On July 11, 2019, the representatives of the Ministry of Enterprise and
Technology will visit the headquarters of the National Key Life Science
Cluster in Krakow. The meeting will aim to present the activities of the
Life Science Cluster. The program of the visit includes acquainting
Cluster Members (including the representatives of KIEŁTYKA GŁADKOWSKI KG
LEGAL) with the representatives of the Polish Ministry of
Entrepreneurship and Technology based in Warsaw (this is one of the 19
Polish government departments).
In Krakow
there will be launched the Centre for New Computational Methods in Personalized
Medicine – a new unit of implementation research, in which innovative methods
of medical and personalized diagnostics will be developed, using advanced
technologies, models and computer simulations for this purpose.
Małgorzata Kiełtyka, Attorney, Founding Partner of KG Legal Kiełtyka Gładkowski indicated by the Legal 500 EMEA 2019 among the leading individuals in healthcare & life sciences sector.
KG LEGAL KIEŁTYKA GŁADKOWSKI included in the top 5 in the category HEALTHCARE AND LIFE SCIENCES in Poland, in the world ranking of the best law firms in the world The Legal 500 – EMEA 2019.
“‘Pro-active‘ Kraków-based healthcare and life sciences boutique KG Legal Kiełtyka Gładkowski handles a variety of matters, including data protection, product labelling, licensing, regulatory issues and the legal aspects of clinical trials. ‘Extremely professional‘ co-founding partners Małgorzata Kiełtyka and Jakub Gładkowski are the key names and are able to draw on their ‘profound sector knowledge‘”
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.
Małgorzata Kiełtyka, Attorney, Founding Partner of KG Legal Kiełtyka Gładkowski indicated by the Legal 500 EMEA 2019 among the leading individuals in healthcare & life sciences sector.
