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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.
Commission Directive 66/683/EEC of 7 November 1966 eliminating all differences between the treatment of national products and that of products which, under Articles 9 and 10 of the Treaty, must be admitted for free movement, as regards laws, regulations or administrative provisions prohibiting the use of the said products and prescribing the use of national products or making such use subject ...
[4] [5] The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry , as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies.
The Poisons Standard organises substances into 10 schedules (and unscheduled substances), [10] therapeutic goods are generally organised only into schedules 2, 3, 4 and 8: unscheduled substances: unscheduled substances are available for purchase at any retailer. schedule 1 (S1) - Blank: this schedule is left intentionally blank.
EUR-Lex contains all EU law (sectors 3 and 4), which can be retrieved by browsing or using the search options. The main types of acts under this heading are EU treaties (sector 1), directives , regulations , decisions as well as consolidated legislation (sector 0), etc. Consolidation is the integration of a basic legal act and all of its ...
Download as PDF; Printable version; In other projects ... EudraLex; EUR-Lex; Eurodac; ... Text is available under the Creative Commons Attribution-ShareAlike 4.0 ...
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 Common Technical Document is divided into five modules: [4] Administrative and prescribing information; Overview and summary of modules 3 to 5; Quality (pharmaceutical documentation)