Legal Framework, Regulatory Profiles of Pharmacy-Owned Cosmetic Lines in Italy
- Avv Aldo Lucarelli
- 10 ore fa
- Tempo di lettura: 3 min
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 general 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.
Italian Sanctions for PIF Documentation (D.Lgs. 204/2015)
The Italian government is particularly strict regarding the Product Information File (PIF). If an inspection by the NAS (Carabinieri for Health) or the Ministry of Health reveals issues, the following sanctions may be applied:
The "Big" Fines
• Missing or Incomplete PIF: If the PIF does not exist or lacks mandatory sections (like the Safety Assessment), the fine ranges from €10,000 to €100,000.
• No Safety Assessment: Specifically, putting a product on the market without a scientific safety report is a criminal offense, punishable by arrest (up to 1 year) and the fine mentioned above.
• Failure to Notify (CPNP): If the product is not registered on the European portal, the fine is between €1,000 and €6,000.
Secondary Sanctions
• Incorrect Labeling: Claims (e.g., "clinically proven") without proof in the PIF: €500 to €5,000.
• Failure to Cooperate: Not providing the PIF to authorities within the required timeframe (usually 48–72 hours): €10,000 to €25,000.
These fines are often "per product." If you have a line of 5 creams and none have a PIF, the financial risk is astronomical.
Mitigating Liability: Strategic Outsourcing and Contractual Safeguards
For pharmacies opting for third-party manufacturing, the supplier represents the most critical link in the regulatory chain. To mitigate the inherent risks of being the "Responsible Person," in our view it should be imperative to move beyond simple purchase orders and establish robust Manufacturing Agreements. First, pharmacies must demand and archive the manufacturer’s ISO 22716 (GMP) certification; this serves as essential evidence of "due diligence" during regulatory inspections.
Furthermore, contracts should feature a rigorous "Termination for Non-Compliance" clause, granting the pharmacy the right to sever the partnership immediately if safety standards or stability benchmarks are missed. Finally, the inclusion of an Operational Indemnity (Manleva) is vital.
This clause should explicitly obligate the manufacturer to reimburse the pharmacy not only for the cost of defective goods but also for any administrative fines and recall expenses arising from manufacturing defects or undetected formula instability.
Avv Aldo Lucarelli
It is not legal recomendation and refers to opinion.