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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.

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Publication | 14.06.2018 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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Pharmaceutical IP and competition law in Poland: overview

Publication | 14.06.2018 The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports.

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Chambers Europe 2018 distinction for DZP

News | 12.03.2018 We are very pleased to announce that both our law firm and our experts have once again been recommended in the Chambers Europe 2018 ranking that was published last week.

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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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Pharmaceutical IP and competition law in Poland: overview

Publication | 01.07.2017 The Q&A gives a high level overview of key issues including patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports.

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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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NAC upholds decision on anti-pneumococcal vaccination

Deals corner | 30.01.2017 On 13 December the NAC dismissed PGF Urtica's appeal against the tender result for the anti-pneumococcal vaccines announced by the Public Procurement Department at the Ministry of Health.

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Distribution and marketing of drugs in Poland: overview

Publication | 01.11.2016 Overview of distribution and marketing of drugs law (pre-conditions for distribution, licensing, wholesale distribution, marketing to consumers and professionals and engagement with patient organisations).

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Commercialisation of healthcare in Poland: overview

Publication | 01.11.2016 Overview of the regulatory framework for the commercialisation of medical products in Poland (requirements for drugs, medical devices, biological products and natural health products).

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USP Zdrowie buys Polish-Swedish Naturell Group

Deals corner | 18.07.2016 USP Zdrowie Group acquired 100% of shares in the Polish-Swedish Naturell Group. We were the main adviser and co-ordinated the Polish-Swedish team of lawyers and tax and financial advisers.

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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

Deals corner | 26.05.2015 DZP advised GlaxoSmithKline in a three-part conditional transaction with Novartis AG in the following areas: health care means (Consumer Healthcare), vaccinations and cancer medicines.

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DZP report on oncology and queuing packages

Deals corner | 02.04.2015 On February saw the publication of a regulatory report drawn up by a team led by Marcin Matczak, Tomasz Zalasiński and Michał Czarnuch on the request of the Supreme Medical Chamber.

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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

News | 16.11.2012 We are pleased to announce that on 16 November Marcin Matczak was registered by the Board of the INFARMA Employers' Union of Innovative Pharmaceutical Companies as an expert to the 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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