Skip to main content
Normal View

Dáil Éireann debate -
Wednesday, 29 Nov 1972

Vol. 264 No. 2

Ceisteanna—Questions. Oral Answers. - Drug Harmonisation.

14.

asked the Minister for Health if he will give details of any discussions held between the Government and EEC Governments regarding proposals for drug harmonisation in respect of quality control, prescription criteria, et cetera.

Only one EEC directive on pharmaceuticals has been adopted—that is, the directive of January, 1965, on the approximation of legislative and administrative provisions concerning proprietary medicines. This document requires the licensing for marketing of such medicines and sets out certain procedures in relation to the granting of licences. My Department has had discussions on two occasions with the EEC Commission on the implementation of the directive. Acceding countries will have a period of 18 months from the date of accession within which to conform with the directive.

The other EEC directives dealing with pharmaceuticals are at draft stage. Generally, they expand and supplement the 1965 directive and also relate to such matters as rights of establishment for manufacturers, wholesalers and retail chemists, the control of advertising and channels of retail sale. The directives do not deal specifically with prescribing.

My Department has been examining these draft directives in consultation with the trade and professional interests with a view to the preparation of a request to the EEC Commission for consultation which it is expected will be made shortly.

Top
Share