Medicines and Complementary Products Inspection and Enforcement Section Profile

MEDICINES REGISTRATION – SECTION PROFILE


Mr. Emmanuel Alphonce Nkiligi. Manager, Medicines and Complementary Products Inspection and Enforcement

Introduction

Medicines and Complementary Products Inspection and Enforcement (MCIE) is a section under the Directorate of Medical Products Control which enforces the Tanzania Medicines and Medical Devices Act, Cap 219 by regulating the quality and safety of medicines and complementary products through import and export control, and inspection of the entire medicines and complementary products supply chain.

Section 106 of the Tanzania Medicines and Medical Devices Act, Cap 219 gives powers to TMDA inspectors to enter, at all reasonable time, any premises which are in the TMDA register and any other premises, stall, vehicle, vessel or conveyance for purpose of enforcing compliance with the Act.

Personnel

The section is headed by a Manager who currently leads a team of medicines and complementary products inspectors. The section is divided into sub-sections namely Import and Export Control, Good Manufacturing Practices (GMP) for Domestic and Overseas, and Coordination of Inspection activities especially special inspections, recalls and disposal off of unfit products including substandard and falsified (SF) medicines. Staff members have adequate knowledge, expertise and experience to perform effectively and efficiently their responsibilities.

Duties and Responsibilities of the Section

Some of the key functions performed by the section in the fulfillment of the Authority’s mission of protecting and promoting public health include the following:

  1. Import and export control which involves processing and issuance of import and export permits for medicines and complementary products as per section 73 of the Act;
  2. Registration and Licensing of premises dealing with importation of medicines and complementary products, and manufacturing facilities as required under section 21 of the Act; Click to view list of registered premises dealing with medicines and complementary products;
  3. Inspection and Enforcement of medicines and complementary products as required under section 106 of the Act. Inspections conducted in the facilities could special or investigative, concise, routine, follow-up or re-inspection and audit inspection;
  4. Good Manufacturing Practices (GMP) inspections of domestic and foreign pharmaceutical manufacturing facilities as required vide GMP Enforcement Regulations, 2018 (GN 295);
  5. Good Storage and Distribution Practices (GSDP) inspection which ensures that medicines which reach the consumers maintain the quality, safety and efficacy specifications from release by the manufacturer;
  6. Recall of unfit medicines including substandard and falsified (SF) from the market as required vide Regulations, 2015 (GN 313);
  7. Disposal of unfit medicines and complementary products as provided for under sections 73 and 99 of the Act and its regulations (GN 313);
  8. Promotion of domestic pharmaceutical manufacturers by dedicating an officer to deal with and facilitate all regulatory matters related to establishment of new pharmaceutical manufacturing facilities. Such matters include providing technical support through timely site visit and offering technical trainings to key personnel; Click here to view list of domestic manufacturing facilities; and
  9. During discharge of its regulatory functions, the Section collaborates with the Medicines Evaluation and Registration Section, in matters related to registration of products from GMP inspected and complied facilities. Furthermore, the section work hand in hand with all TMDA Zone offices to perform regulatory inspection activities targeting to achieve the TMDA mission of protecting and promoting public health.