Which type of products are covered by EudraLex Volume 4?
Medical devices
- Medical Devices – Sector.
- Medical Devices – New regulations.
- Medical Devices – Topics of Interest.
- Medical Devices – Dialogue between interested parties.
- Medical Devices – Expert Panels.
- Medical Devices – EUDAMED.
What is EU GMP Annex?
EU GMP Annex 1: Manufacture of Sterile Medicinal Products – revision November 2008. Supplementary guidelines to the EC-GMP Guide with specific requirements for the manufacture of sterile medicinal products.
What replaced Eudralex 9A?
good pharmacovigilance practice
With the application of the new pharmacovigilance legislation as from July 2012 Volume 9A is replaced by the good pharmacovigilance practice (GVP) guidelines released by the European Medicines Agency.
What is annex 11?
Annex 11 is the FDA 21 CFR part 11 European equivalent. It is a guidance system for electronic records and electronic signatures in the pharmaceutical industry. Annex 11 and FDA 21 CFR are two essential resources available to regulated life-science professionals regarding the validation of computer systems.
Is Volume 9A still valid?
With the application of the new pharmacovigilance legislation as from July 2012 Volume 9A is replaced by the good pharmacovigilance practice (GVP) guidelines released by the European Medicines Agency. However, until the availability of the respective GVP modules Volume 9A remains the reference.
What is EudraLex Volume 4?
Volume 4 of “The rules governing medicinal products in the European Union” contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and …
What is EU Annex II?
Annex II to REACH provides requirements for the compilation of the SDS for substances and mixtures. It includes the format, content, and section-by-section directions for the development of an SDS for the European Union (EU).