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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, 15 May 2026 19:04:05 +0200</pubDate>
            
                <item>
                    <title><![CDATA[List of Members and alternates]]></title>
                    <description><![CDATA[This page lists the current members and alternates of the Coordination Group for Mutual Recognition and Decentralised procedures for veterinary medicinal products (CMDv)
CHAIRPERSON
Ms. Beate Gasser
BASG - Federal Office for Safety in Health Care / AGES - Austrian Agency for Health and Food SafetyTraisengasse 5 - 1200 Wien - Austriae-mail: beate.gasser@ages.at
Vice-chair: Ms. Juliane Schäfer
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit - Federal Office of Consumer Protection and Food SafetyAbteilung Tierarzneimittel - Gerichtstraße 49, D-13347 Berlin - Germanye-mail: juliane.schaefer@bvl.bund.de
AUSTRIA
Member: Ms. Ines Lindner
BASG - Federal Office for Safety in Health Care /AGES - Austrian Agency for Health and Food SafetyTraisengasse 5 - 1200 Wien - Austriae-mail: ines.lindner@ages.at
Alternate: Ms. Tanja Kaufmann
BASG - Federal Office for Safety in Health Care /AGES - Austrian Agency for Health and Food SafetyTraisengasse 5 - 1200 Wien - Austriae-mail: tanja.kaufmann@ages.at 
BELGIUM
Member: Mr. Cédric Maerckx
Federal Agency of Medicines and Health Products (FAMHP)Avenue Galilée 5/03 1210 - Brussels - Belgiume-mail: cedric.maerckx@fagg-afmps.be 
Alternate: Ms. Inge Verfaillie
Federal Agency of Medicines and Health Products (FAMHP)Avenue Galilée 5/03 1210 - Brussels - Belgiume-mail: inge.verfaillie@fagg-afmps.be  
BULGARIA
Member: Ms. Tsvetanka Valova
Bulgarian Food Safety AgencyDirectorate for control of veterinary medicinal products - Shose Bankya 7 - 1331 Sofia - Bulgariae-mail: t_valova@bfsa.bg 
Alternate: Ms. Miglena Goranova
 Bulgarian Food Safety AgencyDirectorate for control of veterinary medicinal products - Shose Bankya 7 - 1331 Sofia - Bulgariae-mail: m_goranova@bfsa.bg 
REPUBLIC OF CROATIA
Member: Dr. Miroslav Andrišić
Croatian Veterinary InstituteSavska cesta 143 - 10000 Zagreb - Republic of Croatiae-mail: andrisic@veinst.hr
Alternate: Ms. Lina Čačić
Croatian Agency for Medicinal Products and Medical Devices (HALMED)Ksaverska cesta 4 - 10000 Zagreb - Republic of Croatiae-mail: lina.cacic@halmed.hr
CYPRUS
Member: Mrs. Alia Michaelidou-Patsia
Ministry of Agriculture, Rural Development and EnvironmentAthalassa, 1417 Nicosia - Cypruse-mail: almichaelides@vs.moa.gov.cy
CZECHIA
Member: Dr. Iveta Obrovská
Institute for State Control of Veterinary Biologicals and MedicinesHudcova Str. 56a - 621 00 Brno–Medlánky - Czechiae-mail: obrovska@uskvbl.cz
Alternate: Dr. Daniel Dušek 
Institute for State Control of Veterinary Biologicals and MedicinesHudcova Str. 56a - 621 00 Brno–Medlánky - Czechiae-mail: dusek@uskvbl.cz 
DENMARK
Member: Mr. Martin Piffet
Danish Medicines AgencyAxel Heides Gade 1 - 2300 Copenhagen S - Denmarke-mail: mapi@dkma.dk
Alternate: Ms. Anne Malene Nissen
Danish Medicines AgencyAxel Heides Gade 1 - 2300 Copenhagen S - Denmarke-mail: maln@dkma.dk
