The Italian Medicine Agency informed that the following types of medicinal products are exempted from the PSUR submission: generic medicinal products authorized according to article 10(1) of Directive 2001/83/EC, medicinal products containing an active substance with a well-established use authorized according to article 10a of Directive 2001/83/EC, traditional herbal medicinal products registered by simplified registration procedure according to article 16a of Directive 2001/83/EC, homeopathic medicinal products registered by simplified registration procedure according to article 14 of Directive 2001/83/EC, and medicinal products authorized according to Ministry Decree November 8th 1993 (so called “national catalogue ex-galenicals”), to which a MA number was assigned with Ministry Decree October 2nd 1995, and containing an active substance included in the EURD list.
The a.m. exemptions are applied unless the PSUR submission is requested by the competent Authority of a Member State, by EMA or by the European Commission, due to problems regarding pharmacovigilance data, according to article 107 and following articles of Directive 2001/83/EC. The submission of the PSUR is requested for all other types of medicinal products.
