Romania Issues New Regulations on Supplementary Protection for Medicinal and Plant Protection Products

On March 31, 2010, the Romanian PTO issued Regulation No. 111, which adds two new points to art. 6 of Regulation No. 146 on Supplementary Protection Certificates for Medicinal and Plant Protection Products from December 28, 2006.

The newly added point 6 provides that the official fee for the examination of a request for a 6-month extension of the supplementary protection certificate (SPC) for medicinal products for pediatric use is EUR 500 (USD 682), the same as for the examination of a request for granting an SPC for other medicinal products.

The newly added point 7 provides that the official fee for the 6-month extension of an SPC for medicinal products for pediatric use, as per the provisions of Council Regulation (EEC) No. 1768/92 with further amendments, is EUR 1,400 (USD 1,913).

On the same date, March 31, 2010, the Romanian PTO issued Regulation No. 112, which establishes the standard form to be used for requesting the extension of an SPC for medicinal products for pediatric use.

These two new regulations establish formal rules for practices regarding the SPCs that were not formerly regulated by the PTO.

For more information, please contact Roxana Sarghi at our Romania office.

Source: Romanian PTO