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            <title>Recently Published Veterinary Medicines</title>
            <link>https://www.hma.eu//rss/recently-published-veterinary-medicines.html</link>
            <description>New contents from the website www.hma.eu. Category: Recently Published Veterinary Medicines</description>
            <language>en</language>
            <copyright>Heads of Medicines Agencies</copyright>
            <pubDate>Sun, 02 Aug 2026 13:29:38 +0200</pubDate>
            
                <item>
                    <title><![CDATA[Guidance on SPC Harmonisation - according to Articles 70 to 72 of Regulation (EU) 2019/6]]></title>
                    <description><![CDATA[Guidance on SPC Harmonisation - according to Articles 70 to 72 of Regulation (EU) 2019/6
Best Practice Guide for the selection of the products for the SPC harmonisation  
Best Practice Guide for the harmonisation procedure of the SPC of the reference products
Best Practice Guide for the harmonisation procedure of the SPC of generic/hybrid veterinary medicinal products
Guidance for Mutual Recognition Procedure after finalisation of an article 82 referral procedure with a positive decision by the EC and after a SPC harmonisation
Clarification for the SPC harmonisation procedure of reference products and alignment of generic/hybrid products and informed consent products

Public consultation on the revision of the Best Practice Guides for SPC harmonisation
After the first experiences with the SPC harmonisation procedure and comments received from industry a reflection took place at the SPC harmonisation WG and on CMDv level. A complete overhaul was carried out, incorporating numerous suggestions and lessons learned. The updated Best Practice Guides can be found on the corresponding subpage. Please send your comments to CMDv@ema.europa.eu until 15 September 2026, using the following template.

Request form for proposing a veterinary medicinal product for SPC harmonisation exercise 2027 (4th round)
According to Article 69-72 of Regulation (EU) 2019/6, National Competent Authorities (NCA) as well as Marketing Authorisation Holders (MAH) may propose harmonisation of the SPCs of Reference Veterinary Medicinal Products (RVMPs) for which a marketing authorisation has been granted in accordance with Article 47. 
The CMDv shall, annually, draw up a list of reference VMPs which shall be subject to SPC harmonisation and the CMDv shall also appoint a reference Member State (RMS) for each VMP concerned. 
Please find here the link to the survey to be completed should you wish to propose candidates for the SPC harmonisation procedure. Candidates proposed after the annual deadline of 31 May will be considered directly as proposals for the next round the subsequent year. Therefore, continuous submission of proposals throughout the year are encouraged and appreciated.  
For the 2027 selection phase, there is a once-only extension of the deadline for submitting proposals of candidate reference VMPs to 31 July 2026. 
Any question can be raised to the CMDv secretariat (CMDv@ema.europa.eu). ]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/spc-harmonisation.html#c6831</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/spc-harmonisation.html#c6831</guid>
                    <pubDate>Thu, 28 Apr 2022 12:17:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Products for SPC harmonisation ]]></title>
                    <description><![CDATA[
Products for SPC harmonisation 
The current list of veterinary medicinal products subject to SPC harmonisation endorsed by the CMDv and the HMA is listed in the table below. The procedures follow the timetables agreed between the MAH and the RMS.
The results of the SPC harmonisation procedures will be published on the CMDv website in due time once the procedures ended.
The lists of veterinary medicinal products subject to SPC harmonisation in previous rounds can be found in the dedicated subpage.
Products for SPC harmonisation 2026 (3rd round)
Name of VMPName of the active substanceName of MAHRMS StatusAction for related VMP MAH to apply for the VRA*Product Information Rimadyl palatable tablets(10 mg, 20 mg, 50 mg)CarprofenZoetisIEpending60 days after the decision of the national competent authority has been issued GalastopCarbergolineCevaDEpending60 days after the decision of the national competent authority has been issued 

