Citation, commencement and interpretation

1.–(1) These Regulations may be cited as the Medicines for Human Use (Miscellaneous Amendments) (No.2) Regulations 2009 and shall come into force on 21st December 2009.

(2) In these Regulations–

"the Marketing Authorisations Regulations" means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(5);

"the Sale or Supply Regulations" means the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980(6).

Amendment of Schedule 1 to the Marketing Authorisations Regulations

2.–(1) Schedule 1 to the Marketing Authorisations Regulations (exemptions and exceptions from the provisions of regulation 3) shall be amended as follows.

(2) In paragraphs 1 and 2(a) and (c)(7) for "or supplementary prescriber" substitute ", supplementary prescriber, nurse independent prescriber or pharmacist independent prescriber".

(3) At the end of paragraph 1 add–

"8. In this paragraph and in paragraph 2–

"nurse independent prescriber" means a person ("N")–

"pharmacist independent prescriber" means a person ("P")–

Amendment of the Sale or Supply Regulations

3.–(1) The Sale or Supply Regulations shall be amended as follows.

(2) In regulation 1(2) (citation, commencement and interpretation), after the definition of "community practitioner nurse prescriber" insert–

""contact lens specialist" means a person who is a registered dispensing optician and against whose name particulars of the contact lens speciality have been entered in the register of dispensing opticians maintained under section 7(b) of the Opticians Act 1989(8);";

""registered dispensing optician" means a person registered in the register of dispensing opticians maintained under section 7(b) of the Opticians Act 1989;".

(3) In regulation 5 (restrictions on persons to be supplied with certain medicinal products) at the end insert–

"(g) to a registered dispensing optician ("D"), prescription only medicines which–

(i) are required for use by registered optometrists and doctors attending D´s practice but only if the medicine contains any one or more of the following substances–

Amethocaine hydrochloride,

Chloramphenicol,

Cyclopentolate hydrochloride,

Fusidic acid,

Lignocaine hydrochloride,

Oxybuprocaine hydrochloride,

Proxymetacaine hydrochloride,

Tropicamide;

(ii) are required for use by D in the course of D´s professional practice as a contact lens specialist but only if the medicine contains any one or more of the following substances–

Lignocaine hydrochloride,

Oxybuprocaine hydrochloride,

Proxymetacaine hydrochloride.".

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")(9). 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.