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.

Communication and advertising activities for OTC and SOP medicinal products addressed to the public are subject to specific rules, with the aim of protecting the consumer.

The advertising must be clear and not misleading and must include some mandatory requirements such as the name of the medicinal product, the active ingredient, the information necessary for a correct use with the invitation to read the package leaflet.

These requirements are checked by the national competent authority, the Ministry of Health (MoH), during the authorization process.

Promotional materials addressed to the public are subject to MoH authorization and a formal opinion is issued approximately 45 days after the submission of the documentation.

However, the outcome is often partially favorable.  The MoH can request amendments to the materials including changes to the graphics. These amendments must be implemented before the material distribution. This sometimes can impact the purpose and the timing of the advertising campaign.

Regulatory Pharma Net has successfully supported its clients in the review of promotional means and in the preparation of counter-arguments in defense of the advertising messages and is ready to guide your company in its promotional campaigns.

The responsible Authority for the evaluation of the advertising concerning OTC/SOP medicinal products on social medial in Italy is the Ministry of Health (MoH).

In general, according to the MoH guidelines the advertising messages shall be static and cannot be modified. Therefore, the use of social media that allow the users to leave and share their own opinions can compromise this mandatory requirement. For this reason, the MoH only authorizes the use of some social media such as Facebook, Instagram and YouTube, respecting the above mentioned rule and other peculiar requirements, specific for each social media.

Each Company owner of OTC/SOP medicinal products can request the authorization for the advertising on social media respecting these specific requirements and keeping in mind that the advertising message must not be misleading.

Regulatory Pharma Net is available to provide your company with any updates on social media advertising regulatory framework and to successfully guide your company in the preparation and submission to the MoH of promotional campaigns on social media.

To know more contact us at info@regulatorypharmanet.com

The Italian healthcare landscape has undergone a significant turning point with the enforcement of Law No. 62 of May 31, 2022, commonly known as the "Sunshine Act." This legislation aims to introduce transparency and clarity in the relationships among various entities involved in the healthcare sector. By fostering integrity and accountability, this law represents a crucial step towards ensuring the highest standards of ethical conduct in healthcare practices.

Indeed, the primary objective of the Sunshine Act is to prevent corruption and counteract conflicts of interest that may compromise the interest in collective and individual health, as protected by the Italian legal system.

The law provides a series of clear definitions, outlining who manufacturing companies, entities in the healthcare sector, and involved healthcare organizations are.

One of the most significant innovations introduced by the Sunshine Act is the establishment of the Public Telematic Registry called "Transparent Health." This telematic platform, set up by the Ministry of Health, will collect all information related to economic transactions among healthcare operators, such as:

• agreements,
• cash payments,
• shareholdings, etc.

To ensure compliance with the law, sanctions are provided for companies that fail to meet communication obligations.

Finally, although the Sunshine Act has already come into force, communication obligations timings have not yet been clarified. However, it is important for companies and other affected operators to begin evaluating the adoption of appropriate measures to comply with the new provisions.

Regulatory Pharma Net is available to provide your company with any updates on the Sunshine Act regulatory framework and to assist on all regulatory needs related to this specific activity.

Regulatory Pharma Net is ready to provide further updates on this hot topic and to support on all regulatory needs related to the “transparent” communication provided for in the Sunshine Act.

Do not hesitate to contact us at info@regulatorypharmanet.com