Sales of over-the-counter or self-medication drugs in shops
Non-prescription drugs, self-medication, parapharmacy, ATECO 47.73
Neighbourhood retail shops, retail shops with smaller medium-sized structures, retail shops with larger medium-sized structures, or stand-alone retail shops with large structures are allowed to sell to the public: over-the-counter or self-medication drugs and all non-prescription medicines or products, homeopathic products, and veterinary medicines that are available for purchase without a medical prescription.
The start of the activity is communicated to several Entities using SUAP:
1. the Italian Ministry of Health and the Italian Medicines Agency, in consideration of the fact that, at a central level, the sale of medicines also directly concerns that Agency. The Italian Ministry of Health provides facsimiles of the notification of the start and termination of the sale of over-the-counter medicines and the corresponding operating instructions;
2. the Central Directorate for health, socio-sanitary integration, social and family policies, the Regional Command of the N.A.S. anti-substitution and health centre, the Professional Order of Pharmacists, and the competent local health Authority.
SUBJECT REQUIREMENTS:
- Anti-mafia requirements of all the individuals prescribed by Article 85 of Italian Legislative Decree dated September 6 2011, number 159
- Moral requirements pursuant to Article 71 of Italian Legislative Decree dated March 26 2010, number 59 of all the individuals prescribed by Article 85 of Italian Legislative Decree dated September 6 2011, number 159
- Professional requirements:
- of the owner or the designated supervisor
- of the legal representative or the designated supervisor
for the sale of food products, prescribed by Article 71 of Italian Legislative Decree dated March 26 2010, number 59.
The designated supervisor must be appointed when the activity is not directly exercised by the owner or legal representative.
- The constant presence of a pharmacist throughout the opening hours of the commercial business.
OBJECT REQUIREMENTS:
Competitions, prize operations, and sales below cost involving pharmaceutical products are prohibited.
It is permitted to use the Italian word Parafarmacia (Parapharmacy)in the sign for retail businesses which are equipped with a section dedicated to the sale of medication. The use of the cross symbol as signage is permitted.
The sale of over-the-counter medicines is permitted during the opening hours of the business premises and must be carried out in a dedicated department, in the presence of and with the personal and direct assistance of one or more pharmacists qualified to practise the profession and registered with the respective professional order.
The start of the activity is subject to notification.
The notification is prescribed by Article 5 of Italian Legislative Decree Law dated July 4 2006, number 223.
The following is recommended before filling in any information:
- consulting the Telematic compilation guide
- selecting the appropriate procedure from the list on the right-hand side of this tab, in order to learn about the necessary forms and annexes to be completed.
Inspections are conducted by:
- the Municipality
- the public health Authorities