Vaccine security Meeting Rome Italy FAO HQ 23-24 January 2020 Pillar I - Improve\1.3 Emerg Vacc\Vaccine Security Meeting\PPTs final\5 Session

1. An agency of the European Union
Impact and opportunities for the new EU
regulation on veterinary medicines on FAST
vaccines
Security of supply of vaccines against Foot-and-mouth disease and other
Similar Transboundary (“FAST”)
Presented by Ivo Claassen on 23 January 2020
Head of Veterinary Medicines Division

2. Classified as internal/staff & contractors by the European Medicines Agency
Presentation outline
 Introduction to VMP-Reg 2019/6
 Relevant changes for vaccine development and authorisation in VMP-Reg 2019/6
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3. Classified as internal/staff & contractors by the European Medicines Agency
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Regulatory framework: key elements that impact on innovation

4. Classified as internal/staff & contractors by the European Medicines Agency
New Veterinary Regulation
Aims to:
• increase the availability of veterinary medicinal products;
• reduce administrative burdens;
• stimulate competitiveness and innovation;
• improve the functioning of the internal market; and
• address the public health risk of antimicrobial resistance (AMR).
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5. Classified as internal/staff & contractors by the European Medicines Agency
• Data protection periods increased
• Provides for elaboration of technical requirements for novel therapies
• Limited markets provision (replaces current MUMS policy)
• Opening up of the centralised procedure
• Obligation on MSs to assist applicants, in particular SMEs
• Art 138. relevant for FAST
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New Veterinary Regulation: opportunities provided

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Smart implementation of the new veterinary regulation
 To support innovation and product development (flexibility to deal with the complex
area of novel therapies)
 To increase efficiency of regulatory processes
 To adopt a more effective risk based approach to activities/decision making
 To foster proportionate decision making
….while promoting and protecting animal and public health, and the environment.
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New Veterinary Regulation: opportunities provided

7. Classified as internal/staff & contractors by the European Medicines Agency
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 The Agency Provides scientific and technical recommendations as and when
requested by the EC
 Responsible for:
 Revising procedures and regulatory and scientific guidance documents
 Leading the implementation of IT systems required by the regulation
 Implementing the outcomes of the implementing and delegated acts.
New Veterinary Regulation: EMA Role in implementation of NVR

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New Veterinary Regulation: EMA Role in implementation of NVR

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TITLE I -Requirements for veterinary medicinal products other than biological
veterinary medicinal products
TITLE II - Requirements for biological veterinary medicinal products
 TITLE IIa - Requirements for biological veterinary medicinal products other than
immunological veterinary medicinal products
 TITLE IIb – Requirements for immunological veterinary medicinal products
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New Veterinary Regulation: Scientific recommendation on
revision of Annex II

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TITLE III - Requirements for specific marketing authorisation applications
 Applications in exceptional circumstances
8. Applications for novel therapies
TITLE IV – Requirements for marketing authorisation applications for particular
veterinary medicinal product
 Vaccine antigen master file
 Vaccine platform technology
 Multi-strain dossier
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New Veterinary Regulation: Scientific recommendation on
revision of Annex II

11. Classified as internal/staff & contractors by the European Medicines Agency
Applications in exceptional circumstances:
Also in Annex II of current Directive 2001/82/EC but additional clarification in NVR in
relation to requirements: part 1 full; parts 2,3&4 reduced data (with conditions)
- Only two guidelines available: avian influenza and bluetongue
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12. Classified as internal/staff & contractors by the European Medicines Agency
Vaccine antigen Masterfile
-New in NVR; it includes guidance on principles and content for different parts of
quality; guidance on evaluation and certification procedures.
-Guidance on specific requirements and administrative procedure need to be drafted
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Vaccine platform technology
-New in NVR; it includes guidance on principles and evaluation and certification
procedures.
-Guidance on specific requirements and administrative procedure need to be drafted

13. Classified as internal/staff & contractors by the European Medicines Agency
Multistrain dossier
-New included in Annex II of NVR; it opens door to additional viruses and guidance on
eligibility requirements
-One guideline available, including requirements for AI, BT and FMD:
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Article 23 Applications for limited markets
Article 23
Applications for limited markets
1. By way of derogation from point (b) of Article 8(1), the applicant shall not be
required to provide the comprehensive safety or efficacy documentation required in
accordance with Annex II, if all of the following conditions are met:
(a) the benefit of the availability on the market of the veterinary medicinal product to
the animal or public health outweighs the risk inherent in the fact that certain
documentation has not been provided;
(b) the applicant provides the evidence that the veterinary medicinal product is
intended for a limited market.
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15. Classified as internal/staff & contractors by the European Medicines Agency
VMP-Reg 2019/6 art.138
Article 138
Scientific opinion for international organisations for animal health
1. The Agency may give scientific opinions, in the context of cooperation with international
organisations for animal health, for the evaluation of veterinary medicinal products intended
exclusively for markets outside the Union. For that purpose, an application shall be submitted
to the Agency in accordance with Article 8. The Agency may, after consulting the relevant
organisation, draw up a scientific opinion.
2. The Agency shall establish specific procedural rules for the implementation of paragraph 1.
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Thank you for your attention
ivo.claassen@ema.europa.eu
EMA address Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands
Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000
Further information
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Limited market definition
‘limited market’ means a market for one of the following medicinal product types:
(a) veterinary medicinal products for the treatment or prevention of diseases that
occur infrequently or in limited geographical areas;
(b) veterinary medicinal products for animal species other than cattle, sheep for meat
production, pigs, chickens, dogs and cats;
Regulation of VMPs in Europe16

18. Classified as internal/staff & contractors by the European Medicines Agency
Companies have less interest in developing veterinary medicinal products for markets
of a limited size. In order to promote the availability of veterinary medicinal products
within the Union for those markets, in some cases it should be possible to grant
marketing authorisations without a complete application dossier having been
submitted, on the basis of a benefit-risk assessment of the situation and, where
necessary, subject to specific obligations. In particular, the grant of such marketing
authorisations should be possible in the case of veterinary medicinal products for use
in minor species or for the treatment or prevention of diseases that occur infrequently
or in limited geographical areas.
Regulation of VMPs in Europe17