Supplementary Protection Certificates in Bulgaria and Romania

Further to the accession of Bulgaria and Romania to the European Union on January 1, 2007, EU regulations concerning the creation of supplementary protection certificates for medicinal products, as well as the regulations concerning the creation of supplementary protection certificates for plant protection products will enter into force in these two countries.

Accordingly, it is important to note the following:

In both Bulgaria and Romania any medicinal product or any plant protection product protected by a valid basic patent and for which the first authorisation to enter the market as a medicinal product or as a plant protection product was obtained after January 1, 2000 may be granted a certificate provided that the application for a certificate is lodged within six months of the date of accession, which is by June 30, 2007.

The above applies even if the actual filing date, calculated according to the EU regulations, has expired.

For more information please contact Loic Dufour or Aura Campeanu.