Search results
Results from the WOW.Com Content Network
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 ...
The derogation was reviewed every five years until Irish received full status as a working language of the EU joining the other 23 official languages of the EU on 1 January 2022. [ 6 ] [ 7 ] [ 8 ] [ needs update ] It is gradually reduced according to a timetable annexed to Council Regulation (EU, Euratom) 2015/2264.
Main page; Contents; Current events; Random article; About Wikipedia; Contact us; Pages for logged out editors learn more
European Union Directive 2001/82/EC [4] and Directive 2001/83/EC, [5] (as amended) state the legally binding character of European Pharmacopoeia texts for Marketing Authorisation Applications (MAA). All manufacturers of medicines or substances for pharmaceutical use therefore must apply the European Pharmacopoeia quality standards in order to ...
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
The European regulatory authorities update the database continuously and expect it to grow extensively over the next few years as more “GMP certificates are imported each year.” [2] The database serves as a quick reference for checking the good manufacturing practice (GMP) of a potential contract manufacturer.
EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines or devices which have received marketing authorisation or are actively being studied in clinical trials in the European Economic Area (EEA).