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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Cooperation of KG Legal, the Polish law firm, specialising with legal assistance to life science entities, with Biotechnology Magazine.
Tripartite Clinical Trial Agreements under Polish law — the article based on KG Legal cases and experience with cross border cases.
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KG Legal participated in OpenLivingLab Days event hosted in Krakow, Poland from 29 August to 1 September 2017. The four-day event was hosted by ENoLL member Krakow Technology Park – one of the key actors in co-creating and implementing the Regional Innovation Strategy and promoting smart specialization and user-driven innovation approaches in the region. The event included interactive sessions, workshops, discussion panels with excursions and off-site visits with the aim of giving the participants a wider insight about models, theories and technologies related to Living Labs.
The strategic partners of the OpenLivingLab Days 2017 conference are the Cracow City Hall and the Marshal’s Office of the Małopolska Region.
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KG Legal will take part in XIII International Symposium “Intellectual property in an innovative economy. Start-ups and what’s next?”, organised by the Polish Patent Office, which will be held in the International Culture Centre in Cracow, on 7-8th September 2017. The event has been announced to be under the patronage of the President of the Republic of Poland and has been organised with the cooperation with the World International Property Organisation, the Industrial Development Agency, the Marshall’s Office of the Małopolskie Voivodeship, the Embassy of the State of Israel, United Stated Embassy and the number of Universities, e.g. Jagiellonian University or AGH University of Science and Technology.
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