Matteo Salvini -

In Italy, the promotion of medicinal products to the public and to healthcare professionals is regulated by legislative decree 219/06. The advertising of a medicinal product must encourage the rational use of a medicinal product, by presenting it objectively and without exaggerating its properties and without being misleading.

AIFA is the competent authority for the promotional material  addressed to healthcare professionals,  whilst the Italian Ministry of Health is the competent authority for the promotional material addressed to the public.

Advertising to healthcare professionals

According to legislative decree no. 219/06, any pharmaceutical company wishing to use promotional material on medicinal products must deposit  it to the Italian Agency before starting the promotional campaign.

Moreover, the below mentioned points have to be considered:

  • The promotional material can be used/distributed by the pharmaceutical companies 10 days after submission to AIFA, provided that no comments are received.
  • The date of submission to the Italian Agency must be reported on the material..
  • All information reported in the promotional material must be exact, up-to-date and verifiable. Articles, tables and figures taken from medical reviews or scientific publications must be reproduced faithfully and entirely, with the exact indication of the source.
  • The promotional material must always include the summary of product characteristics authorized at the time the material is disseminated . The dispensing regimen , the price and the reimbursement class of the medicinal productmust be reported on the material.
  • At any time, with justified decision, AIFA has the right to suspend the distribution of any promotional material considered not compliant with the applicable legislation.

Advertising to the public:

  • Allowed for the over the counter (OTC) medicinal products only
  • The product must be clearly identified as a medicinal product.
  • The promotional material must contain the exact name of the active substance and the trade name, the necessary information for a correct use of the product and a clear invitation to read carefully the package leaflet.
  • It is subject to prior approval by an advisory board operating within the Italian Ministry of Health. However, advertising materials are considered approved if an official denial is not issued by the Ministry of Health within 45 days from the date of submission.

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