Recently Published (last 6 Months)
This is the 'Recently Published' page for the Human Medicines section
Added in October 2020
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)
Added in June 2020
30 June 2020
26 June 2020
23 June 2020
8 June 2020
- NEW - Art.45 assessment report for Clemastine;
- NEW - Art.46 assessment report for Ciclosporin, Lisdexamfetamine dimesylate, Leuprorelin acetate, Mometasone furoate;
- NEW - Meeting with Interested Parties Presentations
- UPDATE - Q&As on Variations;
- UPDATE - End of pilot for splitting of MRP/DCPs
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
3 June 2020
Added in May 2020
29 May 2020
28 May 2020
26 May 2020
11 May 2020
- NEW - Art.46 assessment report for Palexia, Yantil, Tapentadol Grünenthal (tapentadol (as hydrochloride);
- UPDATE - Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP;
- UPDATE - Q&As on the implementation of the outcome of the Art. 31 referral on angiotensin-II-receptor antagonists (sartans) containing a tetrazole group;
- UPDATE - CMDh Best Practice Guide on the use of eCTD in the MRP/DCP;
- UPDATE - Additional Data requested for New Applications in the Mutual Recognition and Decentralised Procedures ;
- 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 - RMS Validation Checklist for human medicinal products in DCP;
8 May 2020
- NEW - HaRP assessment reports for aciclovir; cineolum; diazepam; dienogest_ethinylestradiol; diosminum; doxazosin; ethosuximide; fexofenadine; gemcitabine; meropenem; thiamazole; trospium chloride; zolpidem
- UPDATE - updated HaRP assessment report for vinorelbine
- UPDATE - List of safety concerns per approved Risk Management Plan (RMP) of active substances per product
6 May 2020
4 May 2020
Added in April 2020
29 April 2020
20 April 2020
14 April 2020
6 April 2020
- NEW - PSUFU summary assessment report for bupropion;
- NEW - PSUR summary assessment report for doxylamine hydrogen succinate, pyridoxine hydrochloride;
- NEW - Summary of CMDh Activities 2019;
- NEW - Art. 46 PARs for Fragmin (dalteparin sodium); Boostrix (diphtheria toxoid (D), tetanus toxoid (T), pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN));
- UPDATE - Q&As on generics;
- UPDATE - Applicant's Response document in Mutual Recognition and Decentralised Procedures for Marketing Authorisation Applications;
- UPDATE - Requirements on submissions (number and format) for New MA Applications, Variations and Renewals within MRP, DCP or National procedures;
- UPDATE - CMS Validation Checklist for human medicinal products in DCP and MRP;
3 April 2020