<?xml version="1.0" encoding="utf-8"?>
    
            

    
        



    <rss xmlns:content="http://purl.org/rss/1.0/modules/content/"  version="2.0">
        <channel>
            <title>Recently Published CMDh</title>
            <link>https://www.hma.eu//rss/recently-published-cmdh.html</link>
            <description>New contents from the website www.hma.eu. Category: Recently Published CMDh</description>
            <language>en</language>
            <copyright>Heads of Medicines Agencies</copyright>
            <pubDate>Sun, 05 Jul 2026 08:49:52 +0200</pubDate>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Added in July 2026
03 July
NEW - Summary ARs for doxazosin mesylate/finasterideUPDATE - DCP D70 Overview AR template (incl. instructions) UPDATE - DCP D70 Overview AR template (empty) UPDATE - Instructions for RMS when preparing the PAR based on the FAR UPDATE - PAR template (empty) when prepared based on FARUPDATE - Post-Brexit Q&AUPDATE - Q&A on QP DeclarationUPDATE - Q&A on variationsUPDATE - BPG for the allocation of the MRP variation number for Type I notifications, Type II variations, grouping and worksharing (Chapter 1)UPDATE - BPG for the processing of Type IA minor variations (notifications) in MRP (Chapter 3)UPDATE - BPG for the processing of grouped applications in MRP (Chapter 6)UPDATE - BPG on Variation Worksharing (Chapter 7)UPDATE - Cover letter for variation applications in MRPUPDATE - BPG on the use of eCTD in the MRP/DCPUPDATE - Requirements on submissions for Variations and Renewals within MRP and National Procedures
01 July
NEW - Report from the meeting held on 23-25 June 2026
Added in June 2026
30 June
NEW - 19-20 May CMDh MinutesNEW - Presentations from the 25 June 2026 meeting with Interested Parties
25 June
NEW - Agenda of the CMDh meeting with Interested Parties
22 June
NEW - 23-25 June CMDh agenda
Added in May 2026
27 May
NEW - 21-22 April CMDh MinutesNEW - Art. 46 PAR Rapibloc, Landiolol Hydrochloride Orpha-Devel (landiolol hydrochloride)NEW - Art. 46 PAR Efluelda Tetra (quadrivalent influenza vaccine (split virion, inactivated), 60 micrograms HA/strain)NEW - Art. 46 PAR Vaccin rabique Pasteur, Verorab (rabies virus inactivated (Wistar rabies PM/W138 1503-3M strain))UPDATE - Non Clinical / Clinical AR for Generics - MRP & DCPNEW - Report from the meeting held on 19-20 May 2026
21 May
UPDATE - Contact Points
18 May
NEW - 19-20 May CMDh agenda
07 May
CORRECTION - Questions and Answers on Variations
Added in April 2026
30 April
UPDATE - Contact Points
29 April
UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation UPDATE - Best Practice Guide for Article 45 and 46 – Paediatric Regulation - EU Worksharing ProcedureUPDATE - CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs (PSUFU procedure) NEW - Report from the meeting held on 21-22 April 2026
28 April
NEW - 24-25 March CMDh Minutes
20 April
NEW - 21-22 April CMDh agenda
07 April
NEW - Ramipril/indapamide PSUR WS SmAR
03 April
UPDATE - Position paper common grounds seen for invalidation/delaying day 0 for variationsUPDATE - Questions and Answers on VariationsUPDATE - Examples for acceptable and not acceptable groupings for MRP/DCP productsUPDATE - Type II variation Preliminary Variation Assessment ReportUPDATE - Chapter 1 - CMDh Best Practice Guide for the allocation of the Mutual Recognition variation number for Type I notifications, Type II variations, grouping and worksharingUPDATE - Chapter 6 - CMDh BPG for the Processing of (Super-)Grouped Applications in the Mutual Recognition ProcedureUPDATE - Questions and answers on the Paediatric RegulationUPDATE - Best Practice Guide for Article 45 and 46 – Paediatric Regulation - EU Worksharing ProcedureUPDATE - D70 Overview AR Template (empty)UPDATE - Overview AR Template (incl. instructions)UPDATE - PAR template (empty) - when prepared based on FARUPDATE - Instructions for RMS when preparing the PAR based on the FARUPDATE - CMDh position paper on the use of Mobile scanning and other technologies to be included in the labelling and/or package leaflet in order to provide information about the medicinal productUPDATE - Annex 2 - Applicant's declaration templateNEW - CMDh Multi-annual Workplan to 2028NEW - CMDh Summary of activities 2025
