Recently Published (last 6 Months)
This is the 'Recently Published' page for the Human Medicines section
Added in April 2020
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
Added in January 2020
28 January 2020
8 January 2020
Added in December 2019
20 December 2019
- NEW - Report from the meeting held on 9-11 December 2019
- UPDATE - Questions and answers on “Information on nitrosamines for marketing authorisation holders”
- 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
- NEW - PSUR WS AR for Gaviscon Advance (sodium alginate, potassium hydrogen carbonate) and ciclopirox olamine (all formulations except shampoo);
- UPDATE - Questions and Answers on Pharmacovigilance Legislation;
13 December 2019
9 December 2019
Added in November 2019
27 November 2019
26 November 2019
- NEW - CMDh Best Practice Guide on Multilingual Packaging;
- NEW - Art. 45 assessment report for fluorometholone;
- NEW - Art. 46 assessment report for Enstilar (calcipotriol/betamethasone dipropionate);
- NEW - Agenda and presentations from the November CMDh meeting with Interested parties;
- 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 - Questions and Answers on generic applications;
- UPDATE - Questions and Answers on homeopathic medicinal products;
21 November 2019
20 November 2019
19 November 2019
15 November 2019
12 November 2019
7 November 2019
Added in October 2019
28 October 2019
25 October 2019
- NEW - Art. 46 assessment reports for Daivobet / Xamiol (calcipotriol / betamethasone dipropionate) and Covaxis/Adacel/Triaxis (Diphtheria Toxoid / Tetanus Toxoid / Pertussis Antigens: Pertussis Toxoid / Filamentous Haemagglutinin / Pertactin, Fimbriae Types 2 and 3);
- NEW - Recommendations on submission dates in 2020 for applicants of the DCP;
- NEW - Recommendations on submission dates in 2020 for applicants of the MRP;
- UPDATE - Applicant's Response document in Mutual Recognition and Decentralised Procedures for Marketing Authorisation Applications;
- UPDATE - Cover letter for new applications submitted through MRP/DCP;
- UPDATE - Cover letter for Variation Applications in the Mutual Recognition Procedure;
23 October 2019
22 October 2019
18 October 2019
15 October 2019
14 October 2019
3 October 2019
2 October 2019
- NEW - PSUR WS AR for ceftobiprole medocaril sodium;
- NEW - Art. 46 PAR for Cilodex 3 mg/ml / 1 mg/ml ear drops (ciprofloxacin / dexamethasone) and Polio Sabin (trivalent oral poliovirus vaccine);
- NEW - Timetables 2020 for requests to CMDh for a recommendation on classification of an unforeseen variation - Article 5;
- NEW - Overview of timetables 2020;
- UPDATE - CMDh 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 Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008;
- UPDATE - Monitoring of medicines originating from Japan;
- UPDATE - Cover letter template for renewals;
- UPDATE - Template - RMS End of Renewal Procedure
Added in September 2019
26 September 2019
- NEW - Report from the meeting held on 17-19 September 2019
- NEW - Information on nitrosamines for marketing authorisation holders
- NEW - Questions and answers on "Information on nitrosamines for marketing authorisation holders"
24 September 2019
17 September 2019
2 September 2019
- UPDATE - List of safety concerns per approved Risk Management Plan (RMP) of active substances per product