Pharmaceutical and medical law

Pharmaceutical and medical law

We offer legal service and consultancy related to advertising, distribution, regulation, clinical testing and refunding of medicinal products, dietary supplements and medical products.

We offer:

  • in relation to advertising and marketing of medicinal products:

    • giving opinions and verification of medicinal products advertisements, corporate advertising and promotional campaigns in terms of compliance with the legal regulations in force,

    • legal representation before the Chief Pharmaceutical Inspector (GIF) and administrative courts in proceedings concerning advertising of medicinal products,

  • in relation to distribution of medicinal products:

    • drafting, giving opinions and negotiating distribution agreements and agreements with representatives and entities offering representation services,

    • training in pharmaceutical law for medical and commercial representatives,

  • in relation to regulatory issues:

    • legal representation and/or legal consultancy in proceedings concerning marketing authorization of medicinal products, permits to parallel import, notifications of parallel distribution, licenses for production or import of medicinal products, wholesale permits etc.,

    • legal consultancy related to border products (a medicinal OTC product vs. a cosmetic product or a dietary supplement),

  • in relation to issues of medicinal products refunding

    • legal representation and/or legal consultancy in proceedings concerning medicinal products refunding (legal work-out of refund applications etc.), legal representation in connection with complaints to the Supreme Administrative Court,

    • giving opinions on bonus/discounts and other marketing campaigns concerning refunded medicines in terms of compliance with pharmaceutical law and the Act on benefits financed from public means,

  • in relation to clinical testing of medicinal products

    • preparation of agreements concerning clinical tests, participants’ consent and the like, ○ general legal consultancy – giving opinions on compliance with the legal regulations in force and with Good Clinical Practice, responsibility of sponsors and researchers, insurance, research documentation etc.,

  • legal assistance and service related to advertising and marketing and to regulatory issues (introducing into trade and use, registration filing) distribution agreements and other agreements concerning medical products and dietary supplements.

  • assistance and legal service concerning  Non-Public Healthcare Centers (NZOZ) and self-government hospitals (see more in: Corporate Services and Capital Investments).

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