01 April
NEW - Report from the meeting held on 24-25 March 2026UPDATE - Contact Points
Added in March 2026
31 March
NEW - 24-25 February CMDh Minutes
23 March
NEW - 24-26 March CMDh agenda
04 March
UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric RegulationNEW - Art. 45 PAR Benzocaine / TyrothricinNEW - 2025 Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing proceduresUPDATE - Q&A on BiologicalsNEW - CMDh Multi-Annual Workplan to 2025 - Summary ReportNEW - Report from the meeting held on 24-25 February 2026NEW - Overview of biological active substances of non-recombinant originNEW - 27-28 January CMDh Minutes
03 March
CORRECTION - 09-11 December CMDh minutesCORRECTION - Report from the meeting held on 9-11 December 2025
Added in February 2026
24 February
NEW - 24-25 February CMDh agenda
13 February
UPDATE - Q&A on Generics
10 February
NEW - Art. 46 PAR Elvanse (lisdexamfetamine dimesylate)NEW - Art. 46 PAR Pneumovax and associated names (pneumococcal polysaccharide vaccine)
04 February
NEW - Report from the meeting held on 27-28 January 2026
03 February
NEW - 09-11 December CMDh minutes
Added in January 2026
27 January
UPDATE - Contact PointsNEW - 27-29 January CMDh agenda
19 January
UPDATE - National recommendations for requests to act as RMS
08 January
CORRECTION - CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008 
07 January
UPDATE - ASMF Worksharing Procedure User Guide
Added in December 2025
18 December
UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric RegulationUPDATE - EMA/CMDh Explanatory notes on Variation Application Form - Human medicinal products onlyCORRECTION - Q&A Submission of variations for human medicinal productsUPDATE - Hormone Replacement Therapy - Core SmPCUPDATE - Hormone Replacement Therapy - Core Package Leaflet
17 December
NEW - PSUFU Levonorgestrel intra-uterine devices (LNG-IUDs)NEW - PSUR WS summary AR nebivolol hydrochloride/amlodipine besilateNEW - Art. 45 PAR Mycobutin (rifabutin)NEW - Art. 45 PAR Prothyrid 100 microgram/10 microgram (levothyroxine sodium/liothyronine hydrochloride)NEW - Art. 45 PAR Cynomel 0,025 mg, Thyrotardin inject (liothyronine sodium) / Thybon 20 Henning. Thybon 100 Henning (liothyronine hydrochloride)UPDATE - National recommendations for requests to act as RMSUPDATE - CMDh Best Practice Guide on Variation Worksharing, Chapter 7NEW - Report from the meeting held on 9-11 December 2025NEW - 11-13 November CMDh minutesNEW - Minutes of the 19 November 2025 meeting with Interested Parties
8 December
NEW - 9-11 December CMDh agenda]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/recently-published-history.html#c7757</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/recently-published-history.html#c7757</guid>
                    <pubDate>Tue, 08 Oct 2024 14:35:09 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Doxazosin mesilate, finasteride (MIP Pharma) / Doxazosin mesilate, finasteride (Viatris)Date of publication: 03/07/2026]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/pharmacovigilance/psur/outcome-of-informal-psur-worksharing-procedures.html#c7899</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/pharmacovigilance/psur/outcome-of-informal-psur-worksharing-procedures.html#c7899</guid>
                    <pubDate>Fri, 03 Jul 2026 08:49:13 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Instructions for RMS when preparing the PAR based on the FAR (June 2026) [Track version]PAR template (empty) - when prepared based on FAR (June 2026) [Track version]]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/templates/assessment-reports/public-ar.html#c7791</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/templates/assessment-reports/public-ar.html#c7791</guid>
                    <pubDate>Tue, 29 Jul 2025 09:48:29 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Templates - DCP (AR/Comments) · D70 Preliminary AR and D120 Draft AR]]></title>
                    <description><![CDATA[D70 Preliminary AR        D70 Overview AR Template (empty) (June 2026) [Track version]
        Overview AR Template (incl. instructions) (June 2026) [Track version]        Quality (February 2024)        Non-clinical (October 2016)        Clinical (January 2017)
