The Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2005

Explanatory Note

(This note is not part of the Regulations)

These Regulations make amendments to certain Regulations relating to the sale or supply of medicines.

Regulation 2 further amends the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (“the Marketing Authorisations Regulations”). The Marketing Authorisations Regulations implement certain provisions of Directive 2001/83/EC of the European Parliament and of the Council on the community code for medicinal products for human use (“the 2001 Directive”)(1). In particular, they implement the provisions of the 2001 Directive which relate to marketing authorisations.

Schedule 1 to the Marketing Authorisations Regulations exercises the derogation in article 5 of the 2001 Directive. Schedule 1 contains exceptions to the requirement that no relevant medicinal product may be placed on the market or distributed by way of wholesale dealing unless a marketing authorisation for that product has been granted. The exemption in paragraphs 1 and 2 provide that no marketing authorisation is required in respect of the sale or supply of a relevant medicinal product in response to a bona fide unsolicited order which is formulated in accordance with the specification of a doctor, dentist or supplementary prescriber and for use by his individual patients on his personal responsibility. Regulation 2 amends the definition of “supplementary prescriber” to include certain optometrists, and makes other related amendments to the definitions in the Marketing Authorisations Regulations.

These Regulations also further amend the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 (“the Sale or Supply Regulations”) which impose restrictions on the sale and supply of medicinal products.

Regulation 3 amends the definition of “supplementary prescriber” in the Sale or Supply Regulations to include certain registered optometrists and makes other related amendments to the definitions in these Regulations. Regulation 4 substitutes the term “registered optometrist” for “registered ophthalmic optician” in regulation 5 of the Sale or Supply Regulations. Regulation 5 amends regulation 8 of the Sale or Supply Regulations. This regulation concerns the maximum number of tablets which may be contained in a pack of tablets for human use which are for sale elsewhere than at a registered pharmacy. The amendment changes the maximum number of tablets which may be contained in a pack containing Bisacodyl, from 50 to 40.

These Regulations also amend the Medicines (Child Safety) Regulations 2003 (“the Child Safety Regulations”) which impose requirements relating to the packaging and colouring of certain medicinal products. Regulation 6 amends the definition of “supplementary prescriber” in the Child Safety Regulations to include certain chiropodists and podiatrists, physiotherapists, diagnostic and therapeutic radiographers and registered ophthalmic opticians.

A Regulatory Impact Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament and copies may be obtained from the Department of Health, Medicines and Healthcare products Regulatory Agency, Information Centre, Room 10-202 Market Towers, 1, Nine Elms Lane, London SW8 5NQ.

(1)

OJ No. L311, 28.11.2001, p.34.