healthcare-pharmaceuticals

Healthcare & Pharmaceuticals

The Healthcare & Pharmaceuticals practice advises pharmaceutical, medical device and healthcare companies on regulatory, commercial and contentious matters throughout the life of their products and services in Greece. The firm supports clients from regulatory approval to market access, commercialisation and operation, as well as in disputes when they arise. Drawing on sector knowledge and an understanding of operational considerations, the team helps clients operate effectively within a highly regulated and evolving environment.

The firm’s expertise includes:

Regulatory framework for medicines and medical devices

  • Compliance with EU and national law
  • Guidance on product classification
  • Quality and safety issues

Licensing and approvals

  • Support in proceedings before the National Organization for Medicines (EOF) and European authorities
  • MA, CE marking and conformity assessment
  • File amendments

Signage, promotion & advertising communication

  • Checking labelling and product information
  • Compliance of advertising actions with pharmaceutical legislation
  • Digital marketing, e-health and promotion of health products

Collaborations in the health sector

  • Contracts with Healthcare Professionals (HCPs) and Health Institutions
  • Clinical trial agreements, consulting agreements
  • Compliance with transparency and anti-bribery rules

Pricing & Reimbursement

  • Drug Pricing Procedures
  • Inclusion in reimbursement schemes
  • Negotiation with competent authorities and bodies

Rebate & Clawback

  • Management of mandatory refund and discount schemes
  • Legal assessment of charges
  • Administrative and judicial appeals

Trading & Distribution

  • Distribution, supply and logistics contracts
  • Parallel imports and exports
  • Supply chain management

Intellectual Property & Innovation Protection

  • Patent rights
  • Clinical trial data protection
  • IP disputes in the Pharmaceutical Industry

Regulatory compliance

  • GDPR in the health sector
  • Compliance programs and internal policies
  • Anti-corruption and transparency (HCP interactions)

Litigation & legal representation

  • Disputes with regulators
  • Challenging administrative acts
  • Litigation in the health sector, including public procurement disputes
  • Consumer and user claims

Representative Clients

Solvay, Stryker, Reckitt, Essity, Eurofins, L’Oréal, GE Healthcare, Indivior, Medicover, Phenomenex, Bioderma, inVentiv Health, Premier Research, BREAS, Solutia, Gore, Dokter Online, European Wellness, Healthnet, Pharmsol, Liomar Medical, Labomed, Unicare, Devicor, Kleva Pharmaceuticals, Medica, Malva, ABH Medical Group, NADclinic, Kostas Papellinas SA, Farmeco (Coverdem)

Representative Clients

GE Healthcare, Solvay, Stryker, Solutia, Devicor, Kleva Pharmaceuticals, Kostas Papellinas SA, Farmeco, Gore, Premier Research, Breas Medical.Our clients and companies rely on Kelemenis & Co team of healthcare and pharmaceutical Practice for the right expertise.

Chambers Europe 2012 says:

This growing firm has created a strong name for itself advising on commercial disputes in the energy, leisure, insurance and pharmaceuticals sectors. The firm is expanding its international client base and is attracting more cross-border mandates, advising internationals such as GE and Metaxa.

Chambers Europe 2011 says:

This “very service-minded, co-operative and approachable” team offers litigation and arbitration services and caters to both Greek and international clients. Standout mandates include representing Breas Medical, a Swedish subsidiary of the GE Healthcare Group, in a claim brought by a Greek former distributor.

Practice Areas