Zāļu tiesiskā regulējuma dokumenta krājuma
English translation: The rules governing medicinal products in the European Union
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| 23:11 Oct 30, 2016 |
| Latvian to English translations [PRO] Medical - Medical (general) / clinical trials/studies | |||||||
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|  Selected response from: Erzsébet Czopyk Hungary Local time: 23:02 | ||||||
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| 4 | The rules governing medicinal products in the European Union |
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10 hrs confidence: 
The rules governing medicinal products in the European Union Explanation: https://www.google.hu/search?q=European Commission's Europea... EudraLex - EU Legislation - European Commission ec.europa.eu › ... › EU Pharmaceutical informations The body of European Union legislation in the pharmaceutical sector is compiled in Volume 1 and Volume 5 of the publication "The rules governing medicinal products in the European Union": -------------------------------------------------- Note added at 10 hrs (2016-10-31 10:07:54 GMT) -------------------------------------------------- http://ec.europa.eu/health/documents/eudralex/vol-2/index_en... Volume 2 of the publications "The rules governing medicinal products in the European Union" contains a list of regulatory guidelines related to procedural and regulatory requirements such as renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of product characteristics (SmPC), package information and classification for the supply, readability of the label and package leaflet requirements. Volume 2A - Procedures for marketing authorisation Chapter 1 - Marketing Authorisationpdf(257 KB) (updated version - July 2015) Chapter 2 - Mutual Recognitionpdf(526 KB) (updated version - February 2007) Chapter 3 - Union Referral Procedurespdf(624 KB) (updated version - May 2014) Chapter 4 - Centralised Procedure (deleted - July 2015). Chapter 5 - Guidelines of 16 May 2013 on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures - C (2013) 2804 (OJ C 223, 2.8.2013, p. 1–79). Chapter 6 - Community Marketing Authorisationpdf(91 KB) (updated version - November 2005) Chapter 7 - General Information Information regarding human medicinal products authorised centrally and nationally (Mutual Recognition Procedure/DeCentralised Procedure) contained in this Chapter is transferred to EMA and CMDh websites respectively. An overview of documents replacing the previous sections of Chapter 7 with corresponding website references is available at the following address. For CMDh, see document titled: "Transfer of information contained in Notice to applicants, Volume 2A, Chapter 7" -------------------------------------------------- Note added at 10 hrs (2016-10-31 10:10:50 GMT) -------------------------------------------------- http://www.hma.eu/90.html http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation... http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation... All European Medicines Agency (EMA) IT systems are temporarily unavailable from 18:00 on Friday 28 October to 6:00 on Tuesday 1 November (UK time), due to an essential exercise to test the Agency’s IT recovery capacity in case of a major event. -------------------------------------------------- Note added at 1 day2 hrs (2016-11-01 01:19:16 GMT) -------------------------------------------------- You are always welcome. -------------------------------------------------- Note added at 4 days (2016-11-04 12:22:48 GMT) Post-grading -------------------------------------------------- Paldies. |
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