Our highly experienced regulatory practice is one of few in Sweden and it ties in well with our strong IP practice. We advise clients based on the understanding that the regulatory framework should not be considered a burden for companies, but rather as an important strategic aspect of the business.
We assist clients through out the full life-cycle of products, starting from the development phase, through its market access stage and onto reinforcing their market position. Throughout this, we provide commercial advice and assist in proceedings against relevant authorities and competitors.
Whether for medicinal products, medical devices or healthcare services, we cover the full range of regulatory issues that a client may experience in Sweden.
In the medicinal products field we have, over recent years, provided considerable advice on market access for innovative new products, including the Swedish Trialogue negotiations for pricing and reimbursement. We regularly assist with strategic planning of marketing and promotions to ensure compliance with Swedish marketing law and national self-regulatory rules. Other recent work has concerned substitution and regulatory data protection. We have also worked extensively with questions concerning labelling, permits and licences.
Our advice relating to medical devices has covered areas such as classification and CE-mark issues, marketing and promotion of products in accordance with Swedish marketing law, and national self-regulatory rules.
We also advise clients on questions concerning cosmetics and hygiene products, including classifications, substance issues and recalls.
The competent authorities we generally face in this segment are the Medical Products Agency, the Dental and Pharmaceutical Benefits Agency (TLV), The National Board of Health and Welfare, and the Health and Social Care Inspectorate (IVO).
Our practice in food law is broad and covers all highly-regulated areas such as spirits and other alcoholic beverages, as well as tobacco and nicotine products. We have extensive experience of working with issues concerning product content, additives, novel foods, labelling and health and nutritional claims for products. Our work on geographical indications ties in well with the work of our trademark prosecution practice.
The competent authorities we generally face in this segment are the National Food Agency and the supervising entities of Swedish municipalities.
Recent development in EU regulation has created frameworks similar to the pharmaceutical and health care sectors in other industries. As a consequence, we see a greater demand for further regulatory advice for new categories of clients. These include the chemical industry (with questions relating to REACH, ROHS and the Biocidal Products Regulation) and agriculture.
Our experience in all highly-regulated areas generates knowledge that can also be applied to other industry sectors. Within our regulatory practice, we regularly work on issues relating to product liability, product safety, recalls and sales bans. This includes consumer retail products as well as products subject to the Machinery Directive.