Compliance

We have developed extensive experience in analyzing EU and national legislative and regulatory aspects of product, trade and corporate compliance issues, in the focus sectors of the firm: Digital-Media-Tech and Life Sciences-Healthcare.

In these areas, we advise our clients on identifying and minimization of risks as well as crisis management, to preserve their business’ operations, integrity, and reputation.

In the corporate compliance area, we assist clients in preparing and implementing compliance programs on the administrative liability of legal entities under Legislative Decree No. 231/2001, anti-bribery & corruption, antitrust and data protection.

Some of our professionals sit on the compliance supervisory bodies of large Italian groups and have participated in extraordinary compliance activities related to their restructuring processes. We also assist our clients in proceedings arising from alleged compliance violations, including criminal proceedings against individuals or connected to corporate criminal liability, as well as in regulatory litigation relating to investigations initiated by regulatory agencies.

In most cases, our work is cross-border, for example in connection with FCPA, OFAC, UK Bribery Act, etc.

Within product and trade compliance our track record includes advising on complex import and export control issues regarding release for free circulation, EU market entry, labelling and packaging, EC marking (REACH and CITES, etc.), anti-dumping proceedings, dual use and relevant policies. We also provide assistance on the related customs and courts proceedings as well as on the Consumer Code issues and unfair commercial practices.

Over the years, our professionals have worked for example on:

• implementation and review of national and cross-border antitrust compliance programs and implementation of related procedures for monitoring, training, detecting and reporting;

• implementation of data protection compliance and information governance activities;

• preparation of compliance models and structures aimed at avoiding the administrative liability of legal entities under Legislative Decree No. 231/2001, coordination and performance of due diligence and internal investigations, participation in structuring global compliance programs, business and ethical code of conducts, whistleblowing schemes and anti-corruption policies for multinational groups;

• product and trade compliance activities in the fashion & luxury and cosmetics sectors, including product safety and responsibility, labelling, packaging and claims, GMPs (good manufacturing practices) and PIFs (product information files), EC marking, declaration of origin, “made in”, supply chain compliance to REACH and CITES legislations, and drafting of related policies also included in the organizational model under Legislative Decree No. 231/2001;

• product and trade compliance requirements in terms of EC marking, type approval, product recall (RAPEX), declaration of origin, product import/export customs issues and administrative and judicial proceedings against relevant measures issued by customs authorities, activities to support AEOs, dual use and compliance with trade / export control regulations, including EU – CEC – ECGL and internal compliance programs (ICPs), unfair trade practices;

• product compliance activities in the food sector including labelling and packaging, nutrition, chemical and biological safety, novel food, food supplements, food alerts and food waste, GMOs and pesticides, nutrition and health claims, product recalls (RASFF), designations of origin and geographical indications, unfair trade practices;

• compliance and best practices activities in the pharmaceutical and medical devices sectors concerning the marketing of medicines and medical devices, including advice on launching “wearable” devices, in matters relating to the price and reimbursement of medicines, market access, and in relations with public authorities (including the Ministry of Health, AIFA – Italian Medicines Agency and EMA – European Medicines Agency) and other operators in the sector, as well as in the case of measures restricting the marketing of products, referral procedures, inspections by regulatory authorities, etc.; labelling, packaging and technical reports, review of codes of conduct and organizational models under Legislative Decree No. 231/01, review of policies on transparency and management of HCPs.