Recently Published (last 6 Months)
This is the 'Recently Published' page for the Human Medicines section
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
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
8 December 2020
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
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
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
16 October 2020
13 October 2020
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
23 September 2020
22 September 2020
15 September 2020
Added in August 2020
18 August 2020
UPDATE - Examples for acceptable and not acceptable groupings for MRP/DCP products
10 August 2020
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
24 July 2020
NEW - Minutes from the CMDh meeting with IPs in May 2020
23 July 2020
UPDATE - Article 30 Tracking table ;
21 July 2020
20 July 2020
17 July 2020
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)