a commitment to EU funding into studies on off-patent medicines for children (the so-called “M.I.C.E. Programme”); the establishment of an expert committee, the Paediatric Committee within the European Medicines Agency (EMEA); measures to increase the robustness of pharmacovigilance for medicines for children; an EU inventory of the therapeutic needs of children to focus research, development and authorisation of medicines; an EU network of investigators and trial centres to conduct the research and development required; a system of free scientific advice for the industry, provided by the EMEA; a publicly available database of ...[+++] paediatric studies.

The Commission should draw up, as a matter of urgency, a specific regulation aimed at resolving the problems concerning the availability of medicinal products for veterinary use and should in particular introduce a policy for 'orphan' medicinal products for veterinary use analogous to that established for human medicinal products by Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products , implemented through Commission Regulation (EC) No 847/2000 .

The Commission should draw up, as a matter of urgency, a specific regulation aimed at resolving the problems concerning the availability of medicinal products for veterinary use and should in particular introduce a policy for 'orphan' medicinal products for veterinary use analogous to that established for human medicinal products by Regulation (EC) No 141/2000, implemented through Regulation (EC) No 847/2000.

a new expert committee, within the European Medicines Agency to assess and agree companies’ testing plans; a requirement at the time of marketing authorisation applications for data on the use of the medicine in children (plus a system of waivers from this requirement for medicines unlikely to benefit children and a system of deferrals to ensure medicines are tested in children only when it is safe to do so and to ensure the requirements do not delay the authorisation of medicines for adults); a reward for studying medicines for children of 6-months extension to the supplementary protection certificate - in effect, six-month patent e ...[+++]xtension; for off-patent medicines, ten-years of data protection for new studies awarded via a Paediatric Use Marketing Authorisation (P.U.M.A); increased safety monitoring for children’s medicines and compulsory submission by industry of existing studies in children; an EU inventory of the therapeutic needs of children and an EU network of investigators and trial centres to conduct the studies required; a system of free scientific advice for the industry, provided by the European Medicines Agency.

4. Where a biological veterinary medicinal product which is similar to a reference biological veterinary medicinal product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or in manufacturing processes of the biological veterinary medicinal product and the reference biological veterinary medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided.

(1) The Commission has adopted three proposals on veterinary medicines, namely : - a proposal for a Regulation on tolerances for residues of veterinary medicines, - a proposal for a Directive on the reform of the existing legislation, - a proposal for a Directive on vaccines for veterinary use, introducing specific measures for the production and marketing within the Community of immunological veterinary medicines.