Legal Framework and Regulatory Profiles of Pharmacy-Owned Cosmetic Lines in Italy
- Avv Aldo Lucarelli
- Feb 18
- 2 min read
In Italy, when a pharmacy decides to market its own brand of cosmetics, it steps out of the role of a simple retailer and enters a complex regulatory framework. Here is a summary of the key legal and structural profiles discussed in such contexts:
1. The "Responsible Person" (RP)
Under EU Regulation 1223/2009, every cosmetic product placed on the market must have a designated "Responsible Person."
• The Pharmacy's Role: If the pharmacy markets the product under its own name or brand, the pharmacy owner (or the company owning the pharmacy) becomes the Responsible Person.
• Legal Duty: The RP is legally liable for the safety of the product, the accuracy of the Product Information File (PIF), and compliance with Good Manufacturing Practices (GMP).
2. Role of the Pharmacy Director
The Direttore di Farmacia has a specific oversight role that can overlap with the requirements of the cosmetic line:
• Supervision: The Director is responsible for the overall "hygienic-sanitary" management of the pharmacy.
• Liability: If the cosmetic line is produced in the pharmacy’s own laboratory (galenic preparation), the Director must ensure it meets technical standards. If it is outsourced (Third-Party Manufacturing), the Director must still ensure the pharmacy's "Responsible Person" obligations are met.
Legal Framework and Regulatory Profiles of Pharmacy-Owned Cosmetic Lines in Italy"
3. Structural Models
The choice of how to structure the cosmetic venture impacts the legal risk:
• Internal Production: High regulatory burden. The pharmacy lab must meet strict industrial ISO standards (ISO 22716) which are often more demanding than standard galenic requirements.
• Third-Party Manufacturing (Contract Manufacturing): The pharmacy hires a specialized lab to create the formula. The pharmacy remains the RP if they put their brand on it, but they can contractually shift some technical liability to the manufacturer.
4. Regulatory Compliance Checklist
To operate legally, the pharmacy must manage:
• CPNP Notification: Registering the products on the European Cosmetic Product Notification Portal.
• The PIF (Product Information File): Keeping a detailed dossier (safety assessments, toxicology reports) available for 10 years for authority inspections.
• Labeling: Ensuring claims (e.g., "anti-aging," "dermatologically tested") are backed by scientific evidence to avoid "unfair commercial practices" sanctions.
Avv Aldo Lucarelli
It is not recomendation and refers to opinion.
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