ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

3^rd June, 2024

NOTICE OF REVOCATION OF MARKETING AUTHORIZATION FOR MEDICINAL PRODUCTS CONTAINING AMPICILLIN ACTIVE INGREDIENT AS MONOTHERAPY

1. Tanzania Medicines and Medical Devices Authority (TMDA) is mandated as per section 5(1) of the Tanzania Medicines and Medical Devices Act Cap, 219 to protect public health by ensuring medicinal products' quality, safety and efficacy.
2. TMDA has recently conducted a thorough and comprehensive assessment of all products containing ampicillin as a single moiety. Following this review, it has been clear that microorganisms including Klebsiella pneumoniae, Escherichia coli, other Klebsiella spp, and Proteus spp have demonstrated resistance towards ampicillin monotherapies. Some of the reviewed articles during this assessment have also indicated that resistance has reached up to 100% in some East African Partner States.
3. In view of this and pursuant to section 51 (1) (a) and (b) of the Tanzania Medicines and Medical Devices Act Cap, 219, the Authority has decided to cancel the marketing authorization of medicinal products containing ampicillin as monotherapy across all dosage forms.
4. All marketing authorization holders of the affected products are advised to re-formulate their products to different combinations to allow for the same to be effective against bacterial infections.
5. Similarly, the Authority would like to inform its esteemed stakeholders that, the new applications for registration or renewal applications of ampicillin monotherapy products will not be accepted.