CMD(h) released updated additional data requested for new applications in the MRP/DCP

The Co-ordination Group for Mutual Recognition and Decentralized Procedure - Human (CMD(h)) has released an updated version (Rev 6, April 2011) of the table listing additional data that is requested by EU Member States for new application in the MRP or DCP. Data listed concerns documents and information that is not stated in the current EU legislation, Volume 2B and/or in the EEA approved Guidelines / Recommendations.

There are several significant updates included in revision 6 which are listed by country below:

Belgium (new):

• Requires Declaration of conformity for national translations of SmPC, Package Leaflet and Labelling

Bulgaria:

• Removed: Statement for the MA transfer to local subsidiary
• Removed: Pharmacovigilance responsible in National Territory
• Added: Confirmation of the identical dossier with an original signature

Poland:

• Removed: Proposed Product Information in Polish language at submission
• Removed: Declaration which package sizes will be marketed in Poland (original)
• Removed: Declaration from MAH of submitting samples on request of the President of the Agency (original)

Slovenia (new):

• Requires cover letter to be submitted in Slovene language

Revision 6 of the table listing the additional data requested for new applications in the MRP/DCP is available for download from the CMD(h) website in current clean version (see link at the bottom of this article).

[Source: CMD(h) website]

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