top of page
Image by Michał Parzuchowski

Medicinal products

Knowledge. Quality. Engagement.

We have comprehensive and practical knowledge of pharmaceutical law regulations. We advise at all stages of the "life cycle" of products, from clinical trials, registration, manufacturing and marketing, distribution and in connection with advertising and market communication regarding products, to disputes with regulators and competitors and issues related to product safety.

How can we help you?


Clinical tests

  • drafting contracts for clinical trials

  • negotiating with researchers, centers and CRO

  • preparing and reviewing clinical trial documentation

  • advice on obtaining permits and opinions necessary to conduct a clinical trial

  • legal support in the field of Good Clinical Practice

  • advising on the protection of personal data processed in the course of clinical trials



  • comprehensive legal support in the field of registration under the centralised procedure and national procedures (national, mutual recognition, decentralised)

  • introducing post-registration changes


Manufacture and import

  • advice on obtaining, changing or withdrawing permits

  • legal support in the field of Good Manufacturing Practice

  • preparation of draft production contracts



  • help in building a market access strategy

  • representation in reimbursement proceedings, including negotiations with the Ministry of Health

  • RSS compilation

  • legal representation in disputes with the National Health Fund and the Ministry of Health



  • comprehensive legal support in conducting advertising campaigns

  • legal evaluation of marketing materials

  • drafting contracts with service providers

  • preparation or evaluation of internal procedures for marketing activities addressed to medical professionals, including adapting procedures to national and European codes of good practice

  • advice on umbrella branding

  • advice on personal data processed for marketing purposes

Wholesale distribution

  • advice on obtaining, changing or withdrawing a permit

  • drafting distribution agreements

  • consultancy in the field of ZSMOPL and NMVO

  • consultancy and representation in the field of public procurement, in particular in the field of biological drugs and generic drugs

  • legal support in the field of Good Distribution Practice


Pharmacy distribution and non-pharmacy turnover

  • advice on obtaining, changing or withdrawing a permit

  • advising on proprietary and quantitative restrictions on the pharmacy market

  • consultancy in the field of running an internet pharmacy

  • advice on the prohibition of advertising of pharmacies

  • drafting distribution agreements and lease agreements

  • consultancy in the field of ZSMOPL and NMVO



  • legal services for PASS and PAES tests

  • advice on pharmacovigilance procedures

  • advice on recalling a product from the market

  • support in relations with UPRL



  • preparation or evaluation of internal procedures concerning:
    marketing activities targeted at medical professionals
    tenders, including tender communication
    withdrawing products from the market
    transparency of activities and anti-corruption policy
    response in the event of an inspection
    protection of the company's intangible assets

  • audits of planned or ongoing research or educational projects


Relations with public administration

  • representation in proceedings before the Ministry of Health, Pharmaceutical Inspection, URPL, UOKiK or other authorities in cases concerning, among others:
    obtaining or maintaining the validity of permits or permits
    advertising activities carried out
    distribution models used
    suspending or recalling a product from the market
    practices restricting competition or infringing collective consumer interests

  • stakeholder representation in discussions with decision-makers


Relationships with competitors and patients

  • disputes with competitors:
    within the scope of infringement of rights under patents, SPC, trademarks or other rights on intangible property
    in the field of acts of unfair competition
    in the field of parallel import / export
    in the field of industry codes

  • drafting technology transfer agreements, permits, license agreements and other commercial agreements

  • responsibility for a dangerous product (side effects)

  • management of crisis situations



  • representing industry organizations in the legislative process

  • legislative monitoring

  • creating reports and legislative proposals

bottom of page