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
20 February
7 February
3 February
2 February
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
23 January
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
19 December
16 December
15 December
5 December 2022
2 December 2022
Added in November 2022
17 November
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
7 November
Added in October 2022
26 October
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
10 October
Added in September 2022
28 September
26 September
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
20 September
13 September