News from the Regulators

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.

 

novel veterinary therapy
18 February, 2019
Development & Registration of Novel Veterinary Therapies
Venue: to be confirmedDate: to be confirmedRegistration fee: £450 (may be subject to change)

Addressing the...

4 June, 2019

REGISTER NOW!

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...

Archive

Cyton Biosciences at VMD Pharmaceutical Industry Information Event 2018
14 November, 2018

The UK regulator, the Veterinary Medicines Directorate, will hold its annual information day for veterinary pharmaceutical industry stakeholders, on Wednesday 14th November...

Type:
Questions about the mandatory use of the common repository for veterinary submissions
12 November, 2018

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...

Type:
Business Units:
NOAH_Brexit_Beyond_London_Westminster_Animal_Health
30 October, 2018

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....

Type:
Brexit news veterinary medicines - EMA cuts back non essential activity, Denmark issues guidance and UK prepares for hard Brexit
15 October, 2018

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 -...

Type:
Business Units:
EMA news includes new referrals for paromomycin for pigs and tylosin for sheep
14 October, 2018

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...

Type:
Business Units:
11 October, 2018

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...

Type:
CPhI_worldwide_2018_Madrid_Cyton
9 October, 2018 to 11 October, 2018

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...
Type:
Cyton_TOPRA_veterinary_symposium_2018_stockholm
2 October, 2018 to 3 October, 2018

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...

Type:
Feed additives 2018 animal health Amsterdam
26 September, 2018 to 28 September, 2018

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...

Type:
Child_dog_veterinary_medicine_user_safety_EMA_guidance
18 September, 2018

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...

Type:
Business Units:
Day_Old_Chicks_EMA_European_Medicines_Agency_Animal_Health_News
18 September, 2018
Committee for Medicinal Products for Veterinary Use (CVMP) meeting September 2018

The EMA has posted the press release with details of the CVMP's meeting of 11 - 13 September...

Type:
Business Units:
European_medicines_agency_EMA_veterinary_cvmp_news_animal_health_regulatory
14 August, 2018

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...

Type:
Business Units:
Veterinary_medicines_VMP_regulatory_affairs_brexit_european_regulators
13 August, 2018

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...

Type:
Business Units:
Cat_CMDv_HMA_veterinary_medicines_VMP_regulatory_affairs
12 August, 2018

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...

Type:
Business Units:
EAVPT 2018 Wroclaw Poland European Association for Veterinary Pharmacology and Toxicology
24 June, 2018 to 27 June, 2018
Cyton and VRM at the 14th International Congress of the European Association for Veterinary Pharmacology and Toxicology

As partners in the development and European registration...

Type:
HorseMedicineEuropeNovelTherapyStemCell
22 June, 2018

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...

Type:
Business Units:
20 June, 2018 to 21 June, 2018

Die Chemspec Europe ist Europas führendes Beschaffungs- und Networking-Event für die Fein- und Spezialchemiebranche. Sie ist für Hersteller, Anbieter und Distributoren von Fein...

Type:
19 June, 2018

REGISTER NOW!

Regulatory compliance is getting increasingly important to safeguard your success for sales of chemical products around the globe.

To avoid struggling...

Maximum Residue Limits MRL veterinary medicines VMPs
18 June, 2018
CVMP meeting May 2018 - EudraVigilance update

The EMA has posted the press release with details of the CVMP's meeting of 23 – 25 May 2018 (Link), in which a revised...

Type:
Business Units:
Human biotech veterinary business Cyton Amsterdam
18 June, 2018 to 19 June, 2018
Meet Cyton to discuss product development and regulations for veterinary products 

Dr Karolina Bate, Managing Director at Cyton Biosciences Ltd will attend this exciting event...

Type:
Animal health regulatory affairs information day Ireland
13 June, 2018
Regulatory updates from the Irish Regulator of VMPS

Cyton's Pascale Canning will be attending the veterinary medicines information day, June 13, being hosted by the Irish...

Type:
8 June, 2018

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...

Type:
Business Units:
1 June, 2018

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...

Type:
Business Units:
23 May, 2018

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...

Type:
Business Units:
Veterinary medicines user safety regulatory affairs
16 May, 2018
The EMA has posted the press release with details of the CVMP's meeting of 17 – 19 April 2018 (Link). General news relating to regulatory affairs includesCommunity referrals and...
Type:
Business Units:
Brexit veterinary medicines regulatory affairs
16 May, 2018
European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) provide new information regarding the impact of Brexit on the authorisation of veterinary medicines in the UK...
Type:
Business Units:
Zinc oxide pigs CMDv regulation veterinary medicines
16 May, 2018
The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) has provided the following updates concerning regulatory affairs for veterinary...
Type:
Business Units:
Brexit veterinary medicines EMA centralised procedure
20 April, 2018

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...

Type:
EMA innovation VMP
19 April, 2018

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...

Type:
17 April, 2018

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...

Type:
Business Units:
Brexit veterinary medicines regulatory affairs
31 March, 2018

AnimalhealthEurope, the EMA and Germany have issued the following updated information regarding Brexit and veterinary medicines:

AnimalhealthEurope - “Alignment on animal...
Type:
Business Units:
20 March, 2018

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...

Type:
Business Units:
16 March, 2018

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...

Type:
Business Units:
15 March, 2018

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...
Type:
Business Units:
15 March, 2018

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...

