MEDICINES ACT 1968

Amendment to the European Pharmacopoeia

The Health Ministers, that is to say the Secretaries of State concerned with health in England, in Wales and in Scotland respectively, and the Department of Health and Social Services for Northern Ireland, acting jointly, hereby declare under section 65(7) of the Medicines Act 1968, that on and after 1st October 1998, the revision to the Biological Test for Sterility (Method 2.6.1) adopted by the European Pharmacopoeia Commission on 24th June 1998, and referred to in the Schedule hereto, is to have effect for the purposes of section 65 of the said Act with respect to the text of Method 2.6.1 contained in the 1998 Supplement to the Third Edition of the European Pharmacopoeia, published under the direction of the Council of Europe (Partial Agreement) in accordance with the Convention on the Elaboration of a European Pharmacopoeia.

Schedule

2.6.1 Sterility
Precautions against Microbial Contamination
Replace the first sentence by:

  “The test for sterility is carried out under aseptic conditions, using, for example, a class A laminar-air-flow cabinet located within a class B clean-room, or an isolator.”