MEDICINES REGISTRATION – SECTION PROFILE

MRE Section performs the following functions in regulation of medicines in fulfillment of the Authority’s mission of protecting and promoting public health:

1. Evaluate applications for registration of medicinal products;
2. Register medicines which have fulfilled the quality, safety and efficacy requirements;
3. Review and approved medicinal product labeling and information;
4. To update and publish information on registered medicines;
5. Evaluate and approve promotional materials and advertisements applied for registered medicinal products;
6. Development and review of medicines Regulations, guidelines, standard operating procedures (SOPs) and manuals;
7. To attend and respond to customer enquiries related to medicines registration;

During execution of the functions and implementation of the activities, the Section collaborates with the Medicines and Complementary products Inspection and Enforcement Section, in matters relating to Good Manufacturing Practice (GMP) compliance; and Clinical Trial and Pharmacovigilance Section on issues relating to the quality, safety and efficacy of registered products circulating on the market.

Introduction

Medicines Registration (MRE) is a section under the Directorate of Human and Veterinary Medicines, which deals with assessment of quality, safety and efficacy of human and veterinary medicines including vaccines, biotherapeutics/similar biotherapeutics, herbal medicines, antiseptics and disinfectants (biocidals). According to the Tanzania Medicines and Medical Devices (Registration of Medicinal Products) Regulations, 2015; a medicinal product means any substance or mixture of substances manufactured, sold or presented for use in:-

1. The treatment, mitigation or prevention of a disease, disorder, abnormal physical or mental state, or the symptoms thereof, in man or animal;
2. Restoring, correcting or beneficial modification of organic or mental functions in man or animal; or
3. Articles intended for use as a component of any articles specified in clause (a) or (c); but does not include medical devices or their components, parts or accessories.

Scope of Products

The Section deals with registration of human medicinal products, veterinary medicinal products, herbal drugs and biocidals (antiseptics & disinfectant). The Section is also responsible for notification of tobacco products

Personnel

The Section is headed by a Manager who leads a team of Medicine Assessors (Drug Registration Officers) of different cadres including pharmacists, veterinary surgeons, medical doctor and chemist. In addition to quality aspects of medicines, the staff have been trained in different specialty areas such as assessment of biotherapeutics, vaccines, promotional materials and clinical safety and efficacy data. Thus, the Section is well equipped with adequate knowledge, expertise and experience to ensure that the medicines registered in Tanzania Mainland meet the quality, safety and efficacy requirements

Product Life Cycle management

After the medical product is granted marketing authorization by the Authority, it remains the responsibility of the Marketing Authorization Holder (MAH) to ensure that the product continuously maintains its quality, safety and efficacy profile during its life time on the market. Marketing authorization for all medicinal products remains valid for a maximum period of five years, after its registration.