The Ministry of Health has published new guidelines on the health advertising of over-the-counter (OTC) medicines and of medicines that do not require a prescription (SOP). The guidelines, approved by the Section for the issue of licences for health advertising of the Technical Health Committee, update and replace the previous guidelines published over recent years.
The new guidelines set out the principles and the rules for circulating advertising messages about OTC and SOP medicines in Italy.
General principles
Advertising messages for OTC and SOP medicines must be:
- Informative and not promotional: must not contain information that could mislead or deceive the public.
- Truthful and accurate: must be based on scientific data and must not contain false or misleading information.
- Objectives: must not promote the medicine in an excessively positive or suggestive way.
- Non-discriminatory: must not contain information that is discriminatory or offensive to any group of people.
Mandatory information
Advertising messages for OTC and SOP medicines must carry the following information:
- The name of the medicinal product
- The name of the active substance
- The therapeutic indications
- The methods of administration
- Warnings and contraindications
- The phrase "It is a medicine"
Specific rules for OTC medicines
Advertising for OTC medicines must carry the wording "This is a medicine containing … Read the package leaflet carefully".
Advertising messages for NSAID medicines must carry the wording "This is a medicine containing … which can have side effects, some of them serious. Read the package leaflet carefully".
Specific rules for SOP medicines
Advertising for SOP medicines must carry the wording "This is a medicine that does not require a prescription (SOP) containing … which may only be supplied by a pharmacist. Listen to your pharmacist and read the package leaflet carefully".
Advertising messages for SOP medicines may not be distributed through advertising media such as display units, shelf strips or any other form of advertising that allows, contrary to the rules, an ostentatious display of the medicine's pack or packs.
Other news
The new guidelines also bring the following changes:
- The forms for applying for authorisation to advertise health services have been updated and can be sent, with their attachments, only by PEC (Italy's certified email).
- Advertising messages that contain information about products other than those for which Ministry authorisation is required must be clearly distinguished, graphically, from the advertising message for the medicine and must carry the wording "Promotional material not subject to authorisation under the legislation in force on health advertising".
The new guidelines came into force on 1 July 2023.
official source: Guidelines on health advertising for self-medication medicines (OTC) and of medicines not requiring a prescription (SOP) (salute.gov.it)
