With 28 EU Member States, each of which has its own national agency, and additional pan-European bodies, remaining fully informed of all European regulatory requirements for veterinary medicines is challenging. News from the Regulators consolidates the news items posted on the following websites and more: all Member States of the EU / EEA; the EMA; the CMDv; the European Commission.
As of January 2017, News from the Regulators is provided as a subscription benefit for members of TOPRA. As such, only limited news items will be posted on the Cyton website. For an example of the new service provided through TOPRA, please follow the link below:
TOPRA VetMed Update March 2017
If you would like to know more about the new TOPRA service or if you are not a member of TOPRA but would like to receive News from the Regulators, please contact Will Drury, using the contact form on the right.
If you are selling your products internationally, regulatory compliance should not be a “Terra incognita”. An incomplete world map of the numerous regulations related to...
We are pleased to announce that knoell is bringing all of its Animal Health CRO expertise and service brands under one name to provide a unified face to customers around the...
With the end of the transition period, there has been a final flurry of activity amongst the regulators to clarify the post-Brexit requirements for veterinary medicines.
...
In our first post for 2021, looking at the updates from the EMA, it is not surprising that the news is dominated by the implementation of the Veterinary Medicines Regulation,...
Numerous updates from the CMDV have recently been released, covering the new veterinary regulation (NVR), Brexit and national requirements. New...
CMDv Report for Release July / September 2020
The latest CMDv Report for Release, giving an overview of the activities of the July and September 2020 meetings, is...
EMA says goodbye to Guido Rasi and welcomes Emer Cooke. November sees publication of the latest quarterly newsletter on the New Veterinary Regulation (NVR) highlights the...
With the transition period for Brexit coming to an end from 1 January 2021, the EU regulators and industry for veterinary medicines are publishing final reminders to about what...
Cyton Triveritas and knoell are delighted to announce the addition of the newest member of the knoell family of companies, specializing in Animal Health services - knoell...
The EMA has posted the press release with details of the CVMP's meeting of 8 – 9 September 2020 (Link). Updates from the plenary meeting and other news from the EMA is...
The VMD has re-launched its hub webpage on communications on the changes following the end of the transition period (Link) and has also launched a...
The EMA has posted the press release with details of the Committee for Medicinal Products for Veterinary use - CVMP - meeting of 14 – 16 July 2020 (Link). General news from the...
The EMA has posted the press release with details of the CVMP's meeting of 16 – 18 June 2020 (Link). General news from the CVMP plenary relating to regulatory affairs and other...
Cyton Triveritas will be joining the inaugural Animal Health Investment One virtual event, seeking business opportunities. We will be interested to hear from any of the...
Cyton will be attending the inaugural Manufacturing Chemist Live event in Birmingham, seeking business opportunities. We will be interested to hear from any of the following:...
Cyton's Managing Director and colleagues from our clinical and pharmacovigilance teams, will be at the 50th EMWA conference in Prague, looking to meet with other professionals...
The UK Veterinary Medicines Directorate (VMD) has announced that Marketing Authorisation Holders will be given at least 1 year after the end of the Brexit transition period i.e...
The EMA has posted the press release with details of the CVMP's meeting of 18 – 20 February 2020 (Link) and the meeting of 17 – 18 March 2020, which was the first to be held...
Cyton's Pascale Canning will be attending the EMA's third international awareness session on science and regulation for animal health and welfare, public health and the...
The World Health Organization has declared COVID-19 a global emergency. During this challenging time, our priority has been the protection of the health and wellbeing of our...
Like many other companies, knoell has taken far-reaching measures to support the global effort to stop the spread of COVID-19. Most of our employees work from home now, and...
Cyton will be attending AHIE 2020, seeking business opportunities. We will be interested to hear from any of the following:
* Innovators seeking to understand the...
Following the UK withdrawal from the EU on 31 January 2020, the EMA has made an announcement to clarify the situation, particularly during the transition period (Link). In...
The latest CMDv Report for Release, giving an overview of the activities of the November and December 2019 meetings, is available to view and download (Link). The report...
The EMA has posted the press release with details of the CVMP's meeting of 21 – 23 January 2020 (Link). General news relating to regulatory affairs, from the CVMP meeting and...
Dr. Laure Bidois of Cyton's Regulatory Procedures Group, will be attending the The European Congress on Legal and Regulations in Cannabis, taking place on February 13th and...
Cyton is excited to announce that Triveritas has become part of the knoell group of companies.
20 years of Animal Health Industry Support ServicesCyton was founded in...
With the distractions of Brexit and the publication of the New Veterinary Regulation (NVR), maybe some of the day to day regulatory developments passed you by. You can now...
The EMA has posted the press release with details of the CVMP's meeting of 3 – 5 December 2019 (Link). General news, not relating to specific products, includes notification of...
Management Forum is holding its annual feed and feed additives seminar, which will "review EU legislation, examine procedures and data requirements, and discuss to what extent ...
The EMA has posted the press release with details of the CVMP's meeting of 5 – 7 November 2019 (Link). General news relating to regulatory affairs included MUMS guidance under...
The latest CMDv Report for Release, giving an overview of the activities of the September and October 2019 meetings, is available to view and download (Link). The minutes from...
Dr Cemile Jakupoglu, Clinical Safety and Efficacy Executive at Cyton's office in Germany, will be at the "Symposium on the new European legislation on veterinary medicines",...
Dr. Laure Bidois of Cyton's Regulatory Procedures Group, will be attending the London Vet Show 2019, taking place on November 14th and 15th at ExCel London.
Regulatory...
Cyton will be attending CPhI Worldwide 2019, seeking business opportunities. We will be interested to hear from any of the following:
- Animal health companies seeking...
Dr. Laure Bidois of Cyton's Regulatory Procedures Group, is joined by four other expert presenters from industry and the European regulators to deliver a comprehensive overview...
With ongoing challenges brought by Brexit and associated staff losses at the EMA, resources are being focused on key priorities, such as implementation of the New Veterinary...
The most important event in the diary for professionals in regulatory affairs for veterinary medicines, the programme for TOPRA's 2019 veterinary medicines symposium looks set...
The UK regulator, the Veterinary Medicines Directorate, will hold its annual information day for veterinary pharmaceutical industry stakeholders, on Wednesday 25th September...
After what appeared to be a quiet summer period at the EMA and the European Commission (EC), several significant publications demonstrate that there has been a lot of activity...
Prepare for the emerging issues and future challenges affecting the product stewardship profession.
The Product Stewardship Conference offers an experience like no...
According to the regulations under the jurisdiction of the China Food and Drugs Administration (CFDA), CFDA has cancelled the pharmaceutical excipients pre-market approval...
Over the holiday period, there have been a few general updates as well as news of the paromomycin referral, updated PSUR submission guidance and a Q & A on manufacture of...
With less than three months remaining until the current deadline for the UK to leave the EU, the European Commission has reiterated their message of 21 February 2019, regarding...
This article titled ‘Experts Outline Ramifications of Revised European Bioequivalence Studies Guideline’ was co-written by Cyton Germany’s Cemile Jakupoglu and Maggie Fisher...
A raft of updated question and answers pages has been published on the EMA website, addressing all aspects of life-cycle management for VMPs. There has also been recent news...
With the UK continuing its fight to find a way out of the Brexit political deadlock, the EMA and CMDv have provided further guidance and updates for industry.
Coordination...
Although the May meeting of the CVMP remained quiet in terms of guidance documents, due to Brexit related business continuity planning (BCP), there have been other updates from...
Dr. Laure Bidois of Cyton's Regulatory Procedures Group will be attending the France Vet 2019 conference, taking place on June 14th and 15th in Paris, Porte de Versailles.
...
Cyton's Pascale Canning will be attending the National Office of Animal Health (NOAH) Members' Day in London on Wednesday 12th June 2019 (follow this Link to register: note...
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Besides the quality of your products and your innovative power, the global regulatory compliance is one of the key factors for your success when selling...
You cannot miss this event if you are interested in emerging research, regulatory developments and the latest methodologies in environmental toxicology and chemistry.
...
With the delay of Brexit, the EMA has issued an update and clarification on its Brexit information page (Link). Meanwhile, there have also been updates from the national...
Dr Cemile Jakupoglu, Clinical Safety and Efficacy Executive at Cyton's office in Germany, will be at the 48th EMWA conference in Vienna, looking to meet with other...
The EMA has posted the press release with details of the CVMP's meeting of 19 – 21 March 2019 (Link)....
The EMA’s dedicated web page (Link) giving Brexit-related information for companies has been further updated in February. Some guidance documents...
The EMA has posted the press release with details of the CVMP's meeting of 19 – 21 February 2019 (Link to summary). Opinions were...
The European Chemicals Agency ECHA has published guidance for companies that export hazardous chemicals to the UK that are subject to the PIC regulation.
According to the...
Cyton will be attending AHIE 2019, seeking business opportunities. We will be interested to hear from any of the following:
* Innovators seeking to understand the...
The Chemical Watch ASEAN Product Safety Forum brings together over 20 experts in global chemical risk assessment and...
