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EudraLex consists of 10 volumes: Concerning Medicinal Products for Human use: Volume 1 - Pharmaceutical Legislation. Volume 2 - Notice to Applicants. Volume 2A deals with procedures for marketing authorisation. Volume 2B deals with the presentation and content of the application dossier. Volume 2C deals with Guidelines. Volume 3 - Guidelines.
EudraLex, Volume 4, Chapter 1) The QP is typically a licensed pharmacist, biologist or chemist (or a person with another permitted academic qualification) who has several years' experience working in pharmaceutical manufacturing operations, and has passed examinations attesting to his or her knowledge. The requirement for QP oversight has been ...
EUR-Lex is the official online database of European Union law and other public documents of the European Union (EU), published in 24 official languages of the EU.The Official Journal (OJ) of the European Union is also published on EUR-Lex.
Commission Implementing Regulation (EU) 2019/1293 of 29 July 2019 amending Implementing Regulation (EU) No 577/2013 as regards the list of territories and third countries in Annex II and the model of animal health certificate for dogs, cats and ferrets set out in Annex IV (Text with EEA relevance) Image title: Author: www.legislation.gov.uk
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Cover of the European Pharmacopoeia, 11th Edition. The European Pharmacopoeia [1] (Pharmacopoeia Europaea, Ph. Eur.) is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them. [1]
EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice.The EudraGMP system was launched in April 2007, for use by European Medicines Regulators.
Download QR code; In other projects ... 2019-356 of 13 December 2018 supplementing Regulation (EU) 2015-2365 of the European Parliament and of the Council with regard ...