List of generic/hybrid and informed consent VMPs of the VMPs subject to SPC harmonisation 2026
The generic, hybrid and informed consent VMPs of the VMPs that were subject to the SPC harmonisation is now published. The list of VMPs mentioned in the table may not be exhaustive. So, all MAHs of generic and hybrid VMPs of the reference VMP that were subject to SPC harmonisation are invited to apply for the appropriate VRA to align the SPC of their products to the SPC of the reference product according to the article 71 of the Regulation 2019/6. Similarly to the action required for generic and hybrid MAs, the MAH of an informed consent should submit a VRA to amend the SPC of its informed consent product, within 60 days after the decision of the national competent authority has been issued.
Click here for the 2026 list of generic, hybrid and informed consent VMPs of the VMPs subject to SPC harmonisation.]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/spc-harmonisation.html#c7165</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/spc-harmonisation.html#c7165</guid>
                    <pubDate>Wed, 08 Feb 2023 16:53:14 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[ PUBLIC CONSULTATION ON THE REVISION OF THE BEST PRACTICE GUIDES FOR SPC HARMONISATION]]></title>
                    <description><![CDATA[After the first experiences with the SPC harmonisation procedure and comments received from industry a reflection took place at the SPC harmonisation WG and on CMDv level. A complete overhaul was carried out, incorporating numerous suggestions and lessons learned. Please send your comments to CMDv@ema.europa.euuntil 15 September 2026, using the following template.
Best Practice Guide for the selection of the products for the SPC harmonisation  
Best Practice Guide for the harmonisation procedure of the SPC of the reference products
Best Practice Guide for the harmonisation procedure of the SPC of generic/hybrid veterinary medicinal products]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/spc-harmonisation/public-consultation-on-the-revision-of-the-best-practice-guides-for-spc-harmonisation.html#c7902</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/spc-harmonisation/public-consultation-on-the-revision-of-the-best-practice-guides-for-spc-harmonisation.html#c7902</guid>
                    <pubDate>Tue, 21 Jul 2026 13:00:04 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Previous SPC Harmonisation rounds]]></title>
                    <description><![CDATA[Name of VMPName of the active substanceName of MAHRMS StatusProduct Information 2nd round  RECEPTALBuserelin acetateIntervetIEConcluded on 15 August 2025eu-pi-combined-receptalSYNULOX TABLETS (3 strength)SYNULOX DROPS Amoxicillin trihydrate and Potassium clavulanateZoetisDEConcluded on 13 October 2025spc-pi-synulox-dropsspc-pi-synulox-tablets-50mgspc-pi-synulox-tablets-250mgspc-pi-synulox-tablets-500mgPlease find the list with related products of the 2nd round here. 1st roundCatosalButafosfan, CyanocobalaminElancoDE-BVLConcluded on 06 April 2024Harmonisation of part II closed on 26 May 2024 eu-pi-combined-catosal FinadyneFlunixine meglumineMerckESConcluded on 20 July 2024eu-pi-combined-finadyneEstrumateCloprostenolIntervetFRConcluded on 23 July 2024eu-pi-combined-estrumateDomosedanDetomidine hydrochlorideOrionIEConcluded on 10 April 2024Harmonisation of part II closed on 2 May 2024eu-pl-domosedan-10-mg-ml-injecteu-lab-domosedan-10-mg-ml-injecteu-spc-domosedan-10-mg-ml-injectPlanateCloprostenolMerckNLConcluded on 22 July 2024eu-pi-combined-planatePlease find the list with related products of the 1st round here.]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/spc-harmonisation/previous-spc-harmonisation-rounds.html#c7901</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/spc-harmonisation/previous-spc-harmonisation-rounds.html#c7901</guid>
                    <pubDate>Tue, 21 Jul 2026 13:00:04 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Working Groups]]></title>
                    <description><![CDATA[Active Substance Master File Working Party (Joint)
Borderline Products
        Request form for borderline product classification
        Request form for borderline product discussion
        CMDv Borderline Working Group FAQ 2024
Clinical Trials
SPC Harmonisation
Variation Regulation Working Party (Joint) 

Inactive Working Groups]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/about-cmdv/working-groups.html#c5717</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/about-cmdv/working-groups.html#c5717</guid>
                    <pubDate>Fri, 17 Feb 2023 16:07:00 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Inactive Working Groups]]></title>
                    <description><![CDATA[Autogenous Vaccines]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/about-cmdv/working-groups/inactive-working-groups.html#c6921</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/about-cmdv/working-groups/inactive-working-groups.html#c6921</guid>
                    <pubDate>Wed, 02 Feb 2022 11:06:06 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[CMDv review procedure - according to Regulation (EU) 2019/6]]></title>
                    <description><![CDATA[CMDv review procedure - according to Regulation (EU) 2019/6
Best Practice Guide for Article 54 review procedure [Track version]
Guidance for actions after a Commission decision following a CMDv review procedure (Article 54)]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/cmdv-review-procedure-and-referrals.html#c6835</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/cmdv-review-procedure-and-referrals.html#c6835</guid>
                    <pubDate>Mon, 03 Jul 2023 18:29:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Procedural Contact Points]]></title>
                    <description><![CDATA[Please open the link below for the following contact points:

General issuesAdvice on MRP/DCP/SRP proceduresAdvice on limited market proceduresAdvice on exceptional circumstances procedureAdvice on the SPC harmonisation procedureSubmission of new applications and variationsTechnical validation of e-SubmissionsSubmission of electronic response documents during MRP/DCP/SRP proceduresSubmission of translations in MRP/DCP/SRP proceduresIssues regarding the naming of the VMPLabelling and mock-ups, multilingual packsAddress for advice on fees & terms of paymentAdvice on Clinical Trials vetSubmission of Clinical Trials vetPharmacovigilance proceduresRequest for EU ASMF numberRequest for the classification of a borderline product and EU borderline network contact pointsUPD contact point
Procedural Contact Points (July 2026)]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/procedural-contact-points.html#c5807</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/procedural-contact-points.html#c5807</guid>
                    <pubDate>Tue, 21 Nov 2023 11:20:00 +0100</pubDate>
                </item>
            
                <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: TBD
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. Vanesa Guillén Casla
Agencia Española del Medicamento y Productos SanitariosDepartamento de Medicamentos VeterinariosParque Empresarial Las Mercedes - Edificio 8  - C/ Campezo 1 - 28022 Madrid - Spaine-mail: vguillen@aemps.es
Alternate: Ms. Davinia Negrín Báez
Agencia Española del Medicamento y Productos SanitariosDepartamento de Medicamentos VeterinariosParque Empresarial Las Mercedes - Edificio 8  - C/ Campezo 1 - 28022 Madrid - Spaine-mail: dnegrin@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[General questions]]></title>
                    <description><![CDATA[Best Practice Guide for advice from CMDv on regulatory matters
Summary of questions to CMDv
Including:
General questionsQuestions on generics and data protectionNaming of VMPsProduct literaturePost authorisation
Q&A - List for the submission of variations according to Regulation (EU) 2019/6 [Track version]
CMDh-CMDv Q&A on Active Substance Master Files (ASMF)
CMDh-CMDv Q&A on QP Declaration]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/questions-answers.html#c6217</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/questions-answers.html#c6217</guid>
                    <pubDate>Mon, 29 Jan 2024 16:59:00 +0100</pubDate>
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