Tanzania harmonizes regulatory bodies’ roles, forms drug authority

TANZANIA – Tanzania’s parliament has approved Finance Bill of 2019 which will see harmonization of regulatory bodies’ roles which were overlapping or more less the same.

Following the amendment of Section 130 of the Standards Act No. 2 of 2009, food and cosmetic products, currently under Tanzania Food and Drugs Authority (TFDA), will be regulated by Tanzania Bureau of Standards (TBS), effective 1 July 2019.

To that effect, TFDA has been renamed as Tanzania Drug and Medicinal Authority (TMDA) and will be responsible for controlling medicines, medical supplies and reagents in the country.

TBS, whose mandate is to undertake measures for quality control of products and promotion of standardization will now oversee registration and certification of locally produced and imported food and cosmetics products, as well as registration of their production premises.

TBS will assume the responsibility for registering premises for new applicants using a harmonized system which observes safety and quality requirements for food and cosmetics products.

However, local manufacturers holding premise registration certificates issued by TFDA will still be recognized by TBS till their expiry date which is five years.

Tightening regulatory policy and ease of trade

Tanzania embarked on harmonization of the roles played by regulatory bodies aimed at addressing the challenges impeding business in the country.

TBS has announced several strategies which it says will help minimize testing costs and turnaround time while also simplifying the process a product takes to receive certification.

“A licence or certificate issued by TBS shall be attestation of premise registration and product registration and confirmation of safety and quality of food and cosmetic products.

“This is aimed at reducing annual licensing/certification costs and the piles of licenses and/or certificates at the manufacturer’s premise,” said TBS in a press release.

Tanzania has gone a great milestone to ensure medicines in the healthcare system are of good quality, safe and produce the intended health benefit.

According to WHO, the country is the first in Africa to achieve a well functioning, regulatory system for medical products.

Grip on imported products

The authority has also the mandate to issue a licence for the use of the Standards Mark of Quality for products certified against national standards or a certificate for products certified against other standards.

With a revamped regulatory system, the country is looking to attract local investments by cutting down on importation of food products that can be produced locally.

TBS will assume the responsibility for registering imported food and cosmetics products using a harmonized system by using existing certification schemes, i.e. Pre-Shipment Verification of Conformity to Standards (PVoC) Programmeor Destination Inspection (DI).

Food or cosmetic importers will be required to attach the registration certificate issued earlier by TFDA or TBS while for unregistered products, the importer shall be required to submit samples for assessment and registration before embarking on importation process.

TBS has pledged to uphold quality and safety assurance measures in accordance with international standards including market and factory surveillance to ensure conformity to systems requirements.

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