We are getting close to the deadline relevant to the annual transmission to AIFA of the sales representative data.
Every year, within the end of January, according to the art. 122, par. 1 of the Italian Legislative Decree n. 219/2006, Pharmaceutical Companies are requested to communicate to AIFA the data relevant to the sales representative activity in Italy with reference to the previous year.
For Companies based abroad, the submission should be performed by the Local Representative (i.e.: Legal Representative) or by the Company in charge of the distribution in Italy (i.e.: dealer/Concessionario di vendita).
This transmission should be performed through the AIFA Front END system and the final document generated by the AIFA system should be digitally signed.
Company that did not release on the market any medicinal products and did not perform any kind of promotion in the concerned previous year, has to submit to AIFA a substitutive declaration with a copy of valid and signed identity document of the signatory by certified e-mail.
Regulatory Pharma Net team is available to support companies to comply with this requirement.