With the imminent move of the EMA to Amsterdam, the Agency has issued a progress update, a booklet giving advice for visitors to the EMA and further advice to industry.
EMA...
The latest CMDv Report for release, giving an overview of the activities of the October and November 2018 meetings, is available to view and download. The report includes...
While the February meeting of the CVMP takes place this week, the EMA has posted the press release with details of the CVMP's meeting of 22-24 January (Link). The press...
The Irish Healthcare Products Regulatory Agency (HPRA) will be holding a Brexit stakeholder event, to provide the healthcare and animal health industries with the opportunity...
AnimalhealthEurope and Klifovet are jointly organising an event to discuss the impact of the new veterinary medicines regulation (VMR) on product development and lifecycle...
‘The new veterinary medicines regulation: What we know and what we don't’ was written by one of Cyton’s Managing Directors, Dr. Karolina Bate. The article was written in...
Just in case you missed anything important, you can download Cyton's summary document here, which provides an overview of the major developments in regulatory affairs for...
The January meeting of the CVMP will take place 22nd – 24th, and will be summarised in the February Cyton news review, but since the December meeting of the CVMP, a number of...
‘The evolving regulation of veterinary medicines in Europe: Progress or bureaucracy?’ is a review artilce examining the last few decades of animal health legislation in the...
It appears to have been a frantically busy couple of months at the EMA, with new guidance covering everything from anticoccidials to allergen products, multi-strain dossiers to...
The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) Report for Release from the monthly meetings which took place in July and...
The uncertainty of Brexit for industry makes forwards planning extremely difficult for the animal health and other industries, so the regulators are maintaining strong...
The European Medicines Agency (EMA) has posted the press release with details of the Committee for Veterinary Medicinal Products (CVMP's) meeting of 6 – 8 November 2018 (Link)...
The UK regulator, the Veterinary Medicines Directorate, will hold its annual information day for veterinary pharmaceutical industry stakeholders, on Wednesday 14th November...
The EMA Common Repository has been mandatory for veterinary submissions through the centralised procedure since June 2018 - what does this mean and what difference has it made...
Will Drury, Senior Business Associate, will be at the Brexit and Beyond conference, hoping to learn more about the UK's plans for the animal health industry following Brexit....
With less than six months to go until the UK leaves the EU, the European Medicines Agency (EMA), the Co-ordination Group for Mutual Recognition and Decentralised Procedures -...
The EMA has published the minutes from the CVMP's October meeting, which includes two new referrals for VMPs containing paromomycin and tylosin. Guidance documents adopted in...
At the moment much about Brexit can best be described as being “cloudy”! One thing for sure is that it will have a significant impact on the chemical industries of the UK and...
Cyton will be attending CPhI Worldwide 2018, seeking business opportunities. We will be interested to hear from any of the following:
Animal health companies seeking support...
The most important event in the diary for professionals in regulatory affairs for veterinary medicines, the programme for TOPRA's 2018 veterinary medicines symposium looks set...
Cyton's Dr Luisa Pachés-Samblás, Regulatory Procedures Team Leader, will attend Feed Additives Global 2018 in Amsterdam, Netherlands. Please get in touch if you would like to...
The EMA's new guideline on user safety risk assessments for topically applied VMPs comes into effect in November. The PDF document provided below, is Cyton's review of the new...
The EMA has posted the press release with details of the CVMP's meeting of 11 - 13 September...
The EMA has posted the press release with details of the CVMP's meeting of 17 – 19 July 2018 (Link). The following general news relating to regulatory affairs for veterinary...
As the precise details of Brexit continue to be discussed by the politicians, the European regulators for veterinary medicines and the animal health industry are increasing...
In July and August the website of the Heads of Medicines Agencies (HMA) posted updated information relating to the coordination group for mutual recognition and decentralised...
If you are an animal health company, already well established in America, you will be closely familiar with the regulatory framework of the USA. Looking at export markets,...
As partners in the development and European registration...
The June meeting of the Committee for Veterinary Medicinal Products took place on 19th-21st June (Link to report page).
First veterinary stem cell product authorised in...
Die Chemspec Europe ist Europas führendes Beschaffungs- und Networking-Event für die Fein- und Spezialchemiebranche. Sie ist für Hersteller, Anbieter und Distributoren von Fein...
REGISTER NOW!
Regulatory compliance is getting increasingly important to safeguard your success for sales of chemical products around the globe.
To avoid struggling...
Dr Karolina Bate, Managing Director at Cyton Biosciences Ltd will attend this exciting event...
The EMA has posted the press release with details of the CVMP's meeting of 23 – 25 May 2018 (Link), in which a revised...
Cyton's Pascale Canning will be attending the veterinary medicines information day, June 13, being hosted by the Irish...
The latest CMDv Report for Release (RfR), giving an overview of the activities of the March and April 2018 meetings, is available to view and download (Link). The report...
In May 2018 knoell participated in the Chemicals Management Trade Show in Yokohama organized by Japan Chemical Daily. We presented about the current developments of chemical...
On 7-8 May 2018 the R4BP Key users’ testing exercise took place at ECHA in Helsinki. The hosted event aimed mainly the testing of the new features of the R4BP Version 3.11 and...
Cyton's Luisa Pachés-Samblás recently attended this information day at the EMA.
Following this event, all presentations are now available on the EMA website. Also, if...
Cyton's Luisa Pachés-Samblás recently attended this information day at the EMA.
Held at the EMA on 19 April, Ivo Claasen (Head of the Veterinary Division), stressed that...
The EMA has posted the press release with details of the CVMP's meeting of 13 – 15 March 2018 (Link). General news from this press release and other news items relating to...
AnimalhealthEurope, the EMA and Germany have issued the following updated information regarding Brexit and veterinary medicines:
AnimalhealthEurope - “Alignment on animal...
The European Chemicals Agency ECHA established a new website for consumers. Under https://chemicalsinourlife.echa.europa.eu/ consumers find information on the use of chemicals...
The latest CMDv Report for release (RfR), giving an overview of the activities of the January and February 2018 meetings, is available to view and download (Link). The report...
Updated content posted on the CMDv website during February and March 2018 includes the following:
New Q & A: Art 13.a Bibliographic application, use of assessment...The EMA has posted the press release with details of the CVMP's meeting of 13 – 15 February 2018 (Link). General news relating to regulatory affairs includes:
Community...
The following developments relating to Brexit for veterinary medicines regulatory affairs have been published:
Germany - PEI is making preparations for increased capacity...
Cyton is delighted to announce that we will be an event partner for Animal Health Innovation Europe 2018, taking place in London (February). For full details, please visit the...
We are delighted to announce that Dr. Knoell Consult Thai Co., Ltd. has expanded to a new office in Sathorn area, Bankok, Thailand.
The new premises will be located at:...
The latest CMDv Report for release (RfR), giving an overview of the activities of the November and December 2017 meetings, is available to view and download (Link). The report...
During January and February 2018, the EMA has published updates relating to the following topics:
CMC
Updated guidelines on active substances / new active substances,...Denmark's DKMA has promoted change of RMS from UK to DK, free of charge (Link).
Finland's FIMEA has expressed interest in taking over as RMS (Link).
Notice to MAHs of centrally authorised medicinal products for human and veterinary use (Link).
In January, Echa has added 7 new substances of very high concern (SVHC) to the Candidate List. Substances on this list are candidates for the authorization process under REACH...
EMA surveys pharma companies on their preparedness for Brexit (Link).
The EMA has posted the press release with details of the CVMP's meeting of 16 – 18 January 2018 (Link). General news relating to regulatory affairs includes:
MRLs
...
Interested in learning more about the use of OpenGeoSys (OGS) in the context of modeling subsurface processes in environmental systems? Then you might want to have a look at...
During December 2017 and January 2018, the EMA has published updates relating to the following topics:
New Q & A pages for referrals
Article 13 veterinary referral...In addition to the CVMP minutes of November (Link) and December (Link), the EMA has published updates relating to the following topics:
IMMUNOLOGICALS
Report on the...The EMA has posted the press release with details of the CVMP's meeting of 5 – 7 December 2017 (Link). General news relating to regulatory affairs includes:
Draft...
Save the date! Thursday 16th November 2017
Cyton is excited to announce our latest training course in veterinary regulatory affairs, in association with Anja Holm...
The latest CMDv report for release, giving an overview of the activities of the September and October 2017 meetings, is available to view and download (Link). The report...
The EMA has posted the press release with details of the CVMP's meeting of 7 – 9 November 2017 (Link). General news relating to regulatory affairs includes:
Draft...
During October and November, the EMA has published updates relating to the following topics:
eSubmissions
Updated electronic application forms available from 15...
Cyton will be attending CPhI Worldwide 2017, in Frankfurt (October). For full details, please visit the event website (Link).
We are pleased to inform you that effective October 11, 2017, Critical Path Services, LLC has changed its name to knoell USA, LLC.
Our name change reflects our desire to...
The EMA has posted the press release with details of the CVMP's meeting of 3 – 5 October 2017 (Link). General news relating to regulatory affairs was scarce this month, with...
