AIFA informed Italian companies about the European Commission communication on the obligation of written confirmation by the competent authority of the country of origin for the importation of pharmacologically active raw materials manufactured in extra-EU countries, starting from July 2nd 2013.
The EC communication informed that MAHs using imported pharmacologically active raw materials or derived from other imported pharmacologically active raw materials are invited to check that the extra-EU manufacturer complies with the requirement of the written confirmation within July 2nd 2013 (by checking for instance that the manufacturer was inspected by the competent national Authority of the manufacturing country or by a regulatory authority which is part of the PIC/S).
Pharmacologically active raw materials can be imported from extra-EU countries without the written confirmation only if originated by countries considered as “equivalent” by the European Commission. At the moment these equivalent countries are only four: Israel, Switzerland, Australia and Singapore.
If the concerned manufacturer is not able to grant a written confirmation, the company should proceed to develop an emergency plan to select new sources of the pharmacologically active raw material and submit the relevant variation application to AIFA.
MAHs are reminded that it is their specific responsibility to grant appropriate and continuous supplies of the medicines in order to satisfy the patients needs, according to art. 81 of Directive 2001/83 as amended, implemented in art. 105, sections 2 and 4, of Legislative Decree 219/06. Therefore, MAHs are bound to avert any risk of shortage due to the lack of a written confirmation starting from July 2nd 2013.