ESTONIA
Member: Ms. Epp Ülevaino
State Agency of Medicines1 Nooruse Street - 50411 Tartu - Estoniae-mail: epp.ulevaino@ravimiamet.ee
Alternate: Ms. Annely Aleksejev
State Agency of Medicines1 Nooruse Street - 50411 Tartu - Estoniae-mail: annely.aleksejev@ravimiamet.ee
FINLAND
Member: Ms. Outi Kimmo
Finnish Medicines Agency FIMEAMannerheimintie 103 b - 00280 Helsinki - Finlande-mail: outi.kimmo@fimea.fi
Alternate: Mr. Matias Huhtala
Finnish Medicines Agency FIMEAMannerheimintie 103 b - 00280 Helsinki - Finlande-mail: matias.huhtala@fimea.fi
FRANCE
Member: Dr. Mariette Salery
Agence Nationale du Médicament Vétérinaire (Anses – ANMV)14 rue Claude Bourgelat - Parc d'Activités de la Grande Marche - CS 70611 - Javené - 35306 Fougères Cedex - Francee-mail: mariette.salery@anses.fr
Alternate:  Mr. Guillaume Grach
Agence Nationale du Médicament Vétérinaire (Anses – ANMV)14 rue Claude Bourgelat - Parc d'Activités de la Grande Marche - CS 70611 - Javené - 35306 Fougères Cedex - Francee-mail: guillaume.grach@anses.fr
GERMANY
Member: Ms. Juliane Schäfer
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit - Federal Office of Consumer Protection and Food SafetyAbteilung Tierarzneimittel - Gerichtstraße 49, D-13347 Berlin - Germanye-mail: juliane.schaefer@bvl.bund.de
Alternate: Dr. Dagmar Sommer
Paul-Ehrlich-InstitutBundesinstitut für Impfstoffe und biomedizinische Arzneimittel - Federal Institute for Vaccines and BiomedicinesPaul-Ehrlich-Str. 51-59 - D-63225 Langen - Germanye-mail: dagmar.sommer@pei.de
GREECE
Member: Ms. Eftychia Aravidou
EOF-National Organization for Medicines284 Mesogion Avenue - GR-15562 Cholargos - Athens - Greecee-mail: efaravidou@eof.gr
Alternate: Ms. Olympia Maria Ioannidi
EOF-National Organization for Medicines284 Mesogion Avenue - GR-15562 Cholargos - Athens - Greecee-mail: oioannidi@eof.gr
HUNGARY
Member: Ms. Kinga Csécsei
National Food Chain Safety OfficeDirectorate of Veterinary Medicinal Products - Keleti Karoly utca 24. - H-1024 Budapest - Hungarye-mail: csecseik@nebih.gov.hu 
Alternate: Dr. Gábor Kulcsár
National Food Chain Safety OfficeDirectorate of Veterinary Medicinal Products - Keleti Karoly utca 24. - H-1024 Budapest - Hungarye-mail: kulcsarg@nebih.gov.hu
ICELAND
Member: Ms. Bryndís Ragnarsdóttir
Icelandic Medicines AgencyVinlandsleid 14 - 113 Reykjavik - Icelande-mail: bryndis.ragnarsdottir@lyfjastofnun.is 
IRELAND
Member: Dr. Rhona McHugh
Health Products Regulatory AuthorityKevin O’Malley House - Earlsfort Centre - Earlsfort Terrace - Dublin 2 - D02 XP77 - Irelande-mail: rhona.mchugh@hpra.ie
Alternate: Ms. Sara Hanley 
Health Products Regulatory AuthorityKevin O’Malley House - Earlsfort Centre - Earlsfort Terrace - Dublin 2 - D02 XP77 - Irelande-mail: sarah.hanley@hpra.ie  
ITALY
Member: Dr. Lauro Cascia
Ministry of HealthDirectorate General for Animal Health and Veterinary Medicinal Products - Via Giorgio Ribotta 5 - I– 00144 Roma - Italye-mail: l.cascia@sanita.it
Alternate: Mr. Fiorenza Dario 
Ministry of HealthDirectorate General for Animal Health and Veterinary Medicinal Products - Via Giorgio Ribotta 5 - I– 00144 Roma - Italye-mail: d.fiorenza@sanita.it 
