The Medicines for Human Use (Miscellaneous Amendments) (No.2) Regulations 2009

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 relating to 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 exemptions 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 bone 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 inserts a definition of “nurse independent prescriber” and “pharmacist independent prescriber” into Schedule 1 to the Marketing Authorisations Regulations and adds these to the list of persons to whom the exemptions in paragraph 1 and 2 of that Schedule apply.

These Regulations also 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 inserts the definitions of “contact lens specialist” and “registered dispensing optician” into regulation 1(2) of the Sale or Supply Regulations and amends regulation 5 of those Regulations to provide that people in these groups are able to obtain supplies of certain types of prescription only medicines related to their business.

An Impact Assessment has not been prepared in respect of this instrument as there is no impact on the private and voluntary sectors.

(1)

OJ No. L311, 28.11.2001, p. 67.