P&S Legal offers legal and strategic advice to legal entities operating in the pharmaceutical industry and the related branch of the nutraceutical market.
An excellent understanding of the industry enables the firm’s professionals to provide the client with a comprehensive insight into the market trends of the industry, providing them with guidance throughout the start-up and lift-off phase of the business vehicle, as well as in the establishment of proper governance in accordance with the current legal and regulatory framework.
Top-notch services provided by the firm are summarized below:
– Advisory board;
– Implementation of organizational models;
– Legal opinions;
– Intellectual and industrial property protection;
– Transparency issues;
-Contracts matters (licensing, distribution, co-promotion and fostering, distribution, research and development, etc.);
– Antitrust and anti-corruption;
– Product liability;
– Mergers and Acquisitions and technology transfers;
-Representation in Administrative Courts, in criminal and civil proceedings;
– Consultancy in customs regulation and international trade.
Nutraceuticals is a rapidly expanding discipline that deals primarily with the in-depth study of plant, animal, mineral and microorganism extracts, used as isolated nutrients, supplements or for targeted diets.
Due to the increasing number of foods and/or nutraceuticals bearing nutritional and health claims and in order to avoid misleading claims to consumers, several regulations have been enacted over the years:
– Nr 1167/2009 of 30 November 2009 “refusing to authorise certain health claims made on foods and referring to the reduction of disease risk and to children’s development and health”;
– Nr 1168/2009 of 30 November 2009 ‘refusing to authorise a health claim made on foods other than those referring to the reduction of disease risk and to children’s development and health’;
– Nr 1169/2009 of 30 November 2009 “amending Regulation (EC) No 353/2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council”.
These EU regulatory instruments effectively amended and complemented the existing provisions of former Regulations nr. 108 and 109 of 2008 (on the addition of vitamins and minerals to foods and the safety of foods) and Regulation No 353/2008 “establishing implementing rules for applications under Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council to authorise health claims”.
We boast a solid track-record in the field, along with the required know-how to support and guide our clients throughout the most complex domestic and international operations.