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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 ...
While each document (and each language version) is an individual part of the database, the content is grouped into sectors. There are currently 12 sectors, each represented by a number or a letter: [10] 1 - Treaties; 2 – International agreements; 3 – Legal acts; 4 – Complementary legislation; 5 – Preparatory documents; 6 – Case-law
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]
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relates to medicinal products for human use in mainly countries that are part of the European Union. [1]
The following year, Barnes & Noble [4] purchased SparkNotes and selected fifty literature study guides to publish in print format. When Barnes & Noble printed SparkNotes, they stopped selling their chief competitor, CliffsNotes. [5] In January 2003, SparkNotes developed a practice test service called SparkNotes Test Prep.
[4] Due to its breadth and its incorporation of themes from Marx's earlier writings, the Grundrisse is central to Marx's body of work. Its subject matter includes the prices of production , relations of production , distribution , exchange , alienation , value , labor , capitalism , the rise of technology and automation , pre-capitalist forms ...
Wuthering Heights is the only novel by the English author Emily Brontë, initially published in 1847 under her pen name "Ellis Bell". It concerns two families of the landed gentry living on the West Yorkshire moors, the Earnshaws and the Lintons, and their turbulent relationships with the Earnshaws' foster son, Heathcliff.