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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]
A couple in Australia have been accused of faking their young son's cancer diagnosis "It will be alleged that the accused shaved their 6-year-old child’s head, eyebrows, placed him in a ...
BMW recalled certain 2023-2024 X1, X5, X6, X7, XM, 530i, i5, 740i, 760i, i7, and 750e vehicles.. The NHTSA report said that the integrated brake system may malfunction and result in a loss of ...
The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...
I had been eagerly awaiting the release of Europa Universalis 4, the fourth iteration of Paradox's flagship title that first put the studio on the map and marked the entry of one of the greatest ...
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 ...