Recently Published (last 6 Months)

This is the 'Recently Published' page for the Human Medicines section

Added in January 2021

5 January 2021

• UPDATE - Report from the meeting held on 8-9 December 2020

Added in December 2020

31 December 2020

• UPDATE - CMDh annotated QRD template for MRP/DCP;
• UPDATE - Requirements on submissions (number and format) for Variations and Renewals within MRP and National procedures;
• UPDATE - Requirements on submissions (number and format) for New MA Applications within MRP, DCP or National procedures;

18 December 2020

• NEW - PSUFU for levonorgestrel;
• UPDATED - List of safety concerns per approved Risk Management Plan (RMP) of active substances per product

17 December 2020

• NEW - Bupropion - CMDh recommendation for the WS variation following PSUSA/00000461/201812;
• UPDATE - CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines;
• UPDATE - Chapter 3: CMDh BPG for the processing of Type IA Minor Variations (Notifications) in the Mutual Recognition Procedure;
• UPDATE - Chapter 4 : CMDh BPG for the processing of Type IB Minor Variations (Notifications) in the Mutual Recognition Procedure;
• UPDATE - Chapter 6: CMDh BPG for the processing of Grouped Applications in the Mutual Recognition Procedure;
• UPDATE - Q&As on Pharmacovigilance Legislation;
• UPDATE - Templates for the Preliminary Renewal Assessment Report and the End of Renewal Procedure;
• UPDATE - 'Blue-box' requirements;
• UPDATE - Languages to be used for Marketing Authorisation Applications (MAAs), Variations and Renewals - National, Mutual Recognition and Decentralised applications;
• UPDATE - Mock-ups, Specimens and Samples for new applications;
• UPDATE - Mock-ups, Specimens and Samples for variations;

15 December 2020

• NEW - Report from the meeting held on 8-9 December 2020

14 December 2020

• NEW - Practical guidance on the implementation of the Protocol on Ireland/Northern Ireland for medicinal products for human use approved via MRP/D;
• UPDATE: Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP;

10 December 2020

• NEW - November 2020 CMDh Minutes

8 December 2020

• NEW - December 2020 CMDh Agenda

Added in November 2020

24 November 2020

• NEW - Art. 46 assessment report for Cutaquig (human normal immunoglobulin);
• NEW - Art. 45 assessment report for mebendazole;
• NEW - Agenda and presentations from the CMDh meeting with Interested Parties in November 2020;
• UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation;
• UPDATE - CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines;
• UPDATE - CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs (PSUFU);
• UPDATE - CMDh Best Practice Guide on the processing of renewals in the MRP/DCP;
• UPDATE - Chapter 5: CMDh BPG for the handling of Type II Variations in the Mutual Recognition Procedure;
• UPDATE - Templates for the Preliminary Variations Assessment Report (PVAR) and the Final Variation Assessment Report (FVAR);

18 November 2020

• UPDATE - Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers;

17 November 2020

• NEW - Report from the meeting held on 10-11 November 2020;
• NEW - October 2020 CMDh Minutes;
• UPDATE - Requirements on submissions (number and format) for New MA Applications within MRP, DCP or National procedures;
• UPDATE - Requirements on submissions (number and format) for Variations and Renewals within MRP and National procedures;

10 November 2020

• NEW - November CMDh Agenda
• NEW - Art. 45 assessment report for pethidine hydrochloride
• UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation

4 November 2020

• NEW - Art. 45 assessment report for phenylephrine plus prednisolone;
• NEW - Art. 46 assessment report for Hiberix (haemophilus type B capsular polysaccharide (PRP)/tetanus toxoid;

Added in October 2020

26 October 2020

• UPDATE - Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure, Chapters 3 and 4
• UPDATE - Examples for acceptable and not acceptable groupings for MRP/DCP products
• UPDATE - Update Assessment report for Repeat use procedures
• UPDATE - Pharmacovigilance Legislation
• UPDATE - EU ASMF number request form
• NEW - PSUR Summary of Assesment Reports for Xonvea and Cernevit
• NEW - Recommendations on submission dates in 2021 for Applicants of the DCP
• NEW - Recommendations on submission dates in 2021 for Applications of the MRP

