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.

 

Requirements for a requesting an extension:

  • For a medicinal product to obtain marketing authorisation, clinical trials must be carried out on children in accordance with a paediatric investigation plan (PIP).
  • The results of this PIP must be published in the product information of the medicinal product in question.
  • The application for the marketing authorisation in Switzerland for a paediatric medicinal product must not be made later than six months after the application for marketing authorisation in the European Economic Area.
 
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