Type:
Business Units:
Brexit veterinary medicines regulatory affairs
28 February, 2018

The following developments relating to Brexit for veterinary medicines regulatory affairs have been published:

Germany - PEI is making preparations for increased capacity...
Type:
Business Units:
Animal Health Innovation Europe
20 February, 2018 to 21 February, 2018

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...

Type:
20 February, 2018

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:...

Type:
Business Units:
19 February, 2018

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...

Type:
Business Units:
15 February, 2018

During January and February 2018, the EMA has published updates relating to the following topics:

CMC

Updated guidelines on active substances / new active substances,...
Type:
Business Units:
1 February, 2018

Denmark's DKMA has promoted change of RMS from UK to DK, free of charge (Link).

Type:
Business Units:
31 January, 2018

Finland's FIMEA has expressed interest in taking over as RMS (Link).

Type:
Business Units:
29 January, 2018

Notice to MAHs of centrally authorised medicinal products for human and veterinary use (Link).

Type:
Business Units:
24 January, 2018

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...

Type:
Business Units:
23 January, 2018

EMA surveys pharma companies on their preparedness for Brexit (Link).

Type:
Business Units:
OpenGeoSys Tutorial - Computational Hydrology III: OGS#IPhreeqc Coupled Reactive Transport Modeling
19 January, 2018

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...

Type:
Business Units:
19 January, 2018

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

...

Type:
Business Units:
12 January, 2018

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...
Type:
Business Units:
15 December, 2017

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...
Type:
Business Units:
8 December, 2017

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...

Type:
Business Units:
16 November, 2017

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...

10 November, 2017

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...

Type:
Business Units:
10 November, 2017

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...

Type:
Business Units:
8 November, 2017

During October and November, the EMA has published updates relating to the following topics:

eSubmissions

Updated electronic application forms available from 15...

Type:
Business Units:
24 October, 2017 to 26 October, 2017

Cyton will be attending CPhI Worldwide 2017, in Frankfurt (October). For full details, please visit the event website (Link).

 

Type:
12 October, 2017

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...

Type:
Business Units:
6 October, 2017

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...

Type:
Business Units:
3 October, 2017 to 4 October, 2017

Cyton will be attending TOPRA's annual Veterinary Medicines Symposium, in London (October). For full details, please visit the event website (Link).

Type:
19 September, 2017

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)...
Type:
Business Units:
19 September, 2017

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 (...
Type:
Business Units:
8 September, 2017

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...
Type:
Business Units:
8 September, 2017

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...

Type:
Business Units:
24 August, 2017 to 28 August, 2017

Contact:

Site: http://cdsympo.com/cm2017/

Tel:03-3663-7936  Fax:03-3663-7861
e-mail:event@chemicaldaily.co.jp

Type:
11 August, 2017

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)...
Type:
Business Units:
11 August, 2017

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)...
Type:
Business Units:
3 July, 2017

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...
Type:
Business Units:
3 July, 2017

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...

Type:
Business Units:
ASEAN beach with palm trees
22 June, 2017

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...

22 June, 2017

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” (...
Type:
Business Units:
21 June, 2017

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...

Type:
Business Units:
16 June, 2017

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...

Type:
Business Units:
11 May, 2017

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...
Type:
Business Units:
11 May, 2017

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...

Type:
Business Units:
18 April, 2017

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...

Type:
Business Units:
6 April, 2017

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...
Type:
Business Units:
6 April, 2017

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...
Type:
Business Units:
1 April, 2017

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...

Type:
Business Units:
17 March, 2017

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...

Type:
Business Units:
16 March, 2017 to 17 March, 2017

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).

...

Type:
15 March, 2017

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...

9 March, 2017

In addition to the CVMPs February meeting report (Link), the EMA has published various other updates:

Anthelmintic resistance

Veterinary focus group meeting with...
Type:
Business Units:
24 February, 2017

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...

Type:
Business Units:
Animal Health Investment Europe
22 February, 2017 to 23 February, 2017

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).

...

Type:
20 February, 2017 to 21 February, 2017

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...

17 February, 2017

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:

...

Type:
Business Units:
20 January, 2017

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:

...
Type:
Business Units:
20 December, 2016

The UK VMD and Irish HPRA have released updated guidance on the production of mock-ups for both markets (Link).

Type:
Business Units:
20 December, 2016

IFAH-Europe has released its December edition of the newsletter “Perspectives (Link).

Type:
Business Units:
19 December, 2016

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...
Type:
Business Units:
13 December, 2016

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,...

Type:
Business Units:
9 December, 2016

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...
Type:
Business Units:
9 December, 2016

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...

Type:
Business Units:
7 December, 2016

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...

Type:
Business Units:
5 December, 2016

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...

Type:
Business Units:
1 December, 2016

The CMDv has updated its document “National Authority Fees Terms of Payment and Addresses” (Link).

Type:
Business Units:
1 December, 2016

The EMA has issued updated submission dates for centralised and MRL procedure applications (Link).

Type:
Business Units:
29 November, 2016

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...

Type:
Business Units:
28 November, 2016

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...

Type:
Business Units:
25 November, 2016

The Swedish MPA has developed a checklist for the submission of product information: SPC, package leaflet and labelling (Link).

Type:
Business Units:
24 November, 2016

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...

Type:
Business Units:
22 November, 2016

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...

Type:
Business Units:
21 November, 2016

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...

Type:
Business Units:
17 November, 2016

The EMA has now published the following documents adopted in the November meeting of the CVMP:

Draft reflection paper released for consultation

QUALITY: Chemical...
Type:
Business Units:
17 November, 2016

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 (...

Type:
Business Units:
17 November, 2016

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...

Type:
Business Units:
15 November, 2016

The EMA has prepared a guidance video to assist with completion of eAF v1.20, which can be found on the esubmissions website (Link).

Type:
Business Units:
14 November, 2016

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...

Type:
Business Units:
11 November, 2016

The UK VMD has published the latest edition of MAVIS (Link). Contents include updates on:

LicensingEnforcementPharmacovigilanceAntimicrobial ResistanceVeterinary Products...
Type:
Business Units:
11 November, 2016

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...

Type:
Business Units:
3 November, 2016

FVE and the Standing Committee of European Doctors (CPME) have issued a press release celebrating One Health Day (Link).

Type:
Business Units:
31 October, 2016

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...
Type:
Business Units:
25 October, 2016

The CMDv has updated its links to national agency webpages regarding payment of fees (Link).

Type:
Business Units:
24 October, 2016

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).

Type:
Business Units:
24 October, 2016

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...

Type:
Business Units:
24 October, 2016

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...

Type:
Business Units:
18 October, 2016

Updated versions of 4 electronic Application Forms (eAF v. 1.20.0.3) have been published following reported issues (Link).

Type:
Business Units:
14 October, 2016

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...

Type:
Business Units:
14 October, 2016

A recent VMD survey highlighted that improvements could be made to the Product Literature Standard, so further feedback is being requested (Link).

Type:
Business Units:
13 October, 2016

IFAH-Europe and EGGVP have signed the EPRUMA declaration “Our 7 commitments to the responsible use of veterinary medicines” (Link).

Type:
Business Units:
7 October, 2016

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...

Type:
Business Units:
6 October, 2016

Health for Animals has issued the latest edition of its newsletter (Link).

IFAH-Europe has issued the latest edition of its Perspectives Newsletter (Link).

Type:
Business Units:
4 October, 2016

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...

Type:
Business Units:
1 October, 2016

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...

Type:
Business Units:
30 September, 2016

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...
Type:
Business Units:
28 September, 2016

The EMA has now published the following documents adopted in the September meeting of the CVMP:

Draft Immunologicals guidance released for consultation:

Concept paper...
Type:
Business Units:
22 September, 2016

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...

Type:
Business Units:
22 September, 2016

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 “...

Type:
Business Units:
21 September, 2016

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....

Type:
Business Units:
19 September, 2016

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...

Type:
Business Units:
16 September, 2016

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...

Type:
Business Units:
12 September, 2016

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...

Type:
Business Units:
12 September, 2016

The EMA has published its annual report on the GMP / GDP inspectors working group (Link).

Type:
Business Units:
12 September, 2016

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...

Type:
Business Units:
9 September, 2016

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...

Type:
Business Units:
9 September, 2016

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...

Type:
Business Units:
5 September, 2016

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...

Type:
Business Units:
1 September, 2016

Health for Animals has released two new publications:

Vaccination Myths – Filling the void between vaccination fact and fiction (Link)Global Vision for Regulation of...
Type:
Business Units:
26 August, 2016

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...

Type:
Business Units:
26 August, 2016

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,...

Type:
Business Units:
26 August, 2016

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...

Type:
Business Units:
26 August, 2016

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:...

Type:
Business Units:
26 August, 2016

Presentations and summaries are available, upon request, from the 2014 & 2016 Workshops on the Proposals for new Regulations for veterinary medicinal products and Medicated...

Type:
Business Units:
18 August, 2016

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...

Type:
Business Units:
17 August, 2016

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...

Type:
Business Units:
12 August, 2016

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...

Type:
Business Units:
29 July, 2016

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...

Type:
Business Units:
28 July, 2016

The UK’s National Office of Animal Health (NOAH) has issued a comprehensive response to the O’Neill AMR review report (Link).

Type:
Business Units:
25 July, 2016

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...
Type:
Business Units:
22 July, 2016

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...

Type:
Business Units:
15 July, 2016

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

...
Type:
Business Units:
14 July, 2016

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...

Type:
Business Units:
13 July, 2016

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...

Type:
Business Units:
12 July, 2016

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...

Type:
Business Units:
8 July, 2016

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...

Type:
Business Units:
7 July, 2016

Perspectives Issue 38 is now available to view and download on the IFAH-Europe website (Link).

Type:
Business Units:
6 July, 2016

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,...

Type:
Business Units:
5 July, 2016

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.

Type:
Business Units:
5 July, 2016

The CMDv has updated their list of VMPs available for use in bees in Europe (Link).

Type:
Business Units:
5 July, 2016

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:

...
Type:
Business Units:
5 July, 2016

Minutes of the CMDv stakeholders meeting in January have now been published, summarising the discussions between the CMDv, AVC, IFAH-Europe and EGGVP (Link).

Type:
Business Units:
4 July, 2016

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).

Type:
Business Units:
1 July, 2016

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).

Type:
Business Units:
30 June, 2016

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).

Type:
Business Units:
30 June, 2016

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...

Type:
Business Units:
29 June, 2016

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,...
Type:
Business Units:
28 June, 2016

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...

Type:
Business Units:
28 June, 2016

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...

Type:
Business Units:
24 June, 2016

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).

Type:
Business Units:
23 June, 2016

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:

...
Type:
Business Units:
21 June, 2016

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...

Type:
Business Units:
17 June, 2016

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...

Type:
Business Units:
17 June, 2016

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...

Type:
Business Units:
17 June, 2016

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...

Type:
Business Units:
16 June, 2016

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...

Type:
Business Units:
15 June, 2016

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,...

Type:
Business Units:
8 June, 2016

The EMA has published an updated pre-submission meeting request form for an application for a centralised marketing authorisation for veterinary medicinal products (Link).

Type:
Business Units:
6 June, 2016

FVE has published a position paper stating that it believes all coccidiostats and histomonostats should be under veterinary prescription. The organisation has requested the...

Type:
Business Units:
3 June, 2016

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).

Type:
Business Units:
3 June, 2016

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...

Type:
Business Units:
3 June, 2016

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...

Type:
Business Units:
31 May, 2016

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...

Type:
Business Units:
31 May, 2016

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).

Type:
Business Units:
27 May, 2016

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...

Type:
Business Units:
27 May, 2016

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...

Type:
Business Units:
20 May, 2016

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:

 

...

Type:
Business Units:
19 May, 2016

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...

Type:
Business Units:
18 May, 2016

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...

Type:
Business Units:
17 May, 2016

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...
Type:
Business Units:
17 May, 2016

Health for Animal has published a new pharmacovigilance guidance document titled “The Essentials of Veterinary Pharmacovigilance” (Link).

Type:
Business Units:
13 May, 2016

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...

Type:
Business Units:
11 May, 2016

Notice to Applicants volume 6A (procedures for marketing authorisation) has been updated to delete Chapter 4 (centralised procedure), because the EMA provides all relevant...

Type:
Business Units:
11 May, 2016

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...

Type:
Business Units:
11 May, 2016


Shiran Qiu (CPS), Libby Liebig (CPS), and Steffi Sacher (knoell) attended the Environmental Modeling Public Meeting (EMPM) on Monday, May 9, 2016 at the EPA offices in...

Type:
10 May, 2016

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...

Type:
Business Units:
9 May, 2016

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...

Type:
Business Units:
5 May, 2016

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...

Type:
Business Units:
29 April, 2016

The EMA has now published the following documents adopted in the April meeting of the CVMP:

Efficacy guidance:

Revised reflection paper on anthelmintic resistance (...
Type:
Business Units:
29 April, 2016

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).

Type:
Business Units:
28 April, 2016

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...
Type:
Business Units:
28 April, 2016

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...

Type:
Business Units:
26 April, 2016

Beth Dederick and Michael Cleuvers attended the SCHC Spring 2016 Meeting in Fort Lauderdale, Florida from April 18-20, 2016. SCHC, the Society for Chemical Hazard Communication...

Type:
22 April, 2016

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...
Type:
Business Units:
21 April, 2016

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...
Type:
Business Units:
19 April, 2016
What’s Happening?

June 1, 2016 is the final compliance date associated with the implementation of OSHA’s Hazard Communication Standard 2012 (29 CFR 1910.1200) which provides for...

Type:
18 April, 2016

The presentations given at the IFAH-Europe / EMA infoday 2016 are now available to download from the EMA website (Link).

Type:
Business Units:
18 April, 2016

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...

Type:
Business Units:
15 April, 2016

Beth Dederick, CPS Director of Regulatory Services, and Michael Cleuvers, knoell Managing Director for Industrial Chemicals and Biocides, will attend the Society for Chemical...

Type:
14 April, 2016

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...

Type:
Business Units:
13 April, 2016

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...

Type:
Business Units:
13 April, 2016

The report from the HMA stakeholders’ meeting, Amsterdam, 16 – 18 February 2016 is now available online (Link).

Type:
Business Units:
12 April, 2016

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...

Type:
Business Units:
11 April, 2016

Pat deLisio, Director of Laboratory Services and Rodney Bennett, Director of Agrochemical Services, will attend CropLife America and RISE Spring Conference in Arlington VA...

Type:
8 April, 2016

Beth Dederick, Director of Regulatory Services, will attend the SOCMA Fly-In in Washington, DC on April 11 and 12.

Type:
8 April, 2016

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...

Type:
Business Units:
6 April, 2016

The VMD has reviewed the fee charged for a category of national workshare variations (Link).

Type:
Business Units:
6 April, 2016

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).

Type:
Business Units:
5 April, 2016

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...

Type:
Business Units:
4 April, 2016

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).

Type:
Business Units:
4 April, 2016

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...

Type:
Business Units:
1 April, 2016

The Finnish authority, FIMEA, has published its fees for 2016-2017. More information is available on the website (Link).

Type:
Business Units:
1 April, 2016

The Finnish Authority, FIMEA, has published its fees for 2016, with an unofficial translation into English provided (Link).

Type:
Business Units:
1 April, 2016

The fees page of the EMA website has now been updated, with new fees applicable as of 1st April 2016 (Link).

Type:
Business Units:
1 April, 2016

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...

Type:
Business Units:
1 April, 2016

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...

Type:
Business Units:
31 March, 2016

The fees page of the USKVBL website has now been updated (Link).

