+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz


No prescription drug advertising, MoH updates

The Italian Ministry of Health has updated its website reporting the appropriate procedures to be followed to apply for the authorisation of advertisements of medicinal products with no need of prescription supplied only by pharmacist (“Senza Obbligo di Prescrizione” – SOP) intended for the public.

This is a procedure only recently accepted by the Ministry, that has now become official. The methods for the submission of the authorisation application and the documentation required for the submission essentially correspond to the requirements for the advertising of Over The Counter products (OTCs). However, in compliance with the special type of SOP medicines, there are also specific requirements to be complied with.

In particular, each advertising message regarding a SOP product should include the following mandatory wording: “This is a medicinal product with no need of prescription (SOP) that can be delivered only by pharmacists. Listen to your pharmacist.”

This wording is mandatory also for advertising circulated by radio and should be read at the same speed of the other information and advertising sentences. Alternatively, for this media it is admitted to read a sentence with the same meaning, but shorter (“This medicine can be delivered by pharmacists only. Listen to them”). The main difference between the SOP advertising and that of other types of products is in the admitted media.

For SOP medicinal product, in fact, the use of counter displays, shelf talkers, or any other form of advertising allowing the exhibition of the product is not admitted. This ban comes from the fact that direct access by clients is not allowed to SOP products; the medicinal product must be delivered by the pharmacists. The section regarding health advertising for veterinary products for self-medication and with no prescription was also updated.

For this products it is specified that the authorisation renewal application should be submitted 90 days before expiry. Moreover, in case of an advertising message identical to the one already approved to be renewed, the same authorisation number of the first decree is maintained.