Cyton will be attending TOPRA's annual Veterinary Medicines Symposium, in London (October). For full details, please visit the event website (Link).
During August and September, the CMDv website has been re-organised and updated, with the following amendments and additions:
New page consolidating guidance on ASMF (Link)...During August and September, the EMA has published updates relating to the following topics:
eSubmissions
Updated: VNeeS Q & A (Link) and FAQ relating to PDF/A (...The latest CMDv report for release, giving an overview of the activities of the June and July 2017 meetings, has been published (Link). The report includes news on:
CMDv...The EMA has posted the press release with details of the CVMP's meeting of 5 – 7 September 2017 (Link). General news relating to regulatory affairs includes:
Draft...
Contact:
Site: http://cdsympo.com/cm2017/
Tel：03-3663-7936 Fax：03-3663-7861
e-mail：event@chemicaldaily.co.jp
During July and August, the CMDv has published updates relating to the following topics:
Task force on the availability of authorised medicines (Link)UK Exit (Brexit)...During July and August, the EMA has published updates relating to the following topics:
Mutual recognition agreements, with recent addition of details related to USA (Link)...Publications
CMDv Report for Release February-March 2017 (Link);Minutes of the February CMDv-Interested Parties meeting (Link)CMDv Q&A updates (Link to main...
The latest CMDv report for release, giving an overview of the activities of the April and May 2017 meetings, has been published. The report includes:
Statistics on VMPs...In addition to the CVMP’s May and June meeting reports (Link), the EMA has published updates relating to the following topics:
New Q & A page on the “sunset clause” (...
The webinar on the subject of animal health in the ASEAN region was presented by Thaddao Sookcharoen from our sister company Knoell Thailand, to registrants from a variety of...
During the Maltese presidency, the CMDv held a stakeholders’ meeting on 10th May (Link), with notes from that meeting now available (Link). The following regulatory topics were...
The EMA has posted the press releases with details of the CVMP's meetings of 10 – 12 May (Link) and 13 – 15 June 2017 (Link). General news relating to regulatory affairs...
The latest CMDv Report for release, giving an overview of the activities of the February and March 2017 meetings, is available to view and download (Link). The report includes...
In addition to the CVMP’s April meeting report (Link), the EMA has published various other updates relating to the following topics:
Updated scientific advice request...The EMA has posted the press release with details of the CVMP's meeting of 10 -12 April 2017 (Link). General news relating to regulatory affairs are summarised below, with...
In what has been a very busy period for CMDv, numerous updates have been posted as summarised below:
Recommendations for the manufacture, control and use of inactivated...In addition to the CVMP’s March meeting report (Link), the EMA has published various other updates relating to the following topics:
Updates to “Quality of medicines...As of January 2017, News from the Regulators will be provided as a subscription benefit for members of TOPRA. As such, only limited news items will be posted on the Cyton...
The EMA has posted the press release with details of the CVMP's meeting of 14 – 16 March 2017 (Link). General news relating to regulatory affairs includes:
Community...
The date and agenda for the 2017 EMA/IFAH-Europe Info Day have been published on the IFAH-Europe website. See the notification here (Link), and the agenda here (Link).
...
An exciting new training event from Cyton and our new collaborative partner, Anja Holm, DVM, formerly Senior Scientific Officer at the Danish Medicines Agency and CVMP chair...
In addition to the CVMPs February meeting report (Link), the EMA has published various other updates:
Anthelmintic resistance
Veterinary focus group meeting with...The latest CMDv report for release, giving an overview of the activities of the December 2016 and January 2017 meetings, is available to view and download (Link). The report...
Cyton will be attending the 2017 European Animal Health Investment Forum taking place in London (February). For full details, please visit the event website (Link).
...
An exciting new training event from Cyton and our new collaborative partner, Anja Holm, DVM, formerly Senior Scientific Officer at the Danish Medicines Agency and CVMP chair...
The EMA has posted the press release with details of the CVMP's meeting of 14 – 16 February (Link). General news relating to regulatory affairs includes:
...
The EMA has posted the press release with details of the CVMP's meeting of 17 – 19 January (Link). General news relating to regulatory affairs includes:
Referrals:
...The UK VMD and Irish HPRA have released updated guidance on the production of mock-ups for both markets (Link).
IFAH-Europe has released its December edition of the newsletter “Perspectives (Link).
The EMA has posted the press release with details of the CVMP's meeting of 6 – 8 December (Link).
Community referrals
The Committee concluded the referral procedure...The EMA has released v2.5 of the VNeeS guideline and validation checklist, which come into force in June 2017 (Link). As the rules for technical validation have not changed,...
The HMA has published the CMDv’s October / November report for release (Link), with the following highlights:
A pilot for harmonising Part II (quality) of the VMP dossier is...The EMA has posted the press release with details of the CVMP's meeting of 6 – 8 December 2016 (Link). General news relating to regulatory affairs includes:
Community...
The UK National Office of Animal Health (NOAH) has now published the latest edition of its Code of Practice for the Promotion of Animal Medicines (Link). The new code includes...
A follow-up webinar Q&A session for industry will be held on 12Jan16 (1pm – 3pm GMT) – Mandatory Use of eSubmission gateway to help answer questions industry may still have...
The EMA has issued updated submission dates for centralised and MRL procedure applications (Link).
The CMDv has updated its document “National Authority Fees Terms of Payment and Addresses” (Link).
The Portuguese DGAMV held an information day in November to discuss current issues relating to the registration of VMPs (Link – Portuguese only). The following topics were...
The EMA has issued a statement of intent regarding the future integration of CESP and the EMA eSubmission Gateway to create a Common European Single Submission Portal or ‘CESSP...
The Swedish MPA has developed a checklist for the submission of product information: SPC, package leaflet and labelling (Link).
The EMA has published a draft guideline for consultation regarding the use of approved pictograms on the packaging of VMPs:
Draft QRD guidance on the use of approved...
France and the UK have published their 2015 figures for veterinary antimicrobial usage, both showing a continued fall in usage.
French press release (Link) and full...
The Baltic states of Estonia, Latvia and Lithuania have signed an agreement on a Baltic unified VMP packaging guideline and procedure. The new guideline and procedure is...
The OIE has published its Strategy on Antimicrobial Resistance in animals (Link). The strategy details four objectives and describes workplans in place and in development to...
Health for Animals recently presented at the 5th Global Animal Health Conference in Delhi, India to promote improvements in the global availability of veterinary medicines (...
The EMA has now published the following documents adopted in the November meeting of the CVMP:
Draft reflection paper released for consultation
QUALITY: Chemical...The EMA has prepared a guidance video to assist with completion of eAF v1.20, which can be found on the esubmissions website (Link).
The Slovak USKVBL has announced an update to the bank details for payment of fees (Link).
Links to all member states' webpages regarding fees can be found on the CMDv...
The UK VMD has published the latest edition of MAVIS (Link). Contents include updates on:
LicensingEnforcementPharmacovigilanceAntimicrobial ResistanceVeterinary Products...The EMA has posted the press release with details of the CVMP's meeting of 8 – 10 November 2016 (Link). General news relating to regulatory affairs includes:
Community...
FVE and the Standing Committee of European Doctors (CPME) have issued a press release celebrating One Health Day (Link).
Following the publication of the report on the October meeting of the CVMP, the following additional news has been posted by the EMA:
Monthly report - The EMA’s September...The CMDv has updated its links to national agency webpages regarding payment of fees (Link).
The CMDv has updated the position paper (CMDv/POS/005): Agreeing Product Name During the Decentralised Procedure. It is available as a PDF via the HMA/CMDv website (Link).
In its most recent e-news, BASG notifies that new national applications have to follow VNeeS format starting from 1st January 2018 (Link). Variation and renewal applications...
The latest CMDv Report for release, giving an overview of the activities of the July and September 2016 meetings, is available to view and download (Link). The report includes...
Updated versions of 4 electronic Application Forms (eAF v. 1.20.0.3) have been published following reported issues (Link).
A recent VMD survey highlighted that improvements could be made to the Product Literature Standard, so further feedback is being requested (Link).
The 6th ESVAC report has been published, detailing veterinary antimicrobial usage in Europe from 2011 to 2014 (Link). The report shows that sales of veterinary antibiotics...
IFAH-Europe and EGGVP have signed the EPRUMA declaration “Our 7 commitments to the responsible use of veterinary medicines” (Link).
The EMA has posted the press release with details of the CVMP's meeting of 4 - 6 October 2016 (Link). General news relating to regulatory affairs includes:
Guidance...
Health for Animals has issued the latest edition of its newsletter (Link).
IFAH-Europe has issued the latest edition of its Perspectives Newsletter (Link).
The EMA has issued a concept paper for public consultation on Good Manufacturing Practice and Marketing Authorisation Holders which seeks to clarify the responsibilities of the...
The EMA has posted a note to clarify how to correctly fill in the product details when using the electronic Application Form (eAF), stating that the footnote should only be...
