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The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMD(h)) has released the long awaited updated electronic (eCTD or NeeS) and paper submission requirements for variations and renewals within the Mutual Recognition and/or National procedures.
The updated requirements were now listed per country in three tables: - Table 1 lists the requirements for countries that accept electronic only submissions
- Table 2 details the requirements for countries that request at least parts of the dossier in paper
- Table 3 details the requirements for paper dossiers for these countries that still accept paper submissions in case a valid eCTD or NeeS cannot be provided by applicants.
According to the updated requirements, some Member States do not accept paper submissions for Variations and Renewals any longer: Belgium, Czech Republic, Spain, Hungary, Ireland (Variations only), The Netherlands, Slovak Republic and the United Kingdom. As the update has just been released, a careful analysis of the updated requirements and the impact for MRP and national submissions should be done, as mistakes and misinterpretations did occur in the past. In case of doubt it is always recommended that applicants should liaise with their national competent authority for clarification.
The requirements for some countries are not listed at all. Affected countries are Germany (BfArM only), Luxembourg, and Portugal. In light of this missing data, a further update of the requirements in the near future may be possible.
The updated requirements are available for download from the CMD(h) website (see link at the bottom of this article).
[Source: CMD(h) website]
- Related News:
 CMD(h) posts updated requirements for electronic submissions and paper documentation for Variations and Renewals within MRP or National procedures - 06.01.2011 19:56- EU: CMD(h) releases updated requirements on electronic submissions for New Applications within MRP, DCP or National procedures - 07.11.2010 22:59
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