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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 ...
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]
In January 2003, SparkNotes developed a practice test service called SparkNotes Test Prep. This project was followed by the release of SparkCharts, reference sheets that summarize a topic; No Fear Shakespeare, transcriptions of Shakespeare's plays into modern language; and No Fear Literature, transcriptions of literary classics like The ...
EudraGMP is part of the EU telematics strategy, which has been conceived in order to meet the strategic objectives of the European Commission, the European Medicines Agency and the Member State competent authorities. EudraGMP is part of a larger database known as EudraGMDP, which contains information on: “Manufacturing and import authorisations
Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products.
The first edition of The Norton Anthology of English Literature, printed in 1962, comprised two volumes.Also printed in 1962 was a single-volume derivative edition, called The Norton Anthology of English Literature: Major Authors Edition, which contained reprintings with some additions and changes including 28 of the major authors appearing in the original edition.
[4] [3] [5] Cassius is a dubious possibility for author of the treatise because he wrote in the 3rd century, and no literature later than the 1st century AD is mentioned. The latest is Cicero , who died in 43 BC [ clarification needed ] and their work is now dated to the early 1st century AD.