Module 6

03/10/2024

Paediatric Extension

Procedure • Paediatric Extension Plan (PIP) submitted to EMA • Opinion on whether proposed studies will generate necessary data • Paediatric studies performed • Granted if:- – all measures PIP have been complied with – authorised product information includes relevant information on the results of the studies – product authorised in all Member States

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Duration

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• An extra 6-months on top of the SPC.

The Organisation for Professionals in Regulatory Affairs

SPCs

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Duration of SPC – example 1

• 1 January 1990 : Malergan files UK patent application for the use of botulinum toxins in medicines for use in relieving muscle pain.

• 1 May 1994 : patent granted

• 31 December 1996 : MA granted for the use of the product “ Wotox ”.

• Q1 : What would be the duration of the SPC?

– Hint: what is the time elapsed between filing of the patent and grant of the MA?

• Q2 : When would the SPC expire?

The Organisation for Professionals in Regulatory Affairs

Protection of Biotech and Pharma Inventions

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