. Expected date of arrival
17. Signature and stamp of the supplier

Special application for permits submitted by Medical Stores Department (MSD) must be accompanied with MSD call off order and the medicines must be coming from a GMP compliant facility. For Donations, the application must be supported by a covering letter from the Ministry responsible for health, Regional Medical Officer (RMO), District Medical Officer (DMO) and the certificate of donation.

Special applications for import permits of medicines for neglected diseases, outbreak or natural disaster and those aimed for Government programs, the application should be accompanied with a covering letter from the responsible Government organization while that for clinical trials it has to be accompanied with Clinical Trial Approval letter from TMDA.

All application for import permits and exportation permits of medicines for personal use should be accompanied with proforma invoice for the medicines and a genuine doctor’s prescription. No one will be allowed to import or export narcotic drugs for personal use and for medicines containing psychotropic substances, thorough scrutiny shall be done before consideration of the applications.

Applications for importation of Controlled drugs should in addition to the application for import permit be accompanied with the covering letter requesting to be issued with the Certificates of official approval of import for psychotropic or narcotics substances. This letter should be uploaded during online application for the import permit.

It is advisable to submit applications for import permits six (6) weeks in advance before loading of the consignment in order to avoid cost for storage of the consignment at the PoE and also disposal costs due to presence in the consignment of products which are not allowed for importation.

The importation and exportation permits that are issued have a validity period of six (6) months which is sufficient for preparations of importation and exportation. However, based on the client service charter, processing of special applications for importation and exportation of pharmaceuticals cannot exceed ten (10) working days provided the application meets all the requirements.

The common mistakes that are made during application for import and export permits include failure to declare properly the PoE as declared in the proforma invoice, wrong entry of the proforma invoice reference number and date of the proforma invoice, selecting the wrong currency, not including free of charge goods, not declaring the manufacturer and supplier in the proforma invoice, using one invoice for more than one applications and submission of proforma invoice which are not written in English /Swahili language. These delay issuance of permits because they necessitate the Import Export Control Officers to return the application to the applicant.

Based on the fees and charges regulations, permits for importation of medicines (finished products) are charged a 2% FOB while permits for importation of donated medicines are charged a fee of 0.25%. Permits for importation of raw materials and exportation of finished medicinal products and raw materials are issued free of charge.

After issuance of importation and exportation permits, the consignments need to be inspected at the port of entry and exit. In some special cases, consignments may be released at the PoE under the condition that the consignment should not be opened until it has been inspected at the owner’s premises. In such cases, the consignment shall be inspected within one week after arrival of the consignment at the owner’s premises.

Detailed information about import and export for medicinal products is given in the guidelines Click here and regulations Click here.

To read the Online Trader Portal User Manual Click here.

REGISTRATION AND LICENSING OF PREMISES

Section 21 of the Tanzania Medicines and Devices Act, Cap 219 mandates TMDA to register wholesale pharmacies that import medicines and pharmaceutical manufacturing facilities. Section 37 of the Pharmacy Act, 2011, mandates the Pharmacy Council to register Accredited Dispensing Outlets (ADDOs), retail pharmacies and wholesale pharmacies that do not import pharmaceuticals but distribute pharmaceuticals within the country.

Wholesale pharmacies for veterinary medicines are also registered by TMDA while retail outlets and clinics for veterinary services are registered by the Veterinary Council of Tanzania (VCT) based on the Memorandum of Understanding (MoU) signed by TMDA and VCT. Click here to access the MoU.

The applications for premises registration and business permits shall be submitted to TMDA through a dully filled in application form. Click here to access the application form. For online application, Click here. Applications for registration of all type of premises under the mandate of TMDA and business permits are processed by TMDA zones offices except for licensing of new manufacturing facilities. Click here to link with zone offices.