Practices / Pharma Regulatory

Pharma Regulatory

HOYNG ROKH MONEGIER's EU and national Pharma Regulatory Group is based in Amsterdam and Brussels and has a strong track record in pharmaceutical, biotech and medical devices regulatory matters

Our practice covers the full range of European and national regulatory matters as they appear during the life cycle of the product:

• Clinical trial regulations

• Early access programs

• Marketing Authorisation procedures:
- EU and national requirements for market access
- Appropriate data package and obtaining and maintaining marketing authorisation
- Strategic due diligence
- Support for new applications
- Orphan designation and derogation
- PIP applications, deferrals and waivers

• Regulatory exclusivity:
- Regulatory Data Protection (RDP)
- orphan market exclusivity
- pediatric rewards

• Pharmacovigilance and materio-vigilance
- compliance with pharmacovigilance/ materiovigilance obligations, pharmacovigilance agreements (e.g. QPPV, Safety data exchange)
- risk management plans
- enforcement and inspections

• Pricing and reimbursement

• Supply chain management

• Compliance
- Advertising, sponsoring, consultancy, anti-bribery and other promotional tools
- Labeling

• Product liability

• EU and national legislation on transparency of government information.

Our Pharma Regulatory Group has extensive experience in advising on all aspects of regulatory matters and is in frequent contact with the EU and national competent authorities and industry bodies. Our lawyers also litigate regulatory matters in the EU courts and across the national courts and industry boards in the member states, in cooperation with a trusted network of local counsel in all 30 EEA member states. The team members are equally skilled in the draft and review of contracts in this area