This note is not part of the regulations, but is intended to indicate their general effect.
These regulations, which come into force on 15 October 2004, amend the Misuse of Drugs Regulations 1977 (the
“principal regulations”) to give effect to the following 2 changes:
•to provide that the controlled drug pseudoephedrine, when contained in a slow-release formulation, is classified as a partially exempted drug for the purposes of the principal regulations, and therefore remains for sale without a prescription:
•to require that blister packs of medicines containing ephedrine or pseudoephedrine need only comply with the current requirements for the labelling to such blister packs, as long as the outer package is labelled appropriately under the principal regulations as well as under the Medicines Regulations 1984.
The background to these changes is that ephedrine and pseudoephedrine, which are currently contained in a number of prescription and pharmacy-only cold and influenza medicines, are to become Class C controlled drugs on the same day that these regulations come into force. The policy objective is to ensure that medicines containing ephedrine or pseudoephedrine should largely continue to be available to the public in the same way in which they were available before ephedrine and pseudoephedrine were classified as controlled drugs.
A transitional period of 6 months is provided for. During the transitional period the new labelling requirements for medicines containing ephedrine and pseudoephedrine do not have to be complied with, as long as the medicines continue to be labelled as they were required to be labelled before these regulations came into force.