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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>Wed, 28 Oct 2026 18:20:39 +0100</pubDate>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[List of documents published on CMDh website (October 2026)(to be used to locate documents on the CMDh website)]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh.html#c2090</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh.html#c2090</guid>
                    <pubDate>Tue, 01 Dec 2015 14:47:00 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Added in October 2026
27 October
UPDATE - 'Blue-box' requirements
23 October
UPDATE - Decisions on additional year of market protection/data exclusivity for new therapeutic indication and new active substance status agreed by the CMDh
22 October
UPDATE - MRP/RUP request formUPDATE - 'Blue-box' requirementsUPDATE - List of active substances for which data has been submitted in accordance with Art. 45UPDATE - Request form for RMS in DCPUPDATE - Data requested for Variations and/or Renewal Applications in the MRP/DCPUPDATE - Data requested for New Applications in the MRP/DCPUPDATE - Procedural advice on Validation of MR/Repeat-use/DC ProceduresUPDATE - CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008NEW - Report from the meeting held on 13-14 October 2026
21 October
NEW - 15-17 September CMDh Minutes
12 October
NEW - 13-14 October CMDh agenda
Added in September 2026
29 September
UPDATE - 'Blue-box' requirements
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['Blue-box' requirements]]></title>
                    <description><![CDATA['Blue-box' requirements (October 2026) [Track version]]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/application-for-ma.html#c3055</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/application-for-ma.html#c3055</guid>
                    <pubDate>Wed, 12 Jan 2022 09:53:00 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Decisions on additional year of market protection/data exclusivity for new therapeutic indication and new active substance status agreed by the CMDh (October 2026)]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/advice-from-cmdh/procedural-advice.html#c7207</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/advice-from-cmdh/procedural-advice.html#c7207</guid>
                    <pubDate>Thu, 05 Nov 2015 13:30:00 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Additional Data requested for New Applications in the Mutual Recognition and Decentralised Procedures]]></title>
                    <description><![CDATA[Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers (October 2026) [Track version]]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/application-for-ma.html#c1645</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/application-for-ma.html#c1645</guid>
                    <pubDate>Wed, 12 May 2021 11:30:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[MRP / RUP]]></title>
                    <description><![CDATA[The CMDh has introduced a Request Form for an MRP/RUP procedure available for the National Competent Authorities (NCA). Due to the different organisations and thereby also different working procedures for the approved medicinal products in member states, the Request form may need to be adapted at national level and is not mandatory for the NCAs to use. The Request Form is published on the CMDh website to be transparent, but marketing authorisation holders should approach the reference member state to discuss update of the AR in the MRP/RUP procedure as appropriate and use the request form available from the RMS if applicable. For further guidance the CMDh refers to the NCAs websites. 

Request for MRP/RUP / Updated assessment report (October 2026) [Track version]Appendix 1 to Request for MRP/RUP for Medicinal Products for Human Use]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/templates/rup.html#c5205</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/templates/rup.html#c5205</guid>
                    <pubDate>Mon, 26 Oct 2020 12:41:00 +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 (October 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>
                </item>
            
                <item>
                    <title><![CDATA[Request for RMS in a Decentralised Procedure, medicinal products for human use]]></title>
                    <description><![CDATA[Request for RMS in a Decentralised Procedure, medicinal products for human use 
Common request form (October 2026) [Track version]Please download the document for editing. ]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/templates/applications-for-ma.html#c1665</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/templates/applications-for-ma.html#c1665</guid>
                    <pubDate>Thu, 08 Jul 2021 11:07:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Data requested for Variations and/or Renewal Applications in the MRP/DCP]]></title>
                    <description><![CDATA[Data requested for Variations and/or Renewal Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines / Recommendation papers (October 2026) [Track version]]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/variation.html#c2512</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/variation.html#c2512</guid>
                    <pubDate>Wed, 12 May 2021 18:44:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Procedural advice: Validation of MR/Repeat-use/DC Procedures]]></title>
                    <description><![CDATA[Procedural advice on Validation of MR/Repeat-use/DC Procedures (October 2026) [Track version]]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/application-for-ma.html#c1640</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/application-for-ma.html#c1640</guid>
                    <pubDate>Fri, 10 Oct 2014 11:02:00 +0200</pubDate>
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