We inform you that in connection with the forthcoming promulgation of the Ordinance amending Ordinance No. 27/15.06.2007, on the web site of BDA are published the approved forms of applications for marketing authorization of medicinal product, renewal of marketing authorization, marketing authorization/registration of homeopathic medicinal product, variation to marketing authorization/registry certificate of medicinal product, transfer of the rights over marketing authorization of medicinal product and modification of the product information (the text and/or the package layout and/or leaflet, which is not connected with change of the short product characteristics) (There is no concomitant variation procedure).
The applications should be applied from the date of entry into force of the Ordinace amending Ordinance No. 27/15.06.2007.
