Request to CMDh for a recommendation on the classification of an unforeseen variation under Article 5

• Template Request form for recommendation - Article 5 (March 2009) [PDF]

Recommendation of the CMDh on the classification of an unforeseen on variations to the terms of the marketing authorisation

• Template Recommendation form - Article 5 (September 2010) [.dot]

Submission of a Worksharing procedure to the CMDh according to Article 20 of Commission Regulation (EC) No 1234/2008

• Template of letter of intent for the submission of a worksharing procedure (January 2010) [.dot]

• Template cover letter for worksharing including CAPs and MRPs

• Template for the outcome of variation worksharing procedures [.dot]