This Statutory Instrument has been printed in substitution of the SI of the same number and is being issued free of charge to all known recipients of that Statutory Instrument.
Statutory Instruments
Medicines
Made
22nd March 2011
Laid before Parliament
25th March 2011
Coming into force
30th April 2011
1. These Regulations may be cited as the Medicinal Products (Herbal Remedies) (Amendment) Regulations 2011 and shall come into force on 30th April 2011.
2. Section 12(2) of the Medicines Act 1968(3) is hereby repealed.
Signed by authority of the Secretary of State for Health
Earl Howe
Parliamentary Under-Secretary of State,
Department of Health
22nd March 2011
(This note is not part of the Regulations)
These Regulations repeal section 12(2) of the Medicines Act 1968 (“the Act”) which provides an exemption (from the requirement to comply with the restrictions set out in sections 7 and 8 of the Act) for the manufacture, sale or supply of herbal remedies where the process to which the plant or plants are subjected consists only of drying, crushing or comminuting and certain other specified conditions are met. With effect from 30th April 2011, this exemption is incompatible with EU legal provisions set out in Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (OJ L No 311, 28.11.2001, p.67) and Directive 2004/24/EC of the European Parliament and of the Council as regards traditional herbal medicinal products (OJ L No 136, 30.04.04, p.85).
An Impact Assessment has been prepared. A copy can be obtained from the Medicines and Healthcare Products Regulatory Authority, 151 Buckingham Palace Road, Victoria, London SW1W 9SZ
1972 c.68; section 2(2) was amended by the Legislative and Regulatory Reform Act 2006 (c.51), section 27 (1)(a) and the European Union (Amendment) Act 2000 (c.7), section 3(3), Schedule 1, Part 1.