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Regulatory Affairs

When people get sick they rely on modern medicine to make them better and this is done without a second thought because they know that the manufacturers have spent years developing their products to ensure their effectiveness and safety. The animal health industry also invests huge resources in developing, testing and manufacturing safe, effective veterinary medicines and Europe has one of the world’s most stringent licensing systems for controlling medicines (see Bringing veterinary medicines to market).

EFFICIENT REGULATION

The Europe Commission began a review of the legislation governing veterinary medicinal products in 2010 and IFAH-Europe is pushing for a regulatory process that can deliver a true single market for these products via what the federation has named the “1-1-1 Concept” – i.e. one dossier, one scientific assessment and one decision for marketing authorisation for all veterinary medicinal products. To assist with the preparation of the European commission’s impact assessment IFAH-Europe prepared a comprehensive Impact Assessment Data Package. 

The links below give more detail on the 1-1-1 Concept and the benefits of a more harmonised system.

Roles and responsibilities in the new 1-1-1

A Veterinary Central Committee would be created to run the system.

The VCC would have:

  • 1 member per member state
  • Responsibility for the efficient running of the European Medicines Regulatory Network (EMRN)
  • Administrative support from a central secretariat
  • Chair from the EU Commission and vice-chairs from member states.

It would:

  • Oversee the efficient running of the EMRN, set policy and provide direction
  • Adopt decision based on the scientific assessment
  • Issue a European Marketing Authorisation

The EMRN Secretariat would be coordinated by the VCC and its duties would entail:

  • Receiving and validating applications
  • Receiving fees for the scientific assessment
  • Drafting and issuance of the signed European Marketing Authorisation
  • The regulatory management of the scientific assessment process
  • Appointing a national language project manager if so requested
  • Management of databases
  • Coordination of the pharmacovigilance and inspections, publication of guidelines etc.

National authorities would constitute the membership of the VCC 
(1 member per member state) and be an integral part of the EMRN:

  • Providing experts for assessments and working groups, and local advice/contact.
  • Providing national language project managers
  • Implementing control systems and procedures for products placed in their market with local enforcement
  • Pharmacovigilance
  • Receiving fees from the VCC/EMRN for services provided, as well fees when the products are placed on the national markets
  • Receiving share of fees from the EMRN secretariat if their experts were part of the assessment team
  • Receiving fees for local enforcement activities
  • Participating in a well-organised EMRN with efficient use of resources

The European Commission’s role:

  • Legal caretaker of the system
  • Responsible with the member states for an efficient running of the EMRN
  • Providing legal advice
  • Participation in the EMRN
  • Chairing the VCC
  • Adopting and signature of the EU marketing authorisation decision

Veterinary Review Committee
A single committee comprising a sufficient number of senior scientific experts to fulfil the following responsibilities:

  • Overseeing the Scientific Expert Committees
  • Overall scientific quality, consistency and training of the EMRN
  • Referrals
  • Pharmacovigilance
  • Management of working groups
  • Adoption of specific guidelines
  • Coordination of scientific advice

Scientific Expert Committees
Several committees specialising in different product types (e.g. new pharmaceuticals, vaccines, generic pharmaceuticals and new technologies) comprising a sufficient number of scientific experts to fulifil the following responsibilities:

  • Appointment of a scientific assessment team
  • Maintenance of scientific quality and scientific memory of the SEC
  • Review of scientific assessment
  • Drafting of scientific guidelines
  • Provision of scientific advice

Companies will need to:

  • Invest in the development and registration of veterinary medicines
  • Submit dossiers to the required standard and pay scientific assessment fee centrally
  • Place and maintain the products on the market.
  • Pay market access fees before putting their product on the market
  • Comply with all legal obligations throughout the life cycle of the product
  • Act as responsible stakeholders and provide feedback to ensure this system will meet the needs of both small and large companies.

Contact

IFAH-Europe AISBL
Rue Defacqz, 1
B-1000 Brussels, Belgium

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