Paediatric extensions to supplementary protection certificates

By Ed Vickers

In addition to monopoly protection in the form of a patent and a supplementary protection certificate (SPC), medicinal products may also be protected by a paediatric extension, which extends the lifetime of an SPC by a further six months.

The governing legislation is the Paediatric Regulation (Regulation (EC) 1901/2006). The aim of the legislation, among other things, is to: ‘facilitate the development and accessibility of medicinal products for use in the paediatric population; to ensure that medicinal products used to treat the paediatric population are subject to ethical research of high quality and are appropriately authorised for use in the paediatric population; and to improve the information available on the use of medicinal products in the various paediatric populations’ …

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