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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, 08 Apr 2026 10:54:13 +0200</pubDate>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[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 product (March 2026) [Track version] - Annex 2 - Applicant's declaration template  (March 2026) [Track version]]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/general-info.html#c3734</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/general-info.html#c3734</guid>
                    <pubDate>Thu, 08 Jul 2021 11:34:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Instructions for RMS when preparing the PAR based on the FAR (March 2026) [Track version]PAR template (empty) - when prepared based on FAR (March 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[    Position paper on common grounds seen for invalidation/delaying day 0 for Variations (December 2010) [Track version]]]></title>
                    <description><![CDATA[Position paper on common grounds seen for invalidation/delaying day 0 for variations (March 2026) [Track version]]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/variation.html#c1787</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/variation.html#c1787</guid>
                    <pubDate>Wed, 05 Jan 2011 12:42:20 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Added in April 2026
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
Added in November 2025
27 November
NEW - Presentations from the 19 November 2025 meeting with Interested PartiesNEW - Art. 46 PAR Cleviprex (clevidipine)NEW - Art. 46 PAR Botox (botulinum toxin type A)NEW - Art. 46 PAR Pentavac (Corynebacterium diphtheriae toxoid, Clostridium tetani toxoid, Haemophilus influenzae type B polysaccharide, Bordetella pertussis, filamentous hemagglutinin, Bordetella pertussis toxoid, poliovirus type 1, strain Mahoney, inactivated, poliovirus type 3, strain Saukett, inactivated, poliovirus type 2, strain MEF-1, inactivated)UPDATE - Instructions for RMS when preparing the PAR based on the FARUPDATE - PAR template (empty) - when prepared based on FARUPDATE - CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised ProceduresUPDATE - D70 Overview AR Template (empty) 
19 November
NEW - Report from the meeting held on 11-13 November 2025
17 November
NEW - 14-15 October CMDh minutes
10 November
NEW - 11-13 November CMDh agenda
07 November 
UPDATE - Contact Points
04 November 
UPDATE - Guidance on the application of the revised variations framework
Added in October 2025
23 October 
MOVED - National information on MAH transfersNEW - Q&A Post-BrexitNEW - D70 Overview AR Template (incl. instructions)NEW - Art. 46 PAR Riamet (artemether / lumefantrine)NEW - Art. 46 PAR Panzyga and associated names (human normal immunoglobin (IVIg))NEW - Art. 46 PAR Xalatan / Latanoprost Viatris (latanoprost)NEW - Art. 46 PAR Hiberix (haemophilus influenzae type b polysaccharide (PRP) conjugated to tetanus toxoid (TT))NEW - Recommendations on submission dates in 2026 for Applications of the MRPNEW - Recommendations on submission dates in 2026 for Applications of the DCP
22 October
NEW - Report from the meeting held on 14-15 October 2025UPDATE - Guidance on eSubmissions
21 October
UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
17 October
NEW - 16-18 September CMDh minutes
13 October
NEW - 14-15 October CMDh agenda
Added in September 2025
25 September
NEW - Art. 46 PAR HavrixNEW - Art. 45 PAR Pheniramine maleate, naphazoline hydrochlorideNEW - Overview referral timetables 2026UPDATE - Criteria for selection of products for SmPC HarmonisationUPDATE - RMS Validation Checklist for human medicinal products in DCPUPDATE - Common request form for RMS in DCPNEW - 22-23 July CMDh minutesNEW - Q1-Q2 2025 Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
24 September
NEW - Report from the meeting held on 16-18 September 2025UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
22 September
UPDATE - Guidance on the application of the revised variations framework
15 September
NEW - 16-18 September CMDh agenda
09 September
UPDATE - Contact Points
Added in August 2025
27 August
UPDATE - Contact Points
11 August
Update - List of safety concerns per approved Risk Management Plan (RMP) of active substances per product
08 August
NEW - HaRP assessment reports (Acetylcysteine, Adenosine, Ambroxol, Captopril, Combined Hormonal Contraceptives, Chlormadinone acetate/Ethinylestradiol, Flurbiprofen, Gabapentin, Gliclazide, Lactulose, Levosimendan, Linezolid, Loperamide, Olmesartan/Amlodipine/Hydrochlorthiazide, Piperacillin/Tazobactam, Warfarin)
01 August
NEW - Art. 46 AR Repevax, Adacel-Polio, Triaxis-PolioUPDATE - Member States Recommendations on the Cover Letter for New Applications submitted through MRP/DCPUPDATE - Cover letter template for renewalsUPDATE - Cover letter for Variation Applications in the Mutual Recognition ProcedureUPDATE - Template cover letter for new applications submitted through MRP/DCPUPDATE - Overview AR Template (incl. instructions)UPDATE - D70 Overview AR Template (empty)NEW - Instructions for RMS when preparing the PAR based on the FARNEW - PAR template (empty) - when prepared based on FAR]]></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[Ramipril/indapamideDate of publication: 07/04/2026]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/pharmacovigilance/psur/outcome-of-informal-psur-worksharing-procedures.html#c7877</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/pharmacovigilance/psur/outcome-of-informal-psur-worksharing-procedures.html#c7877</guid>
                    <pubDate>Wed, 01 Apr 2026 10:53:14 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Summary of CMDh activities 2025]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/about-cmdh/cmdh-reports.html#c7876</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/about-cmdh/cmdh-reports.html#c7876</guid>
                    <pubDate>Wed, 01 Apr 2026 10:53:14 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[CMDh Multi-annual Workplan to 2028 (March 2026)]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/about-cmdh/cmdh-activities.html#c7875</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/about-cmdh/cmdh-activities.html#c7875</guid>
                    <pubDate>Wed, 01 Apr 2026 10:53:14 +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) (March 2026) [Track version]
        Overview AR Template (incl. instructions) (March 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[Paediatric Regulation: Article 45 and Article 46

Best Practice Guide for Article 45 and 46 – Paediatric Regulation - EU Worksharing Procedure (March 2026) [Track version]]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/guidance-documents.html#c1718</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/paediatric-regulation/guidance-documents.html#c1718</guid>
                    <pubDate>Thu, 30 Sep 2021 15:00:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Questions and Answers on Paediatric Regulation]]></title>
                    <description><![CDATA[Paediatric Regulation [Track version] (March 2026)Further Q&As have been published on the EMA website]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/questions-answers.html#c1721</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/questions-answers.html#c1721</guid>
                    <pubDate>Thu, 30 Sep 2021 20:58:00 +0200</pubDate>
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