The HMA has published updated versions of the following:
CMDv/BPG/020 – Best Practice Guide for Handling of Periodic Safety Update Reports (PSURs) in the context of the EU...The EMA has now published the following documents adopted in the September meeting of the CVMP:
Draft Immunologicals guidance released for consultation:
Concept paper...The former chair of the CVMP, (Anja Holm) and Mel Munro (Triveritas) / Rhona Banks (RA-Elect) have been shortlisted for TOPRA awards in the categories “Communication” and “...
IFAH-Europe has issued a press release (Link) after the UN High Level meeting on AMR, stating that it welcomes the conclusions on AMR and is confident that the key actions in...
Following some necessary corrections to the data originally published by the BVL, the report on veterinary use of antimicrobials in Germany from 2014 to 2015 has been updated....
Since 19Sep16, use of the eAF v1.20 is now mandatory (Link). Use of previous versions is accepted only for ongoing applications – the version of the form should not be changed...
Drugs with the combination of lincomycin and spectinomycin, which is currently being used against a number of diseases in pigs and poultry, are to be de-registered following...
The EMA has published its annual report on the GMP / GDP inspectors working group (Link).
Further to the adoption of the “Framework for interaction between the European Medicines Agency and industry stakeholders” in October 2015, the EMA has published an application...
A new survey commissioned by IFAH-Europe has revealed the need for awareness raising on the benefits of veterinary medicines (Link). The survey shows that EU citizens are...
Following a conference involving 19 countries, the EC repealed restrictions on trade of chilled meat and milk from cows vaccinated against Lumpy skin disease with other EU...
The EMA has posted the press release with details of the CVMP's meeting of 6 – 8 September 2016 (Link). General news relating to regulatory affairs includes:
Community...
EPRUMA and the Slovak Presidency of the EU will hold a workshop on 'Creating a common understanding on the responsible use of veterinary medicines', taking place at the...
Health for Animals has released two new publications:
Vaccination Myths – Filling the void between vaccination fact and fiction (Link)Global Vision for Regulation of...Presentations and summaries are available, upon request, from the 2014 & 2016 Workshops on the Proposals for new Regulations for veterinary medicinal products and Medicated...
21 July
The Veterinary Medicines Division of the EMA has issued the monthly report for June 2016, publishing statistics on all types of veterinary regulatory activities:...
19 July
An updated version of a HMA/CMDv guidance document has been published, including postal correspondence addresses and general email addresses for all the EEA...
20 July
This year’s VMD open meetings will be held from 10:30-13:00 on 16 September 2016. VMD staff will give presentations based on the advance questions received,...
Cyton is looking to recruit a medical devices regulatory consultant to join our team in Bristol. Follow the link below to find out more.
Medical Devices Regulatory...
The Netherlands’ CBG-MEB has updated guidance on the substantiation of claims made on animal nutrition (Link). The guidance has been made available to download in English and...
Cyton is looking to recruit an experienced regulatory toxicologist to join our team in Bristol. Follow the link below to find out more.
Experienced Regulatory...
The OIE has introduced its new ‘One health’ web portal, where a large amount of information on the ‘One Health’ concept can be found on, along with details of global level...
The EC has published the responses to the public consultation, on revision of the EU GMP guidelines, Annex 17 on Real Time Release Testing, including the responses submitted by...
The UK’s National Office of Animal Health (NOAH) has issued a comprehensive response to the O’Neill AMR review report (Link).
The EMA has now published the following documents adopted in the July meeting of the CVMP:
Draft guidance released for consultation
SAFETY: Draft guideline on approach...The latest CMDv Report for release, giving an overview of the activities of the May and June 2016 meetings, is available to view and download. The report includes amongst other...
The EMA has posted the press release with details of the CVMP's meeting of 12 – 14 July 2016 (Link). General news relating to regulatory affairs includes:
Governance
...The Slovak Republic will preside over the Council of the European Union from 1st July to 31st December 2016. IFAH-Europe has issued a memorandum highlighting priorities in...
On behalf of the ESVAC species Expert Advisory Group, the EMA has published a concept paper on guidance for the collection of data on antimicrobial consumption by species from...
The EMA have notified technical issues with the latest versions (v1.20.0.1) of all four eAFs via the e-submissions website. It is planned to release updated versions with fixes...
The VMD has published information about the changes to the way mock-up VMP literature is submitted (Link). Any change to mock-up product literature that does not affect...
Perspectives Issue 38 is now available to view and download on the IFAH-Europe website (Link).
The EMA has stated that its procedures and work streams continue as usual, following the outcome of the UK referendum (Link). In response to enquiries from some Member States,...
The CMDv has updated their list of VMPs available for use in bees in Europe (Link).
Minutes of the CMDv stakeholders meeting in January have now been published, summarising the discussions between the CMDv, AVC, IFAH-Europe and EGGVP (Link).
The CMDv has adopted an updated Best Practice Guide for the repeat use MRP (CMDv/BPG/003), together with a track changes version to highlight where updates have been made:
...The EMA has published corrected versions of the VICH EIA GL6 and GL38 (Link). A summary of the updates is provided in a footnote to page1 of the revised guidance.
Following the outcome of the UK referendum on EU membership, the UK industry association, NOAH has issued a statement of support for its members (Link).
The EMA has issued a statement that there are no exceptions to the VNeeS format and clarified the relationship between VNeeS, CTD and eCTD format (Link).
All three of the veterinary electronic application forms have been updated to version 1.20.0.1, following correction of an issue the proof of payment section (Link).
The corporate success stories that only seem to happen in Hollywood really do exist. The same goes for Silicon Valley. Whereas traditional job creators such as ABB, Deutsche...
In light of the recent UK referendum result, Cyton would like to confirm our position as a continued provider of European regulatory expertise:
Although based in the UK,...The EMA has now published the following documents adopted in the June meeting of the CVMP:
Safety guidance
A draft guideline was adopted for consultation, on user...
Health for Animals and IFAH-Europe have published the 2015 Global Benchmarking Survey (Link). Health for Animals provides the following summary of the report:
Since 1996...
TOPRA has issued a statement regarding the result of the UK’s referendum on membership of the EU, including a statement from the EMA (Link).
Updated guidance on variations has been published by the EMA, clarifying what can be considered an editorial change and how can it be submitted as part of a variation:
...The EMA has released v1.20 of the electronic application forms as of 14 June 2016, but it has since been discovered that the variations form has issues relating to its use for...
The EMA has adopted updated “Criteria to be fulfilled by industry stakeholder organisations involved in European Medicines Agency (EMA) activities” (Link). The EMA’s summary...
The EMA has posted the press release with details of the CVMP's meeting of 14 – 16 June 2016 (Link). General news relating to regulatory affairs includes:
Quality...
The Federation of Veterinarians in Europe (FVE) has re-iterated its commitment to the fight against AMR, in its position paper “Relationship between animal welfare and the use...
IFAH-Europe held its annual conference on 16 June, titled “Animal health matters: Will the legislation deliver?”. An overview of the meeting can be found on the IFAH-Europe...
The 2016 VMD Pharmaceutical Industry Information Event will be held on Friday 1 July 2016 from 10:00 to 14:30. The event will cover seven topics including enforcement,...
The EMA has published an updated pre-submission meeting request form for an application for a centralised marketing authorisation for veterinary medicinal products (Link).
FVE has published a position paper stating that it believes all coccidiostats and histomonostats should be under veterinary prescription. The organisation has requested the...
A new guidance note has been issued by the CMDv, regarding so-called ‘partial MAH transfer’. The document contains requirements and best practice recommendations to manage the...
The CMDv’s 2015 annual report, which contains statistics and a summary of work undertaken for the previous year, can now be viewed via the HMA website (Link).
The EMA has updated the user interface for their Gateway / Web Client. Whereas submissions made via this route previously required use of specific filenaming conventions to...
The EMA will host a focus group meeting regarding the revision of the reflection paper on anthelmintic resistance, on 13th June 2016. The agenda for the meeting (by invitation...
The validation criteria and VNeeS Checker has been revised. As of 1st July 2016, a new guideline on electronic submissions will come into force (Link).
AMR and prudent use of veterinary antimicrobials continue to dominate discussion relating to the veterinary sector, with news from OIE and G7, whilst Finland has published data...
The EMA has now published the following documents adopted in the May meeting of the CVMP:
Antimicrobial resistance
Following the adoption of the updated advice on...
The EMA has posted the press release with details of the CVMP's meeting of 17 – 19 May 2016 (Link). General news relating to regulatory affairs includes:
...
News from the Regulators has now been running for 18 months and we need your feedback to decide if it is to continue. If you find the service valuable, we would be very...
Health for Animal has published an overview of how the veterinary sector plays an active role in fighting anti-microbial resistance “What the veterinary world does to fight...
Health for Animal has published a new pharmacovigilance guidance document titled “The Essentials of Veterinary Pharmacovigilance” (Link).
The EMA’s monthly report on the VMP sector activities for April 2016 and the annual report for 2015 have been published.
The monthly report gives details of application...Following adoption by the CVMP and CHMP, the EMA has published for consultation a “Reflection paper on the dissolution specification for generic oral immediate release products...
