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.
What is the 1-1-1 Concept?
The 1-1-1 Concept proposes a single licensing system for veterinary medicines based on:
- 1 single EU dossier in English submitted to a scientific expert committee which assigns the assessment team. This assessment team could be multi-national or 'local' depending on the needs of the product and the applicant;
- 1 single assessment, peer reviewed, using the best expertise available in Europe and with a single fee paid to the centrally;
- 1 decision for marketing authorisation valid in all member states, with the payment of a national fee to each member state where the product is placed on the market (pay and do).
and this for ALL products.
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, and:
- 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 the key objectives of 'Better Regulation' and simplification, creating a regulatory environment proportionate to the needs of the animal health industry
- Ensure efficient utilisation of resources within national competent authorities.
