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APPENDIX IXAn Runai, An Roinn Slainte. I am directed by the Chairman of the Joint Committee, Mr. Mervyn Taylor, T.D., to refer to the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 (S.I. No. 210 of 1984). I am to enquire if any of the provisions of this instrument are intended to give effect to any provisions contained in secondary legislation of the European Economic Community. If so I am to ask you to identify the provisions of the instrument and the secondary legislation in question. In relation to Article 10 of the Regulations I am to ask on what statutory provision does the Minister rely for authority to assume power to fix charges administratively and why it was not possible to specify the charges in the Regulations. T. DWAN, Cleireach an Chomhchoiste. 25 Aibrean, 1985. 30 May, 1985. Mr. T. Dwan, Clerk of the Joint Committee on Legislation, Leinster House, Dublin 2. I am directed by the Minister for Health to refer to your recent minute concerning the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 (S.I. No. 210 of 1984). These Regulations replaced the European Communities (Proprietary Medicinal Products) Regulations, 1975 (S.I. No. 301 of 1975) which implemented EEC Council Directives 65/65, 75/318 and 75/319 relating to proprietary medicinal products. Non-proprietary medicines (generics) were not therefore subject to control under the 1975 Regulations. In order to ensure an equivalent system of control for both proprietary and non-proprietary medicines, it was therefore decided to introduce comprehensive regulations under the Health Acts. The necessary legislation is now contained in the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984. These Regulations incorporate a licensing scheme and labelling requirements for all medicines on the market in this country and in this regard take into account the provisions of EEC Council Directives 65/65, 75/318, 75/319 and 83/570 relating to proprietary medicinal products. A copy of the Explanatory Memorandum on the Regulations is enclosed, for your information. Regarding the question of authority of the Minister to fix charges, I am to say that this power is provided for in section 5 of the Health Act, 1947 on condition that the consent of the Minister for Finance to such charges is obtained. The Department of Finance now require that fees for product authorisations should be revised every year to take account of movements in the cost of living index, the expenses of administration of the scheme and the anticipated yield from authorisation fees. That Department has indicated that provided this formula is adhered to, specific approval to each new scale of fees will not be necessary. This avoids the necessity for formal amendment of the Regulations by the Minister for Health every twelve months, countersigned by the Minister for Finance. The trade bodies concerned are consulted about the variation in the scale of charges each year. I trust the above information is of assistance to you. N. P. Usher, Public Health Division. EXPLANATORY NOTE The purpose of these Regulations is to control the marketing of medicines for human use. The control is effected by means of a common licensing scheme which applies to all human medicines, both proprietary and non-proprietary. In addition the Regulations provide for certain labelling requirements for medicines - this provision is given effect by way of amendment to the Medical Preparations (Advertisement and Sale) Regulations, 1958 which apply to medicines generally. The Regulations come into force on 1st October, 1984. The application of the licensing scheme to non-proprietary medicines will commence on 1st October, 1984 in the case of all new preparations and on a phased basis for those non-proprietaries already on the market. |
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