Notice to Applicants volume 6A (procedures for marketing authorisation) has been updated to delete Chapter 4 (centralised procedure), because the EMA provides all relevant...
The following updates have recently been announced by the VMD:
The VMD has updated its calendar which shows the events the VMD will be attending, hosting or participating...
TOPRA held a meeting on 3rd May where members discussed the possible exit of the UK from the EU and what impact this could have on the pharmaceutical industry. A short report...
An updated policy on the prescription categories of VMPs was published by the Medicines Evaluation Board (MEB), but it is expected to have minimal impact (Link). The policy...
An application for the declaration of sales for VMPs containing antibiotics is now available, in Spanish language only (Link). The deadline for the declaration will be...
The latest issue of the news bulletin for small and medium-sized enterprises is now available on the EMA website, included updates on guidance for VMPs (Link).
The EMA has now published the following documents adopted in the April meeting of the CVMP:
Efficacy guidance:
Revised reflection paper on anthelmintic resistance (...The EMA has published updated information regarding the standard units of measurement for the ESVAC project:
EMA webpage on ESVAC (Link).Defined daily doses for animals and...The EMA has published a new quality Q & A document responding to the question: “Can an active substance be used in either powdered or granulated forms in a single marketing...
The EMA has posted the press release with details of the CVMP's meeting of 19 – 21 April 2016 (Link). General news relating to regulatory affairs includes:
Positive opinion...The CVMPs Quality Working Party has released two new Q & A documents:
API mixes (Link). The combined human and veterinary Q & A page has also been updated with this...Health for Animals will hold its 2016 Global Animal Health Conference in New Delhi, India with a focus on “India and South Asia and the need for appropriate regulatory systems...
The presentations given at the IFAH-Europe / EMA infoday 2016 are now available to download from the EMA website (Link).
Following the implementation of VICH guidelines (GL30, GL35 and GL42), the “Guideline on data elements for the electronic submission of adverse reaction reports related to...
The report from the HMA stakeholders’ meeting, Amsterdam, 16 – 18 February 2016 is now available online (Link).
The EMA has published a draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container, for public consultation, as first...
Due to the large volume of testing feedback for the new version of the eAF (version 1.20), the publication date has been postponed from that originally planned. The new date...
The European Surveillance Veterinary Antimicrobial Consumption (ESVAC) project’s draft vision and strategy document for 2016-2020 has been launched by the EMA (Link). More...
The VMD has reviewed the fee charged for a category of national workshare variations (Link).
CESP users who have not yet moved over to the CESP platform will need to do so now, as the old version has been retired. View the announcement here (Link).
The report, which gives details of application procedures, guidelines and related documents for veterinary medicines, is available to view on the EMA website (Link to Word...
The incident management plan for VMPs has been reviewed in 2015 and revised, taking account the experience gained with the incidents handled to date (Link).
The PV report for 2015 recently published by the Danish Authority shows that more and more adverse events are being reported. The report can be found on the DMA website (Link...
The Finnish Authority, FIMEA, has published its fees for 2016, with an unofficial translation into English provided (Link).
The Guidance regarding Animal Test Certificates has been updated by the VMD. Applicants must apply for an Animal Test Certificate to undertake a veterinary (clinical) field...
The fees page of the EMA website has now been updated, with new fees applicable as of 1st April 2016 (Link).
The Finnish authority, FIMEA, has published its fees for 2016-2017. More information is available on the website (Link).
The latest CMDv Report for release, giving an overview of the activities of the January and February 2016 meetings, is available to view and download. The report includes...
The fees page of the USKVBL website has now been updated (Link).
As part of the five-yearly renewal of veterinary medicinal products, the MAH shall submit the updated supplementary documentation that demonstrates the adaptation to...
Updated EU Harmonised Birth Dates, Data Lock-in Points & Allocated RMS have been published in the HMA website (Link).
European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) held their stakeholders annual meeting on 2nd March 2016. The agenda and presentations from the meeting...
This issue of the Perspectives newsletter includes discussion of the new veterinary medicines legislation, the EFSA-ECDC report on antimicrobial resistance, and the...
The DGAMV will participate in X Aquaculture Seminar on April 29th 2016. The presentation of the SAGD - " The rational use of antimicrobials in aquaculture" aims to elucidate...
IFAH-Europe has published a press release in response to the 'Eurobarometer on Consumer Attitudes towards Animal Welfare', noting that EU-wide, the public have an interest and...
The 6th Annual Report on Veterinary MUMS/limited market covers activities from 1 January 2015 - 31 December 2015. The report is available to view and download as a PDF (Link...
The rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency have been revised – the revisions to the Fee Regulation...
From Monday 18th to Friday 22nd April, it will be possible for industry representatives to participate in functionality testing for use of XML delivery files with Gateway and...
Following the successful Global Conference on One Health (GCOH) that was held in Madrid in May 2015, the WVA and WMA in close collaboration with the Japan Medical Association (...
The EMA has posted the press release with details of the CVMP's meeting of 15 - 17 March 2016 (Link). General news relating to regulatory affairs includes:
The Committee...Import Certificates
Guidance on how to apply for a certificate to import a Veterinary Medicine into the UK has been published by the Veterinary Medicines Directorate (...
SAM will host a veterinary information day on 5th May 2016. The day will include a series of lectures. A more detailed agenda will be published soon (Link).
Members of the European Parliament’s Agriculture Committee adopted a report which seeks to harmonise the rules for placing on the market of medicated feed across Europe.
...
Several amendments to the medicated feed regulation text have been proposed. FVE highlights that some which are very important for the veterinary profession are not covered by...
As a global provider of regulatory services for the Chemical Industry, Dr. Knoell Consult GmbH is actively pursuing business opportunities in Japan. However, when communicating...
The report, which gives details of application procedures, guidelines and related documents for veterinary medicines, is available to view on the EMA website (Link to Word...
EGGVP’s statement highlights areas of particular interest to the generic veterinary medicines industry. You can access the statement via their website (Link to PDF document)....
IFAH-Europe has responded positively to the European Parliament's recent discussions around animal health, following the recent adoption of the Transmissible Animal Diseases...
The updated version of the Scientific Advice letter of intent template can be accessed via the EMA website (Link to Word document).
The recently implemented new Act on the Registration and Evaluation of Chemicals (“K-REACh”), includes the option for non-Korean companies to appoint an “Only...
The Spanish Authority, AEMPS, has updated its guide for the correct translation of SPCs and product literature, and development of mock-ups for VMPs for veterinary drugs (Link...
EGGVP has issued a press release giving recommendations for the support or opposition of the latest amendments to the proposed regulation on veterinary medicines (Link).
The CMDV workplan for 2016 has been published (Link) and includes key tasks for:
Increasing the availability of VMPsReducing administrative burdenProviding input in the...The CMDV has adopted two updated BPGs for the handling of PSURs:
CMDv/BPG/020 – Handling of PSURs in the context of the EU PSUR Worksharing (Link)CMDv/BPG/014 – Handling of...The EMA has now published the CVMP Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT’s) first two problem statements for public consultation:
Stem cell-based...The guidance documents adopted by the CVMP in their February meeting have now been published on the EMA website:
In response to the EC’s request for updated advice regarding...The EMA’s bulletin on veterinary pharmacovigilance data received in 2015 has now been published, summarising the latest data relating to centrally authorised VMPs (Link).
The EMA has issued an updated eAF for variations to address bugs and has also announced the schedule for User Acceptance Testing relating the next versions of the eAF (Link)....
The EMA has posted the press release with details of the CVMP's meeting of 16 – 18 February 2016 (Link). General news relating to regulatory affairs includes:
The Committee...IFAH-Europe, FVE and EPRUMA have issued press releases in response to the vote of the Environment Committee of the European Parliament (ENVI) on 17th February regarding a...
The following updates have been published by the CMDv:
Updated contact points for the EU borderline product network (Link)Updated Best Practice Guide for Type II variations...The European Parliament’s ENVI committee has voted in favour of the amended proposal for VMPs legislation and the amendment of Reg (EC) 726/2004:
Press release (Link)Result...February has seen press releases from NOAH, EPRUMA and IFAH-Europe highlighting the animal health sector’s commitment to the responsible use of veterinary antibiotics:
NOAH...The European Parliament’s ENVI committee has published 39 proposed compromise amendments to satisfy concerns raised by the AGRI committee (Link – see Points 11 and 12). The...
AEMPS will hold a conference to report on the new "electronic Application Form” on February 29th 2016. The forms will be used for application of new marketing authorizations...
Marketing Authorisation Holders must pay an annual fee 250 € to the Slovakian authority on 28th February every year. More information is provided on the Authority’s website (...
The Estonian agency for medicines has published the 2015 data for AERs relating to VMPs, together with reports since 2005 (Link).
The Lithuanian National Food and Veterinary Risk Assessment Institute (NMVRVI) has joined the CESP system and will accept submissions via CESP from February 15th 2016 (Link)....
