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            <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>Thu, 24 Sep 2026 10:27:25 +0200</pubDate>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Pyridoxine hydrochloride/lysozyme hydrochlorideDate of publication: 23/09/2026]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/pharmacovigilance/psur/outcome-of-informal-psur-worksharing-procedures.html#c7908</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/pharmacovigilance/psur/outcome-of-informal-psur-worksharing-procedures.html#c7908</guid>
                    <pubDate>Tue, 22 Sep 2026 10:27:04 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Added in September 2026
23 September
NEW - PSUR assessment for Iberogast Balance and Iberogast SelectNEW - PSUR assessment for Pyridoxine hydrochloride/ lysozyme hydrochlorideNEW - Recommendations on submission dates in 2027 for Applications of the MRPNEW - Recommendations on submission dates in 2027 for Applications of the DCPNEW - Overview of CMDh referral timetables 2027UPDATE - BPG for the processing of grouped applications in MRP (Chapter 6)NEW - Report from the meeting held on 15-17 September 2026
22 September
UPDATE - Guidance published by Member States on the implementation of the Falsified Medicines DirectiveNEW - 21-22 July CMDh Minutes
16 September
CORRECTION - 24-25 February CMDh minutes
14 September
NEW - 15-17 September CMDh Agenda
Added in August 2026
04 August
UPDATE - Guidance published by Member States on the implementation of the Falsified Medicines Directive
Added in July 2026
29 July
NEW - Report from the meeting held on 21-22 July 2026UPDATE - Template of letter of intent for the submission of a worksharing procedureUPDATE - EMA/CMDh Explanatory notes on Variation Application Form - Human medicinal products onlyUPDATE - Chapter 7 - CMDh BPG on Variation WorksharingUPDATE - Type II variation Preliminary-Final Variation Assessment ReportNEW - 2026 (Jan-Jun) - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
28 July
NEW - 23-25 June CMDh MinutesNEW - Minutes of the 25 June 2026 meeting with Interested Parties
23 July
UPDATE - Contact Points
20 July
NEW - 21-22 July CMDh agenda
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[Iberogast Select / Iberogast BalanceDate of publication: 23/09/2026]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/pharmacovigilance/psur/outcome-of-informal-psur-worksharing-procedures.html#c7906</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/pharmacovigilance/psur/outcome-of-informal-psur-worksharing-procedures.html#c7906</guid>
                    <pubDate>Tue, 22 Sep 2026 10:27:04 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Recommendations on submission dates for Applications of the Mutual Recognition Procedure]]></title>
                    <description><![CDATA[Recommendations on submission dates in 2027 for Applications of the MRP (September 2026)Recommendations on submission dates in 2026 for Applications of the MRP (October 2025)]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/application-for-ma/mrp/rup.html#c1782</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/application-for-ma/mrp/rup.html#c1782</guid>
                    <pubDate>Thu, 29 Oct 2020 13:30:00 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Recommendations on submission dates for Applicants of the DCP]]></title>
                    <description><![CDATA[Recommendations on submission dates in 2027 for Applications of the DCP (September 2026)Recommendations on submission dates in 2026 for Applications of the DCP (October 2025)]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/application-for-ma/dcp.html#c1779</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/application-for-ma/dcp.html#c1779</guid>
                    <pubDate>Wed, 03 Nov 2021 20:20:00 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Overview of timetables]]></title>
                    <description><![CDATA[Overview of timetables 2027 (September 2026)Overview of timetables 2026 (September 2025)]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/cmdh-referrals.html#c3415</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/cmdh-referrals.html#c3415</guid>
                    <pubDate>Thu, 01 Jan 1970 01:00:00 +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 (September 2026) [Track version]Chapter 7:  CMDh BPG on Variation Worksharing (July 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[CMDH PRESS RELEASES 2026]]></title>
                    <description><![CDATA[Report from the meeting held on 15-17 September 2026Report from the meeting held on 21-22 July 2026Report from the meeting held on 23-25 June 2026Report from the meeting held on 19-20 May 2026Report from the meeting held on 21-22 April 2026Report from the meeting held on 24-25 March 2026Report from the meeting held on 24-25 February 2026Report from the meeting held on 27-28 January 2026]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/press-releases.html#c7863</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/press-releases.html#c7863</guid>
                    <pubDate>Tue, 03 Feb 2026 17:20:16 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Guidance published by Member States on the implementation of the Falsified Medicines Directive  (September 2026)]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/falsified-medicines.html#c5941</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/falsified-medicines.html#c5941</guid>
                    <pubDate>Fri, 18 Aug 2017 13:38:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Meeting 15-17 September: AgendaMeeting 21-22 July 2026: Agenda - MinutesMeeting 23-25 June 2026: Agenda - MinutesMeeting 19-20 May 2026: Agenda - MinutesMeeting 21-22 April 2026: Agenda - MinutesMeeting 24-25 March 2026: Agenda - MinutesMeeting 24-25 February 2026: Agenda - Minutes - Correction 16/09/2026Meeting 27-29 January 2026: Agenda - Minutes]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/agendas-and-minutes.html#c7862</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/agendas-and-minutes.html#c7862</guid>
                    <pubDate>Wed, 21 Jan 2026 13:06:11 +0100</pubDate>
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