Update of Guideline on the packaging information of medicinal products for human use authorised by the Union (July 2015) [EudraLex - Volume 2]
EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use.
Volume 2 of the publications "The rules governing medicinal products in the European Union" contains a list of regulatory guidelines related to procedural and regulatory requirements such as renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of product characteristics (SmPC), package information and classification for the supply, readability of the label and package leaflet requirements.
The Notice to Applicants below has been prepared by the European Commission, in consultation with the competent authorities of the Member States and the European Medicines Agency (EMA) . This Notice has no legal force anddoes not necessarily represent the final views of the Commission. In case of doubt, therefore, reference should be made to the appropriate Union Directives and Regulations.
The Notice to Applicants was first published in 1986 and is regularly updated.
Update of Guideline on the packaging information of medicinal products for human use authorised by the Union (July 2015) now published.
(342 KB) Source: EMA Website
