Council adopts the new legislation for veterinary medicinal products

Brussels, Belgium, 18 March 2004: The Council formally adopted the proposed new legislation covering human and veterinary medicinal products on 11 March 2004. The Council’s decision marked the end of its second reading of the legislative package review and more than two years of debate within the co-decision procedure.

IFAH-Europe welcomes the Council’s decision to adopt the text without any further changes, thus avoiding a conciliation procedure and enabling the text to be adopted and published before EU enlargement. It is essential to the veterinary medicines industry that any period of regulatory uncertainty is quickly brought to an end, as a stable and predictable regulatory framework is a prerequisite to major investment decisions in medicines product development.

“IFAH-Europe now looks forward to a new era for veterinary medicines regulation, as the long-awaited new legislation is designed to take the sector forward in a rapidly changing environment. It addresses important issues not only from a regulatory and industry point of view, but also for veterinarians, animal owners and consumers” explained Jean-Louis Delforge, Chairman of the IFAH-Europe Council.

IFAH-Europe particularly welcomes the new rules which will inter alia streamline the current regulatory procedures, reduce product registration time and improve transparency of decision-making, restrict to a single renewal of the marketing authorisation after 5 years, adapt the EMEA and its scientific committees to an enlarged EU, harmonise regulatory data protection, grant one extra year of data protection for adding additional species to a product’s indications and give new definitions of generics and of ‘biosimilar’ medicinal products. IFAH-Europe is also pleased that the possibility to choose between the decentralised/centralised procedures was maintained for the authorisation of new veterinary medicines that do not involve biotechnology.

However, the Federation regrets that the opportunity to recognise the different national distribution systems for veterinary medicinal products was missed, as these have evolved to meet the specificities of the different national market conditions.

IFAH-Europe supports the legislative package that, overall, strikes a reasonable balance between the diverse interests of the various stakeholders involved and should allow a better availability of new products. It encourages innovation and the competitiveness of the research-based industry, while at the same time improves the regulatory procedures for generics and maintains a high level of consumer protection. It was also essential to adapt the regulatory structures and procedures to an enlarged European Union of 25 Member States in order to, in particular, strengthen market surveillance (i.e. pharmacovigilance) of products on the market, in the interest of public and animal health.

IFAH-Europe will now follow very carefully the implementation process as it is essential that this be achieved in a harmonised and timely manner.

Notes to Editors:

IFAH-Europe is the representative body of manufacturers of veterinary medicines, vaccines and other animal health products in Europe. It is a major operating division of a broader organisation – the International Federation for Animal Health (IFAH), an international non-profit organisation registered under Belgian law.

For further information on IFAH and IFAH-Europe, please visit http://www.ifahsec.org/

For further information on this issue please contact Rick Clayton, Technical Project Manager :

c/o IFAH, International Federation for Animal Health
Rue Defacqz, 1 - 1000 Brussels (Belgium)
Tel.: +32 (0)2 543 7576
Fax : +32 (0)2 537 0049
E-mail:
[email protected]


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