The importation permits once issued are valid for a period of six (6) months and they can be used to clear imported products up to three (3) partial shipments.

All registered products have a validity of five (5) years from the registration issue date except for Antiseptics and Disinfectants which have a validity of three (3) years. The renewal applications of the products should be launched prior to their expiry.

Accessories and/or spare parts, supplied for the replacement of existing components of a registered medical device, are not considered to be medical devices unless they are likely to significantly change the characteristics or performance of the device. In the later case, the accessories and/or spare parts may be considered as medical devices in their own existence and therefore could require registration.

TMDA welcomes the application for registration of RDTs for Corona virus, provided that they are intended for research and not for public use.

The devices for detection of Corona virus are polymerase chain reaction (PCR) machines that have been recommended by Ministry of Health, Community Development, Gender, Elderly and Children (MoHCDGEC).

There are 16 official ports of entry as per the existing regulations. Click here for more details.

Various studies have been conducted from time to time in line with other TMDA systematic enforcement measures including Post Marketing Surveillance (PMS) activities, whereby the market is considered to be generally safe.

For example, Mziray et al., (2017: 6:1) Pharmaceutical Regulatory Affairs Journal, a study conducted by TFDA (now TMDA) with the aim of monitoring the quality of registered anti-malarial medicines circulating on the market in Tanzania Mainland.

The results showed that a total of 1,444 samples of oral solid formulations from different types of anti-malarials were sampled. Out of these, 132 (9.1%) failed labelling requirements of product information. A high percentage of samples passed the identification test by TLC (97.9%) and the disintegration test (99.8%). A small failure rate of 4.8% (7/145) was observed in confirmatory testing, from which only one of the samples (i.e. quinine sulphate 300 mg tablets) was confirmed to be falsified.

Yes, TMDA takes several measures in promoting the pharmaceutical industries as follows:

• Establishment of a special desk which can provide assistance to investors,
• Provision of technical support whenever required,
• Reduction in time for registration of medicines and premises,
• Conducting stakeholders meeting and distribution of information, education and communication (IEC) materials; participating in different exhibition and events to sensitize companies to invest in Tanzania,
• Provision of statistics and advice related to pharmaceutical products to investors, and
• Frequent training of technical staff from the manufacturing industries.

Only medicines that are recommended for registration directly by TMDA or under EAC harmonization initiatives are registered in Tanzania. However, medicinal products which are registered by other EAC NMRAs (including Kenya and Uganda) outside the EAC harmonization programs should be applied for registration in Tanzania.