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            <title>Recently Published All categories</title>
            <link>https://www.hma.eu//rss/recently-published-all-categories.html</link>
            <description>New contents from the website www.hma.eu. Category: Recently Published All categories</description>
            <language>en</language>
            <copyright>Heads of Medicines Agencies</copyright>
            <pubDate>Fri, 29 May 2026 09:36:04 +0200</pubDate>
            
                <item>
                    <title><![CDATA[CTCG Members and Alternates]]></title>
                    <description><![CDATA[CTCG Members and Alternates are nominated by each EU/EEA National Competent Authorities (NCA) and represent the NCA.The Chair and the Vice-Chair of the CTCG are elected amongst the members for a period of three years. Currently CTCG is chaired by Marianne Lunzer, PhD (AGES MEA, Austria) and vice-chaired by Monique Al, PhD (CCMO, Netherlands)The secretariat is supported by the EMA and an expert from an NCA. The secretariat acts as the contact point for the group.The EMA and the Commission attend the meetings as observers.Representatives from other interested parties and national experts may be consulted and invited to attend the CTCG meetings on an ad hoc basis.
List of CTCG Members and Alternates

Member StateRoleMember NameAT - AustriaChair/MemberMarianne LunzerAT - AustriaAlternateJudith SecklehnerBE - BelgiumMember Anne Lenaers BE - BelgiumAlternate Nele SteensBG - BulgariaMember Ivelina GushlekovaBG - BulgariaAlternate Ivan TodorovCY - CyprusMemberEleni GeorgiadouCY - CyprusAlternateTheognosia PatsaledouCZ - Czech RepublicMember Eva Hrušková Reinová CZ - Czech RepublicAlternateJan NemecekDE - Germany (BfArM)MemberClaudia Riedel DE - Germany (BfArM)AlternateSarah Heil DE - Germany (PEI)MemberSusanne LerchDE - Germany (PEI)Vice-Chair/AlternateAndreas BonertzDK - DenmarkMemberLene Grejs PetersenDK - DenmarkAlternatePernille SterlingEE - EstoniaMemberKeiu HeinlaEE - EstoniaAlternateIngrid KiiskES - SpainMemberJuan Estévez Álamo ES - SpainAlternateLaura Lavin de JuanFI - FinlandMemberMarita Kailajärvi FI - FinlandAlternatePirjo InkiFR - FranceMemberCorinne KigerGR - GreeceMemberLeonidas KlironomosHR - Croatia (HALMED)MemberMaja PuklekHR - Croatia (HALMED)Alternate Ivana Kosier MihalicHR - Croatia (Miz)MemberIvana Matelic HR - Croatia (Miz)  Alternate Nikolina JozancHU - HungaryMemberÁgnes Zita Hajdú HU - HungaryAlternateHuba Eleőd IE - IrelandMemberClaire Temple IE - Ireland   Alternate  Tracy Keane IS - IcelandMemberAgnes Engilráð Scheving IS - IcelandAlternateUnnur IngólfsdóttirIT - ItalyMemberSandra PetragliaIT - ItalyAlternateDiego Alejandro DriLI - LiechtensteinMemberVlasta ZavadovaLT - LithuaniaMemberArūnas Vaitkevičius LT - LithuaniaAlternateEglė Daniulevičiūtė LU - LuxembourgMemberEdwige ChokotéLU - LuxembourgAlternateDounia BouzidLV - LatviaMemberJana MiglinieceLV - LatviaAlternateVita Berzina MT - MaltaMemberJohn Joseph BorgMT - MaltaAlternateBenjamin MicallefNL - NetherlandsMemberMonique AlNL - NetherlandsAlternatePaula VossebeldNO - NorwayMemberIngvild Aaløkken NO - NorwayAlternateIngvild Løberg Tangen PL - PolandMemberEwa Ołdak PL - PolandAlternateAgnieszka DzierwaPT - PortugalMemberJoel PassarinhoPT - PortugalAlternateSusana MarquesRO - RomaniaMemberMirela Vîță RO - RomaniaAlternateSilviu Istrate SE - SwedenMemberGunilla Andrew-Nielsen SE - SwedenAlternateAnn Marie Janson LangSI - SloveniaMemberMaja SkofSI - SloveniaAlternateJurij ŽelSK - SlovakiaMemberJana Grobarčík BallekováSK - SlovakiaAlternateLenka Igazová]]></description>
                    <link>https://www.hma.eu//about-hma/working-groups/clinical-trials-coordination-group/clinical-trials-coordination-group.html#c7043</link>
                    <guid>https://www.hma.eu//about-hma/working-groups/clinical-trials-coordination-group/clinical-trials-coordination-group.html#c7043</guid>
                    <pubDate>Thu, 04 Aug 2022 11:13:00 +0200</pubDate>
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                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[]]></description>
                    <link>https://www.hma.eu/</link>
                    <guid>https://www.hma.eu/</guid>
                    <pubDate>Thu, 19 Sep 2024 14:31:38 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[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[Meeting 19-20 May 2026: AgendaMeeting 21-22 April 2026: Agenda - MinutesMeeting 24-25 March 2026: Agenda - MinutesMeeting 24-25 February 2026: Agenda - MinutesMeeting 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>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Vaccin rabique Pasteur / Verorab (rabies virus inactivated (Wistar rabies PM/W138 1503-3M strain))End of procedure: 10/04/2026Date of publication: 27/05/2026]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/assessment-reports/article-46-work-sharing.html#c7887</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/assessment-reports/article-46-work-sharing.html#c7887</guid>
                    <pubDate>Tue, 26 May 2026 13:22:42 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Efluelda Tetra (quadrivalent influenza vaccine (split virion, inactivated), 60 micrograms HA/strain)End of procedure: 14/04/2026Date of publication: 27/05/2026]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/assessment-reports/article-46-work-sharing.html#c7886</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/assessment-reports/article-46-work-sharing.html#c7886</guid>
                    <pubDate>Tue, 26 May 2026 13:22:42 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Rapibloc / Landiolol Hydrochloride Orpha-Devel (landiolol hydrochloride)End of procedure: 09/04/2026Date of publication: 27/05/2026]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/assessment-reports/article-46-work-sharing.html#c7885</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/assessment-reports/article-46-work-sharing.html#c7885</guid>
                    <pubDate>Tue, 26 May 2026 13:22:42 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Non Clinical / Clinical AR for Generics - MRP & DCP]]></title>
                    <description><![CDATA[Non Clinical / Clinical AR for Generics - MRP & DCP (May 2026) [Track version]

]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/templates/assessment-reports/dcp-ar/comments.html#c1333</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/templates/assessment-reports/dcp-ar/comments.html#c1333</guid>
                    <pubDate>Fri, 10 Oct 2014 10:34:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[CMDH PRESS RELEASES 2026]]></title>
                    <description><![CDATA[Report 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[CMDhCMDvMRI Product Index - HUMMRI Product Index - VETMedicines Approval SystemCompassionate Use ProgrammesAvailability of Medicines]]></description>
                    <link>https://www.hma.eu//about-hma.html#c3847</link>
                    <guid>https://www.hma.eu//about-hma.html#c3847</guid>
                    <pubDate>Thu, 01 Jan 1970 01:00:00 +0100</pubDate>
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