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Pharmaceutical law

Our advice covers problems associated with medicinal products, dietary supplements, foods for special nutritional purposes and medical devices, including:

  • developing marketing structures, including international structures (particularly pricing and reimbursement rules),
  • drawing up distribution and marketing agreements, obtaining the required manufacturing and marketing licences,
  • dvising during wholesale distribution and retail sales carried out for pharmacies,
  • withdrawing medicinal products from the market,
  • support with mergers and acquisitions between entities operating on the pharmaceutical and food markets,
  • drawing up internal procedures to regulate marketing activity and minimise legal risks arising from the company’s day-to-day operations and contacts between the company’s employees and healthcare workers,
  • day-to-day co-operation in assessing advertising and promotional communiqués and proper marking of medicinal products, medical devices, dietary supplements and foods for special nutritional purposes, also in tax matters,
  • support in proceedings to have products listed as reimbursable and in setting official prices,
  • running training sessions on legal regulations for medical representatives and regional management, and for marketing department staff and management of pharmaceutical companies,
  • advising sector organisations, especially on the legislative process,
  • support in organising and day-to-day running of clinical trials, including drafting agreements, applications and correspondence with supervisory authorities,
  • professional support and representation in disputes with public authorities supervising the pharmaceutical sector, e.g. Main Pharmaceutical Inspector, Main Sanitary Inspector, local sanitary inspection authorities, voivodship pharmaceutical inspectors and the National Health Fund.

Lawyers



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Pharmaceutical company owners merged with FMCG market leader

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Chambers Europe recommends DZP and its experts

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English translation of the Pharmaceutical Law available in bookshops

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New regulations will aff ect the relationship between manufacturers and distributors of cosmetic products

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From 25 May 2018 the General Data Protection Regulation (GDPR) applies in Poland and other European Union countries. We would therefore like to give you several details on the subject of how DZP processes personal data.

The administrator of the personal data is Domański Zakrzewski Palinka Sp.k. (“DZP”; address: Rondo ONZ 1, 00-124 Warszawa). Data are processed for contact purposes and to impart information on changes to provisions and authority practices and on other issues, including events concerning day-to-day legal, economic and cultural issues, inter alia, by sending DZP newsletters. The above is carried out on the basis of legitimate interests, i.e. in accordance with art. 6(1)(f) of the GDPR. Data can also be processed where necessary for the conclusion or performance of a contract and for compliance with a legal obligation to which DZP is subject, i.e. pursuant to art. 6(1)(b) and (c) of the GDPR. Data can be transferred to entities with whose help DZP achieves the indicated aims, including entities maintaining IT infrastructure. Giving data is voluntary and in contractual relations is a requirement for concluding and performing a contract. It is possible to object to data processing, request access to, rectification and erasure of personal data or restriction of processing and data portability. Data are kept until an objection is made, and in contractual relations – throughout the term of the contract and thereafter for a period specified in provisions on archiving and limitations period for claims. Anyone has the right to file a complaint with the President of the Personal Data Protection Office. Questions concerning privacy at DZP can be sent to DZP’s Data Protection Inspector at: iod@dzp.pl.

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