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Practical comments on fortified foods, NANDO system and introducing dietary supplements on the market

Publication date: January 09, 2025

Dictionary:

  • Fortified foods – these are food products that have had additional nutrients added (such as vitamins, minerals, fiber) to improve their nutritional value and prevent deficiencies of these nutrients in the diet, e.g. enriching spring water with minerals changes the qualification of this water to mineral water.
  • NANDO – (New Approach Notified and Designated Organisations) notification is the act by which a Member State informs the Commission and the other Member States that a body that meets the relevant requirements has been designated to carry out conformity assessments in accordance with the directives. Notification of notified bodies and their withdrawal are the responsibility of the notifying Member State.

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Biosimilar Medicines in Poland

Publication date: January 09, 2025

A biosimilar is a medicine that is similar to another biological medicine that is already on the market in different countries of the European Union. A medicine that is close in similarity is a medicine that has only minor differences compared to another biological medicine that is already on the market. The term “Biosimilar” is used in the European Union and refers to the comparability between a biologically similar medicine and its reference medicine. Biosimilar medicines are made from living organisms and are used when a serious disease such as cancer occurs.

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Role of Polish bioethical committees in clinical trials – practical comments

Publication date: January 08, 2025

Undertaking clinical trials plays a fundamental role in the development and marketing authorisation of medicinal products. The aim of clinical trials is to test the safety and effectiveness of the products being studied. A trial sponsor is an individual, company, institution or organisation that is responsible for undertaking, managing and organising the financing of a clinical trial.

Bioethics Commission

The composition and functioning of the bioethics commission are specified in Article 29 of the Act of 5 December 1996 on the professions of physician and dentist (consolidated text: Journal of Laws of 26 March 2018, item 617) and in the Regulation of the Minister of Health of 11 May 1999 on the detailed principles of establishing and financing and the mode of operation of the bioethics commission (Journal of Laws No. 47, item 480).

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New classification of business activity codes in Poland – important information from tax perspective

Publication date: January 08, 2025

The classification of business activity is a system used to classify types of business activity and is regulated by the Regulation of the Council of Ministers on the Polish Classification of Activities. This system plays a key role when starting a business, because entrepreneurs are required to assign appropriate business activity codes, which precisely define the scope of the business activity conducted. In practice, however, as shown by the judgment of the Supreme Administrative Court of 7 July 2016 (ref. II GSK 342/15) [1], assigning the appropriate business activity code is not always unambiguous. The court ruled on a case in which the entrepreneur had doubts as to which category of activity he should choose to best reflect the actual nature of his company. What seems like a simple formality – assigning one of the many available business activity codes – in practice can become a problematic issue, with serious legal consequences. In this particular case, the entrepreneur indicated a code that he believed best suited his business, but the administrative authorities found that the assigned business activity code may not correspond to the actual activity, which led to the need to correct the registration. This judgment emphasizes how important it is for the business activity code to accurately reflect the scope of the business activity conducted. Correct classification is the foundation for the correct settlement of business activities in terms of tax liabilities, such as VAT or income, as well as other administrative obligations. Correct assignment of the business activity code affects what regulations will apply to the entrepreneur, and thus what VAT rates apply to his services or goods, or what group of tax reliefs he falls into. In the discussed judgment, the Supreme Administrative Court pointed out that incorrect assignment of the business activity code may result not only in problems with tax settlement, but also in negative consequences in the context of tax audits. In practice, the tax administration may question the incorrectly assigned code, and as a result of such verification, the entrepreneur is forced to correct tax returns, which is associated with additional costs and formalities. Moreover, the court indicated that entrepreneurs may be forced to re-verify their activities, which in the long term may lead to unnecessary administrative complications. An equally important aspect that appeared in the ruling is the issue of the ambiguity of some business code categories. In many cases, business activities may cover different areas that fit several business activity codes, which is why the entrepreneur may encounter difficulties in choosing the right one. The Supreme Administrative Court ruling shows that in such situations, the entrepreneur must demonstrate great diligence in choosing the code so as not to mislead the administrative authorities, and thus avoid potential consequences. For this reason, it is so important for entrepreneurs to take special care to correctly assign the appropriate business activity code already at the stage of registering the business.

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Discrimination in the Polish Labor Code

Publication date: January 07, 2025

What is the prohibition of discrimination?

The prohibition of discrimination at work is included in Article 183a) of the Labour Code and in the Constitution in Article 32, which requires equal treatment in all aspects, including those related to work.

Discrimination may be related to;

  • gender,
  • age,
  • disability,
  • race,
  • religion,
  • nationality,
  • views,
  • origin,
  • religion or sexual orientation
  • either due to employment for a fixed or indefinite period or on a full-time or part-time basis.

The above criteria are not socially acceptable and any unjustified unequal treatment of employees is considered discrimination.

Direct and indirect discrimination

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