The EMA has published updated distribution requirements for submitting PSURs for VMPs authorised through the CP (Link).
The guidance documents adopted by the CVMP in their January meeting have now been published on the EMA website:
Draft guideline on efficacy and target animal safety data...The EMA has published the latest requirements of the EMA and CVMP for submissions of MA and MRL applications (Link).
The AEMPS veterinary product information database is now available as a free app for mobile phones (Link).
The annual report is a digital report with links back to key highlights from the past year on the IFAH-Europe website. It includes key facts and figures on the animal health...
The Coalition aims to increase availability of VMPs in farmed aquatic animals, thereby encouraging growth in the aquaculture sector and improving the welfare situation. The...
The EMA has published its annual highlights of veterinary medicines 2015, including summaries of the numbers of positive opinions for various categories of products (Link).
The UK VMD has published a thorough review of the 5,743 AERs they received in 2014, grouped by species and medicine type (Link).
The Marketing Authorisations Veterinary Information Service (MAVIS) edition 97 is now available to view on the VMD’s website (Link).
European Medicines Agency has done a reconsideration of the indications and treatment regimens for gentamicin preparations for horses. Most indications are now removed from the...
The EMA has posted the press release with details of the CVMP's meeting of 19 – 21 January 2016 (Link). General news relating to regulatory affairs includes:
Community...As of January, Latvia’s PVD (food & veterinary service) and Cyprus’s MOH (veterinary service) have joined the CESP system and will accept submissions via CESP.
...
The CMDv's consolidated guide (CMDv-GUI-025) to payment of National Authority fees has been updated. The revised version can be downloaded as a PDF for reference (Link).
The medicines working group of The Federation of Veterinarians of Europe (FVE) has agreed a draft position paper on the veterinary use of anticoccidials and published the...
The European Parliament’s ENVI (Committee on Environment, Public Health and Food Safety) has stated the following in their latest newsletter: “As to veterinary medicinal ...
The CMDv Editorial Board is to help develop certain draft documents before circulation to the CMDv, in order to increase efficiency. The list of document types to be reviewed...
The Irish Authority (HPRA) has appointed Ms Lorraine Nolan as the new Chief Executive. Ms Nolan, who takes up office with immediate effect, previously held the position of...
TOPRA (The Organisation for Professionals in Regulatory Affairs) has posted an introduction to its new president, Thomas Kuhler and their vision for 2016 (Link).
Slides from the eAF webinar which took place on December 1st 2015 can now be viewed online. The EMA have made the slides available here, in PDF format (Link).
After 11 January 2016, only version 1.19.0.1 of the eAF will be accepted for new MA applications.
eAFs for procedures which have already been submitted do not need to be...
Following the meeting of the CVMP of December 2015, where the need was identified to update its advice of 2013 on the responsible use of colistin in animals, the European...
Thomas Senderovitz has been hired as the director of the Danish Medicines Agency as of 1st April 2016 (Link).
The CMDv has referred applicants from the veterinary sector to the recently updated CMDh “Q/A-List for the submission of variations according to Commission regulation (EC) 1234...
Fees payable to the Estonian agency for medicines have been updated for 2016 (Link).
The European Commission’s roadmap on evaluation of the EMA fee system has been published (Link). Stakeholders are able to provide feedback before 29Jan16 through the “Your...
The EMA has published the new eSubmission validation checklist v2.4, which will come into force on 1st June 2016 (Link). Whilst v2.3 should continue to be used until June,...
In collaboration with HealthforAnimals and NOAH, IFAH-Europe has published a critique on the 2015 O'Neill report on antimicrobial resistance (Link).
The programme of the 2016 EMA / IFAH-Europe info day, to be held on 17th and 18th March, has been announced and registration is open. The registration form and programme can be...
The HMA has issued an announcement to remind industry that the eAF will be mandatory for all European procedures from 1st January 2016 (Link). The EMA will be providing a...
The EMA has posted the press release with details of the CVMP's meeting of 8 – 10 December 2015 (Link). General news relating to regulatory affairs includes:
Immunologicals...The guidance document "Link to National Databases of Authorised Products" can be found on the CMDv website (Link).
The CMDh / CMDv have published examples of acceptable and not acceptable groupings for MRP/DCP products (Link).
The outcome of the public consultation on Proposed Human and Veterinary Medicines, Medical Devices, and Compliance Fees for 2016 has been recently published by HPRA. The report...
The press release stresses the joint responsibility of all sectors for reduction of antibiotic resistance, the need for reducing resistance as opposed to simply reducing...
The guidance gives details of the documentary requirements for a Marketing Authorisation transfer (different legal entity) in all EU/EEA Member States (Link).
The guidance document, which sets out responsibilities of the National Competent Authorities when acting as Reference Member State and Concerned Member State, is available to...
The CMDv Report for Release from the September and October meetings is now available (Link). The following points are noted:
A CMDv editorial board has been established to...The Management Division and Veterinary Medicinal Products Authorisation SAGD will carry out a session on future legislation for VMPs and GMP for VMPs on 4th December 2015 at 10...
The European Platform for the Responsible Use of Medicines in Animals (EPRUMA) celebrates 10 years of collective action in ensuring best practice in animal health. Members met...
The most recent members list, which gives details of all CMDv members and their qualifications, includes a new representative for Bulgaria (Link).
The EMA has posted the press release with details of the CVMP's meeting of 4 – 6 November 2015 (Link). General news relating to regulatory affairs includes:
Community...In advance of the European Antibiotic Awareness Day, the French Authority ANSES has published an article about antimicrobial resistance, with details on sales and exposure of...
The UK authority (VMD) has published the Marketing Authorisations Veterinary Information Service (MAVIS) edition 96 (Link).
The National Office of Animal Health (NOAH) has commented on the publication of the report published by the All Party Parliamentary Group on Antibiotics (APPG): “Non-human uses...
Austria’s AGES has updated two forms available on its website for the purpose of reporting adverse events relating to administration of veterinary medicines (Link - German...
IFAH-Europe Chairman Christian Behm spoke today at a conference in Brussels to support a science-based approach to European policy on antimicrobials for veterinary use.
...
The document, available via the HMA website (Link), gives the position of the individual Member States’ NCAs regarding Veterinary Medicinal Products for use in rabbits kept as...
The list, which has been recently updated, and is available under the CMDv guidance on the HMA website (see link CMDv GUI-26 Addresses for delivery of dossier), and can be...
The European Commission has issued updates to Eudralex Volume 4, guidance on GMP (Link):
Annex 15 (qualification and validation) – in operation since 1Oct15Annex 16 (...The UK’s VMD has published new and updated information as follows:
Copycat Marketing Authorisations: Change to variation validation procedure (Link)VMD open meeting ...IFAH-Europe’s latest press releases and Perspectives newsletter are focused on the promotion of prudent use of antimicrobial VMPs:
Veterinary medicines legislation update...The EMA has published the fifth ESVAC report, covering data from 2013, together with an interactive database.
ESVAC Report (Link)Database (Link)TOPRA has announced that Will Drury, representing the animal health sector, has been elected to the board of directors, to take office from 1st January 2016 (Link).
Sweden’s MPA has co-organised the Uppsala Health Summit “A world without antibiotics” (Link). A full report in English has been prepared, including a summary of the workshop on...
The EMA has posted the press release with details of the CVMP's meeting of 6 – 8 October 2015 (Link). No new guidance documents were adopted in October, but the following...
A guide to good advertising practice for veterinary medicines has been made available by France’s ANSES (Link - French language only).
France’s ANSES has announced updated fees for MA applications and other procedures (Link), in response to Decree 2015-1172 of September 22 2015 in the Journal Officiel de la...
The new VNeeS 2.3 Guideline and tools are effective from 01/10/15 and should now be used (Link).
Ireland’s HPRA wishes to seek comments on the annual review and proposal for fees 2016 (Link). The consultation will remain open until 30th October.
Belgium’s FAGG-AFMPS has new telephone numbers in use at their agency offices as of October 1st. Details of the main contact numbers and formula for extensions can be found on...
EGGVP has issued a position paper on the protection of technical documentation, as proposed for the new legislation governing veterinary medicinal products (Link).
The Spanish AEMPS has published a second edition of its National Antibiotic Resistance Plan, taking a holistic approach with the scope covering both human and veterinary...
EGGVP has issued a press release highlighting the benefits of generic VMPs and raising concerns about the new Regulation for VMPs (Link).
ANSES will hold a scientific conference in Paris, 2nd November 2015, on antimicrobial resistance in animal health and the environment (Link). Article and programme in French...
The UK VMD has changed its procedures to remove inconsistency in the date of issue of MAs shown on authorisation certificates (Link), relating to the following:
the date the...The EC has published a draft update to Eudralex Volume 4 (GMP), Annex 17 - Real Time Release Testing (Link). All interested parties are invited to comment by 11th December 2015...
The EC has issued guidance document 2015/C 299/04 for all parties involved the manufacture, sale and use of veterinary antimicrobials (Link). The responsibilities for the...
