EU - Food, Drug and Medical Device Regulatory
Pharmaceutical, food and medical devices companies that market their products and services in Europe face an intricate web of rules and regulations. EU regulation is continually evolving: it is adopted in Brussels, applied by European and national administrations and interpreted by the European and national courts. In order to ensure compliance, companies need up-to-date, practical advice on how the EU rules affect their industry.
Sidley’s EU life sciences lawyers provide integrated legal services that encompass the entire spectrum of corporate, transactional, litigation and government matters. We have substantial experience addressing a wide variety of regulatory and market access issues related to pharmaceuticals, biotechnology, medical devices, cosmetics, food and food supplements.
Our EU life sciences lawyers regularly advise pharmaceutical clients on good clinical practice (GCP); marketing authorizations; the importation and manufacture of medicinal products and ingredients and good manufacturing practice (GMP); pharmacovigilance (drug safety); marketing and advertising of medicinal products; pricing and reimbursement; labeling; environmental issues; counterfeit products; and compassionate use.
Our EU lawyers advise medical device manufacturers on rules for placing medical devices on the market, importing and manufacturing devices, post-market surveillance and device safety. We also work with medical device companies on market access and customs issues.
Areas of advice for food companies include novel foods, general EU food law and food safety, the Food Supplements Directive, food for special medicinal purposes, rules on genetically modified organisms (GMOs), legislation on irradiated food, and generally the application in the EU of the precautionary principle.
For cosmetics clients, our EU practice includes matters related to market access, product formulation, labeling, permissible claims, borderline determinations (between cosmetic products, medicinal products and medical devices), and safety issues.
For all sectors, we advise on all aspects of the distribution chain, including stock allocation systems.
Drawing from previous regulatory and legal experience at the European Commission, as well as decades of private-sector experience, our EU life sciences lawyers have built and continue to maintain close contacts with the relevant EU authorities such as the European Commission’s Health and Consumer Protection Directorate-General (DG SANTE), the Internal Market, Industry, Entrepreneurship and SMEs Directorate-General (DG GROW), and the European Commission’s Legal Service. We also work with other official EU bodies such as the European Medicines Agency, the European Food Safety Authority (EFSA) and the Scientific Committee on Consumer Products.