Recently Published (last 6 Months)
This is the 'Recently Published' page for the Human Medicines section
Added in September 2023
27 September
- NEW - Art. 45 assessment report for Oxycodone
- NEW - SmAR on Bilastine
- UPDATE - Applicant's response template
- UPDATE - Questions & Answers on Variations
- UPDATE - Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP
26 September
- UPDATE - User Guide for the electronic Application Form for a Marketing Authorisation
- UPDATE - Applicant's response document in Mutual Recognition and Decentralised Procedures for Marketing Authorisation Applications
- NEW - Overview of timetables 2024 - CMDh 60-day procedures for MRP/DCP applications
- NEW - 18-20 July 2023 CMDh minutes
20 September
11 September
Added in July 2023
28 July
- NEW - Report from the meeting held on 18-20 July 2023
- 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 - Step 2 - Nitrosamine detected response template (docx)
- UPDATE - Chapter 4: CMDh BPG for the processing of Type IB Minor Variations (Notifications) in the Mutual Recognition Procedure
- UPDATE - Chapter 5: CMDh BPG for the handling of Type II Variations in the Mutual Recognition Procedure
- UPDATE - Chapter 7: CMDh BPG on Worksharing
- UPDATE - Chapter 9: CMDh BPG on fast track procedure for annual update of Human Influenza Vaccines
- NEW - Outcome of PSUSA follow-up via variation - Lisdexamfetamine
- NEW - SmAR on Ramipril/bisoprolol
- NEW - Art 45 assessment report for Ginkgo folium
- NEW - Art 46 assessment report for Fragmin (dalteparin sodium)
- NEW - Art 46 assessment report for Imovax polio
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
- NEW - 2023 - January-June - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
- UPDATE - Hormone Replacement Therapy - Core Package Leaflet
27 July
25 July
20 July
- NEW - Minutes of the meeting with IPs on variations held on 16 May 2023
- NEW - Minutes of the meeting with IPs held on 31 May 2023
17 July
Added in June 2023
30 June
- UPDATE - Template - request for RMS in a decentralised procedure for medicinal products for human use
- UPDATE - CMDh SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivity
- UPDATE - Best Practice Guide for Article 45 and 46 – Paediatric Regulation - EU Worksharing Procedure
- UPDATE - Q&A on Paediatric Regulation
- NEW - Art. 45 & 46 PAR on Wilfactin (Human Von Willebrand Factor)
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
27 June
- NEW - 23-25 May 2023 CMDh minutes
- NEW - Report from the meeting held on 20-21 June 2023
- UPDATE - CMDh letter to MAHs of tenofovir disoproxil-containing medicinal products
19 June
- NEW - 20-21 June 2023 CMDh agenda
- UPDATE - Best Practice Guide on (1) Introduction of substances/combinations onto the EURD list and setting the initial PSUR DLP and frequency and (2) Assessment of PSURs of products where the EU Reference Date is not yet legally binding
6 June
- NEW - Agenda for the meeting with Interested Parties on 31 May 2023
- NEW - Presentations from the meeting with Interested Parties on 31 May 2023
- NEW - Presentations from the meeting with Interested Parties on variations on 16 May 2023
2 June
- UPDATE - Q&A on variations
- UPDATE - CMS validation checklist in MRP
- UPDATE - Hormone Replacement Therapy - Core Package Leaflet
- UPDATE - Hormone Replacement Therapy - Core SmPC
- UPDATE - CMDh Guidance Document for Submission of Summary of the Pharmacovigilance System
- UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
- NEW - Art. 45 assessment report for Prazosin
- NEW - Art. 46 assessment report for Fluarix Tetra
1 June
Added in May 2023
25 May
22 May
3 May
- UPDATE - Assessment report template for the nitrosamine risk assessment for the outcome of step 2 – “nitrosamine detected”
- 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 - D100 CMS Comments
- UPDATE - Template - D145 CMS Comments
- UPDATE - Template - D205 CMS Comments
- UPDATE - Template for the End of Procedure in MRP/RUP
- NEW - Art 46 assessment report for Riamet (artemether/lumefantrine)
- NEW - Outcome of PSUSA follow-up via variation - Levonorgestrel intra-uterine devices (LNG-IUDs)
2 May
Added in April 2023
25 April
21 April
19 April
- UPDATE - Recommendations on Informed Consent Applications in Mutual Recognition and Decentralised Procedures
- UPDATE - Common grounds seen for delaying Day 0 Renewals
- UPDATE - Member State agreement upon conditions under which the RMS can start renewal procedures
- UPDATE - Request for MRP/RUP / Update assessment report
18 April
12 April
- UPDATE - Chapter 9: CMDh BPG on fast track procedure for annual update of Human Influenza Vaccines
- UPDATE - Template - RMS End of Renewal Procedure
- UPDATE - CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008
- NEW - PSUR Follow-Up assessment report on testosterone (topical use)
- NEW - PSUR Follow-Up assessment report on testosterone (all formulations apart from topical use)
- NEW - Outcome of PSUSA follow-up via variation - Ifosfamide
- NEW - Art 45 assessment report for Avaxim (hepatitis A virus, GBM strain (inactivated))
- NEW - Art 46 assessment report for Wynzora (calcipotriol and betamethasone dipropionate)
4 April
3 April