The EMA has posted the press release with details of the CVMP's meeting of 8 - 10 September 2015 (Link). General news relating to regulatory affairs includes:
Quality...The CMDv Report for Release for June/July 2015 has been published on the HMA website (Link). Among the items in the report:
New CMDv members for Italy and Bulgaria have been...The Nordic ministers (those of Denmark, Norway, Sweden, Finland and Iceland) have agreed a joint declaration on the fight against antibiotic resistance, using a "One Health"...
The UK VMD's summary of FOI requests received in Q1/2 2015 (Link) shows requests for access to data included in the MA applications for new veterinary products such as...
On the advice of the Commission of VMPs, the Belgian AFMPS has decided to place all topically applied ectoparisiticides for cats and dogs, which have a claim for flea allergy...
The TOPRA elections are now open and Will Drury is standing for election to represent the interests of the veterinary sector. If you are a member of TOPRA, please read the...
The UK VMD and RUMA have announced that they will hold a conference on 3rd November 2015 at the Sainsbury’s Conference Centre, Holborn, London on the responsible use of...
IFAH-Europe has made available an online leaflet which outlines its role and states key objectives of the animal health industry in Europe. It can be downloaded from the IFAH-...
The Irish HPRA has published its annual report (Link) which highlights the activity of the HPRA in 2014.
Also published is a notice on the hazards of the off-label use (...
The Belgian AFMPS has published its annual report and newspaper. The links below take you to the English version, but French and Dutch versions are also available (Link):
...The UK VMD has published general information about the validation of applications for veterinary medicines (Link) and has also provided advice on how to appeal against VMD...
The VMD open meeting will take place on 2nd October 2015 (Link). Requests for tickets should be submitted by 4th September.
The EMA has extended its fee reductions for pharmacovigilance-related variations to marketing authorisations for VMPs (Link).
The latest edition of the VMD's MAVIS publication covers topics including the following:
Details of the VMD open meeting to be held on 2nd October 2015
A list of...
Updated documents relating to good practice in distribution of veterinary medicines have been made available on the ANSES/ANMV website, in French language only (Link).
A combined One Health report from the VMD and Public Health England reviews the latest information on antimicrobial resistance and usage patterns in the human and veterinary...
The following updated guidance documents adopted by the CMDv have been published on the website of the HMA:
The Best Practice Guides for the Decentralised Procedure and...The Austrian AGES MEA has published its latest fees document, effective from 4th May 2015 in both German (Link) and English (Link)
Tuesday 1 September 2015,10:00 (view timezones)
A free 60 minute webinar with Montira Sriyai, our expert from Dr. Knoell Consult Thai Co Ltd looking at the key...
Senior leaders from the United States Food and Drug Administration (FDA), the European Commission and the European Medicines Agency (EMA) reviewed their ongoing cooperative...
The EMA has posted the press release with details of the CVMP's meeting of 7 – 9 July 2015 (Link). General news relating to regulatory affairs includes:
The Committee...The EMAs report on the “Joint EMA / HMA workshop on requirements for the authorisation of veterinary vaccines” has now been published, focusing on how to improve the...
The UK VMD and Irish HPRA have issued updated guidance for industry on the production of mock-ups for products intended for the UK and Ireland. The updated document can be...
The CMDv has published the report from its meetings of April and May 2015 (Link). Among the items reported:
There is to be a Presidency meeting from 20th-22nd September, at...The German BVL and PEI have adopted the EU logo for online sale of medicines for use in association with veterinary medicines (Link). Whilst the logo has been developed for use...
The Spanish AEMPS has published a report on their Coordination Meeting of the National Plan on Resistance to Antibiotics, which recognises the need for a collaborative approach...
The European Parliament has published additional amendments to the European Commission's proposal for revision of Reg 726/2004 (Amendments 16 - 53).
In addition, there...
The UK VMD has published the slides presented at their pharmaceutical information day held on 25th June (Link).
The Federation of Veterinarians of Europe (FVE) has welcomed the European Commission's proposal for a regulation on VMPs, but fears the current wording is too vague with...
The Irish HPRA has issued updated application forms for veterinary clinical trial licences:
Application for a Clinical Field Trial Licence under Animal Remedies Legislation...The sixth report of the Belgian Veterinary Surveillance of Antibiotic Consumption has been published in collaboration between the FAMHP and the Faculty of Veterinary Medicine...
Decree 2015-647 of the 10 June 2015 has been published on the ANSES website, regarding advertising and promotion of veterinary medicines. This decree is a substantial change to...
The EMA has published a number of new and updated guidance documents:
Updates to the VeDDRA clinical terms following the annual review (Link)Concept paper on the testing...IFAH-Europe has published the following position papers, relating the the European Commission's proposals of September 2014:
Position paper on proposal for a regulation on...AGES has published a short clarification regarding the applicable approval dates for Type 1A and Type 1AIN variations, in German language only (Link).
IFAH-Europe has issued a press release from its ‘Healthy Animals, Healthy Food, a Healthy Future’ conference, which addressed the need for responsible use of veterinary...
The EMA has adopted its recommendation on pharmacovigilance surveillance and signal detection of veterinary medicinal products (Link). Also published is the overview of...
The EMA has posted the press release with details of the CVMP's meeting of 2 – 4 June 2015 (Link). General news relating to regulatory affairs includes:
The Committee...As part of the move to the new .gov.uk website, the VMD has made the former VMGNs available in a new format (Link). Subjects currently addressed in the new guidance pages are...
The Spanish AEMPS has issued various information updates:
The use of the cascade (Q & A in Spanish only), with much detail relating to use of the cascade in horses (Link...The use of electronic Application Forms (eAF) is mandatory for the Centralised Procedure from 1 July 2015. The eAFs must be used for all Human and Veterinary applications :...
The European Group for Generic Veterinary Products (EGGVP) has issued a press release raising concerns about the European Commission's proposals for the new veterinary...
The CMDv has published their workplan for 2015, dated 2Mar15 (Link). Also posted by the CMDv is a link to a CMDh Q & A document regarding the ASMF, dated 28May15 (Link).
The Dutch CBG-MEB has issued updated documentation for the product literature of VMPs, including templates matched to those of the Belgium authorities. Full information and...
BASG-AGES has published various guidance on their website regarding use of their product registration and life-cycle electronic services. Full German language guidance can be...
TOPRA will be running the follow two courses in June:
CRED Veterinary Variations (Link)CRED Veterinary e-submissions (Link)The Estonian agency, Ravimiamet, will hold an industry information day on 2nd June 2015, relating to human and veterinary medicines. The agenda, as well as contact details for...
In May, both Spain and Sweden published their 2014 pharmacovigilance bulletins, summarising adverse events reported last year. Their respective reports can be found here:
...The European Commission has published the responses from stakeholders to consultation on GMP guidance Annex 15, relating to Qualification and Validation, which includes the...
The EMA has posted the press release with details of the CVMP's meeting of 5 – 7 May 2015 (Link). General news relating to regulatory affairs includes:
Two new community...The Spanish AEMPS has requested that industry submits their sales data for antimicrobial VMPs by 31st July. Full details, in Spanish, on how such data should be submitted can...
Presentations from the joint EMA / HMA workshop on requirements for the authorisation of veterinary vaccines in the EU are now available online (Link). The presentations can be...
The UK VMD has published the latest edition of MAVIS, highlighting work on improvements to their guidance notes and specifically an updated guidance on export certificates:
...The Finnish FIMEA has published its first Pharmacopoeia-Newsletter (January 2015) which includes current news related to the Pharmacopoeia and information about training for...
The Romanian ICBMV has published new legislation which simplifies the procedure for approval of parallel import licences. The legislation page can be found here (Link), which...
The UK VMD has posted advice encouraging industry to meet them before submitting applications concerning PBTs or biopharmaceuticals (Link).
The European Parliament has published its draft report on the Commission's proposal for the new regulation on VMPs, which the ENVI Committee will consider on 6th May (Link). In...
The HMA has published a statement on the review of the VMPs legislation (Link), highlighting "unintended and unacceptable consequences" and missed opportunities. Their most...
The CMDv has published the clock-start dates for MRPs and DCPs starting in 2016 and 2017 (Link).
The EMA has posted the press release with details of the CVMP's meeting of 8 - 10 April 2015 (Link). General news relating to regulatory affairs includes:
A referral...The Finnish FIMEA has announced a new decree on fees relating to medicines, including VMPs, which came into effect 1st April 2015. An unoffical translation into English has...
The CMDv has issued a new Q & A document regarding changes to an invented name during MRP (Link) and an updated best practice guide for Type 1B variations (Link).
The CMDv has published the report from its meetings of February and March 2015 (Link). Content of the report includes a summary of the meeting of the CMDv-Industry joint task...
The Lithuanian NMVRVI has posted their veterinary pharmacovigilance data for 2014 and highlights the need for greater reporting by veterinarians and animal owners (Link). The...
The UK VMD has published a number of new documents on their website:
An updated form to apply for a new animal test certificate (ATC) - LinkAn updated form to apply for a...The Romanian ICBMV has posted its plan for sampling and testing of VMPs for 2015 (Link).
