Regulation 2019/5 - Amendment of Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Regulation (EC) No 1901/2006 on medicinal products for paediatric use and Directive 2001/83/EC on the EC code relating to medicinal products for human use - Main contents

EN

Official Journal of the European Union

L 4/24

Directive 2001/82/EC of the European Parliament and of the Council (3) and Regulation (EC) No 726/2004 (4) of the European Parliament and of the Council constituted the Union regulatory framework for the manufacture, authorisation and distribution of veterinary medicinal products. In the light of experience and following the assessment by the Commission of the functioning of the internal market for veterinary medicinal products, the regulatory framework for veterinary medicinal products has been reviewed, and Regulation (EU) 2019/6 of the European Parliament and of the Council (5) on veterinary medicinal products has been adopted, with a view to harmonisation of the laws of the Member States.

It is appropriate to maintain in Regulation (EC) No 726/2004 certain provisions relating to veterinary medicinal products, in particular those relating to the European Medicines Agency (‘the Agency’), but as the procedures applicable to the centralised marketing authorisation of veterinary medicinal products are laid down in Regulation (EU) 2019/6, the parts of Regulation (EC) No 726/2004 that relate to procedures for such marketing authorisations and that are covered by Regulation (EU) 2019/6 should be repealed.

The costs of the procedures and services associated with the operation of Regulation (EC) No 726/2004 need to be recovered from undertakings making medicinal products available on the market and from undertakings seeking authorisation. As Council Regulation (EC) No 297/95 (6) and Regulation (EU) No 658/2014 of the European Parliament and of the Council (7) establish the fees payable to the Agency for the services it provides, it is not necessary to maintain any provisions on the structure and level of those fees in Regulation (EC) No 726/2004. However, in order to ensure that the entire current legal framework for fees payable to the Agency in relation to medicinal products for human use and veterinary medicinal products remains unchanged until an agreement on changes thereto has been reached, it is appropriate to provide that Commission Regulation (EC) No 2049/2005 (8) remain in force and continue to apply unless and until repealed. When reviewing the regulatory framework for fees payable to the Agency, the Commission should pay attention to potential risks related to the fluctuations in the fee revenue of the Agency.

Before a medicinal product for human use is authorised for placing on the market of one or more Member States, it generally has to undergo extensive studies to ensure that it is safe, of high quality and effective for use in the target population. However, in the case of certain categories of medicinal products for human use, in order to meet unmet medical needs of patients and in the interest of public...