21 October 2020

• NEW - Report from the meeting held on 13-14 October 2020

16 October 2020

• NEW - September 2020 CMDh Minutes

13 October 2020

• NEW - October 2020 CMDh Agenda

Added in September 2020

29 September 2020

• NEW - PSUR summary assessment report for standardised allergen extract from birch (Betula verrucosa);
• NEW - Art. 46 assessment reports for Vaxigrip Tetra (quadrivalent influenza virus vaccine (inactivated, split)); Wilate (and associated names) (human von Willebrand factor, human coagulation factor VIII); Foster NEXThaler (and associated names) (beclometasone dipropionate, formoterol fumarate dihydrate); Temesta/Tavor/Ativan (lorazepam);
• NEW - 2020 January - June Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures;
• NEW - Timetables 2021 for requests to CMDh for a recommendation on classification of an unforeseen variation - Article 5;
• NEW - Overview of timetables 2021 - CMDh 60-day procedures for MRP/DCP applications;
• UPDATE - CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines;
• UPDATE - Procedural Advice on Repeat Use;
• UPDATE - Decentralised Procedure Members States' Standard Operating Procedure;
• UPDATE - Best Practice Guide for the Decentralised and Mutual Recognition Procedures;
• UPDATE - Best Practice Guide on the Assessment Report for Mutual Recognition and Decentralised Procedures;
• UPDATE - MSs Recommendations on Extension Applications in Mutual Recognition and Decentralised Procedures;
• UPDATE - 'Blue-box' requirements;

24 September 2020

• NEW - Report from the meeting held on 15-16 September 2020

23 September 2020

• NEW - July 2020 CMDh Minutes

22 September 2020

• UPDATE - European Medicines Regulatory Network COVID-19 Business Continuity Plan

15 September 2020

• NEW - September 2020 CMDh Agenda

Added in August 2020

18 August 2020

UPDATE - Examples for acceptable and not acceptable groupings for MRP/DCP products

10 August 2020

UPDATE - CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines

06 August 2020

UPDATE - Information on nitrosamines for marketing authorisation holders

Added in July 2020

31 July 2020

NEW - Template for RMS Assessment Report on Similarity
UPDATE - RMS Day 70 Overview template
UPDATE - RMS Day 120 Overview template
UPDATE - PSUR summary assessment report for doxylamine hydrogen succinate, pyridoxine hydrochloride

29 July 2002

NEW - Report from the meeting held on 21-22 July 2020
NEW - Art.45 Assessment report on valproic acid
NEW - Art.46 Assessment report on fosrenol
NEW - Recommendations on common regulatory approaches for allergen products
 

27 July 2020

NEW - June 2020 CMDh Minutes

24 July 2020

NEW - Minutes from the CMDh meeting with IPs in May 2020

23 July 2020

UPDATE - Data requested for Variations and/or Renewal Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines / Recommendation papers;

UPDATE - Article 30 Tracking table ;

21 July 2020

• NEW - July 2020 CMDh Agenda

20 July 2020

• UPDATE - Questions &Answers on QP declaration

17 July 2020

• UPDATE - Languages to be used for Marketing Authorisation Applications (MAAs), Variations and Renewals - National, Mutual Recognition and Decentralised applications

10 July 2020

• Cover letter for Variation Applications in the Mutual Recognition Procedure
• Cover letter for new applications submitted through MRP/DCP
• Requirements on submissions (number and format) for Variations and Renewals within MRP and National procedure
• Art. 61.3 Procedure Notification form

08 July 2020

• Flow chart of the Decentralised Procedure
• CMDh Best Practice Guide on Multilingual Packaging
• Procedural guidance during COVID-19 pandemic
• CMDh Best Practice Guide on the processing of renewals in the MRP/DCP
• Hormone Replacement Therapy - Core Package Leaflet
• Hormone Replacement Therapy - Core SmPC
• Art 46. PAR - Silkis ointment (calcitriol)