§ Mr. HammondTo ask the Secretary of State for Health what preparations his Department has made and what discussions it has held with the pharmaceutical industry to ensure that the European Union directives relating to pharmaceutical packaging which come into force on 1 January 1999 will be implemented in the United Kingdom; and what assessment he has made of the industry's ability to comply with the regulations. [64198]
§ Ms Jowell[holding answer 15 December 1998]: Numerous discussions have taken place with representatives of the pharmaceutical industry on compliance with Directive 92/27/EEC (on the labelling of medicines for human use and on package leaflets). The most recent meeting was held on 15 December 1998.
The directive requires approval of a package leaflet and labelling when market authorisation is granted or renewed. Authorisation by the Medicines Control Agency (MCA) was completed on 1 January 1999.
To facilitate effective compliance with the directive, the MCA recently consulted on proposals to require marketing authorisation holders to provide additional leaflets and labels so as to ensure that an approved label, and, where required, a leaflet would accompany every medicine dispensed to a consumer. This consultation exercise specifically sought details of the impact of these proposals on the pharmaceutical industry. The responses to this exercise are being considered.