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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>Sun, 02 Aug 2026 13:10:40 +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[EMA/CMDh explanatory notes on Variation Application Form - Human medicinal products only (December 2021) [Track version]]]></title>
                    <description><![CDATA[EMA/CMDh Explanatory notes on Variation Application Form - Human medicinal products only (July 2026) [Track version]]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/variation.html#c2195</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/variation.html#c2195</guid>
                    <pubDate>Mon, 10 Jan 2022 09:05:00 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Added in July 2026
29 July
NEW - Report from the meeting held on 21-22 July 2026UPDATE - Template of letter of intent for the submission of a worksharing procedureUPDATE - EMA/CMDh Explanatory notes on Variation Application Form - Human medicinal products onlyUPDATE - Chapter 7 - CMDh BPG on Variation WorksharingUPDATE - Type II variation Preliminary-Final Variation Assessment ReportNEW - 2026 (Jan-Jun) - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
28 July
NEW - 23-25 June CMDh MinutesNEW - Minutes of the 25 June 2026 meeting with Interested Parties
23 July
UPDATE - Contact Points
20 July
NEW - 21-22 July CMDh agenda
03 July
NEW - Summary ARs for doxazosin mesylate/finasterideUPDATE - DCP D70 Overview AR template (incl. instructions) UPDATE - DCP D70 Overview AR template (empty) UPDATE - Instructions for RMS when preparing the PAR based on the FAR UPDATE - PAR template (empty) when prepared based on FARUPDATE - Post-Brexit Q&AUPDATE - Q&A on QP DeclarationUPDATE - Q&A on variationsUPDATE - BPG for the allocation of the MRP variation number for Type I notifications, Type II variations, grouping and worksharing (Chapter 1)UPDATE - BPG for the processing of Type IA minor variations (notifications) in MRP (Chapter 3)UPDATE - BPG for the processing of grouped applications in MRP (Chapter 6)UPDATE - BPG on Variation Worksharing (Chapter 7)UPDATE - Cover letter for variation applications in MRPUPDATE - BPG on the use of eCTD in the MRP/DCPUPDATE - Requirements on submissions for Variations and Renewals within MRP and National Procedures
01 July
NEW - Report from the meeting held on 23-25 June 2026
Added in June 2026
30 June
NEW - 19-20 May CMDh MinutesNEW - Presentations from the 25 June 2026 meeting with Interested Parties
25 June
NEW - Agenda of the CMDh meeting with Interested Parties
22 June
NEW - 23-25 June CMDh agenda
Added in May 2026
27 May
NEW - 21-22 April CMDh MinutesNEW - Art. 46 PAR Rapibloc, Landiolol Hydrochloride Orpha-Devel (landiolol hydrochloride)NEW - Art. 46 PAR Efluelda Tetra (quadrivalent influenza vaccine (split virion, inactivated), 60 micrograms HA/strain)NEW - Art. 46 PAR Vaccin rabique Pasteur, Verorab (rabies virus inactivated (Wistar rabies PM/W138 1503-3M strain))UPDATE - Non Clinical / Clinical AR for Generics - MRP & DCPNEW - Report from the meeting held on 19-20 May 2026
21 May
UPDATE - Contact Points
18 May
NEW - 19-20 May CMDh agenda
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]]></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[Templates Variation Assessment Report]]></title>
                    <description><![CDATA[Type II variation Preliminary-Final Variation Assessment Report (July 2026) [Track version] (Note: Premilinary and Final Variation Assessment Reports have been merged) ]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/templates/assessment-reports/variations.html#c485</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/templates/assessment-reports/variations.html#c485</guid>
                    <pubDate>Tue, 24 Nov 2020 10:53:00 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure]]></title>
                    <description><![CDATA[Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition ProcedureChapter 1: CMDh BPG for the Allocation of the Mutual Recognition Variation Number for Type I Notifications, Type II Variations, Grouping and Worksharing (June 2026) [Track version]Chapter 2: Procedure for Automatic Validation of Mutual Recognition Procedures for Variations (October 2025) [Track version]Chapter 3: CMDh BPG for the Processing of Type IA Minor Variations (Notifications) in the Mutual Recognition Procedure (June 2026) [Track version]Chapter 4: CMDh BPG for the Processing of Type IB Minor Variations (Notifications) in the Mutual Recognition Procedure (October 2025) [Track version]Chapter 5: CMDh BPG for the Handling of Type II Variations in the Mutual Recognition Procedure (October 2025) [Track version]Chapter 6: CMDh BPG for the Processing of (Super-)Grouped Applications in the Mutual Recognition Procedure (June 2026) [Track version]Chapter 7:  CMDh BPG on Variation Worksharing (July 2026) [Track version]Chapter 8: CMDh BPG on CMDh Recommendations on Unforeseen Variations (October 2024) [Track version]Chapter 9: CMDh BPG on fast track procedure for annual update of Human Influenza Vaccines (October 2025) [Track version]]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/variation.html#c2126</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/procedural-guidance/variation.html#c2126</guid>
                    <pubDate>Thu, 30 Sep 2021 12:00:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[Template of letter of intent for the submission of a worksharing procedure (July 2026) [Track version]

Link to EMA website for Template for letter of intent for worksharing including CAPs and MRPs]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/templates/variations.html#c2210</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/templates/variations.html#c2210</guid>
                    <pubDate>Fri, 02 Aug 2013 09:29:00 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[2026 (Jan-Jun) - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/statistics.html#c7903</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/statistics.html#c7903</guid>
                    <pubDate>Tue, 21 Jul 2026 13:00:04 +0200</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[CMDH PRESS RELEASES 2026]]></title>
                    <description><![CDATA[Report from the meeting held on 21-22 July 2026Report from the meeting held on 23-25 June 2026Report from the meeting held on 19-20 May 2026Report from the meeting held on 21-22 April 2026Report from the meeting held on 24-25 March 2026Report from the meeting held on 24-25 February 2026Report from the meeting held on 27-28 January 2026]]></description>
                    <link>https://www.hma.eu//human-medicines/cmdh/press-releases.html#c7863</link>
                    <guid>https://www.hma.eu//human-medicines/cmdh/press-releases.html#c7863</guid>
                    <pubDate>Tue, 03 Feb 2026 17:20:16 +0100</pubDate>
                </item>
            
                <item>
                    <title><![CDATA[]]></title>
                    <description><![CDATA[SUBSCRIBE to NEWSLETTER
29/7/2026      HMA newsletter July 2026
8/7/2026        HMA newsletter June 2026
1/6/2026        HMA newsletter May 2026
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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