![]() This is a legally binding act published by the European Commission in June 2012 that provides details on the operational aspects for the new legislation GVP modules refer to the Commission Implementing Regulation No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities. However, until the availability of the respective GVP modules, volume 9A remains the reference. Volume 9 – Pharmacovigilance: With the application of the new pharmacovigilance legislation as from July 2012, volume 9A is replaced by the good pharmacovigilance practice.Volumes 5 to 8 apply only to veterinary medicinal products.Volume 4 – Good manufacturing practices.renewal procedures, variation procedures, summary of product characteristics (SmPC), package information and classification for the supply, readability of the label and package-leaflet requirements Volume 2C - Regulatory guidelines: related to procedural and regulatory requirements, e.g.Volume 2B - Presentation and content of the dossier: provides guidance for the compilation of dossiers for applications for marketing authorisation, and is applicable for the centralised procedure and national procedures, including mutual-recognition and decentralised procedures.Chapter 6 – Community marketing authorisation.Volume 2A - Procedures for marketing authorisation:. ![]() ![]() Volume 1 – Pharmaceutical legislation, contains most of the relevant Directives, Regulations, decisions and communications.The rules governing medicinal products in the European Union concerning medicinal products for human use is published on the European Union website: Information about the hierarchy of the European Union texts can be found in annex I to Procedures for marketing authorisation“, The Rules governing Medicinal Products in the European Union, Volume 2A, Notice to Applicants, Chapter 1. ![]() To exercise the Union's competences, the institutions may adopt regulations, directives, decisions, recommendations and opinions. The treaties on which the European Union and the European Communities are founded are available. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |