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July's Veterinary Regulatory update: something for all technical specialisms, and official documents galore

There has been another flurry of EMA/CVMP activity this month, with reports, guidelines, regulatory resources and consultations all being issued.

EMA/CVMP

Preparation for the new EU Regulation 2019/6 (the new VMP-Reg) continues apace: July has seen several new and revised scientific guidelines issued, no fewer than seven consultations opened, as well as miscellaneous presentations and video recordings from Agency meetings and webinars, and publication of official reports, procedural information and reference documents.

The CVMP meeting highlights can be accessed here, and include a helpful summary of EMA/CVMP guidance that has been updated in line with the content and terminology found in the new VMP-Reg - without public consultation in the cases where the scientific aspect of the guidance has not changed.

A number of new and updated scientific guidance documents adopted following consultation have been published this month:

GUIDANCE

QUALITY/CMC

Version 2 of the guideline on data requirements for the veterinary MAA dossier, on manufacture of the finished dosage form, has been adopted: the new version comes into effect on 28th January 2022. The updated document can be accessed here.

LIMITED MARKETS

A reflection paper on classification of a product as intended for a limited market, and eligibility for authorisation under Article 23 of Regulation (EU) 2019/6, is now finalised and can be accessed online, as well as an overview of comments received during consultation. 

Guidelines on the safety and residue data and efficacy and target animal safety data requirements for non-immunological veterinary medicinal products intended for limited markets, have been adopted following consultation. These replace the 'Guideline on safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market' and 'Guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor uses or minor species' respectively, coming into force with the new VMP-Reg on January 28th 2022.

A further guideline on data requirements for immunological veterinary medicinal products intended for limited markets has been adopted in July, replacing the previous guidance. 

BIOLOGICALS

The CVMP guideline on data requirements for adjuvants in vaccines for veterinary use (Revision 1) was adopted in July. It will come into force on 28th January 2022, with the new VMP-Reg. It replaces the Note for guidance on the use of adjuvanted veterinary vaccines (Link to guideline PDF).

PHARMACOVIGILANCE

A revised (Version 12) list of VeDDRA clinical terms for reporting suspected adverse reactions to veterinary medicinal products, in animals and humans, was adopted in July. The related guidance has also been updated.

Procedural and reference information

  • A new fee list has been published by the EMA, and is applicable from 15th July 2021.
  • Union Product Database: certain chapters of the Implementation Guide have been updated in July, and chapter 6 is newly published – along with a summary of comments from the stakeholder consultation. See the UPD webpage
  • Version 2.1 of the user guidance for EMA's IRIS submission platform (for scientific applications) has been published online.
  • The new veterinary QRD template (version 9.0) is to be used in all MAA applications that will be validated after January 28th, 2022. There is a summary of the changes made and the rationale behind them, as well as links to the new template: annotated and highlighted PDFs, and new Word document (English language version only, all EU language versions will be available from October 2021).
  • The EMA has issued an updated contacts list for translation review, for human and veterinary procedures (see PDF of the document here).
  • EMA has published a list of stakeholders eligible to be consulted or to co-operate directly with the Agency (human and veterinary) (Link).
  • The Q&A on renewals, in the context of the new VMP-Reg, have been updated.

New concept papers and draft guidelines have also been made available for consultation. These are summarised below:

CONSULTATIONS

Pharmacovigilance (PV)

Six draft guidelines on good Veterinary PV Practice were published in July. These are linked from the main consultation page and address the following topics: 

  • Collection and recording of SAEs (Link)
  • Controls and PV inspection (Link)
  • PV systems, Quality Management Systems and PV Master Files (Link)
  • Signal management (Link)
  • Veterinary PV communication (Link)
  • Glossary of terms and abbreviations (Link)

Consultation is open with comments invited until September 5th.

BIOLOGICALS / IMMUNOLOGICALS

Consultation has opened on the CVMP draft guideline on data requirements for vaccine platform technology master files (vPTMF). The intention of the guideline is to describe the type of data to be included in a vPTMF, and the possible omission and/or reduction of data required for subsequent dossier submissions for Marketing Authorisations based on a vPTMF. Comments can be sent until 29th October 2021.

Another consultation has opened on data requirements for authorisation of immunological veterinary medicinal products under exceptional circumstances. The resulting guidance will replace existing CVMP guidance on exceptional authorisation of vaccines for bluetongue virus and avian influenza. Comments can be sent until 29th October 2021. 

Comments are invited until 29th October on a draft CVMP guideline on clinical trials with immunological veterinary medicinal products. The guideline will replace the note for guidance 'Field trials with veterinary vaccines'.

Safety

A concept paper has been published on MRL evaluation for biological substances; consultation is open until 30th September. The paper can be viewed on the EMA website here.

Another consultation has opened in July with the aim to provide clear guidance on how to perform an environmental risk assessment (ERA) for veterinary medicinal products intended to be used in aquaculture. Comments are invited until 31st October.

ANTHELMINTICS

Consultation is open on a draft guideline on the summary of product characteristics (SPC) for anthelmintics. The aim of the guidance is to highlight that development of resistance is directly affected by the use of anthelmintics; it recommends adding standard warnings in the SPC for anthelmintic products where appropriate. Comments are invited until 30th September.

 

REPORTS, MEETINGS, AND OTHER DOCUMENTS PUBLISHED

  • The EMA’s SME office has published a report on its activities for the period 2016-2020. The press release can be viewed here, with a link to the report PDF.  Presentation slides have also been published from a roundtable meeting that took place in November 2020. 
  • Presentations, infographics and a recording of the web seminar on EMA’s categorisation of antibiotics used in animals, that took place on June 23rd, are now available to view online
  • A report published jointly by EFSA, the EMA and the European Centre for Disease Prevention and Control (ECDC) shows that use of antibiotics in animals is decreasing. The third JIACRA report presents data on antibiotic consumption, and development of antimicrobial resistance (AMR) in Europe for 2016-2018 (see news item on EMA website).
  • Key conclusions from the first Vet Big Data Stakeholder Forum, and presentations and videos from the day, have been published on the event page.
  • An information day for micro, small and medium-sized enterprises operating in the veterinary sector has been planned for 28th October. The virtual meeting is aimed at companies that have been assigned SME status by EMA, and representatives of stakeholder organisations. More information can be found on the event page

 

HMA / CMDv

An important new Q&A document has been published by CMDv to assist regulators and industry during the transition between the ‘old’ veterinary regulations (Directive 2001/82) and the new Regulation 2019/6. Among key topics addressed in the document are renewals where the date of MA expiry falls after implementation of the VMP-Reg, transition from PSUR submission to signal management, and QRD template versions.

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