As lawyers in Wels, we offer comprehensive advice and support in all areas of pharmaceutical law.
Not only the Austrian regulations (in particular the Medicines Act – Arzneimittelgesetz – AMG), but also a number of EU directives and EU regulations are to be observed here.
We advise you inter alia at questions concerning
Authorization and distribution of medicines (Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen – BASG) / AGES); MRP (Mutual Recognition Procedure); Decentralized Procedure – DCP; Authorization via the European Medicines Agency in accordance with Regulation (EC) No 726/2004
Differentiation to medical devices (Medical Devices Act (Medizinproduktegesetz – MPG), Food (nutritional supplements) and cosmetics
Import of medicines
Parallel import acc. § 10c Medicines Act (Arzneimittelgesetz) or centrally approved specialty drug according to Regulation (EC) No. 726/2004 – European Medicines Agency (Europäischen Arzneimittelagentur – EMA)
We as lawyers in Wels accompany you at
authorization and registration procedures for proprietary medicinal products,
the creation of the labeling, the product information and the package information leaflet,
the application for entry into the Reimbursement Code (Erstattungskodex), as well as
in regard to the quality assurance.
You will receive advice from our law firm in Wels for your sales and marketing.
Furthermore, as a law firm in Wels we also are at your disposal for advice and preparation of cooperation agreements, in the area of import – export, such as dealer agreements, distribution contracts and agency agreements, confidentiality agreements, terms of purchase, clinical trials, R & D contracts, and other requirements applicable to your business.