§ Mr. FlynnTo ask the Secretary of State for Health what criteria his Department sets for medicinal drugs permitted to be sold over the counter; and if he will make a statement. [14584]
§ Mr. MaloneThe criteria set for allowing medicines to be available over the counter are laid down in Council directive 92/26/EEC and have been incorporated into section 58A of the Medicines Act 1968. Medicines are considered unsuitable for sale or supply without a doctor's prescription when they:
- are likely to present a danger either directly or indirectly, even when used correctly, if utilised without medical supervision, or
- are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health, or
- contain substances or preparations thereof the activity and/or side effects or which require further investigation, or
- are normally prescribed by a doctor to be administered parenterally.