Enforcement actions
The main aim is to protect public health and, where appropriate the public purse, by addressing all illegal activities involving human and veterinary medicines and their availability, manufacture, import, possession, sale, supply and administration, including substances of abuse controlled under Misuse of Drugs legislation.
Cases can involve the illegal importation, possession or supply of medicines by doctors, dentists, pharmacists, other health service professionals, veterinary surgeons and by individuals.
Where cases involving professionals are proven, these also result in automatic referral to the respective professional body for disciplinary action.
Recent investigations
- advertising of prescription only medicines to the public
- the production and distribution of counterfeit medicines
- unauthorised importation and diversion of medicinal products from and into legal distribution networks
- false or misleading medicinal claims for unlicensed products
- identification of products which have been adulterated with prescription only medicines
It should be noted that sanctions under the Medicines Act 1968 are, on indictment, up to two years in jail and/or an unlimited fine.
- Examples of Enforcement cases dealt with by prosecution/statutory or professional body
- Contact details for enforcement officer
This list is by no means exhaustive and only highlights exemplar cases and does not include cases which have been dealt with by way of advice notes, improvement notices and written or verbal warnings.
Compliance 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 Regulatory Group (MRG) within the Department.
The governing medicines-related legislation under which MRG acts includes the Human Medicines Regulations 2012, 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. MRG 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.
Fitness to practise
The Medicines Regulatory Group works with the Pharmaceutical Society of Northern Ireland (PSNI) to ensure that pharmacists are fit to practise.
The Pharmacy Inspectors undertake routine compliance visits of all registered pharmacies to ensure that the premises and the pharmacist on duty are complying with the standards of conduct and performance set by the Pharmaceutical Society of Northern Ireland and the department and with obligations imposed on the profession of pharmacy by statute.
Where a person registered with the Society or lawfully conducting a retail pharmacy business fails to comply with those standards and legal obligations, the Medicines Regulatory Group takes action to enforce those standards and legal obligations.
The legislation that provides powers for compliance and enforcement and sets out the procedures for the Society’s disciplinary committee is The Pharmacy (Northern Ireland) Order 1976.
This legislation is currently being revised to update the fitness to practise machinery to ensure that it meets the requirements of a modern regulator.
Pharmacy inspectors
The routine compliance visits of pharmacies are carried out by the department’s pharmacy inspectors.
Compliance visits are conducted according to relevant legislation and the professional standards and ethics of the Pharmaceutical Society of Northern Ireland.
Training of officers
The Department’s Head of the Medicines Regulatory Group and the Inspectors, are pharmacists.
The Senior Medicines 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 GPhC 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.