Module 1 2021

01/07/2021

• More medicines for children available; Output:

The Organisation for Professionals in Regulatory Affairs

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When is a PIP necessary?

• Pharmaceutical companies need to produce data from paediatric studies, done in accordance with an agreed PIP: • When applying for a new marketing authorization for a product that is on patent; • in case of an already authorized and “patented” product, when applying for a new indication / route / dosage form • When applying for a PUMA, for an off-patent product

• A PIP is not necessary: • Off patent products already authorized in the EU; • New medicinal products with the following legal basis; • Traditional herbal medicinal products • Homeopathic products

• Generic products • Hybrid products • Biosimilar products • When there is a class-waiver; for a class of products used in a specific condition

The Organisation for Professionals in Regulatory Affairs

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