Anna Mirek

Radca prawny
Senior Associate
Practice Group: Corporate/Mergers & Acquisitions

Anna specialises in intellectual property law and life sciences. She has over ten years of professional experience, which includes advising leading global as well as emerging companies, both as an in-house counsel and within the frames of international law firms.
She has participated in numerous comprehensive cross border legal projects which required multidisciplinary approach to the commercial, regulatory and intellectual property matters specific for the FMCG industry (especially medicinal products, medical devices, food and borderline products), including new technologies, transfer, licensing and protection of IP rights, compliance & anti-bribery, as well as patent litigation.
Anna provides not only sector counsel but also strategic advice with respect to IP, regulatory, white collar crime issues, compliance, and other benchmark advice.
Speaker and trainer on multiple conferences, congresses and workshops. Former arbiter of Polmed’s disciplinary court.

Expertise

  • Intellectual Property
  • Life Sciences
  • Regulatory
  • Compliance
  • White collar crime and anti-bribery

Career

  • Master of law, Jagiellonian University (Poland)
  • Postgraduate studies in copyright and press law, Jagiellonian University (Poland)
  • Worked as a lawyer at international law firms in Warsaw/Poland
  • Worked as legal counsel in an international pharmaceutical company, Warsaw 
  • Admitted to the National Chamber of Legal Advisors 
  • With Noerr since 2020

Selected Projects

  • Advising a UK listed pharmaceutical company on regulatory and nuclear requirements for placing a medical device containing radioactive isotopes on the Polish market. Our advice covered the regulatory obligations for medical devices, nuclear safety requirements and authorisations for radioactive products, as well as the obligations of hospitals which intend to administer/use radioactive products in Poland.
  • Appealing against the decisions concerning food supplements and foodstuffs for particular nutritional uses in respect of withdrawal from the market, unfair marketing, financial penalties for an alleged non-compliance, as well as providing strategic advice on health claims, classification of borderline products and notification proceedings.
  • Advising numerous investors on the financing of the construction and operations of a hospital in Żywiec (the first integrated PPP facility in Poland).
  • Advising numerous pharmaceutical companies on strategic projects comprising complex compliance issues, including identifying risks and proposing an entirely new model of business organisation. Providing a general review of the client’s educational and marketing strategies, as well as a complex audit of relevant documentation.
  • Advising a leading American company on a strategic and large-scale project (which will initially provide a few thousand jobs) on regulatory aspects of storage, packaging and shipment of different types of FMCG products, including food.
  • Advising an American oncology company on regulatory issues regarding orphan medicinal products and other legal matters, as well as coordinating work in a number of CEE jurisdictions.
  • Advising a leading global medical device company on regulatory issues concerning both medical devices and medicinal products, in such areas as compliance, reimbursement, marketing, promotion and distribution.

Memberships

  • National Bar of Legal Advisors
  • Disciplinary court arbiter at Izba POLMED (the biggest and most representative organisation of medical devices on the Polish market)