Veterinary medicinal products; reagents and diagnostic kits for veterinary use.

Wholesale distribution of veterinary medicinal products, reagents and diagnostic kits for veterinary use

Order amending the Sanitary-Veterinary Rule on the conditions for the organisation and operation ofveterinary pharmaceutical establishments and the procedure for sanitary-veterinary registration / sanitary-veterinary authorisation of establishments and activities in the veterinary pharmaceutical sector

- the definition of authorisation for wholesale distribution of veterinary medicinal products, reagents anddiagnostic kits for veterinary use in Article 3(ț) has been clarified;

- Article 9(1) has been amended by adding to the list of veterinary medicinal products which may not bemarketed through veterinary pharmacies veterinary medicinal products containing anaesthetic and tranquilisingsubstances, substances having a hormonal, thyrostatic or beta-agonist action, external anti-parasitic veterinarymedicinal products of the emulsifiable concentrate type authorised for food-producing animals, includingequidae;
- the requirement in Article 27(1) has been deleted in order to leave no room for interpretation, in the sensethat the activity of wholesale distribution of veterinary medicinal products on Romanian territory could besubject to the possession of an authorisation issued only by the competent Romanian authorities; inaccordance with Article 100(1) of Regulation (EU) 2019/6, applications for a wholesale distributionauthorisation shall be submitted to the competent authority in the Member State in which the site or sites of thewholesaler are located and, in accordance with Article 99(3) of that Regulation, wholesale distributionauthorisations shall be valid throughout the Union;
- Article 59 on the documents accompanying the application for a wholesale distribution authorisation ofveterinary medicinal products, veterinary reagents and diagnostic kits has been amended in order to delete theparagraphs which may impose additional requirements to Regulation (EU) 2019/6, while maintaining theprovision on the submission of proof of payment of the fee provided for in the veterinary legislation in force, thisrequirement being in line with Article 2(8) of Regulation (EU) No 2019/6;
- in order to make the text uniform, the following terms: storage/placing in storage/wholesale have beenreplaced, where appropriate, by terms, wholesale distribution/wholesaler.