Lead Executive Office Profile
The Medicines Manufacturers Inspection and Enforcement (MMIE) LEO is a section under the Deputy Director General of the Medicine Sector, responsible for enforcing the Food and Medicine Administration Proclamation No.1112/2019. Its role is to regulate manufacturers to ensure their compliance with Good Manufacturing Practices (GMP).
Article 63 of the Food and Medicine Administration Proclamation No. 1112/2019 gives EFDA inspectors the powers to enter, at all reasonable time, any premises which are licensed by EFDA and any other premises, stall, vehicle, vessel or conveyance for the purpose of enforcing compliance with the proclamation.
Some of the key functions performed by the MMIE in the fulfillment of the Authority’s mission of protecting and promoting public health include the following:
- Registration and Licensing of manufacturing establishments
- 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;
- Good Manufacturing Practices (GMP) inspections of domestic and foreign pharmaceutical manufacturing facilities as required;
- Recall of unfit medicines including substandard and falsified (SF) products from the market as required;
- Ensure proper disposal of unfit medicines;
- Provide capacity building of domestic pharmaceutical manufacturing establishments related to regulatory matters
During discharge of its regulatory functions, the section collaborates with Medicines Evaluation and Marketing Authorization Lead Executive Office, Pharmacovigilance and Clinical Trial Lead Executive Office, Quality Control Lead Executive Office, and Branch offices.