Review Of The Marketing Authorisations For Veterinary Agency Containing «Colistin» Dasomministrare Orally.

Original Language Title: Modifica delle autorizzazioni all'immissione in commercio deimedicinali per uso veterinario contenenti «colistina» dasomministrare per via orale.

Read the untranslated law here:

The DIRECTOR GENERAL of the animal health and veterinary drugs Saw the art. 4 of legislative decree March 30, 2001, n. 165, as amended; Having regard to Directive 2001/82/EC, as amended, on the Community code relating to veterinary medicinal products; Having regard to the Legislative Decree of April 6, 2006, n. 193, as amended; Having regard to the European Commission's implementing decision of March 16, 2015 on, under art. 35 of the aforementioned Directive 2001/82/EC, authorisation for all veterinary medicinal products that contain "colistin" to be administered orally;
Decrees: Art. 1 the marketing authorisations of veterinary medicinal products containing "colistin" to be administered orally, should be changed in the summary of product characteristics, labelling and package leaflet in accordance with annex III of the aforementioned Commission decision of March 16, 2015. To this end, the marketing authorisation holders company listed above are required to submit immediately its variation application provided for by law and to conform within sixty days handouts of packaging on the market under the provisions of this Decree. This Decree shall enter into force on the day of its publication in the official journal of the Italian Republic.
Roma, April 21, 2015 Director General: Borrello