Type:
Business Units:
31 March, 2016

As part of the five-yearly renewal of veterinary medicinal products, the MAH  shall submit the updated supplementary documentation that demonstrates the adaptation to...

Type:
Business Units:
30 March, 2016

European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) held their stakeholders annual meeting on 2nd March 2016. The agenda and presentations from the meeting...

Type:
Business Units:
30 March, 2016

Updated EU Harmonised Birth Dates, Data Lock-in Points & Allocated RMS have been published in the HMA website (Link).

Type:
Business Units:
23 March, 2016

This issue of the Perspectives newsletter includes discussion of the new veterinary medicines legislation, the EFSA-ECDC report on antimicrobial resistance, and the...

Type:
Business Units:
22 March, 2016

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...

Type:
Business Units:
22 March, 2016

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...

Type:
Business Units:
21 March, 2016

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...

Type:
Business Units:
21 March, 2016

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...

Type:
Business Units:
21 March, 2016

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...

Type:
Business Units:
18 March, 2016

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 (...

Type:
Business Units:
18 March, 2016

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...
Type:
Business Units:
18 March, 2016

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 (...

Type:
Business Units:
17 March, 2016

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).

Type:
Business Units:
15 March, 2016

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.

...

Type:
Business Units:
14 March, 2016

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...

Type:
Business Units:
14 March, 2016

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...

Type:
Business Units:
11 March, 2016

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)....

Type:
Business Units:
11 March, 2016

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...

Type:
Business Units:
10 March, 2016

IFAH-Europe has responded positively to the European Parliament's recent discussions around animal health, following the recent adoption of the Transmissible Animal Diseases...

Type:
Business Units:
9 March, 2016

The updated version of the Scientific Advice letter of intent template can be accessed via the EMA website (Link to Word document).

Type:
Business Units:
9 March, 2016
Seoul, Korea

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...

Type:
Business Units:
8 March, 2016

What’s Happening?

OSHA has requested comments from the general public on its draft Guidance on Data Evaluation for Weight of Evidence Determination (OSHA-2016-0004)....

Type:
8 March, 2016

Bonnie MacCulloch, CPS Regulatory Scientist, will present during a free ACS AGRO webinar, “Seed Treatment Background, Testing and Analytical Tools.” Click here for more...

Type:
8 March, 2016

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...

Type:
Business Units:
8 March, 2016

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).

Type:
Business Units:
7 March, 2016

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...
Type:
Business Units:
7 March, 2016

The CMDV workplan for 2016 has been published (Link) and includes key tasks for:

Increasing the availability of VMPsReducing administrative burdenProviding input in the...
Type:
Business Units:
3 March, 2016

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...
Type:
Business Units:
29 February, 2016

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...
Type:
Business Units:
26 February, 2016

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).

Type:
Business Units:
23 February, 2016

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)....

Type:
Business Units:
19 February, 2016

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...
Type:
Business Units:
18 February, 2016

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...

Type:
Business Units:
18 February, 2016

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...
Type:
Business Units:
18 February, 2016

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...
Type:
Business Units:
17 February, 2016

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...
Type:
Business Units:
17 February, 2016

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...

Type:
Business Units:
15 February, 2016

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...

Type:
Business Units:
14 February, 2016

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 (...

Type:
Business Units:
12 February, 2016

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)....

Type:
Business Units:
12 February, 2016

The Estonian agency for medicines has published the 2015 data for AERs relating to VMPs, together with reports since 2005 (Link).

Type:
Business Units:
12 February, 2016 to 23 February, 2016
  What’s Happening?

The deadline of February 23, 2016 is quickly approaching for the submission of specific information with regards to nanomaterials that may be in commerce in...

Type:
8 February, 2016

The EMA has published updated distribution requirements for submitting PSURs for VMPs authorised through the CP (Link).

Type:
Business Units:
3 February, 2016

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...
Type:
Business Units:
2 February, 2016

The EMA has published the latest requirements of the EMA and CVMP for submissions of MA and MRL applications (Link).

Type:
Business Units:
1 February, 2016

The AEMPS veterinary product information database is now available as a free app for mobile phones (Link).

Type:
Business Units:
1 February, 2016

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...

Type:
Business Units:
28 January, 2016

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...

Type:
Business Units:
27 January, 2016

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).

Type:
Business Units:
26 January, 2016

The UK VMD has published a thorough review of the 5,743 AERs they received in 2014, grouped by species and medicine type (Link).

Type:
Business Units:
26 January, 2016

The Marketing Authorisations Veterinary Information Service (MAVIS) edition 97 is now available to view on the VMD’s website (Link).

Type:
Business Units:
22 January, 2016

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...

Type:
Business Units:
22 January, 2016

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...
Type:
Business Units:
21 January, 2016

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.

...

Type:
Business Units:
20 January, 2016
What’s Happening?

Health Canada has updated its regulatory requirements for workplace chemicals by aligning WHMIS (Workplace Hazardous Materials Information System) with GHS (...

Type:
20 January, 2016

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).

Type:
Business Units:
14 January, 2016

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 ...

Type:
Business Units:
14 January, 2016

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...

Type:
Business Units:
14 January, 2016

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...

Type:
Business Units:
14 January, 2016

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...

Type:
Business Units:
13 January, 2016

TOPRA (The Organisation for Professionals in Regulatory Affairs) has posted an introduction to its new president, Thomas Kuhler and their vision for 2016 (Link).

