Paediatric extensions and transitional provisions: a question of timing

The SPC Blog learns from Martin Paltnoi (Managing Director, MPA Business Services Ltd) that there may be some confusion regarding the timing of forthcoming paediatric extensions. He explains as follows:

"The European Regulation governing paediatric extension on medicinal products for paediatric use was covered by Regulation 1901/2006 of 12 December 2006, which finally came into force on 27 January 2007.

I have noticed that an amendment to this covered by Regulation 469/2009 concerning the application of Paediatric Certificates may have gone through unnoticed by people who may be involved. Under the present system those conducting work allowing for an extension for paediatric use can file their application no later than six months prior to the expiry to the appropriate SPC. This newer Regulation alters that transitional period of which, we believe, those interested parties should be fully aware. Under Article 7 of the Regulation, Paragraph 4, the application for the duration of the Certificate for Paediatric Use for SPCs already granted shall not be lodged later than two years before the expiry of the SPC. Paragraph 5 of Article 7 indicates that this will come into effect five years from the entry into force of Regulation 1901/2006. So, from 27 January 2012 those companies wishing to make an application for an extension for paediatric use of an SPC will have to ensure that it is carried out not less than two years before the expiry of the SPC. In those instances where the duration of an SPC would be less than two years the application for that SPC and the extension for paediatric use would have to be carried out concurrently.

This is bound to cause some confusion but it would seem that those SPCs already granted prior to 27 January 2012 will still be bound by the six month period. It will be interesting to see the effect of this change and the significance to those interested parties".

Thanks, Martin!