§ Baroness Whartonasked Her Majesty's Government:
What information they have about (a) the timetable; (b) the purpose; and (c) the extent of the forthcoming review by the European Commission of the Medicines Directive EC 65/66. [HL1821]
§ Baroness HaymanCouncil Directive 65/65/EEC of 26 January 1965 laid down criteria for the regulation or administrative action relating to medicinal products. The Government are not aware of any specific plans to review the operation of this directive. We will, however, continue to watch developments closely, as any ongoing discussion with the European Commission on the question of the regulation of herbal medicines could entail review of the impact of 65/65 EEC.
110WAThe European Commission is required to undertake a review of Regulation 2309/93/EEC laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. The terms of the review are set out in the Regulation (Article 71) as "within 6 years of the entry into force on this Regulation [on 1 January 1995], the Commission shall publish a general report on the experience acquired as a result of the operation of the procedures laid down in this Regulation".
The Commission has not published details of how it intends to undertake the review.