Local representative of the Marketing Authorisation Holder

A marketing authorisation may only be granted to an applicant established in the European Community (Art 8 2001/83/EC). Furthermore, some member states require a local representative be appointed and included in the contact details of the Patient Leaflet, as is the case in the Netherlands (Article 71 Dutch Medicines Law). DADA has the required legal entities and organisation in-house to act as your European Community establishment and/or as local representative in the Netherlands, including liaison with health care professionals or the public in the local language, handling of product questions or complaints, and more.