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Inspection and Enforcement

The Department of Health, Social Services and Public Safety has responsibility for inspection and enforcement under all medicines related legislation in Northern Ireland. This is assumed by the Medicines Inspection and Investigation Team within the Department.
The governing medicines-related legislation under which Team act includes the Medicines Act 1968 and the Misuse of Drugs Act 1971 (together with a raft of attendant subordinate legislation), the Pharmacy (Northern Ireland) Order 1976 and the Poisons (Northern Ireland) Order 1976.  It also embraces joint responsibility with the Department of Agriculture and Rural Development (DARD) for the Veterinary Medicines Regulations.  The team also works closely with the Police Service of Northern Ireland to regulate preparations controlled under the Commission Regulations governing drug precursor chemicals.
Compliance is achieved through a system of unannounced and pre-arranged inspections, follow-up visits and investigation and enforcement activities in areas including:
  • 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
  • Community Pharmacies
  • Medical, Dental and Veterinary Practices
  • Private Hospitals, Clinics and 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
  • Hospital based Aseptic Dispensing Units
  • 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
  • Manufacturers/suppliers of precursor drugs

Training of Officers

The Department’s Head of Inspection and Investigation and the Inspectors, are pharmacists The Senior Enforcement Officer and enforcement team have extensive backgrounds in criminal investigation.
All of the team participate in a wide range of training opportunities alongside MHRA and RPSGB Inspectors, Controlled Drugs Liaison Officers and Home Office Drugs Licensing personnel.
They are in addition afforded training in PACE (Police and Criminal Evidence Order) Codes of Practice, PEACE interviewing techniques, Regulation of Investigatory Powers Act (RIPA), Data Protection and Freedom of Information issues.
Two of the Inspectors are legally qualified and individuals across the Inspectorate possess formal qualifications in Advanced Investigative Practice and in Controlled Drugs Inspections.
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