News

Paediatric Extension of SPC's
20. juni 2017

The Norwegian parliament has voted to implement Regulation (EC) No. 1901/2006 on medicinal products for paediatric use, as amended on 5 May 2017 after negotiations between the EU and the EFTA.

The regulation will enter into force in Norway on 1 September 2017. Applications for paediatric extension of SPC's may be filed with the NIPO from 1 August 2017.

For an application for paediatric extension of an SPC you will need to submit the following:

  • a Compliance Statement from the European Medicinal Agency (EMA) as to compliance with the agreed paediatric investigation plan
  • a declaration to the effect that there exists a marketing allowance for all the EEC countries, with the possible exception of Liechtenstein
  • a declaration to the effect that the owner of the SPC has neither applied for nor obtained a one-year extension of the period of marketing protection for the medicinal product concerned, on the grounds that this new paediatric indication brings a significant clinical benefit in comparison with existing therapies, in accordance with Article 14(11) of Regulation (EC) No 726/2004 or the fourth subparagraph of Article 10(1) of Directive 2001/83/EC
  • a declaration to the effect that the medicinal product is not designated as orphan medicinal product pursuant to Regulation (EC) No 141/2000

There is no specific format for the three last mentioned declarations. You may make such declarations in your instruction letter to us. We will then make the proper statements in the application form.

In general, an application for paediatric extension should be filed at the latest 2 years before the SPC expires.

For existing SPC's the following transition provisions were agreed:

  • For SPC's expiring before 1 March 2017, a paediatric extension will not be possible.
  • For SPC's expiring between 1 March and 31 August 2017, extension may be granted, but only for that part of the 6-month period (from the regular expiry date) that is left after 1 September 2017 or the date on which the NIPO publishes the application, whichever date is later. The validity of such SPC's will therefore have a gap from the expiry of the regular SPC until the regulation enters into force on 1 September 2017, or the date on which the NIPO publishes the application if the NIPO publishes the application later than 1 September 2017. Intermediate rights may exist for third parties who in good faith have started commercializing the medicinal product in the time between expiry of the original SPC and publication of the application for paediatric extension. It is therefore recommended to file such applications for extension as soon as possible after 1 August 2017 so that the application for extension may be published as soon as possible.
  • For SPC's expiring between 1 September 2017 and 1 April 2018, an application for paediatric extension must be filed by 1 October 2017.
  • For SPC's expiring between 1 April 2018 and 1 September 2022, an application for paediatric extension must be filed by 6 months before expiry of the regular term of the SPC.
Please contact us should you have any questions or comments.

 

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