Recently Published (last 6 Months)

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

Added in September 2021

27 September 2021

• NEW - 20-22 July CMDh Minutes

24 September 2021

• NEW - September 2021 CMDh Monthly Report
• UPDATE - Step 2 - Nitrosamine detected response template (doc) 
• NEW - CMDh Letter to MAHs - Risk of azido impurity in losartan-containing medicinal products

14 September 2021

• NEW - 14-16 September CMDh Agenda

Added in August 2021

25 August 2021

Correction - Minutes of the CMDh meeting of 22-23 June 2021

03 August 2021

• UPDATE - Chapter 6 of the CMDh BPG for the processing of Grouped Applications in the Mutual Recognition Procedure 

02 August 2021

• Correction - Q&As on the implementation of the outcome of the Art. 31 referral on angiotensin-II-receptor antagonists (sartans) containing a tetrazole group (June 2021) [Tracked]

Added in July 2021

30 July 2021

• Correction - Minutes for May 2021 CMDh with IPs 

29 July 2021

• UPDATE - CMDh Recommendation for classification of unforseen variations according to Article 5 of Commission Regulatoin (EC) 1234/2008 (July 2021)
• NEW - July 2021 CMDh Monthly Report

27 July 2021

• NEW - Minutes for May 2021 CMDh with IPs

• NEW - June 2021 CMDh Minutes

20 July 2021

• NEW - July 2021 CMDh Agenda

8 July 2021

• NEW - PSUR assessment for Edarclor (azilsartan medoxomil chlorthalidone)
• 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 - Template for requests for RMS in a DCP for medicinal products for human use
• UPDATE - CMDh position paper on the use of Mobile scanning and other technologies to be included in labelling and PL in order to provide information about the medicinal product

7 July 2021

• UPDATE - Q&As on the implementation of the outcome of the Art. 31 referral on angiotensin-II-receptor antagonists (sartans) containing a tetrazole group

6 July 2021

• UPDATE - Step 2 - Nitrosamine detected above acceptable intake or new nitrosamine detected response template

1 July 2021

• UPDATE - EMA/CMDh Q&As on the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations

Added in June 2021

30 June 2021

• NEW - May 2021 CMDh Minutes
• NEW - Report from the meeting held on 22-23 June 2021
• UPDATE - Report from the meeting held on 18-20 May 2021

22 June 2021

• NEW - June 2021 CMDh Agenda

10 June 2021

• UPDATE - List of safety concerns per approved Risk Management Plan (RMP) of active substances per product

7 June 2021

• NEW - HaRP assessment reports for olmesartan/amlodipine and etofenamate; 

3 June 2021

• NEW - Assessment report template for the nitrosamine risk assessment for the outcome of step 2 – “nitrosamine detected”;
• NEW - Agenda and presentations from the CMDh meeting with Interested parties in May 2021;
• NEW - Article 45 assessment reports for brotizolam, cefuroxime axetil and cefuroxime sodium;
• NEW - HaRP assessment reports for eletriptan, ethambutol hydrochloride, amitriptyline, baclofen, minoxidil (topical), paroxetine, perindopril/amlodipine, bleomycin, hydromorphone hydrochloride, olmesartan/hydrochlorothiazide, sumatriptan;
• UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation;

Added in May 2021

28 May 2021

• NEW - April 2021 CMDh Minutes

26 May 2021

• NEW - Report from the meeting held on 18-20 May 2021

18 May 2021

• NEW - May 2021 CMDh Agenda

12 May 2021

• NEW - CMDh Letter to MAHs - Risk of azido impurity in sartan-containing medicinal products;
• NEW - PSUFU summary assessment reports for dinoprostone and phenobarbital; 
• NEW - Joint Article 45 and 46 PAR for ENGERIX B Junior (r-DNA Hepatitis B surface antigen (HBsAg);
• UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
• UPDATE - Requirements on submissions (number and format) for Variations and Renewals within MRP and National 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 - Cover Note to List of safety concerns per approved Risk Management Plan (RMP) of active subtances per product 
• 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 - Annex 2: HaRP (Harmonisation of RMP Project) - methodology of harmonising RMPs;
• 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;
• UPDATE - Requirements on submissions (number and format) for New MA Applications within MRP, DCP or National procedures;

6 May 2021

• UPDATE - CMDh annotated QRD template for MRP/DCP

3 May 2021

• UPDATE - Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP

Added in April 2021

30 April 2021

• UPDATE - List of safety concerns per approved Risk Management Plan (RMP) of active substances per product

28 April 2021

• NEW - Report from the meeting held on 20-22 April 2021
• UPDATE - List of safety concerns per approved Risk Management Plan (RMP) of active substances per product

26 April 2021

• NEW - March 2021 CMDh Minutes

20 April 2021

• NEW - April 2021 CMDh Agenda

8 April 2021

• NEW - PSUR assessment reports for doxylamine hydrogen succinate, pyridoxine hydrochloride and drospirenone
• UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
• UPDATE - Q&A on the Paediatric Regulation
• UPDATE - RMS validation checklist for human medicinal products in DCP

Addedd in March 2021

31 March 2021

• NEW - Report from the meeting held on 23-25 March 2021

26 March 2021

• NEW - February 2021 CMDh Minutes

24 March 2021

• UPDATE - List of safety concerns per approved Risk Management Plan (RMP) of active substances per product

23 March 2021

• NEW - March 2021 CMDh Agenda

9 March 2021

• NEW - January 2021 CMDh Minutes
• NEW - Summary of risk management plan for dexamethasone for treatment of coronavirus disease 2019 (COVID-19)
• NEW - Summary of CMDh Activities 2020
• NEW - Art. 45 assessment report for Varicella virus vaccine live
• NEW - Art. 46 assessment reports for Foradil Aerolizer (formoterol fumarate) and Varivax (Varicella virus vaccine live)
• UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
• UPDATE - CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs (PSUFU)
• UPDATE - Lead Member State PSUR Follow-Up assessment report template

8 March 2021

• NEW - Flow chart on the assessment and procedure for adoption by CMDh of HaRP Assessment reports prepared by the HaRP Peer Review Group
• 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 - Q&As on the implementation of the outcome of the Art. 31 referral on angiotensin-II-receptor antagonists (sartans) containing a tetrazole group

4 March 2021

• UPDATE - Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP;
• UPDATE - 'Blue-box' requirements;

3 March 2021

• NEW - Report from the meeting held on 23-24 February 2021

2 March 2021

• UPDATE - National recommendations for requests to act as RMS

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