§ Mr. FlynnTo ask the Secretary of State for Health (1) what plans his Department has to require clearer labelling on medicinal drugs in respect of (a) verbal descriptions of products, (b) symbols and (c) the use of colours to draw attention to the possible side effects and dangers of products; and if he will make a statement; [14583]
(2) what guidelines his Department issues to drug manufacturers on the labelling of their products in respect of (a) their contents and (b) dangers associated with their use; and if he will make a statement. [14520]
§ Mr. MaloneAll medicines are required by United Kingdom legislation implementing directive 92/27/EEC—on the labelling of medicines for human use and on package leaflets—to give essential particulars of the product on the labelling, including a description of the product and any necessary warnings. Where appropriate the warnings are placed separately in a boxed area to draw the reader's attention. Symbols and pictograms which can be readily identified by the public are actively encouraged as a means of simplifying essential messages. Medicines must also be accompanied by further detailed information724W in an enclosed patient leaflet unless the labelling contains all the information necessary under the directive. The directive requirements are being phased in by therapeutic category and it is anticipated that these requirements will be met for all medicines by the end of 1998.
The European Community is currently consulting on detailed guidelines for the labelling of medicines covering, in particular, special warnings and information on excipients which are known to have a recognised action or effect. We are participating in producing these guidelines which are expected to be available later this year.
The Medicines Control Agency prepared guidelines for the pharmaceutical industry when directive 92/27/EEC was implemented into UK law and intends to issue a revised edition to reflect EC guidance as appropriate.