Slovenian National Assembly

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on veterinary medicinal products

Scrutiny details

Subsidiarity deadline: 27/11/2014
Scrutiny Information

Scrutiny date: 19/12/2014

Subsidiarity Concern:

No Important information to exchange

No Veto

Information on parliamentary scrutiny

The Committee on Health discussed the proposal at its 1st meeting of 9 December 2014.

And at it's 18th meeting of 19 December 2014 the Committee on EU Affairs of the National Assembly of the Republic of Slovenia adopted the following Position

The Republic of Slovenia supports the purpose, main targets and general solutions of the Proposal for a Regulation of the European Parliament and of the Council on veterinary medicinal products which is to achieve the simplification of regulatory procedures for obtaining and maintaining marketing authorisations for veterinary medicinal products, thus contributing to greater availability of the said medicinal products, improved supply and availability, greater security in treatment of risks to public health, animal health and environmental protection with regard to the use of antimicrobials in veterinary medicine, the regulation of market for these medicinal products and the competitiveness and innovations in the field of use of veterinary medicinal products.  

However, the Republic of Slovenia believes that in the process of negotiations it is necessary to find more suitable solutions as regards the submission of application for marketing authorisation only in the reference Member State, which also has financial implications for Member States concerned and other Member States, and as regards the set of languages for labelling medicinal products. Moreover, as regards the proposed changes in the field of data protection, it will be necessary to re-examine the balance and harmonisation of proposals between the manufacturers and users of medicinal products. To ensure adequate traceability in the wholesale marketing of medicinal products, the Proposal should be supplemented by a provision on the basis of which the provider of wholesale medicinal products should report to the authority responsible for veterinary medical products in the Member State in which wholesale distribution will also be carried out.  Concerning the definition of terms, the Republic of Slovenia will suggest that in the retail of veterinary medicinal products, the term "small quantity of medicinal products" is defined more precisely.  In terms of cross-border provision of veterinary services, it is necessary to agree on the transparency and traceability of veterinarians who provide their services the Member State other than that in which they have registered their activity.

Contact points for EU matters

IPEX Correspondents:
Phone: 00 386 478 9482  Email Mrs. Aleksandra-Saša Lavrič Phone: 00 386 478 9664  Email Ms. Polona Klemenčič
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