Since 1 July 1993 with the Legislative decree 30 December 1992, n. 541 and after its abolition following the entry into force of the Legislative Decree 219/2006 (still applicable), any company in possession of a marketing authorization in Italy shall appoint a Scientific responsible person (RSS) in charge of information on medicines put on the market (Art. 126). This is a mandatory requirement that each company must fulfill.
The scientific responsible person must have a master’s degree in one of the following fields: medicine and surgery, pharmacy or chemistry and pharmaceutical technology.
Which are the main responsibilities of this professional figure?
- RSS ensures that the Sales Representatives (ISF) are adequately trained on performing their activity in compliance with the applicable legislation in Italian Territory
- RSS interfaces with AIFA to provide/for providing information and assistance, if necessary
- RSS ensures that the measures adopted by the Ministry of Health and by the AIFA are respected immediately and in full.
- RSS ensure that the pharmaceutical advertising is in compliance with the applicable legislation in Italy
What’s new on promotional activity?
It has been/passed almost a year since/from the entry into force of the new submission procedure related to promotional materials addressed to healthcare professionals through the “AIFA Front End” system/IMS – Informatori Scientifici (Sales Representatives).
The new procedure has provided lots of advantages (i.e. less use of paper, e-submission, rapid feedback from AIFA and so on).
A lot as changed/Lots have changed since 2006 and therefore the necessity of new guidelines on promotional activity has been raised. Currently AIFA, in collaboration with pharmaceutical companies, is/are working on drafting the new guidelines. The guideline has not been released yet/is still expected.
Regarding the advertising to public, from July 2018 great news from the Ministry of Health has arrived: the promotional activity addressed to public has been extended to SOP medicinal products, in addition to promotional items related to OTC medicinal products.
However, some restrictions have been provided from the MoH with the communication of 5 May, 2018 published only on July 2018 in the Ministry of Health website, e.g. restrictions concerning advertising at points of sale. Further clarifications from the MoH are expected.
RPN is supporting companies with regulatory aspects, with their compliance with the Italian legislation and with other activities.