Recently Published (last 6 Months)

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

Added in March 2023

1 March 

• NEW - Report from the meeting held on 21-22 February
• NEW - CMDh letter to MAHs of tenofovir disoproxil-containing medicinal products
• UPDATE - CMDh Best Practice Guide on the processing of renewals in the MRP/DCP
• UPDATE - Cover letter template for renewals
• NEW - Summary of CMDh activities 2022
• UPDATE - Position paper common grounds seen for invalidation/delaying day 0 for variations
• NEW - PSUFU Summary AR - Hydroxychloroquine
• NEW - Art. 46 assessment report for Certican (everolimus)
• NEW - Art. 45 assessment report for Hiberix (Haemophilus influenzae type b vaccine)
• UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation

Added in February 2023

27 February

• NEW - 24-26 January CMDh Minutes

20 February

• NEW - 21-22 February CMDh Agenda

7 February

• NEW - 2022 - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures

3 February

• NEW - 13-14 December CMDh minutes 

2 February

• UPDATE - List of documents published on CMDh website 

1 February

• NEW - Report from the meeting held on 24-26 January 2023
• 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
• UPDATE - Decentralised Procedure Members States' Standard Operating Procedure
• UPDATE - Chapter 7: CMDh BPG on Worksharing
• UPDATE - Guidance on Oral Explanations to CMDh - Annex to CMDh SOP on Disagreement in Procedures, Referral to CMDh 
• 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 - Art 46 assessment report for Acarizax, Aitaro, Amitend (standardised allergen extract from the house dust mites)
• NEW - Art 46 assessment report for Fluarix Tetra (Influenza virus (inactivated, split)

Added in January 2023

31 January

• Minutes of the meeting with IPs held on 9 November 2022

23 January

• NEW - 24-26 January CMDh Agenda

5 January

• UPDATE - Chapter 2: Procedure for automatic validation of Mutual Recognition Procedures for Variations 
• 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 5: CMDh BPG for the handling of Type II Variations in the Mutual Recognition Procedure
• UPDATE - Chapter 6: CMDh BPG for the processing of Grouped Applications in the Mutual Recognition Procedure
• UPDATE - Chapter 7: CMDh BPG on Worksharing
• UPDATE - CMDh Best Practice Guide on the processing of renewals in the MRP/DCP
• UPDATE - Cover letter for Variation Applications in the Mutual Recognition Procedure
• UPDATE - Position Paper concerning Applicants’ request of submission of multiple applications during ongoing DCPs or inclusion of new CMS or additional strength(s) in an already ongoing DCP
• UPDATE - Applicant's response template
• NEW - PSUFU AR for methotrexate
• NEW - Art 46 assessment report for Augmentin ES Powder for Oral Suspension (amoxicillin + clavulanate)

Added in December 2022

22 December

• NEW - Report from the meeting held on 13-14 December 

19 December

• NEW - 8-10 November CMDh Minutes

16 December

• UPDATE - Decisions on additional year of market protection/data exclusivity for new therapeutic indication agreed by the CMDh

15 December

• NEW - 13-14 December CMDh Agenda

5 December 2022

• UPDATE - Questions & Answers for the Active Substance Master File

2 December 2022

• NEW - Agenda of the CMDh meeting with Interested Parties on 9 November 202

Added in November 2022

17 November

• NEW - Presentations from the CMDh meeting with Interested Parties in November 2022

16 November 

• NEW - Report from the meeting held on 8-10 November 2022
• UPDATE - Addendum to the Quality Review of Documents templates for SmPC, Labelling and Patient Leaflet on Mutual-recognition and Decentralised procedures specific for (Traditional) Herbal Medicinal Products ((T)HMPs)
• UPDATE - HaRP Assessment report template
• NEW - Art 45 assessment report for Gabapentin
• NEW - Art 45 assessment report for Haemophilus influenzae type b [Hib] conjugate vaccine (Act-HIB)
• NEW - Art 45 assessment report for Tretinoin
• NEW - Art 45 assessment report for Vaccinum hepatitidis B (ADNr)
• NEW - Art 46 assessment report for Decapeptyl / Diphereline /Arvekap (Triptorelin pamoate)
• NEW - Art 46 assessment report for Dexilant (dexlansoprazole)
• NEW - Art 46 assessment report for Haemocomplettan,Riastap (human fibrinogen)
• NEW - Art 46 assessment report for Haemophilus influenzae type b vaccine conjugated to Tetanus Protein (Act-HIB)
• NEW - Art 46 assessment report for Zithromax (Azithromycin (dehydrate))
• UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation

15 November

• NEW - 11-13 October CMDh Minutes
• UPDATE - Step 2 - Nitrosamine detected response template

7 November

• NEW - 8-10 November CMDh Agenda

Added in October 2022 

26 October

• UPDATE - Chapter 5: CMDh BPG on Worksharing

25 October

• NEW - Recommendations on submission dates in 2023 for Applications of the DCP
• NEW - Recommendations on submission dates in 2023 for Applications of the MRP
• NEW - Art 46 Assessment Report for Pneumovax 23
• NEW - Outcome of PSUSA follow-up via variation - Iohexol
• NEW - Outcome of PSUSA follow-up via variation - Iopromide
• UPDATE - CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs (PSUFU) 

21 October

• NEW - 13-14 September CMDh Minutes
• NEW - Report from the meeting held on 11-13 October

10 October

• NEW - 11-13 October CMDh Agenda

Added in September 2022

28 September 

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

26 September

• NEW - Template for MAHs response during type II variations

23 September

• NEW - Template for Applicants to Prepare Similarity Report
• UPDATE - Applicant's response document in Mutual Recognition and Decentralised Procedures for Marketing Authorisation Applications
• UPDATE - RMS validation checklist for human medicinal products in DCP
• UPDATE - Request for MRP/RUP / Update assessment report
• UPDATE - CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised Procedures
• UPDATE - CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008
• NEW - Overview of timetables 2023 - CMDh 60-day procedures for MRP/DCP applications
• NEW - HaRP Assessment Report on Amorolfin
• NEW - HaRP Assessment Report on Azithromycin (systemic formulations)
• NEW - HaRP Assessment Report on Betahistine
• NEW - HaRP Assessment Report on Cefepime
• NEW - HaRP Assessment Report on Celecoxib
• NEW - HaRP Assessment Report on Clarithromycin
• NEW - HaRP Assessment Report on Cyclophosphamide
• NEW - HaRP Assessment Report on Fluticasone propionate
• NEW - HaRP Assessment Report on Hydrochlorothiazide
• NEW - HaRP Assessment Report on Ibuprofen
• NEW - HaRP Assessment Report on Levonorgestrel (for emergency contraception)
• NEW - HaRP Assessment Report on Nitrofurantoin
• NEW - HaRP Assessment Report on Paracetamol and Ibuprofen
• NEW - HaRP Assessment Report on Paracetamol
• UPDATE - HaRP Assessment Report on Olmesartan hydrochlorothiazide

22 September

• NEW - Report from the meeting held on 13-14 September 2022

20 September

• NEW - 19-20 July CMDh Minutes

13 September

• NEW - 13-14 September CMDh Agenda