Cmdh 173 Rev 10 July Form
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People also ask
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What is Annex 3 in the CMDh best practice guide?
ANNEX 3 - Documents to submit Renewal applications with full documentation have to contain a consolidated version of the file, containing at least the documents listed below. Further documentation should be available from the MAH on request if considered necessary to complete the benefit/risk assessment. -
What does CMDh stand for?
Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) | European Medicines Agency. -
What is co ordination group for mutual recognition and decentralized procedures human?
Coordination Group for Mutual Recognition and Decentralised Procedures - Human. The group responsible for the examination and coordination of questions relating to the marketing authorisation of human medicines in two or more Member States in ance with the mutual recognition or decentralised procedure. -
What is the full form of CMDh?
More information can be found under 'Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)'. About us. -
What are the responsibilities of CMDh?
The CMDh examines questions relating to the marketing authorisation of human medicines in two or more European Union (EU) Member States in ance with the mutual recognition or the decentralised procedure, and questions concerning variations of these marketing authorisations. -
What is unforeseen variations?
“A variation is considered 'unforeseen' when the proposed variation is not considered a minor variation of Type IB following the Commission Guideline, or has not been classified as a Type IB variation in an Article 5 recommendation.
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