Medicines Regulatory Group

Prof Mike Mawhinney , Senior Principal Pharmaceutical Officer, is Head of the Medicines Regulatory Group (MRG).

MRG provides specialist professional advice to the Minister, Department of Health and wider HSC, other government Departments and national and international partner enforcement agencies on key matters relating to medicines regulation.

Role of MRG

MRG is responsible, on behalf of the Minister,  for key aspects of medicines control in Northern Ireland, including the monitoring of the production, import/export, possession, supply and administration of controlled drugs and other medicinal products.

It has a statutory obligation to ensure compliance with legislative requirements in a wide variety of areas within  health and social care (and in the wider non healthcare sector).

MRG also provides a lead and professional input into a wide range of Department policy and business areas and has key responsibilities for and under the following statutes:

It also embraces joint responsibility with the Department of Agriculture and Rural Development (DARD) for the Veterinary Medicines Regulations ,with the Medicines Healthcare products Regulatory Agency (MHRA) and with the Home Office in matters pertaining to controlled drug licences.

Additionally, MRG has developed international collaborative work on matters pertaining to the detection of international pharmaceutical crime including the supply of counterfeit and unlicensed medicines. MRG is the Northern Ireland lead (with the Police Service and with the Border Force) in participating in the annual Operation Pangea aimed at tackling the online sale of counterfeit and illicit medicines.

Authority

All officers have the powers conferred by the Medicines Act 1968 and subordinate legislation in applying the Act.

These include the right to enter any premises to inspect, to take samples and to require production of any books or documents, to take copies of, or of any entry in, any such book or document for the purposes specified in sections 111 and 112 of that Act, or in subordinate legislation applying those sections.

Similar powers are given to inspectors by the Misuse of Drugs Act, The Misuse of Drugs Regulations (Northern Ireland) 2002, Pharmacy Order and Poisons Order.

Officers operate to the Police and Criminal Evidence (Northern Ireland) Order 1989 (PACE) and the PACE Codes of Practice.

Functions and responsibilities

The MRG gives effect to the DoH functions and responsibilities in relation to:  

  • assisting other agencies in the fulfilment of the United Kingdom’s general obligations in the international field of drug abuse control
  • co-operation with enforcement agencies at national and international level.
  • intelligence gathering, investigation and enforcement involving local production, possession, supply, import, export and stocks of drugs controlled under the legislation
  • the issue of licences and other authorities and inspection of licensed and other authorised persons including pharmacies, trust hospitals and medical/dental/veterinary practitioners
  • ruling on the suitability of applicants for licences and authorities to produce, possess and supply controlled drugs and on the conditions to be attached to such licences and authorities.
  • inspection of licensed/authorised premises, including manufacturers and wholesalers of medicinal products in liaison with the Medicines and Healthcare products Regulatory Agency (MHRA) and of other licensed/authorised persons
  • inspection of registered agricultural merchants and saddlers, in conjunction with the Animal Medicines Inspectorate of the Veterinary Medicines Directorate  and sellers of Part 1 Poisons
  • advising on the terms of Misuse of Drugs Act Section 11 notices relating to the security of stocks of controlled drugs on licensed premises
  • the investigation and preparation of cases  involving the illegal production, possession, administration and supply of medicinal products (including controlled drugs) and other statutory offences to be considered for prosecution by the Public Prosecution Service
  • maintaining liaison with national and international enforcement Agencies including: the Permanent Forum on International, Pharmaceutical Crime, European Medicines Enforcement group and Cross-border controlled drug group
  • the gathering of information on the application of the legislation and the provision of early warning of possible abuse of new substances
  • maintaining liaison with organisations concerned with the treatment of drug abuse
  • advising the department and other government bodies on the development and drafting of all medicines related regulations as it applies to Northern Ireland

Regulatory activities

This involves regulatory activities in the following areas:

  • pharmaceutical manufacturers (human, veterinary and controlled drug)
  • pharmaceutical wholesalers (human, veterinary and controlled drug)
  • exporters and importers of medicinal products and controlled substances
  • trust hospitals
  • medical, dental and veterinary practices
  • community pharmacies
  • private hospitals and clinics
  • hospices
  • universities and other research facilities
  • Northern Ireland Prisons Service
  • police forensic laboratories and police training facilities
  • hospital based manufacturing units
  • Regional Medical Physics Agency
  • clinical trials facilities
  • cannabis/hemp growers
  • commercial analytical laboratories
  • Department of Agriculture facilities
  • private narcotic detection dog training facilities
  • Northern Ireland Mountain Cave and Cliff Rescue
  • registered agricultural merchants and saddlers
  • Northern Ireland Ambulance Service Trust
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