LATVIA
Member: Ms. Renāte Kušķe
Food and Veterinary ServicePeldu street 30 - LV-1050 Rīga - Latviae-mail: Renate.Kuske@pvd.gov.lv
Alternate: Ms. Zanda Auce
Food and Veterinary ServicePeldu street 30 - LV-1050 Rīga - Latviae-mail: zanda.auce@pvd.gov.lv
LIECHTENSTEIN
Member: Dr. Vlasta Zavadova
Liechtensteinische LandesverwaltungAmt für Gesundheit - Office of HealthÄulestrasse 51 - 9490 Vaduz - Liechtensteine-mail: vlasta.zavadova@llv.li
LITHUANIA
Member: Ms. Aurelija Ciegytė
State Food and Veterinary ServiceSiesiku g. 19, Vilnius - Lithuaniae-mail: aurelija.ciegyte@vmvt.lt 
Alternate: Ms. Marija Gintaliene
State Food and Veterinary ServiceSiesiku g. 19, Vilnius - Lithuaniae-mail: marija.gintaliene@vmvt.lt
LUXEMBOURG
Member: Dr. Caroline Coner
Ministry for HealthDivision de la pharmacie et des médicaments1273 Luxembourg-Hamm - Luxembourge-mail: Caroline.Coner@ms.etat.lu
Alternate: Dr. Despoina Iatridou
Ministry for HealthDivision de la pharmacie et des médicaments1273 Luxembourg-Hamm - Luxembourge-mail: externe.ms.etat.lu@despoina-iatridou.eu  
MALTA
Member: Mr. Stephen Spiteri
Ministry for Agriculture, Fisheries and Animal RightsVeterinary medicines and animal nutrition - Animal Health and Welfare DepartmentAbattoir Square - Albert Town - MRS 1123 Marsa - Maltae-mail: stephen.spiteri@gov.mt
Alternate: Ms. Maria Bartolo
Ministry for Agriculture, Fisheries and Animal RightsVeterinary medicines and animal nutrition - Animal Health and Welfare DepartmentAbattoir Square - Albert Town - MRS 1123 Marsa - Maltae-mail: maria.bartolo.2@gov.mt
THE NETHERLANDS
Member: Mr. C.H. (Rico) Slingerland
College ter Beoordeling van GeneesmiddelenMedicines Evaluation BoardVeterinary Medicinal Products Unit – P.O. Box 8275 NL – 3503 RG Utrecht -The Netherlandse-mail: r.slingerland@cbg-meb.nl
NORWAY
Member: Ms. Tora Gauslaa
Norwegian Medicines AgencyPostboks 240 - Skøyen - 0213 Oslo - Norwaye-mail: tora.gauslaa@noma.no
POLAND
Member: Ms. Marlena Sychowicz
The Office for Registration of Medicinal Products, Medical Devices and BiocidesAl. Jerozolimskie 181C - 02-222 Warszawa - Polande-mail: marlena.sychowicz@urpl.gov.pl
Member: Ms. Joanna Kubisa
The Office for Registration of Medicinal Products, Medical Devices and BiocidesAl. Jerozolimskie 181C - 02-222 Warszawa - Polande-mail: joanna.kubisa@urpl.gov.pl
PORTUGAL
Member: Mr. João Pedro Duarte da Silva
Direcção Geral de Alimentação e Veterinária (DGAV)Campo Grande 50 - 1700-093 Lisboa - Portugale-mail: jpsilva@dgav.pt
Alternate: Ms. Inês Flor Dias
Direcção Geral de Alimentação e Veterinária (DGAV)Campo Grande 50 - 1700-093 Lisboa - Portugale-mail: idias@dgav.pt
ROMANIA
Member: Ms. Diana Laura Stan
Institutul pentru Controlul Produselor Biologice si Medicamentelor de uz Veterinar39 Dudului Street - Sector 6 - 060603 Bucharest - Romaniae-mail: diana.stan@icbmv.ro
Alternate: Ms. Gabriela Tuchila
Institutul pentru Controlul Produselor Biologice si Medicamentelor de uz Veterinar39 Dudului Street - Sector 6 - 060603 Bucharest - Romaniae-mail: gabriela.tuchila@icbmv.ro 
SLOVAKIA
Member: Ms. Mária Hazuchová
