SPCs (Supplementary protection certificates) were introduced to compensate for the long time needed to obtain regulatory approval of these products. A supplementary protection certificate comes into force only after the corresponding general patent expires. It normally has a maximum life time of 5 years. The duration of the SPC can, however, be extended to 5.5 years when the SPC relates to a human medicinal product for which data from clinical trials conducted in accordance with an agreed Paediatric Investigation Plan (PIP) have been submitted (as set out in Article 36 of Regulation (EC) No 1901/2006).
Legislation has provided the requirements and procedural aspects related to SPC but its not give clear picture about the same and due to that many contoversial situation was aroused related to grant of SPC for some products.
Here is the article where you can get some happenings around the comlicationof SPC law. Click here
No comments:
Post a Comment