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

 

Registration

• 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

 

Reimbursement

• 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

 

Marketing

• 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

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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

 

Pharmacovigilance

• legal services for PASS and PAES tests

• advice on pharmacovigilance procedures

• advice on recalling a product from the market

• support in relations with UPRL

 

Compliance

• preparation or evaluation of internal procedures concerning:
  marketing activities targeted at medical professionals
  tenders, including tender communication
  pharmacovigilance
  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

 

Legislation

• representing industry organizations in the legislative process

• legislative monitoring

• creating reports and legislative proposals