ISO 9001: 2015: CERTIFIED

NOTICE TO STAKEHOLDERS

15^th June, 2023

THE USE OF ANTIMICROBIAL PRESERVATIVES IN ORAL SOLID DOSAGE FORMULATIONS

1. Tanzania Medicines and Medical Devices Authority (TMDA) is an Executive Agency under the Ministry of Health established under the Tanzania Medicines and Medical Devices Act, Cap. 219. TMDA is responsible for controlling the quality, safety and effectiveness of medicines, medical devices and diagnostics as well as regulation of tobacco products.
2. In line with Section 51 of the Tanzania Medicines and Medical Devices Act Cap. 219, the Authority is mandated to impose any requirement at any time as may deem necessary for the public interest. This provision aims to ensure that medicines at all times of their life cycle adhere to the current and emerging technical requirements for the registration of medicinal products.
3. In view of this, we wish to bring to the attention of all Marketing Authorization Holders (MAHs) that the use of chemical preservatives in oral solid dosage formulations is generally not acceptable because of associated health risks. In the event that preservatives cannot be avoided at all in the oral solid formulation, the rationale for their use and their concentration in the formulation should be provided.
4. All MAHs who have registered solid oral dosage forms containing preservatives as excipients, are required to review their formulations to omit preservatives through re-formulation within six (6) months from the date of this notice. Thereafter, from 1st January 2024, registration of all solid oral dosage forms containing preservatives shall be withdrawn.
5. The application for the re-formulated product should be submitted through a variation procedure. This is a major variation to the registered product and it should meet all requirements as outlined under section 27b.2 of the Guidelines on Variations of Registered Medicinal Products March 2020.
6. We highly anticipate your cooperation in this matter.