MEDICINES ACT

The provision of the National Health Service on the Island is set out in the NHS Act 2001. A copy of which is available from the Government Information Centre

The Department of Health and Social Security is responsible for the regulation of trade in medicinal products and is the licensing authority under the Medicines Act 2003.

The Medicines Act 2003 contains a system of regulation for the manufacture, import, export, sale, supply and advertising of medicinal products (for both human and animal use) in the Isle of Man. The contents of the Medicines Act closely resemble the requirements of the equivalent UK Act and the European Directives on human and animal medicines.

The Department of Health and Social Security does not directly regulate all of the activities concerning medicinal products, as the Act contains powers recognising other schemes of regulation operated in countries which export medicinal products to the Island.

The Department maintains registers for retail pharmacy premises, local wholesale distribution of human medicines and sets standards for these activities through Codes of Conduct.

Import Licences

The Department does not issue licences, however, the Medicines Act 2003 acknowledges licences issued by the UK Medicines and Healthcare products Regulatory Agency. (www.mhra.gov.uk)

Wholesale Dealer's Licences

The Department maintains a register of Wholesale Dealers or distributors of human medicinal products and issues licences to those companies who are registered. Licences are only issued to those companies who have registered premises on the Island and who actively distribute products within the Island.

Pharmacy Premises

A register of retail pharmacy premises is maintained which includes all pharmacies which are licensed to sell or supply medicinal products to the general public.

Further details

Mrs Gill Corran

Strategy & Performance Officer, Strategy & Performance Directorate.

Department of Health and Social Security, Health Services Division, Crookall House, Demesne Road, Douglas, Isle of Man. IM1 3QA British Isles.

Tel: +44 (1624) 642614

Fax: +44 (1624) 642617

e-mail: gill.corran@gov.im

Downloadable Documents
Register of Retail Pharmacy Premises 2009 (78 kb) Format:Acrobat PDF File Register of Retail Pharmacy Premises 2009
Register of Distributors of Medicinal Products 2009 (224 kb) Format:Acrobat PDF File Wholesale Dealers Register 2009
The Prescription Only Medicines (Human Use) Regulations 2005 (39 kb) Format:Acrobat PDF File Explanatory Memorandum - Contains a list of medicinal products which can only be sold or supplied on prescription
The Medicines (Pharmacy and General Sale List - Exemption) Regulations 2005 (34 kb) Format:Acrobat PDF File Explanatory Memorandum - Make exemptions to allow the sale or supply by pharmacists of human medicinal products without a prescription
The Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 2005 (88 kb) Format:Acrobat PDF File Places additional controls on the sale or supply of certain medicinal products
The Medicines (General Sales List) Regulations 2005 (62 kb) Format:Acrobat PDF File Contains a list of human medicinal products which can be sold from general retail premises
Medicines (Advertising) Regulations 2005 (436 kb) Format:Acrobat PDF File Places restrictions on the advertising and promotion of human medicinal products
The Medicines for Human Use Regulations 2005 (173 kb) Format:Acrobat PDF File Statutory Document - Establish the general provisions relating to the sale or supply of human medicinal products
Medicines (Pharmacies) (Registration Fees) Regulations 2005 (27 kb) Format:Acrobat PDF File Establish the fees payable for the registration, renewl and restoration of pharmacy premises
Code of Practice for Agricultural Merchants (27 kb) Format:Acrobat PDF File Registered distributors of animal medicinal products who are also Agricultural Merchants are required to comply with this code of practice.
Code of Practice for Saddlers (22 kb) Format:Acrobat PDF File Registered distributors of animal medicinal products who are also Saddlers are required to comply with this code of practice.
Wholesale Dealers - Code of Practice (13 kb) Format:Acrobat PDF File The Code of Practice which all wholesale dealers in human medicinal products must comply

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