Institute for State Control of Veterinary Biologicals and MedicamentsBiovetská 34 - 949 01 Nitra - Slovakiae-mail: hazuchova@uskvbl.sk
Alternate: Ms. Marta WagnerováInstitute for State Control of Veterinary Biologicals and MedicamentsBiovetská 34 - 949 01 Nitra - Slovakiae-mail: marta.wagnerova@uskvbl.sk
SLOVENIA
Member: Mrs. Laura Maček
Agency for Medicinal Products and Medical Devices of the Republic of SloveniaSector for Medicinal Products for Veterinary UseSlovenčeva ulica 22 - 1000 Ljubljana - Sloveniae-mail: laura.macek@jazmp.si
SPAIN
Member: Ms. Elena Sanchez Pallares
Agencia Española del Medicamento y Productos SanitariosSubdirección General de Medicamentos de Uso VeterinarioParque Empresarial Las Mercedes - Edificio 8  - C/ Campezo 1 - 28022 Madrid - Spaine-mail: esanchezpa@aemps.es
Alternate: Ms. Vanesa Guillén Casla
Agencia Española del Medicamento y Productos SanitariosSubdirección General de Medicamentos de Uso VeterinarioParque Empresarial Las Mercedes - Edificio 8  - C/ Campezo 1 - 28022 Madrid - Spaine-mail: vguillen@aemps.es
SWEDEN
Member: Ms. Sofia Håkansson
Swedish Medical Products AgencyDag Hammarskölds Väg 42 - 751 03 UPPSALA - Swedene-mail: sofia.hakansson@lakemedelsverket.se 
Alternate: Mr. Niclas Falk
Swedish Medical Products AgencyDag Hammarskölds Väg 42 - 751 03 UPPSALA - Swedene-mail: niclas.falk@lakemedelsverket.se



]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/about-cmdv/cmdv-composition.html#c6477</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/about-cmdv/cmdv-composition.html#c6477</guid>
                    <pubDate>Wed, 10 Apr 2019 16:53:50 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[FAST-EU Facilitating and Accelerating Strategic Clinical Trials in the EU/EEA
FAST-EU is an initiative by HMA, CTCG and MedEthics EU that enables an accelerated assessment of multinational clinical trials in the European Union. Operating within the EU Clinical Trials Regulation and CTIS, FAST-EU offers sponsors a predictable and efficient pathway for initial clinical trial applications.
The core feature of FAST-EU is a maximum overall timeline of 10 weeks (70 calendar days) from CTIS submission to final conclusion, including sponsor response times. This is achieved through parallel validation and assessment workflows and a strengthened role of the RMS, while maintaining scientific, safety and ethical standards. Ethics Committee opinions are fully integrated across all participating Member States.
Beyond accelerating individual applications, FAST-EU also functions as a structured learning and evidence-generation exercise. The pilot is designed to provide practical insights into the feasibility and challenges of the accelerated assessment model, thereby supporting the future implementation of the EU Biotech Act.
FAST-EU is a voluntary pilot with a planned duration of a year and a limited number of applications per month, so participation cannot be guaranteed.
The following Member States are participating in FAST-EU:
AT, BE, BG, CY, CZ, DE, DK, EE, ES, FI, FR, GR, HR, HU, IE, IT, LT, LV, NL, NO, PL, PT, RO, SE, SI, SK
Detailed procedural information is provided in the FAST-EU Sponsor Guide.
