Review Of The Marketing Authorisations For Veterinary Agency «Suanovil 20 And Associated Names, Captalin And Associated Names, And Its Generic Products» Contenentila Active Substance «Spiramycin».

Original Language Title: Modifica delle autorizzazioni all'immissione in commercio deimedicinali per uso veterinario «Suanovil 20 e nomi associati,Captalin e nomi associati, e relativi prodotti generici» contenentila sostanza attiva «spiramicina».

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 December 11, 2014, related, in the context of art. 35 of the aforementioned Directive 2001/82/EC, marketing authorisations for veterinary medicinal products "Suanovil 20 and associated names, Captalin and associated names, and products containing the active substance," generic "Spiramycin";
Decrees: Art. 1 marketing authorisations for veterinary medicinal products "Spiramin, Captalin, Spiravet and 20 generic products", containing the active substance "Spiramycin", should be amended in the summary of product characteristics, labelling and package leaflet in accordance with annex III of the aforementioned Commission decision of December 11, 2014. To this end, the marketing authorisation holders company listed above are required to submit immediately its variation application provided for by law, and to bring in commercial packaging printed matter within thirty days as provided for in this Decree. This Decree shall enter into force on the day of its publication in the official journal of the Italian Republic.
Roma, March 31, 2015 Director General: Borrello