Publication date: October 15, 2024
Parallel import of medicinal products is an institution that has its source in the EU law, resulting from the free movement of goods (Articles 34-36 TFEU), consisting in importing medicinal products from the European Union countries or a Member State of the European Free Trade Agreement. According to Article 21a of the Pharmaceutical Law, the medicinal products subject to parallel import must have “the same active substance or the same combination of active substances, at least the same indications up to level 3 of the ATC/ ATCvet code […], the same strength, the same route of administration and the same form as a medicinal product authorized for marketing in the territory of the Republic of Poland or a similar form that does not cause therapeutic differences in relation to a medicinal product authorized for marketing in the territory of the Republic of Poland.”[1]
Publication date: October 15, 2024
The need for doctors to use a medicinal product not approved for marketing in Poland raises the question of whether the lack of registration of the drug in Poland is equivalent to a ban on its use.
The solution to this problem can be found in Article 45 paragraph 3 of the Act of 5 December 1996 on the professions of physician and dentist (Journal of Laws of 2024, item 1287), which indicates that in justified cases, a physician may prescribe medicines admitted to trading in other countries, with a detailed justification in the medical documentation.
Publication date: October 10, 2024
The Polish Ministry of Health will promote free applications that allow monitoring of the health of patients. Applications will be able to receive the title of “MZ Certified Application” (Software certified by the Ministry of Health) for a period of 24 months. According to the regulations for awarding applications the title of Ministry of Health Certified Application, the aim of the competition is not only to find applications that will provide information on health, but will also store data safely and their software will be a medical device.
Publication date: October 10, 2024
There were attempts to introduce into the Polish legal system the compassionate use procedure, when implementing the amendments to the Polish Clinical Trial Act and Pharmaceutical Law. The changes were to enter into force in 2022, however, ultimately, the Act did not include any mention of the so-called compassionate use procedure. This procedure, also known as the use of medicines in exceptional situations, allows patients to access therapies that have not yet been registered on the market. This is particularly important in the context of rare and serious diseases, where available treatments are insufficient or ineffective. In many European countries, including in EU law, compassionate use is regulated and is an important tool in protecting public health. Unfortunately, in Poland, the implementation of this procedure encounters numerous obstacles, which is a serious problem for patients and doctors.