HMA: Draft Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure

These Best Practice Guides are intended to facilitate the practical application of the guidance for the handling of Mutual Recognition variations outlined in Notice to Applicants, Volume IIA, Chapter 5 [to be updated]. They provide detail on the actions undertaken by the Reference Member State (RMS), Concerned Member States (CMS) and the applicant at each step of the variation process, and the involvement of CMD(h) where applicable. The CMD(h) recommends that the Best Practice Guides are followed by all member states and applicants to ensure that a consistent approach is maintained and that variations are processed in an efficient and timely manner.