D100 CMS Comments (February 2025) [Track version]
D105 clock stop (March 2012)
D120 Draft AR        Non-clinical (October 2016)        Clinical (October 2016)
D120/D180 Quality AR (December 2018)
D145 CMS Comments (February 2025) [Track version]
D205 CMS Comments (February 2025) [Track version]]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/templates/assessment-reports/dcp-ar/comments.html#c480</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/templates/assessment-reports/dcp-ar/comments.html#c480</guid>
                    <pubDate>Fri, 31 Jul 2020 17:41:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Post-Brexit (June 2026) [Track version]]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/questions-answers.html#c7835</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/questions-answers.html#c7835</guid>
                    <pubDate>Thu, 16 Oct 2025 10:52:27 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[QP declaration (June 2026) [Track version] ]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/questions-answers.html#c5222</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/questions-answers.html#c5222</guid>
                    <pubDate>Mon, 10 Jan 2022 09:00:00 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure]]></title>
                    <description><![CDATA[Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition ProcedureChapter 1: CMDh BPG for the Allocation of the Mutual Recognition Variation Number for Type I Notifications, Type II Variations, Grouping and Worksharing (June 2026) [Track version]Chapter 2: Procedure for Automatic Validation of Mutual Recognition Procedures for Variations (October 2025) [Track version]Chapter 3: CMDh BPG for the Processing of Type IA Minor Variations (Notifications) in the Mutual Recognition Procedure (June 2026) [Track version]Chapter 4: CMDh BPG for the Processing of Type IB Minor Variations (Notifications) in the Mutual Recognition Procedure (October 2025) [Track version]Chapter 5: CMDh BPG for the Handling of Type II Variations in the Mutual Recognition Procedure (October 2025) [Track version]Chapter 6: CMDh BPG for the Processing of (Super-)Grouped Applications in the Mutual Recognition Procedure (June 2026) [Track version]Chapter 7:  CMDh BPG on Variation Worksharing (June 2026) [Track version]Chapter 8: CMDh BPG on CMDh Recommendations on Unforeseen Variations (October 2024) [Track version]Chapter 9: CMDh BPG on fast track procedure for annual update of Human Influenza Vaccines (October 2025) [Track version]]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/variation.html#c2126</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/variation.html#c2126</guid>
                    <pubDate>Thu, 30 Sep 2021 12:00:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Variations [Track version] ]]></title>
                    <description><![CDATA[Variations  (June 2026) [Track version]]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/questions-answers.html#c3193</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/questions-answers.html#c3193</guid>
                    <pubDate>Mon, 10 Jan 2022 09:00:00 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Cover letter for Variation Applications in the Mutual Recognition Procedure]]></title>
                    <description><![CDATA[Variation applications

Cover letter for Variation Applications in the Mutual Recognition Procedure (June 2026) [Track version]]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/templates/variations.html#c1789</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/templates/variations.html#c1789</guid>
                    <pubDate>Fri, 10 Jul 2020 10:20:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[CMDh Best Practice Guide on the use of eCTD in the MRP/DCP]]></title>
                    <description><![CDATA[CMDh Best Practice Guide on the use of eCTD in the MRP/DCP  (June 2026) [Track version]]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/esubmissions.html#c6371</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/esubmissions.html#c6371</guid>
                    <pubDate>Mon, 11 May 2020 17:16:00 +0200</pubDate>
                </item>
            
        </channel>
    </rss>




    


        



