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            <title>Recently Published CMDv</title>
            <link>https://www.hma.eu//rss/recently-published-cmdv.html</link>
            <description>New contents from the website www.hma.eu. Category: Recently Published CMDv</description>
            <language>en</language>
            <copyright>Heads of Medicines Agencies</copyright>
            <pubDate>Thu, 25 Jun 2026 15:27:11 +0200</pubDate>
            
                <item>
                    <title><![CDATA[REPORTS FOR RELEASE 2026]]></title>
                    <description><![CDATA[Report for Release January - February 2026
Report for Release March - April 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[Products for SPC harmonisation ]]></title>
                    <description><![CDATA[
Products for SPC harmonisation 
The lists of veterinary medicinal products subject to SPC harmonisation endorsed by the CMDv and the HMA are listed in the tables below. The procedures follow the timetables agreed between the MAH and the RMS.
The results of the SPC harmonisation procedured will be published on the CMDv website in due time once the procedures ended.

Products for SPC harmonisation 2026
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.

Products for SPC harmonisation 2023
Name of VMPName of the active substanceName of MAHRMS Status Action for generic/hybrids MAH to apply for the VRA* Product Information   CatosalButafosfan, CyanocobalaminElancoDE-BVLConcluded on 06 April 2024Harmonisation of part II closed on 26 May 202460 days after the decision of the national competent authority has been issued eu-pi-combined-catosal FinadyneFlunixine meglumineMerckESConcluded on 20 July 202460 days after the decision of the national competent authority has been issuedeu-pi-combined-finadyneEstrumateCloprostenolIntervetFRConcluded on 23 July 202460 days after the decision of the national competent authority has been issuedeu-pi-combined-estrumateDomosedanDetomidine hydrochlorideOrionIEConcluded on 10 April 2024Harmonisation of part II closed on 2 May 202460 days after the decision of the national competent authority has been issuedeu-pl-domosedan-10-mg-ml-injecteu-lab-domosedan-10-mg-ml-injecteu-spc-domosedan-10-mg-ml-injectPlanateCloprostenolMerckNLConcluded on 22 July 202460 days after the decision of the national competent authority has been issuedeu-pi-combined-planate
* According to article 71 of the Regulation (EU) 2019/6, MAHs of generic/hybrid products shall apply within 60 days a variation requiring assessment in order to align the SPC (concerning target species, clinical information referred to in point (c) of article 35(1) and withdrawal period) of their products. In the case of hybrid marketing authorisations, whereby parts of the SPC have been supported by product-own data (for example additional target species or a withdrawal period based on product-own data), the information in the SPC, based on product-own data will not be harmonised.MAHs are advised to consult the CMDv best practice guide.






List of generic/hybrid products of the VMPs subject to SPC harmonisation
The generic and hybrid products of the VMPs that were subject to the SPC harmonisation is now published. The generic VMPs are highlighted in green and hybrids in orange. The list of VMP mentioned in the table may be not exhaustive. So, all MAHs of generic/hybrid products of the reference products 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.
Click here for the 2023 list of generic/hybrid products of the VMPs subject to SPC harmonisation.

Products for SPC harmonisation 2024
Name of VMPName of the active substanceName of MAHRMS StatusAction for generic/hybrids MAH to apply for the VRA*Product Information RECEPTALBuserelin acetateIntervetIEConcluded on 15 August 202560 days after the decision of the national competent authority has been issuedeu-pi-combined-receptalSYNULOX TABLETS*SYNULOX DROPSAmoxicillin trihydrate and Potassium clavulanateZoetisDEConcluded on 13 October 202560 days after the decision of the national competent authority has been issuedspc-pi-synulox-dropsspc-pi-synulox-tablets-50mgspc-pi-synulox-tablets-250mgspc-pi-synulox-tablets-500mg
*The VMP ‘SYNULOX TABLETS’ is constituted of 3 strengths.
List of generic/hybrid products of the VMPs subject to SPC harmonisation
The generic and hybrid products of the VMPs that were subject to the SPC harmonisation is now published. The list of VMP mentioned in the table may be not exhaustive. So, all MAHs of generic/hybrid products of the reference products 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.
Click here for the 2024 list of generic/hybrid products 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[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

