The pediatric regulation

The pediatric regulation will be implemented in Norwegian law as from 1 September 2017. The pharmaceutical industry can apply for a patent extension from 1 August.

The Pediatric Regulation (no. 1901/2006) is a separate regulation on medicines for children. The Regulation was adopted by the EU already in 2006. The regulation is now being implemented in Norwegian law.

The purpose of the new regulation is to ensure better documentation of safety and efficacy, as well as to increase the availability, of drugs specifically intended for children. While it has not been studied on children earlier, it has now been recognized that children may have a different effect of drugs than adults. In the medical sense, children are not young adults, and it is not always a matter of dose adjustment to adapt new drug regimes.

To encourage studies on drugs intended for children, an incentive is provided. According to Regulation 469/2009/EC (the SPC Regulation), once an EMA-approved plan for testing the drug for use on children has been completed (Pediatric Investigation Plan (PIP), this provides for a six-month extension of the Supplementary Protection Certificate (SPC) for the medicinal product. In reality, this implies an extension of the patent protection.

Application for extended protection may be submitted for the first time on 1 August 2017.

The rule further requires that ESA be given the authority to impose fines on drug companies in case of breach of the provisions.

The new legislation is planned to enter into force in Norway on 1 September 2017.With this, the pharmaceutical industry in Norway gets the same framework conditions as the EU countries.

Both regulations provide for transitional arrangements for SPCs that have already expired or will expire before Pediatric Regulation enters into force, including an opportunity to apply for an extension if the SPC has expired less than 6 months prior to the enforcement. Suppliers that hold SPCs for medicinal products in Norway or who are planning to launch new generic drugs in Norway should review the transitional arrangement closely to ensure their positions.

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