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Petra den Boer

Petra is part of Axon Lawyers since 2021. Petra advises and litigates on various aspects of pharmaceutical and medical devices law, with a specific focus on compliance and advertising. Before joining Axon Petra worked in the life sciences regulatory unit of an international law firm.

Expertise:

• Pharmaceutical law
– Compliance for pharmaceutical companies
– Advertising of (veterinary) medicinal products
– Market access of medicinal products, including advice on
marketing authorizations and regulatory exclusivities
(e.g. data exclusivity and the qualification of a new active substance)
– Pharmaceutical compounding and onward delivery
– Parallel trade
– The new Veterinary Medicines Regulation ((EU) 2019/6)

• Medical devices law
– Compliance for medical device companies
– Advertising of medical devices
– Combination products and companion diagnostics

• Commercial contracts and mergers & acquisitions in the life sciences industry

More about Petra

Petra graduated from the Erasmus University in Rotterdam in 2015 and was admitted to the bar in 2016. In her spare time she enjoys spending time with friends and family, visiting her horse and listening to podcasts.

Twitter

https://t.co/3uvqdIvjtS

Petra's articles

Article

Regulatory exclusivity rights: the General Court annulled the decision of EMA to not accept a marketing authorization application

On May 5 2021 the General Court published a (lengthy) judgement in which it annulled the decision of EMA to not validate (and thus not accept and review) a marketing authorization application…

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