2009 No. 3063
The Medicines for Human Use (Miscellaneous Amendments) (No.2) Regulations 2009
Made
Laid before Parliament
Coming into force
The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 19721. He has been designated for the purpose of that section in relation to medicinal products2.
In so far as these Regulations are not made under powers conferred under section 2(2) of the European Communities Act 1972, the Secretary of State and the Minister for Health and Social Services and Public Safety, acting jointly, make these Regulations in exercise of powers conferred upon them by sections 61 and 129(4) and (5) of the Medicines Act 19683, or, in the case of the Minister, the powers conferred by those provisions now vested in the Minister4.
In accordance with section 129(6) of that Act, they have consulted such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations.
Citation, commencement and interpretation1
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.
Amendment of Schedule 1 to the Marketing Authorisations Regulations2
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—
In this paragraph and in paragraph 2—
“nurse independent prescriber” means a person (“N”)—
- a
who is a registered nurse or a registered midwife, and
- b
against whose name is recorded in the professional register an annotation signifying that N is qualified to order drugs, medicines and appliances as a nurse independent prescriber or a nurse independent/supplementary prescriber;
“pharmacist independent prescriber” means a person (“P”)—
- a
who is a pharmacist, and
- b
against whose name is recorded in the relevant register an annotation signifying that P is qualified to order drugs, medicines and appliances as a pharmacist independent prescriber.
Amendment of the Sale or Supply Regulations3
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 19898;
“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.
Signed by authority of the Secretary of State for Health
(This note is not part of the Regulations)