Changes in Polish pharmaceutical law

On 4th January, 2019 there was initiated the preparation of changes in the Polish Pharmaceutical Law. Such changes are required due to the commencement of a direct applicability in Poland of the delegated regulation of the European Commission No. 2016/161 from 9th February, 2019.
The main aim of such regulation is to prevent falsification of medicines and placing them on the market. Changes in Polish legislation will concern the introduction of a Unique Identifier which will be enabling the verification of the authenticity of medicinal products, as well as the identification of individual packaging. Moreover, Anti-Tampering Devices, sort of security measures, will be introduced to prevent violation of the packaging of medicinal products available on prescription, however, some freedom in selection of measures has been in this respect left to the Polish state.
The changes will also concern the manufacturers of medicinal products, who will have to establish a specific system of databases. The control of entities authorized to purchase medicinal products from pharmaceutical wholesalers (e.g. doctors, nurses, veterinary surgeons, pharmacies, research institutes, universities) will also be made more strict.
Non-compliance with the obligations of the said regulation will be sanctioned by the Chief Pharmaceutical Inspector by, among others, revoking the permission to manufacture or import medicinal products, operating a pharmaceutical warehouse and imposing financial penalties.

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KG Legal Kiełtyka Gładkowski, Polish law firm, participates in workshops organized by the major Life Science Cluster (Hub) in Poland as a part of Excellence Cluster for Regional Improvement programme. KG Legal Kiełtyka Gładkowski, thanks to its business networking, finds for its international Clients Polish companies operating in pharmaceutical sector and then provides legal assistance in life science projects (often cross border ones). 

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KG Legal will take part in a meeting entitled “The road to success – how to create an excellent business model” organized by the Life Science Cluster on Wednesday, 12 September 2018 in Krakow. The meeting will focus on discussing with experts the issue of business models and strategies supporting the work and activities of new start-ups.

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In the amended Pharmaceutical Law (Journal of Laws of 2017, item 2211 and of 2018 items 650, 697 and 1039) in the most visible way, the changes will affect the institution of the Main Pharmaceutical Inspector – this office will be granted new rights, its position will also be strengthened. From now on it will be the competent authority to issue, refuse, revoke, withdraw, and change the permit for the manufacture or import of a medicinal product, by means of a decision; it will also be decisive in the case of medicine production in the so-called advanced therapy.

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Laboratory research in science and medical setting.

The new regulations which have become effective since January 1st, 2018, introduced the tax relief in Poland for companies operating in research and development (R&D) sector (an increase from the current level of 50% up to 100 percent tax relief), and in the case of research and development centres up to 150 percent of tax relief. The new act introduces a uniform deduction system in Poland for all companies regardless of the size of the enterprise or the type of these costs.

The changes also apply to universities that will be able to set up companies to manage research infrastructure. The so-called infrastructural companies have to build and share research infrastructure in a more efficient and easier way for the entrepreneurs. It also affects the need to commercialize research on the part of scientific and research institutions. This, in turn, is intended to enable entrepreneurs to use the material and human resources of higher education institutions.

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