In accordance with Legislative Decree 219/2006, medical sales representatives are the only professional profiles that are allowed to promote medicinal products to healthcare professionals in Italy. In addition to the general requirements defined by the afore mentioned decree, every Italian region has set its own rules to regulate the access of sales representatives to healthcare facilities.
Regional decisions are legally binding and the set requirements have to be taken into consideration when a pharmaceutical company is willing to advertise medicinal products to healthcare professionals.
Non-compliance with regional requirements may lead to sanctions by the Italian regions.
Requirements are specific to each Italian region and sometimes they can also change between healthcare divisions located in the same region.
For the majority of the Italian regions, it is required to:
- Request the accreditation of sales representatives to the regional office in charge of scientific information management. The communication shall also include the list of the sales representatives active on the territory.
- Equip each sales representative with an identification card containing all the information that allows the sales representative to be identified during the visits to the healthcare facilities.
- Communicate any change to the sales representative list to regions.
- Communicate to regions, once or twice a year based on the specific regional requirements, the number of visits performed by sales representatives on the regional territory.
Some regions also regulate the access to healthcare facilities for professional figures different from the sales representatives, such as Medical Science Liasons (MSLs), Regional Affairs Managers (RAMs), Key Account Managers (KAMs), Territory Sales Managers (TSMs), Regional Sales Managers (RSMs) and Senior Product Specialists (SPSs).
In all cases it is always recommended an identification card and in some cases the accreditation request is also needed.
RPN is available support your company with the activities related to the regional accreditation of sales representatives and to provide any updates on all regulatory needs on this topic.