Type:
Business Units:
12 January, 2016

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...

Type:
Business Units:
12 January, 2016
What’s Happening?

The deadline of January 31 is quickly approaching for submitting the Polymer Exemption Report to the EPA for those companies who relied upon the Polymer...

Type:
12 January, 2016

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).

Type:
Business Units:
11 January, 2016

Thomas Senderovitz has been hired as the director of the Danish Medicines Agency as of 1st April 2016 (Link).

Type:
Business Units:
11 January, 2016

Beth Dederick, Director of Regulatory Services, will attend Informex in New Orleans, LA from February 2-3, 2016.

More information is available here.

Type:
11 January, 2016

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...

Type:
Business Units:
8 January, 2016
What’s Happening?

EPA’s TSCA Chemical Data Reporting Rule (“CDR Rule”) requires manufacturers and importers to report information on chemical substances which they produce or...

Type:
Business Units:
7 January, 2016

Visit us at NAICC in Orlando January 26-29, 2016 booth number 203.

More information is available here.

Type:
Business Units:
7 January, 2016

Critical Path Services, LLC encourages anyone affected by the current restructurings with a background in regulatory or any regulatory science, e.g., toxicology, eco toxicology...

Type:
Business Units:
5 January, 2016

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...

Type:
Business Units:
31 December, 2015

Fees payable to the Estonian agency for medicines have been updated for 2016 (Link).

Type:
Business Units:
22 December, 2015

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...

Type:
Business Units:
21 December, 2015

In collaboration with HealthforAnimals and NOAH, IFAH-Europe has published a critique on the 2015 O'Neill report on antimicrobial resistance (Link).

Type:
Business Units:
21 December, 2015

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...

Type:
Business Units:
21 December, 2015

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,...

Type:
Business Units:
18 December, 2015

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...

Type:
Business Units:
11 December, 2015

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...
Type:
Business Units:
10 December, 2015

The guidance document "Link to National Databases of Authorised Products" can be found on the CMDv website (Link).

Type:
Business Units:
27 November, 2015

The CMDh / CMDv have published examples of acceptable and not acceptable groupings for MRP/DCP products (Link).

Type:
Business Units:
24 November, 2015

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...

Type:
Business Units:
18 November, 2015

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...

Type:
Business Units:
16 November, 2015

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...
Type:
Business Units:
16 November, 2015

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...

Type:
Business Units:
16 November, 2015

The guidance gives details of the documentary requirements for a Marketing Authorisation transfer (different legal entity) in all EU/EEA Member States (Link).

Type:
Business Units:
10 November, 2015

The most recent members list, which gives details of all CMDv members and their qualifications, includes a new representative for Bulgaria (Link).

Type:
Business Units:
10 November, 2015

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...

Type:
Business Units:
10 November, 2015

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...

Type:
Business Units:
9 November, 2015

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...
Type:
Business Units:
2 November, 2015

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...

Type:
Business Units:
28 October, 2015

The UK authority (VMD) has published the Marketing Authorisations Veterinary Information Service (MAVIS) edition 96 (Link).

Type:
Business Units:
27 October, 2015

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...

Type:
Business Units:
27 October, 2015

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...

Type:
Business Units:
23 October, 2015

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.

...

Type:
Business Units:
23 October, 2015

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...

Type:
Business Units:
23 October, 2015

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...

Type:
Business Units:
20 October, 2015

The European Commission has issued updates to Eudralex Volume 4, guidance on GMP (Link):

Annex 15 (qualification and validation) – in operation since 1Oct15Annex 16 (...
Type:
Business Units:
15 October, 2015

The UK’s VMD has published new and updated information as follows:

Copycat Marketing Authorisations: Change to variation validation procedure (Link)VMD open meeting ...
Type:
Business Units:
15 October, 2015

IFAH-Europe’s latest press releases and Perspectives newsletter are focused on the promotion of prudent use of antimicrobial VMPs:

Veterinary medicines legislation update...
Type:
Business Units:
15 October, 2015

The EMA has published the fifth ESVAC report, covering data from 2013, together with an interactive database.

ESVAC Report (Link)Database (Link)
Type:
Business Units:
14 October, 2015

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).

Type:
Business Units:
12 October, 2015

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...

Type:
Business Units:
9 October, 2015

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...

Type:
Business Units:
9 October, 2015

A guide to good advertising practice for veterinary medicines has been made available by France’s ANSES (Link - French language only).

Type:
Business Units:
5 October, 2015

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...

Type:
Business Units:
5 October, 2015

The new VNeeS 2.3 Guideline and tools are effective from 01/10/15 and should now be used (Link).

Type:
Business Units:
2 October, 2015

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.

Type:
Business Units:
1 October, 2015

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...

Type:
Business Units:
29 September, 2015

EGGVP has issued a position paper on the protection of technical documentation, as proposed for the new legislation governing veterinary medicinal products (Link).

Type:
Business Units:
21 September, 2015

EGGVP has issued a press release highlighting the benefits of generic VMPs and raising concerns about the new Regulation for VMPs (Link).

Type:
Business Units:
21 September, 2015

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...

Type:
Business Units:
18 September, 2015

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...

Type:
Business Units:
17 September, 2015

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...
Type:
Business Units:
15 September, 2015

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...

