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            <title>Recently Published Human Medicines</title>
            <link>https://www.hma.eu//rss/recently-published-human-medicines.html</link>
            <description>New contents from the website www.hma.eu. Category: Recently Published Human Medicines</description>
            <language>en</language>
            <copyright>Heads of Medicines Agencies</copyright>
            <pubDate>Fri, 29 May 2026 09:35:02 +0200</pubDate>
            
                <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[Contact Points]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/contact-points.html#c4478</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/contact-points.html#c4478</guid>
                    <pubDate>Thu, 07 Oct 2021 14:43:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Variations [Track version] ]]></title>
                    <description><![CDATA[Variations  (March 2026, correction April 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[List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation]]></title>
                    <description><![CDATA[List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation (April 2026)]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/article-45-and-previous-worksharing.html#c2202</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/article-45-and-previous-worksharing.html#c2202</guid>
                    <pubDate>Thu, 30 Sep 2021 17:00:00 +0200</pubDate>
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