Recently Published (last 6 Months)
This is the 'Recently Published' page for the Human Medicines section
Added in August 2020
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
Added in March 2020
31 March 2020
27 March 2020
25 March 2020
- NEW - March 2020 CMDh Agenda
- UPDATE - Information on nitrosamines for marketing authorisation holders
16 March 2020
- NEW - CMDh Guidance Document on the Numbering System for the Procedures for Mutual Recognition and Decentralised;
- UPDATE - CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised Procedures;
- UPDATE - Best Practice Guide for the Decentralised and Mutual Recognition Procedures;
- UPDATE - Best Practice Guide for the Reference Member State in the MRP/DCP;
- UPDATE - Flow chart of the Mutual Recognition Procedure (MRP) and Repeat Use Procedures (RUP);
- UPDATE - Q&As on Biologicals;
- UPDATE - Q&As on Variations;
10 March 2020
- UPDATE - National recommendations for requests to act as RMS in DCPs;
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation;
9 March 2020
- NEW - Art. 45 assessment reports for econazole nitrate & triamcinolone acetonide and oxcarbazepine;
- NEW - Art. 46 assessment reports for Ismigen/PMBL tablet (polyvalent mechanical bacterial lysate), Valtrex (valaciclovir), Palexia, Yantil, Tapentadol Grünenthal (tapentadol (as hydrochloride) (DE/W/123+124/pdWS/01);
- UPDATE - CMDh Standard Operating Procedure - Disagreement in procedures -Referral to CMDh;
- UPDATE - Decentralised Procedure Members States' Standard Operating Procedure;
6 March 2020
5 March 2020
- NEW - January 2020 CMDh Minutes
- NEW - 2019 - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
4 March 2020
Added in February 2020
27 February 2020
25 February 2020
20 February 2020
14 February 2020
- NEW - Minutes from the CMDh meeting with Interested parties - 13 November 2019
- NEW - PSUR AR for highly refined fish oil (eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) dl-α-tocopherol), glycerol, purified egg, phosphatide);
- NEW - PSUFU AR for valaciclovir;
- NEW - Art. 46 PARs for Sandimmun/Sandimmun Neoral (ciclosporin), Infanrix-IPV/Hib (Diphtheria, Tetanus, Pertussis (acellular, component), Poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)) and Foradil Aerolizer (formoterol fumarate);
- UPDATE - Chapter 1: CMDh BPG for the allocation of the mutual recognition variation number for Type I Notifications, Type II Variations, Grouping and Worksharing;
- UPDATE - 'Blue-box' requirements;
- UPDATE - CMDh annotated QRD template for MRP/DCP;
5 February 2020
4 February 2020