Extending protection for medicinal products tested on children

Pharmaceutical companies can extend the protection period of an authorised medicinal product by up to a further five years after the expiry of the patent with a supplementary protection certificate (SPC). In addition, they can extend protection for a further six months (where necessary) if they have carried out paediatric studies for a medicinal product (known as a paediatric extension).

 

The six-month extension can be obtained in one of two ways:

  • either by extending an already granted conventional SPC, or if no conventional SPC exists...
  • with a paediatric SPC, which is directly linked to the term of the patent.
 

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