The MAH may be a natural or legal person. The granting of a marketing authorisation by a competent authority does not discharge the holder from civil and criminal liability as provided for by the Union law. The Marketing Authorisation Holder (MAH) is the person who holds the authorisation to place a medicinal product on the market and is legally responsible for marketing the medicinal product. Commission Implementing Regulation No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Councilġ.2 How can I tell if I am duly established in the EEA as an applicant? Rev.Procedures for marketing authorisation“, The Rules governing Medicinal Products in the European Union, Volume 2A, Notice to Applicants, Chapter 1.human post-authorisation questions and answers.

similar-biological-medicine applications.

The Agency also publishes procedural and technical guidance and document templates, which are intended to provide technical and procedural advice to applicants for marketing authorisations for medicinal products coming within the scope of the centralised procedure, in particular: Scientific guidelines related to quality, safety and efficacy are available, together with concept papers, draft guidelines and overviews of comments received during the consultation on draft versions.

The European Commission website offers the possibility to create a CD-ROM with the content of the rules governing medicinal products in the European Union, which can be used off-line with an integrated search engine. 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.

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