S.I. No. 86/1984 - European Communities (Proprietary Medicinal Products) (Amendment) Regulations, 1984. Skip to content Disclaimer Feedback Helpdesk Gaeilge Léim go dtí an t-ábhar Séanadh Aiseolas Deasc chabhrach English Gaeilge English Produced by the Office of the Attorney General Táirgthe ag Oifig an Ard-Aighne Home Legislation Acts of the Oireachtas Statutory Instruments Pre-1922 Legislation Constitution External Resources Bills (Houses of the Oireachtas) Iris Oifigiúil / Official Gazette Revised Acts (LRC) Classified List of Legislation (LRC) Translations (acts.
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- s)or rangeBliain nó blianta nó raon TypeCineál All Legislation Acts Statutory Instruments Advanced SearchCuardach Casta HomeBaile Statutory InstrumentsIonstraimí Reachtúla 1984 S.I. No. 86/1984 - European Communities (Proprietary Medicinal Products) (Amendment) Regulations, 1984. S.I. No. 86/1984 - European Communities (Proprietary Medicinal Products) (Amendment) Regulations, 1984. AmendmentsLeasuithe S.I. No. 86 of 1984. EUROPEAN COMMUNITIES (PROPRIETARY MEDICINAL PRODUCTS) (AMENDMENT) REGULATIONS, 1984. The Minister for Health, in exercise of the powers conferred on him by section 3 of the European Communities Act, 1972 (No. 27 of 1972), hereby makes the following Regulations: 1. These Regulations may be cited as the European Communities (Proprietary Medicinal Products) (Amendment) Regulations, 1984. 2. There shall be substituted for article 5 of the European Communities (Proprietary Medicinal Products) Regulations, 1975 ( S.I. No. 301 of 1975 ) the following article— "5
(1)Applications for authorisations under these Regulations and the Directives referred to in article 3 of these Regulations shall be made to the Minister for Health.
(2)A fee as prescribed hereunder shall be paid to the Minister for Health in respect of applications made to him pursuant to sub-article
(1)of this article, in the following cases, that is to say— (
- a)in the case of an application for an authorisation to place a proprietary medicinal product on the market— £260; (
- b)in the case of an application for an authorisation in respect of a proprietary medicinal product which consists of an additional dosage strength of a product for which an authorisation has already been granted— £52; (
- c)in the case of an application for a renewal of any authorisation— £52." 3. The European Communities (Proprietary Medicinal Products) (Amendment) Regulations, 1983 ( S.I. No. 57 of 1983 ) are hereby revoked. 4. These Regulations shall come into effect on the 1st day of April, 1984. GIVEN under the Official Seal of the Minister for Health, this 30th day of March, 1984. BARRY DESMOND, Minister for Health. EXPLANATORY NOTE. These Regulations provide for increases in connection with the charging of fees in respect of product authorisations under the European Communities (Proprietary Medicinal Products) Regulations, 1975. Privacy Statement Accessibility European Legislation Identifier (PDF) Open Data License Ráiteas Príobháideachais Inrochtaineacht Aitheantóir Eorpach Reachtaíochta (ELI) Ceadúnas Sonraí Oscailte Liosta Fianán © Government of Ireland. Oireachtas Copyright Material is reproduced with the permission of the Houses of the Oireachtas © Rialtas na hÉireann. Atáirgtear ábhar faoi Chóipcheart le cead ó Thithe an Oireachtais