Request form for proposing a veterinary medicinal product for SPC harmonisation exercise 2027 
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[Clock Start Dates DCP 2027-2028]]></title>
                    <description><![CDATA[Clock Start Dates DCP 2027-2028]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/applications-for-marketing-authorisation/clock-start-dates.html#c7824</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/applications-for-marketing-authorisation/clock-start-dates.html#c7824</guid>
                    <pubDate>Mon, 15 Sep 2025 09:45:11 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Post Marketing Procedures]]></title>
                    <description><![CDATA[Guidance documents - Regulation (EU) 2019/6
Best practice guide for changing the reference member state
Guidance for marketing authorisation transfer - National requirements
Guidance for Management of Post-Authorisation Procedures and Pharmacovigilance Activities after Partial Marketing Authorisation Transfer at National Level Following Mutual Recognition or Decentralized Procedure or subsequent Recognition Procedure (so-called Partial MAH Transfer)]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/post-marketing-procedures.html#c6026</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/post-marketing-procedures.html#c6026</guid>
                    <pubDate>Wed, 23 Aug 2023 12:17:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Q&A on transitional arrangements]]></title>
                    <description><![CDATA[
Q&A on transitional arrangements
CMDv has prepared a Q&A document in order to assist both MAHs and NCAs in the management of the transition between the requirements of Directive 2001/82/EC and Regulation (EU) 2019/6.Several items are developed in this document as renewals, update of QRD templates and transition from PSUR to signal management.This document has also been updated with new developments, for instance the transition from the DDPS to the PSMF.
Q&A on transitional arrangements (link)
Additional informationEMA: Q&A on renewals (link)EMA: publication of version 9.1 of the QRD templates (link)EC: Commission Notice on marketing authorisations for veterinary medicinal products for which the expiry of the 5-year period of validity falls on or after the date of entry into application of Regulation (EU) 2019/6 2021/C 274/02 (link) ]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/implementation-of-the-vmp-regulation.html#c6810</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/implementation-of-the-vmp-regulation.html#c6810</guid>
                    <pubDate>Fri, 30 Sep 2022 19:33:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Public assessment report]]></title>
                    <description><![CDATA[Public assessment report
For the “Best Practice guide for Production and Publication of Public Assessment Reports”, please refer to the section Authorisation Procedures]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/post-marketing-procedures/variations.html#c7893</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/post-marketing-procedures/variations.html#c7893</guid>
                    <pubDate>Thu, 28 May 2026 09:34:50 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Decentralised procedure]]></title>
                    <description><![CDATA[Decentralised procedure
Best practice guide for veterinary decentralised procedure
Position paper on agreeing the product name during the decentralised procedure

]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/applications-for-marketing-authorisation/authorisation-procedures.html#c6851</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/applications-for-marketing-authorisation/authorisation-procedures.html#c6851</guid>
                    <pubDate>Wed, 09 Feb 2022 11:44:00 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Subsequent recognition procedure]]></title>
                    <description><![CDATA[Subsequent recognition procedure
Best practice guide for subsequent recognition procedure

]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/applications-for-marketing-authorisation/authorisation-procedures.html#c6853</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/applications-for-marketing-authorisation/authorisation-procedures.html#c6853</guid>
                    <pubDate>Wed, 20 Apr 2022 19:18:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Mutual recognition procedure]]></title>
                    <description><![CDATA[Mutual recognition procedure
Best practice guide for veterinary mutual recognition procedure

]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/applications-for-marketing-authorisation/authorisation-procedures.html#c6852</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/applications-for-marketing-authorisation/authorisation-procedures.html#c6852</guid>
                    <pubDate>Mon, 13 Dec 2021 14:26:08 +0100</pubDate>
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