To enter a trial that is ready for submission in CTIS into FAST-EU , sponsors should express their interest by sending the Expression of Interest Template which can also be found as Annex to the FAST-EU Sponsor Guide via e-mail to FAST-EU@hma.eu. Submission windows are provided in the table below. Expression of Interest should indicate whether CTIS submission would be feasible in the first or second half of the relevant month.
‑A response can be expected within 5 business days.
MonthSubmission windowResponse June 20-21 May28 MayJuly22-23 June30 JuneAugust22-23 July30 JulySeptember20-21 August28 AugustOctober22-23 September30 SeptemberNovember22-23 October30 OctoberDecember19-20 November27 November
A total of 68 Expressions of interest have been received from the launch of the project with 15 clinical trials already selected for the accelerated assessment. In response to this high level of interest, and due to the substantial number of applications received, participating Member States agreed to accept more applications than initially planned. This collaborative decision underlines the commitment of the National Competent Authorities involved to keep supporting the project’s fast pace and broad participation. The following Reporting Member States have been selected for FAST EU until now:
AustriaBelgiumCzech RepublicDenmarkFinland  France Germany  Hungary ItalyNorwayNetherlandsPoland  PortugalSpain  Sweden   
These selections reflect efforts to distribute workload appropriately while maintaining feasibility across participating Member States. To support an equitable distribution of workload and to broaden Member State participation in the pilot, sponsors are encouraged to select RMS that have not yet been chosen in previous FAST-EU rounds whenever feasible.]]></description>
                    <link>https://www.hma.eu//about-hma/working-groups/clinical-trials-coordination-group/clinical-trials-coordination-group.html#c7860</link>
                    <guid>https://www.hma.eu//about-hma/working-groups/clinical-trials-coordination-group/clinical-trials-coordination-group.html#c7860</guid>
                    <pubDate>Wed, 21 Jan 2026 10:36:12 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Variations requiring assessment (VRA)]]></title>
                    <description><![CDATA[Variations requiring assessment (VRA)
Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations
Best Practice Guide for variations requiring assessment
Guidance on the submission of G.I.18 Variations Requiring Assessment]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/post-marketing-procedures/variations.html#c6891</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/post-marketing-procedures/variations.html#c6891</guid>
                    <pubDate>Wed, 18 Oct 2023 12:30:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Added in May 2026
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
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[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[REPORTS FOR RELEASE 2026]]></title>
                    <description><![CDATA[Report for Release January - February 2026]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/about-cmdv/planning-reporting/reports-for-release.html#c7878</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/about-cmdv/planning-reporting/reports-for-release.html#c7878</guid>
                    <pubDate>Thu, 23 Apr 2026 18:31:20 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[SUBSCRIBE to NEWSLETTER
30/4/2026      HMA newsletter April 2026
31/3/2026      HMA newsletter March 2026
26/2/2026      HMA newsletter February 2026
27/1/2026      HMA newsletter January 2026
22/12/2026    HMA newsletter December 2025
3/12/2025      HMA newsletter November 2025
20/10/2025    HMA newsletter October 2025
24/09/2025    HMA newsletter September 2025
15/07/2025    HMA newsletter July 2025
17/06/2025    HMA newsletter June 2025
14/05/2025    HMA newsletter May 2025
16/04/2025    HMA newsletter April 2025
16/04/2025    HMA Launches its Newsletter to provide updates about its coordinated work in the European regulatory network]]></description>
                    <link>https://www.hma.eu//about-hma/newsletter/newsletters.html#c7736</link>
                    <guid>https://www.hma.eu//about-hma/newsletter/newsletters.html#c7736</guid>
                    <pubDate>Thu, 10 Apr 2025 15:28:08 +0200</pubDate>
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                <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[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>
                </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 (April 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>
            
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