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.