Efficient regulation                                                                                                                                                        Download this page as PDF

A review of the legislation governing veterinary medicinal products has begun in 2010 and IFAH-Europe is pushing for a regulatory process that can deliver a true single market 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.

IFAH-Europe arrived at this policy decision following the results of several surveys run between 2006 and 2008 to identify those areas of the European legislation that function well, and those areas that could benefit from improvement.

IFAH-Europe, has one vision: to attain one true single market in veterinary medicinal products through one final review of the legislative framework.

Common goals
• A single market for veterinary medicines in Europe.
• The availability of safe, efficacious veterinary medicines of appropriate quality to protect both animal health and public health.

Objectives
• Enhanced availability of veterinary medicines
• Efficient use of resources
• Simplified yet robust regulatory system

'IFAH-Europe’s Impact Assessment Data Package’

IFAH-Europe has prepared a comprehensive Impact Assessment Data Package(download as PDF) to assist with the preparation of the European commission’s impact assessment which precedes the review of the legislation. IFAH-Europe’s Impact Assessment looks at the consequences of the current EU legislation on innovation and the availability of veterinary medicines in Europe, and provides a wealth of solid information on the industry’s position that the current situation in Europe is unsustainable

What is 1-1-1? An overview  

Why do we need a single system?
The current licensing system is complex, leading to a high administrative burden and inefficiencies. A lack of sufficient alignment between member states implementing the legislation and guidelines creates additional bureaucratic hurdles.

The 1-1-1 Concept is a preferred solution as it would maintain existing safety standards, while:

• Improve veterinary medicines availability
• Reduce administrative burden, thereby improving competitiveness
• Ensure a harmonized and practical implementation of the legislation leading to predictable, efficient and proportionate regulatory procedures
• Achieve a Better Regulation and simplification, creating a regulatory environment proportionate to the needs of the animal health industry
• Efficient utilisation of resources within national competent authorities.

The benefits of 1-1-1

The 1-1-1 leads to a more efficient regulatory system, benefitting to all stakeholders:

• Efficient use of the European Medicines Regulatory Network’s (EMRN) resources: reducing bureaucracy, removing duplication, attracting/retaining high quality staff
• Workload sharing for the national authorities
• Fair and equitable regulatory environment for all applicants
• Harmonised implementation leading to an efficient and proportionate system
• Better regulation, giving increased public confidence
• Increased access to EU markets creating business opportunities for small and medium entreprises
• Improved product availability benefiting animal health and welfare through improved access to veterinary medicines for pet owners, vets and farmers
• Enhanced food safety, food security, and protection of public health from zoonotic diseases
• Resources freed to provide market control and surveillance which will increase public confidence in the EMRN

Roles and responsibilities in the new 1-1-1

A Central Coordinating Body would be created to run the new system. The CCB would have:

• 1 member per member state
• Joint responsibility for the efficient running of the procedures
• Administrative support from a central secretariat
• Chair from the EU Commission and vice-chairs from member states.

It would:

• Assign the scientific assessment team (from pool of experts within the EMRN)
• Coordinate the harmonized standard of assessment
• Adopt decision based on the scientific assessment
• Issue a European Marketing Authorisation
• Appoint a 2nd scientific team for referrals and arbitration when necessary

The Central Secretariat would report to the Central Coordinating Body and its duties would entail:

• Receiving and validating applications
• Receiving fees for the scientific assesment and issuance of the 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 Central Coordinating Body 
(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 CCB for services provided, as well fees for products placed on the national markets
• Receiving share of fees from the central 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 procedures
• Providing legal advice
• Participation in the EMRN
• Chairing the central coordination body.

Companies will need to:

• Invest in the development and registration of veterinary medicines
• Submit dossiers to the required standard and pay scientific assessment fee
• Place and maintain the products on the market.
• Pay accession fees before putting their product on the market
• Comply with all legal obligations throughout the life cycle of the product.

This system will accommodate both small and large companies.

Downloads