The Medicines for Human Use (Prescribing by EEA Practitioners) (Amendment) (No. 2) Regulations 2010 No. 2785


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United Kingdom Statutory Instruments


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Statutory Instruments

2010 No. 2785

Medicines

The Medicines for Human Use (Prescribing by EEA Practitioners) (Amendment) (No. 2) Regulations 2010

Made

17th November 2010

Laid before Parliament

23rd November 2010

Coming into force

20th December 2010

The Secretary of State makes the following Regulations in the exercise of the powers conferred by section 2(2) of the European Communities Act 1972(1). He has been designated for the purpose of section 2(2) of the European Communities Act 1972(2) in relation to medicinal products.

Citation, commencement and interpretation

1.-(1) These Regulations may be cited as the Medicines for Human Use (Prescribing by EEA Practitioners) (Amendment) (No. 2) Regulations 2010 and shall come into force on 20th December 2010.

(2) In these Regulations "the principal Regulations" means the Medicines for Human Use (Prescribing by EEA Practitioners) Regulations 2008(3).

Amendment of regulation 1 of the principal Regulations

2. In regulation 1 of the principal Regulations (citation, commencement and interpretation), for the definition of "controlled drug" in paragraph 2, substitute the following-

""controlled drug" means any substance or product for the time being specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations 2001(4) or in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations (Northern Ireland) 2002(5);".

Amendment of regulation 7 of the principal Regulations

3. In regulation 7 of the principal Regulations (exemption in case of emergency sale or supply), in paragraph (1), for "paragraphs (2)(d) and (5)" substitute "paragraph (5)".

Signed by the authority of the Secretary of State for Health.

Earl Howe

Parliamentary Under-Secretary of State,

Department of Health

17th November 2010

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the Medicines for Human Use (Prescribing by EEA Practitioners) Regulations 2008 ("the principal Regulations").

Regulation 2 substitutes the definition of "controlled drug" to ensure that prescriptions for controlled drugs included in Schedules 1 to 3 to the Misuse of Drugs Regulations 2001 or Schedules 1 to 3 of the Misuse of Drugs Regulations (Northern Ireland) 2002 are automatically excluded from being dispensed in the UK. EEA prescriptions for controlled drugs listed in Schedules 4 or 5 to those respective Regulations can be lawfully dispensed against provided the conditions contained in the principal Regulations are met.

Regulation 3 amends regulation 7 of the principal Regulations to ensure that the emergency sale or supply of certain controlled drugs is permitted where this is pursuant to a request by an EEA health professional or where such treatment has previously been prescribed by such a person.

An impact assessment has not been prepared for this instrument as there is no significant impact on the private and voluntary sectors.

(1)

1972 c.68; section 2(2) was amended by the Legislative and Regulatory Reform Act 2006 (c.51), section 27(1)(a) and by the European Union (Amendment) Act 2008 (c.7), Part 1 of Schedule 1.

(4)

S.I. 2001/3998. Schedule 1 has been amended by S.I. 2005/1653, 2009/3136, 2010/1144 and 1799. Schedule 2 has been amended by S.I. 2003/1432 and 2009/3136. Schedule 3 has been amended by S.I. 2007/2154.

(5)

S.R. (NI) 2002 No 1. Schedule 1 has been amended by S.R. (NI) 2005 No 360, 2009 No 390, 2010 Nos 148 and 247. Schedule 2 has been amended by S.R. (NI) 2003 No 314 and 2009 No 390. Schedule 3 has been amended by S.R. (NI) 2007 No 348.


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