The activities carried out by Licensing and Enforcement Division (LED) for which it is competent are all documented in the Medicines and Allied Substances Control Act (Chapter 15:03). Compliance to the quality management systems is monitored by the Quality Office. Operational documentation comprises of legislation, standards, manuals, SOPs, guidelines and checklists. The MCAZ is mandated by MASCA to carry out pharmaceutical inspections, including inspections of pharmaceutical manufacturers, pharmacies, dispensing clinics, dispensing medical practitioners, public institutions, veterinary medicines general dealers (VMGD), wholesale dealers and medicine distributors. The Authority makes decisions concerning the issue or withdrawal of establishment and person’s licences or authorizations of their activities, the issue or withdrawal of GMP compliance recognition and handling suspected quality defects.
The activities and functions of the LED are guided by the multi-disciplinary Licensing and Advertising Committee and subsequently all the licensing, inspection and enforcement activities of the LED are tabled before this Committee for the purpose of decision making. This provides impartiality as the regulatory officers who review applications for licences and conduct inspections do not have decision making powers. The decisions of the Licensing and Advertising Committee are further ratified by the Authority.
The LED has three functional units; the Licensing Unit, the Enforcement Unit and the Import and Export Unit led by Chief Regulatory Officers (CROs) reporting to the Head of Licensing and Enforcement (HLED) who in turn reports to the Director-General. The responsibilities of the three units are as follows:
Licensing Unit Functions
- Verifying the completeness of applications for premises and persons licences before they are submitted for processing.
- Licensing of persons and premises.
- Inspection of premises for new applications to verify compliance with the minimum requirements for licensing.
- Approval of applications for the importation of unregistered medicines/donations under the provisions of section 75 of MASCA for individuals and institutions.
- Processing and approval of narcotic and psychotropic licences, and precursor permits.
- Compilation of statistics for internationally controlled substances which are submitted on a quarterly basis to the International Narcotics Control Board (INCB).
- Reviewing of advertising material submitted for approval.
- Administration of the forensic pharmacy examinations.
Enforcement Unit Functions
- Inspection of establishments.
- Product defects and recalls.
- Market surveillance and control.
- Investigation of complaints.
Import and Export Unit Functions
- Processing of applications for import and export of medicines.
- Verification of consignments at the ports of entry.
- Training of and liaison with port officials.
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