Type:
Business Units:
11 September, 2015

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...
Type:
Business Units:
11 September, 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...

Type:
Business Units:
11 September, 2015

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...
Type:
Business Units:
9 September, 2015

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"...

Type:
Business Units:
7 September, 2015

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...

Type:
Business Units:
4 September, 2015

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...

Type:
Business Units:
3 September, 2015

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...

Type:
Business Units:
3 September, 2015

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-...

Type:
Business Units:
3 September, 2015

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...

Type:
Business Units:
1 September, 2015

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 (...

Type:
Business Units:
27 August, 2015

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):

...
Type:
Business Units:
25 August, 2015

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...

Type:
Business Units:
18 August, 2015

The VMD open meeting will take place on 2nd October 2015 (Link). Requests for tickets should be submitted by 4th September.

Type:
Business Units:
29 July, 2015

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...

Type:
Business Units:
29 July, 2015

The EMA has extended its fee reductions for pharmacovigilance-related variations to marketing authorisations for VMPs (Link).

Type:
Business Units:
27 July, 2015

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).

Type:
Business Units:
22 July, 2015

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...
Type:
Business Units:
22 July, 2015

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...

Type:
Business Units:
16 July, 2015

The Austrian AGES MEA has published its latest fees document, effective from 4th May 2015 in both German (Link) and English (Link)

Type:
Business Units:
15 July, 2015

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...

Type:
14 July, 2015

Senior leaders from the United States Food and Drug Administration (FDA), the European Commission and the European Medicines Agency (EMA) reviewed their ongoing cooperative...

Type:
Business Units:
10 July, 2015

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...
Type:
Business Units:
10 July, 2015

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...

Type:
Business Units:
10 July, 2015

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...

Type:
Business Units:
10 July, 2015

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...
Type:
Business Units:
9 July, 2015

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...

Type:
Business Units:
9 July, 2015

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...

Type:
Business Units:
3 July, 2015

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...

Type:
Business Units:
2 July, 2015

The UK VMD has published the slides presented at their pharmaceutical information day held on 25th June (Link).

Type:
Business Units:
30 June, 2015

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...

Type:
Business Units:
25 June, 2015

The Irish HPRA has issued updated application forms for veterinary clinical trial licences:

Application for a Clinical Field Trial Licence under Animal Remedies Legislation...
Type:
Business Units:
22 June, 2015

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...

Type:
Business Units:
18 June, 2015

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...
Type:
Business Units:
18 June, 2015

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...

Type:
Business Units:
15 June, 2015

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...
Type:
Business Units:
12 June, 2015

AGES has published a short clarification regarding the applicable approval dates for Type 1A and Type 1AIN variations, in German language only (Link).

Type:
Business Units:
11 June, 2015

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...

Type:
Business Units:
10 June, 2015

The EMA has adopted its recommendation on pharmacovigilance surveillance and signal detection of veterinary medicinal products (Link). Also published is the overview of...

Type:
Business Units:
5 June, 2015

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...
Type:
Business Units:
5 June, 2015

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...

Type:
Business Units:
5 June, 2015

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...
Type:
Business Units:
2 June, 2015

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 :...

Type:
Business Units:
1 June, 2015

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...

Type:
Business Units:
28 May, 2015

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).

Type:
Business Units:
22 May, 2015

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...

Type:
21 May, 2015

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...

Type:
15 May, 2015

TOPRA will be running the follow two courses in June:

CRED Veterinary Variations (Link)CRED Veterinary e-submissions (Link)
Type:
13 May, 2015

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...

Type:
12 May, 2015

In May, both Spain and Sweden published their 2014 pharmacovigilance bulletins, summarising adverse events reported last year. Their respective reports can be found here:

...
Type:
11 May, 2015

The European Commission has published the responses from stakeholders to consultation on GMP guidance Annex 15, relating to Qualification and Validation, which includes the...

Type:
8 May, 2015

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...
Type:
4 May, 2015

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...

Type:
29 April, 2015

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...

Type:
29 April, 2015

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:

...
Type:
28 April, 2015

The Finnish FIMEA has published its first Pharmacopoeia-Newsletter (January 2015) which includes current news related to the Pharmacopoeia and information about training for...

Type:
23 April, 2015

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...

Type:
15 April, 2015

The UK VMD has posted advice encouraging industry to meet them before submitting applications concerning PBTs or biopharmaceuticals (Link).

Type:
14 April, 2015

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...

Type:
14 April, 2015

The HMA has published a statement on the review of the VMPs legislation (Link), highlighting "unintended and unacceptable consequences" and missed opportunities. Their most...

Type:
13 April, 2015

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...
Type:
13 April, 2015

The CMDv has published the clock-start dates for MRPs and DCPs starting in 2016 and 2017 (Link).

Type:
13 April, 2015

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...

Type:
10 April, 2015

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).

Type:
10 April, 2015

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...

Type:
2 April, 2015

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...
Type:
2 April, 2015

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...

Type:
31 March, 2015

The Romanian ICBMV has posted its plan for sampling and testing of VMPs for 2015 (Link).

Type:
31 March, 2015

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...

Type:
31 March, 2015
As of the 23rd March, Cyton's offices are now located at the following address: 68 Macrae RoadEden Office ParkHam GreenBristolBS20 0DD All contact email addresses and telephone...
Type:
31 March, 2015

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...

