The guidelines for the simplified registration of homeopathic products in Italy are coming. An ad hoc table made up of representatives of Aifa, the Italian drug agency, the ministry, the ISS and companies in the sector prepared and licensed them. And the requirements for companies to proceed with the streamlined product registration process are also being defined. This was communicated by Aifa itself in a note released yesterday. In the document, the agency recalls that "the acquisition of medicinal status for homeopathic products, established by Community legislation transposed and applied at national level, subjects them in Italy for the purposes of registration to the same rules in force for all medicines in general providing, however, simplified paths for those formulations that can be administered orally, or externally, without specific therapeutic indications and with a degree of dilution such as to guarantee their safety".
ItaliaOggi of 03/31/2009 p. 30
AF
