Life Sciences Regulatory and Compliance

Arthur Cox’s Life Sciences Group benefits from having one of the first regulatory and compliance teams within an Irish law firm dedicated specifically to pharmaceutical, biotechnology, medical devices, food and cosmetics industries. With previous regulatory and legal experience at the European Commission, as well as private-sector experience, our team can offer responsive and practical solutions to regulatory and compliance issues.

We have extensive experience in managing contentious and non-contentious matters in relation to actions taken by self-regulatory bodies or the competent national authorities.

We also work with a range of specialist life sciences law firms throughout Europe to ensure that our clients benefit from first in class pan-European advice when required.

 

EXPERTISE

Our regulatory expertise includes the following areas:

Clinical trials, investigations and research

  • Drafting and advising on clinical trial/investigation documents for all phases (including post-market trials), material transfer agreements, clinical trial and principal investigator agreements, sponsor agreements with contract research organizations.
  • Transparency of trial data and data protection issues including drafting trial subject informed consent forms.

Authorisation and life cycle management

  • Product classification for medicinal products, medical devices, food and feed, food supplements and dietary foods and food for special medical uses.
  • Regulatory strategy pathways including borderline/combination products.
  • Pricing and reimbursement strategies.
  • Challenges to competent authority or notified body decisions and responses to inspection reports.
  • Orphan drug designation.
  • Data and market exclusivity.
  • Supply, distribution, manufacturing and packaging requirements.
  • Advice on pharmacovigilance and other safety related actions.

Anti-bribery, ethics and transparency

  • Compliance with industry code and legal requirements including disclosure obligations.
  • Interactions with healthcare professionals and organisations including sponsorship, consultancy arrangements, hospitality and gifts.

Promotion and marketing

  • Reviewing advertising programmes and strategies.
  • Labelling and advertising claims advice.
  • Developing and reviewing promotional and marketing policies.
  • Advising on all promotional and non-promotional activities.

Transactional

  • Conducting due diligence in connection with mergers, acquisitions and reorganisations.

 

RECENT EXPERIENCE

  • Advising a market-leading medical devices company on the regulation and accreditation of medical devices in Ireland, and on the packaging and labelling requirements.
  • Assisting a leading medical device manufacturer in challenging a notified body decision not to renew the CE Certificate of Conformity for their medical device.
  • Providing advice in relation to disclosure of payments to healthcare professionals and healthcare organisations and other related transparency requirements.
  • Dairy products labelling advice for global food nutrition company.
  • Serving on the promotional and non-promotional review board of a global biotech company advising on all aspects of compliance and ethics.
  • Advice in relation to the import, sale and distribution of a food supplement in Ireland.
  • Advising manufacturers, brokers and wholesalers of medicinal products on their registration requirements, the Falsified Medicines Directive and their obligations in relation to the licensing, importation and distribution of medicinal products.
  • Advising on all aspects of reimbursement of medicinal products under the IPHA/HSE Agreements, including advice in relation to applications under the Hi-Tech Scheme and challenges to the reimbursement framework.
  • Advising and assisting companies set up and establish food business operations in Ireland and guiding them through various regulatory requirements from HACCP management to FSAI registration and inspection.
  • Advising academic and non-academic sponsors of clinical trials in relation to the establishment of their clinical trial programme in Ireland.