Type:
30 March, 2015

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...

Type:
30 March, 2015

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...

Type:
30 March, 2015

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.

Type:
27 March, 2015

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...

Type:
26 March, 2015

EFSA has published a scientific report highlighting deficiencies in technological feed additive dossiers, identified during preparatory work for the re-evaluation feed...

Type:
26 March, 2015

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...

Type:
23 March, 2015

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...

Type:
16 March, 2015

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).

Type:
13 March, 2015

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...
Type:
13 March, 2015

If you’re manufacturing or selling anything, customer satisfaction matters. A lot. If there are production issues anywhere along the supply chain, the result is often unhappy...

Type:
10 March, 2015

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...
Type:
10 March, 2015

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...
Type:
9 March, 2015

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...

Type:
6 March, 2015

The list of bee products authorised in Europe, published via the CMDv, has been updated to include those authorised in Estonia (Link).

Type:
4 March, 2015

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...

Type:
4 March, 2015

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...

Type:
3 March, 2015

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...

Type:
27 February, 2015

The EMA has published two revised VICH guidelines, relating to “Studies to Evaluate the Metabolism and Residues Kinetics of Veterinary Drugs in...

Type:
27 February, 2015

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...

Type:
26 February, 2015

The original press release and further details can be found here.

Type:
26 February, 2015

This progress report (full report here) gives an update on the European actions being implemented in the context of antimicrobial resistance including:

Strengthening the...
Type:
25 February, 2015

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...

Type:
25 February, 2015

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...

Type:
25 February, 2015

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...

Type:
16 February, 2015

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...

Type:
16 February, 2015

The annual report can be found online here.

Type:
13 February, 2015

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...
Type:
12 February, 2015

Roxane Feller, previously Director of the Economic Department in FoodDrinkEurope, has been appointed as the International Federation for Animal Health Europe (IFAH-Europe's)...

Type:
12 February, 2015

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...

Type:
11 February, 2015

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....

Type:
11 February, 2015

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.

Type:
6 February, 2015

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...

Type:
5 February, 2015

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...

Type:
5 February, 2015

The ANMV has updated their online searchable database of veterinary medicinal products authorised in France. The new search pages can be found here.

Type:
4 February, 2015

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...

Type:
2 February, 2015

The statement from IFAH-Europe can be found here and the joint report of ECDC, EFSA and EMA can be found here.

Type:
30 January, 2015
Reflection paper on the risk of antimicrobial resistance transfer from companion animals can be found here.Draft guideline on the procedure to be followed when a batch of a...
Type:
30 January, 2015

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....

Type:
30 January, 2015

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...

Type:
27 January, 2015

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...

Type:
26 January, 2015

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.

Type:
21 January, 2015

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@...

Type:
21 January, 2015

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...

Type:
19 January, 2015

The HPRA published a guide to Display of Chemical Group Symbols on Product Literature of Sheep Anthelmintics, which can be found here.

Type:
16 January, 2015

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...
Type:
16 January, 2015

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...
Type:
16 January, 2015

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...

Type:
4 January, 2015

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...

Type:
2 January, 2015

Updated fees are payable to AEMPS from January 1st 2015.  See this page for details (in English).

Type:
1 January, 2015

New rates for state fees apply to regulatory submissions made to the Estonian Authority from January 1st 2015.  See this page for details.

Type:
22 December, 2014

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...

Type:
22 December, 2014

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/...

Type:
Business Units:
22 December, 2014

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/...

Type:
Business Units:
19 December, 2014

The USKVBL published a notice to marketing authorisation holders discussing the payment of annual maintenance fees for authorised veterinary medicinal products. An English...

Type:
10 December, 2014

An industry information seminar was held at USKVBL on 20th – 21st November, regarding the regulation of veterinary medicinal products (VMPs). Topics covered included: import...

Type:
9 December, 2014

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...

Type:
1 December, 2014

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...

Type:
28 November, 2014

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...

Type:
4 November, 2014

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...

Type:
22 October, 2014 to 23 October, 2014
The must attend forum for the food, feed and additives industry

Recognised for the in-depth and uncontested analysis on raw material feed levels, alternative sources of protein...

Type:
13 October, 2014 to 14 October, 2014
Bringing together representatives of industry and regulatory authorities to understand today’s regulatory requirements and debate future plans for regulation.

The timing of this...

Type:
25 September, 2014 to 26 September, 2014

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...
Type:
25 February, 2014

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...

Type:
Business Units:
5 February, 2014

The European Commission has published an updated version of Eudralex Volume 6B, Part 1A of the Marketing Authorisation application for VMPs (the application form):

...

Type:
14 January, 2014

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...

Type:
Business Units:
10 January, 2014

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...

Type:
24 December, 2013

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...

Type:
4 December, 2013 to 5 December, 2013
Why is Veterinary Vaccines a MUST ATTEND for 2013? 

Explore innovations and future opportunities in veterinary vaccine development

Identify technology breakthroughs and...

Type:
31 October, 2013

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....

Type:
Business Units:
13 June, 2013

knoell is pleased to announce the integration of Critical Path Services, LLC (CPS), a contract research organization that offers GLP-compliant laboratory analysis,...

Type:
Will Drury Senior Business Associate
+44 (0) 208 293-5632 +44 (0) 127 537-3281 send mail LinkedIn profile