General Information

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• Best Practice Guide for the Reference Member State in the MRP/DCP (February 2020)[Track version]

• CMDh procedural advice on changing the RMS (March 2022) [Track version]

• Template for RMS change (June 2018)

• Best Practice Guide for the exchange of regulatory and administrative information regarding orphan medicinal products between EMA and National Competent Authorities (October 2016, correction March 2024) [Track version]

• CMDh position paper on sunset clause and its application to marketing authorisations granted in more than one MS (March 2016) [Track version]

• Phasing in EU procedures: MRP and referrals (September 2003)

• CMDh Recommendation on the Summary of the Pharmacovigilance System and Risk Management Plan in the Mutual Recognition and Decentralised Procedures (October 2015) [Track version]

• CMDh Best Practice Guide for the Public Assessment Report and Summary Public Assessment Report in MRP/DCP (September 2014) [Track version]

• CMDh Best Practice Guide on the submission of high quality national translations (February 2017)[Track version]

• Publication of decisions to grant or revoke a marketing authorisation (October 2018)

• Transfer of information contained in Notice to applicants, Volume 2A, Chapter 7 (July 2012)

• CMDh position paper on the use of Mobile scanning and other technologies to be included in labelling and PL in order to provide information about the medicinal product (October 2023) [Track version]  - Annex 2 - Applicant's declaration template  (January 2023)

• CMDh Best Practice Guidance on collaboration between Member States in relation to serious GMP non-compliance issues (March 2017) [Track version]

• CMDh Guidance Document on the Numbering System for the Procedures for Mutual Recognition and Decentralised (February 2020)

• Template of the Public Assessment Report and Updates

• CMDh Recommendations on common regulatory approaches for allergen products (July 2020)
  - Submission of comments on Draft CMDh Guideline ‘Recommendations on Common Regulatory Approaches for Allergen Products’ (July 2020)