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 amends 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 for human use. Regulation 6(1) of, and Schedule 2 to, the Sale or Supply Regulations impose a requirement on persons conducting a retail pharmacy business to record the sale or supply of a prescription only medicine except in specified circumstances, in particular where the sale or supply is in pursuance of a “health prescription”. Regulation 2(2) amends regulation 1 of the Sale or Supply Regulations, so that a “health prescription” includes a prescription issued by a community practitioner nurse prescriber, a nurse independent prescriber or a pharmacist independent prescriber, under or by virtue of legislation relating to the National Health Service. Regulation 2(2) also makes consequential amendments to regulation 1 of the Sale or Supply Regulations to reflect changes which have been made to the nurses' professional register and to the entries in that register indicating who is qualified to act as a prescriber. Regulation 2(3) amends Schedule 2 to the Sale or Supply Regulations, so that the particulars which must be included in pharmacy records kept pursuant to regulation 6(1) must include certain particulars relating to such prescribers.
Regulation 3 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. Regulation 3 makes consequential amendments to reflect changes which have been made to the nurses' professional register and to the entries in that register indicating who is qualified to act as a prescriber.
Regulation 4 amends the Medicines (Child Safety) Regulations (“the Child Safety Regulations”) which in particular impose requirements relating to the packaging of certain medicinal products. Regulation 3 of the Child Safety Regulations specifies certain exemptions from those requirements. Regulation 4 amends regulations 1 and 3 of the Child Safety Regulations so that the requirements do not apply to the retail sale, or supply corresponding to retail sale, of a product by a pharmacy, where that sale or supply is in accordance with a prescription given by a pharmacist independent prescriber. Regulation 4(2) makes consequential amendments to the Child Safety Regulations to reflect changes which have been made to the nurses' professional register and to the entries in that register indicating who is qualified to act as a prescriber.
Regulation 5 amends the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 (“the Traditional Herbal Medicinal Products Regulations”) which implement Directive 2004/24/EC of the European Parliament and of the Council(2) amending, as regards traditional herbal medicinal products, the 2001 Directive. Regulation 5 makes consequential amendments to the Traditional Herbal Medicinal Products Regulations to reflect changes which have been made to the nurses' professional register and to the entries in that register indicating who is qualified to act as a prescriber.
A full regulatory impact assessment of the effect that this instrument will have on the costs of business is available from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ. Copies of the assessment have been placed in the libraries of both Houses of Parliament.
OJ No. L311, 28.11.2001, p34.
OJ No. L136, 30.3.2004, p85.