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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 IP and competition law in Poland: overview

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Medicinal product regulation and product liability in Poland

Publication | 01.07.2017 The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability.

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Chambers Europe: 24 experts in 15 specialisations

News | 10.04.2017 An expanded, i.e. European, part of the Chambers and Partners ranking has just been published. The Europe Guide is a supplement to the Global Guide, and also distinguishes DZP and its experts.

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Distribution and marketing of drugs in Poland: overview

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USP Zdrowie buys Polish-Swedish Naturell Group

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DZP distinguished in Ist Ranking of Regulatory Law Firms 2016

News | 29.01.2016 28 January 2016 Polityka Insight announced the results of its first Ranking of Regulatory Law Firms 2016. Our law firm has been distinguished in three out of five categories: Pharmaceutical, Banking, Energy.

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Pharmaceutical company owners merged with FMCG market leader

Deals corner | 23.10.2015 Maspex Wadowice Group purchased shares in Sequoia sp. z o.o. from a minority shareholder, Sorabot investment fund. Our Law Firm acted for the Sequoia majority shareholders.

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DZP coordinates three-part transaction with GSK and Novartis

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Chambers Europe recommends DZP and its experts

News | 25.04.2014 Yestarday the European edition of Chambers & Partners was published. We are pleased to inform you that both our law firm and DZP’s experts have again been recommended in the following categories:

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English translation of the Pharmaceutical Law available in bookshops

News | 28.10.2013 We are pleased to announce that an English version of the Pharamaceutical Law and the Act on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Uses and Medical Devises is now available in bookshops.

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

Publication | 13.03.2013 There are less than six months until the introduction of several new legal requirements for both manufacturers and distributors of cosmetic products.

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Marcin Matczak joins the team of INFARMA Disciplinary Court

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DZP – once again out in front in Rzeczpospolita ranking

News | 11.05.2010 It is our great pleasure to inform you that our Law Firm has for the eighth time in a row taken first place in the leading ranking of law firms published in the Rzeczpospolita newspaper on 11 May.

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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, Macieja Maciejewskiego, at: iod@dzp.pl.

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