- Jahrgang 10 (2013), Ausgabe 4
- Vol. 10 (2013), Nr. 4
- >
- Seiten 173 - 180
- pp. 173 - 180
The Scope of Global Marketing Authorisations within the EU Legal Framework of Regulatory Data Protection for Reference Medicinal Products
I. Background of Regulatory Data Protection Regulatory Data Protection (“RDP“) shelters research and development investments carried out by pharmaceutical companies, at a point where the term of a patent might be exceeded. During the RDP term the data generated as investment results of pre-clinical tests and of clinical trials of a medicinal product may not be referred to by generic competitors. Thus, it completes the patent protection and provides an