European Medicines Agency issues reminder on PIP deferral obligations

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13/04/2011

European Medicines Agency issues reminder on PIP deferral obligations

The European Medicines Agency reminds all marketing authorisation holders that have been granted a deferral in their agreed paediatric investigation plan (PIP) that they are obliged to submit an annual report on deferred measures.

Companies should submit their annual reports in line with the guidance on annual reports on deferrals using the template for annual report on a deferral.

The Agency can grant a deferral to a PIP when there is insufficient information to demonstrate a medicine's effectiveness and safety in adults. A deferral allows the company developing the medicine to delay its development in children until this information is available.

The obligation to submit an annual report on deferrals is defined in Article 34(4) of the 'Paediatric Regulation' (Regulation (EC) No 1901/2006). This states that the annual report should provide an update on the company's progress with the agreed paediatric studies.

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