kingvova.blogg.se - Dossier definition in pharma

When applying for a variation number for a grouped type IA variation(s) for more than one marketing authorisation (obtained via MRP or DCP), please use the application form for requesting this variation number.

So-called horizontal grouping of variations: relating to one or more variation(s) that all apply to several strictly national marketing authorisations (a separate procedure number is not required for this).

Grouped variations of (more than) one type IA variation(s) for several marketing authorisations including so-called “supergrouped” type IA variation(s) for more than one marketing authorisation.

Grouped applications of more than one variation for one marketing authorisation.

The following grouped variations are possible:

Question and answer document concerning changes not covered by the Variation Regulation 1234/2008.Question and answer document pertaining to variations for medicines for human use.Specific questions relating to the method of submission of variations in the Netherlands are described in two Variations question and answer documents: These Best Practice Guides and advice are also followed by the MEB for the submission of variations for strictly national marketing authorisations. Guidelines of the European Commission as published in Chapter 5 of Volume 2 of the Notice to Applicants.īest Practice Guides van de CMDh with regard to variations and other procedural advice from the CMDh about the submission of variations for medicinal products with a marketing authorisation obtained via the mutual recognition or decentralised procedure can be found on the website of the CMDh.The Regulations of the European Commission: Regulation (EC) 1234/2008 en Regulation (EU) 712/2012.The definitions of these variations are available in: There are four different types of variations: Type IA, Type IB, Type II and Line extension.

A variation is a change in the dossier of an authorised product.