Application for Marketing Authorisation (MA)

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• Best Practice Guide for the Decentralised and Mutual Recognition Procedures (April 2013) [Track version]

• Best Practice Guide on the Assessment Report for Mutual Recognition and Decentralised Procedures (July 2011) [Track version]

• Best Practice Guide on Break-out Sessions (March 2013) [Track version]

• Best Practice Guide for authorisation of non-prescription medicines in the Decentralised and Mutual Recognition procedures (February 2012)

• Recommendations on Informed Consent Applications in Mutual Recognition and Decentralised Procedures (September 2010) [Track version]

• Recommendations on Multiple Applications in Mutual Recognition and Decentralised Procedures (June 2007)

• MSs Recommendations on Extension Applications in Mutual Recognition and Decentralised Procedures (November 2011) [Track version]

• Position Paper concerning Applicants’ request of submission of multiple applications during ongoing decentralised procedures or inclusion of new CMS or additional strength(s) in an already ongoing decentralised procedure (DCP) (October 2012)

• Procedural Advice on Repeat Use (July 2011) [Track version]

• Declaration form for the submission of DDPS already approved by a competent authority (June 2011) [.dot]

• CMDh guidance for Declaration form submission DDPS already approved by a competent authority (June 2011) [Track version]

• Requirements on submissions (eCTD and NeeS) for New Applications within MRP, DCP or National procedures

• Languages to be used for Marketing Authorisation Application (MAA), Variations and Renewals (June 2012)

• Mock-ups, Specimens and Samples for new applications (September 2012)

• 'Blue-box' requirements (March 2013)

Validation Procedure

• Member state agreement upon conditions under which the RMS can start MRP/DCP (October 2012) [Track version]

• Procedural advice: Automatic validation of MR/Repeat-use/DC Procedures (March 2012) [Track version]

• Additional Data requested for New Applications in the Mutual Recognition and Decentralised Procedures (September 2011) [Track version]

• Common Grounds for Invalidation/Delaying Validation (September 2010)[Track version]

• Member States Recommendations on the Cover Letter for New Applications submitted through Mutual Recognition and Decentralised Procedures (March 2012) [Track version]

• CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted through the Mutual Recognition and Decentralised Procedures (March 2008)

Introduction to Published Papers on Validation has been taken off the website as it was considered to be obsolete.

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