Recently Published (last 6 Months)
This is the 'Recently Published' page for the Human Medicines section
Added in June 2021
22 June 2021
10 June 2021
7 June 2021
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
26 May 2021
18 May 2021
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
3 May 2021
Added in April 2021
30 April 2021
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
20 April 2021
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
26 March 2021
24 March 2021
23 March 2021
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
2 March 2021
Added in February 2021
23 February 2021
19 February 2021
8 February 2021
5 February 2021
- NEW - Minutes for November 2020 CMDh meeting with IPs;
- NEW - PSUR assessment report for Eszopiclon;
- NEW - Art. 46 assessment reports for OctaplasLG (plasma protein, human) and Fibryga (human fibrinogen);
- NEW - 2020 - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures;
- 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 - Applicant's Response document in Mutual Recognition and Decentralised Procedures for Marketing Authorisation Applications;
3 February 2021
- NEW - Report from the meeting held on 26-27 January 2021;
- UPDATE - Templates for MAHs for the submission of Step 1 - Risk evaluation and Step 2 - Confirmatory test on nitrosamine impurities
1 February 2021
Added in January 2021
26 January 2021
5 January 2021
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 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