The EMA and HMA have released a draft common strategy document for public consultation, with press release titled "Making a difference to human and animal health". The draft...
EFSA is extending the use of its harmonised sample-based data reporting model to the collection of data on veterinary medicinal product residues in animals and animal products...
The EMA has published the presentations from their 2015 infoday with IFAH-Europe on the EMA website (Link). The presentations can be found under the "Documentation" tab.
The Irish HPRA has changed its previous policy in relation to combining multiple presentations of parenteral products in one product authorisation (Link). It is no longer...
IFAH-Europe has published a new infographic outlining the differences between the veterinary and human medicines sectors, which highlights some of the processes involved with...
Following the publication of the decision no. 2015-03-076 in the Official Journal of the Republic of France, regarding Good Manufacturing Practice (GMP), ANSES has published an...
EFSA has published a scientific report highlighting deficiencies in technological feed additive dossiers, identified during preparatory work for the re-evaluation feed...
The Irish HPRA has issued new documentation relating to MA transfers for VMPs:
Updated application form (Link)Updated guidance document (Link)The track changes version of...
The UK VMD has announced the first details of the pharmaceutical industry info day, to be held on 25th June 2015 (Link). Suggested topics for discussion include product...
EFSA has published a catalogue of support services available from the Agency during applications for regulated products. The new catalogue can be found here (Link).
The EMA has published the minutes of the latest CVMP meeting (link). The following general regulatory developments are noted:
A revised guideline for the testing and...IFAH-Europe has published four facts sheets on the subject of antibiotic usage in animals:
Why are antibiotics needed in animal health? (Link)Why do veterinarians need...The HPRA has published a new fee application form and a guide to fees payable in 2015:
Fee Application Form (Veterinary) 2015 (Link)Guide to Fees for Veterinary Products...Following IT systems improvements, the DHMA are now able to transfer WDAs and GDP certificates directly to EudraGMDP.
You can read the article via the DHMA website (Link...
The list of bee products authorised in Europe, published via the CMDv, has been updated to include those authorised in Estonia (Link).
The EMA has released a first draft of the CVMP's "Guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial...
Following the initial publication of the first draft in 2013, the EMA has released a second draft of the CVMP's "Guideline for the demonstration of efficacy for veterinary...
The report for release of the December 2014/January 2015 CMDv meetings is now available to view (Link). Section 14 of the report gives summaries of the meetings of interested...
The UK Veterinary Medicines Directorate has openned a public consultation for review of Veterinary Medicines Guidance Note No 6 - Animal Test Certificates. The VMD aims to...
The EMA has published two revised VICH guidelines, relating to “Studies to Evaluate the Metabolism and Residues Kinetics of Veterinary Drugs in...
The original press release and further details can be found here.
This progress report (full report here) gives an update on the European actions being implemented in the context of antimicrobial resistance including:
Strengthening the...On behalf of the medicines agencies of the five Nordic countries (SE, DK, NO, FI, IS), the Swedish MPA has published Edition 2 of the Guideline on Nordic Packages for human and...
AEMPS has issued a reminder that Chapters 3, 5 and 8 of EudraLex Volume 4 (Good Manufacturing Practice guidelines) have been updated and the deadline for coming into operation...
Electronic application forms must be used for all centralised procedure applications from July 2015 and for all other EU procedures, including national procedures, from January...
A new Romanian language version of the application form for a Marketing Authorisation (Part IA) has been posted on the ICBMV website, and can be downloaded from the 'public...
The annual report can be found online here.
The EMA has published the minutes of the latest CVMP meeting, which can be found here. The following general regulatory developments are noted:
The veterinary...Roxane Feller, previously Director of the Economic Department in FoodDrinkEurope, has been appointed as the International Federation for Animal Health Europe (IFAH-Europe's)...
The CMDv has published an answer to a question from industry regarding the variation category associated with establishment of a new vaccine working seed. The Q & A...
These authorisations are being issued by the DHMA in a different way following update of their IT systems, which allows transfer of MIAs to EudraGMP via the EMA's XML form....
The Austrian authority has added some new questions and answers to their Q&A list regarding good manufacturing and distribution practices, which can be found here.
The HMA has published a report on their meeting held in Rome, 27th-28th November 2014, where discussions of the CMDv were largely focused on the publication of the Commission’s...
This concept paper addresses the need to update annex 1 (manufacture of sterile medicinal products) of the good manufacturing practice (GMP) guide. Full details can be found...
The ANMV has updated their online searchable database of veterinary medicinal products authorised in France. The new search pages can be found here.
The European Parliament has published a draft report discussing further recommendations to tackle the issue of AMR in the areas of both human and veterinary medicine. The draft...
The statement from IFAH-Europe can be found here and the joint report of ECDC, EFSA and EMA can be found here.
The latest recommendations for classification of unforeseen variations can be found here.
Updated guidance on blue box requirements in the MRP / DCP can be found here....
Edition 93 of the Marketing Authorisation Veterinary Information Service (MAVIS) has been published by the UK VMD and can be found here. It is noted that the VMD pharmaceutical...
In recognition of the fact that Marketing Authorisations for the same VMP in different Member States may require different withdrawal periods, and that MAHs may be in...
The HPRA has published in its quarterly newsletter a brief update for applicants intending to use the DDPS declaration. The newsletter can be found here.
During 2014, the registration team of FAGG-AFMPS suffered from a lack of staff, leading to backlogs in the processing of applications made to the generic inbox ‘registrations@...
The Austrian Authority has published on the BASG/AGES website a list of 'functional' email addresses (shared inboxes allocated by category of enquiry). Applicants/MAHs are...
The HPRA published a guide to Display of Chemical Group Symbols on Product Literature of Sheep Anthelmintics, which can be found here.
The full report for release can be found here and highlights are as follows:
Following a successful pilot phase, the CMDv has announced that the DDPS declaration can be used...The press release from the CVMP meeting that took place on 13-15 January 2015 is now available to view here. The following general updates are noted:
A reflection paper was...MAHs should be aware that there have been some alterations to ATCvet codes and ATCvet level names in the WHOCC ATCvet Index, valid from 2015. MAHs should apply to update any...
The EMA has published an updated guidance document for Applicants seeking classification of veterinary medicines intended for Minor Use and Minor Species (MUMS). This is a...
Updated fees are payable to AEMPS from January 1st 2015. See this page for details (in English).
New rates for state fees apply to regulatory submissions made to the Estonian Authority from January 1st 2015. See this page for details.
The VMD has published its calendar of events for 2015, which can be found here. Most recently announced as a new event is the biologicals information day to be held on 25 March...
The EMA has published a checklist for marketing authorisation holders to use prior to notification of Type IA or Type IAIN variation:
http://www.ema.europa.eu/docs/en_GB/...
The EMA has published the press release with details of the December meeting of the CVMP:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/12/...
The USKVBL published a notice to marketing authorisation holders discussing the payment of annual maintenance fees for authorised veterinary medicinal products. An English...
An industry information seminar was held at USKVBL on 20th – 21st November, regarding the regulation of veterinary medicinal products (VMPs). Topics covered included: import...
A 'bee health day' took place at ANSES on 9th December 2014, with the aim of bringing together professionals, scientists and stakeholders to discuss the latest work on...
Following a day of presentations to industry on 16th October 2014, an article and several documents relating to good practice in pharmacovigilance have been made available on...
The DHMA commits to comment on the VMP name applied for on Day 54 (for MRP) and on Day 100 (for DCP) of the MAA procedure. It should be noted, however, that comments given at...
The ANMV has, since 1999, kept records of the sale of veterinary antibiotics. The 2013 report on veterinary antibiotic sales was published in October 2014, and shows for the...
Recognised for the in-depth and uncontested analysis on raw material feed levels, alternative sources of protein...
The timing of this...
A two-day Conference bringing together experts from the USA and Europe to discuss latest developments in the regulation of Biocides (Antimicrobials).
About this eventThis...GET UP TO SPEED… with the latest news on registration of vet medicines. In a series of 4 articles published in Animal Pharm, Cyton and knoell sister company Shotwell and Carr...
The European Commission has published an updated version of Eudralex Volume 6B, Part 1A of the Marketing Authorisation application for VMPs (the application form):
...
Amongst other developments at CMDv is the news that the mandate of the new working group on improvement of the MRP/DCP has now been published on the HMA website. It is hoped...
Thailand, with its solid agricultural tradition and strong industry sector, is a centre and pivotal point of the chemical industry in the ASEAN-region. Within this region it...
In the continual move towards greater transparency of the decisions made at the EMA, the Agency has now started to publish the agenda’s for the meetings of their scientific...
Explore innovations and future opportunities in veterinary vaccine development
Identify technology breakthroughs and...
A joint article by Phil McGuire of Cyton and Cemile Jakupoglu of knoell entitled “The use of GMOs in Animal Health” has been published in the Oct 23rd issue of AnimalPharm....
knoell is pleased to announce the integration of Critical Path Services, LLC (CPS), a contract research organization that offers GLP-compliant laboratory analysis,...