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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, 04 Jun 2026 09:40:01 +0200</pubDate>
            
                <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>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Guidance documents on authorisation procedures - Regulation (EU) 2019/6
Requests to act as RMS in DCP – Pre-submission instructions for applicants

]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/applications-for-marketing-authorisation/authorisation-procedures.html#c6850</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/applications-for-marketing-authorisation/authorisation-procedures.html#c6850</guid>
                    <pubDate>Mon, 13 Dec 2021 14:26:08 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Public assessment report]]></title>
                    <description><![CDATA[Public assessment reportBest Practice guide for Production and Publication of Public Assessment Reports

]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/applications-for-marketing-authorisation/authorisation-procedures.html#c7892</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/procedural-guidance/applications-for-marketing-authorisation/authorisation-procedures.html#c7892</guid>
                    <pubDate>Thu, 28 May 2026 09:34:50 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Article 141(1) procedure: Quarter-based selective dry cow therapy]]></title>
                    <description><![CDATA[]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/advice-from-cmdv.html#c7888</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/advice-from-cmdv.html#c7888</guid>
                    <pubDate>Thu, 28 May 2026 09:34:50 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[The European Medicines Agency (EMA) has recently concluded a scientific review of quarter-based selective antibiotic dry cow therapy. In the context of prudent use of antibiotics, the EMA’s veterinary medicines committee (CVMP) received a request from a member state to assess whether it is scientifically justified to generally allow quarter-based selective dry cow therapy with antibiotic intramammary veterinary medicines. The request also sought clarity on whether the product information (summary of product characteristics, package leaflet and labelling) for these veterinary medicines should be updated to reflect this practice. CVMP considered how this approach could be reflected in the product information of intramammary antibiotic dry cow veterinary medicines and made recommendations for possible amendments, see https://www.ema.europa.eu/en/medicines/veterinary/referrals/quarter-based-selective-dry-cow-therapy
Translations of the wording can be found here: Translations
After discussion at the CMDv April 2026 meeting the Member States recommend to amend the product information with a VRA G.I.4.b. However a VNRA C.8 may be used in case no deletions regarding the current wording of the product literature are necessary and only the sentences exactly as proposed for SPC section 3.4/4.4 and/or 3.9/4.9 (depending on the QRD version) and corresponding section(s) of the package leaflet have to be added. The MAHs are asked to liaise with the RMS/NCA, as necessary, to confirm the classification. The proposed timeframe for submission of the variations is 6 months after publication of this notice, 02.06.2026.
The MAHs are reminded of their duty to, according to Article 58(4) of Regulation (EU) 2019/6, ensure that the summary of product characteristics, package leaflet and labelling is kept up to date with current scientific knowledge. The NCAs may apply Article 130(3)(a) if the MAH does not comply with the requirements set out in Article 58.]]></description>
                    <link>https://www.hma.eu//veterinary-medicines/cmdv/advice-from-cmdv.html#c7890</link>
                    <guid>https://www.hma.eu//veterinary-medicines/cmdv/advice-from-cmdv.html#c7890</guid>
                    <pubDate>Thu, 28 May 2026 09:34:50 +0200</pubDate>
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