Explanatory note

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