The Polish medical and pharmaceutical industry has a long tradition. In recent years, its structure and dynamics have changed significantly. The domestic pharmaceutical industry is one of the strategic industries of the Polish economy. It plays a key role in the whole healthcare system, providing Polish patients with examined, effective, high-quality and affordable medicines. Most Polish pharmaceutical companies have been privatized and numerous companies have been taken over by large foreign pharmaceutical corporations. In addition, new successful companies are emerging, which thanks to their innovation and implementation of new technologies, are entering foreign markets and becoming competitors of foreign companies. They also contribute to a significant increase in the competitiveness of the Polish economy.
The withdrawal of the United Kingdom from the European Union had an impact on the rules on the flow of personal data. From that point on, the UK became a third country as defined in the GDPR, the consequence of which – among other things – was intended to limit the free flow of personal data to and from the EU. However, this has not happened. Initially, on December 24, 2020, UK and EU representatives signed a Trade and Cooperation Agreement (TCA) that allowed the free transfer of personal data from the UK to the EU 6 months longer.
New decisions of the
European Commission
This year the European Commission has
adopted two implementing decisions finding an adequate level of
protection for personal data in the UK: implementing decision dated 28.06.2021
in accordance with Regulation (EU) 2016/679 of the European Parliament
and of the Council on the adequate protection of personal data by the United
Kingdom and implementing decision of 28.06.2021 in accordance with Directive
2016/680 of the European Parliament and of the Council on the adequate
protection of personal data by the United Kingdom.
KIELTYKA GLADKOWSKI KG LEGAL constantly supervises and prepares its lawyers for the specialization in which they provide services for foreign clients. In order to systematize the conceptual grid of very specialized fields of IT, fintech, blockchain, KIELTYKA GLADKOWSKI conducts internal consultations to improve the experience of our lawyers specializing in legal assistance for foreign clients from the IT and TECH sector. As a result of such internal research, KIELTYKA GLADKOWSKI creates and publishes texts on topics related to modern legal problems, but also to explain the basic concepts of specialized technology and IT fields. In this way, KIELTYKA GLADKOWSKI aims to demonstrate to potential clients within specialized industries that our lawyers are also familiar with specialist terms necessary for a proper understanding of our foreign client’s business and legal needs, especially in relation to clients operating in all sectors of production with the use of blockchains as well as supply chains using blockchains.
This is one of those texts. We invite you to
read it.
BLOCKCHAIN TECHNOLOGY APP IN FINTECH AND FOOD SUPPLY CHAIN IN THE TIMES OF GLOBALISATION
On 20 October 2021 KIELTYKA GLADKOWSKI will take part in 20TH EDITION OF CEE INDUSTRY LEADERS EXPO for E-COMMERCE. The event is dedicated for online sellers in Poland.
The fairs will consist of case studies,
presentation of services and analysis of the market. Some of the topics
discussed by the panelists will include: InPost Fulfillment; Shipping to the
Czech Republic, Slovakia, Hungary, Romania, Bulgaria, Greece; How to increase
sales thanks to Ceneo; Real Time Bidding auctions; SXO or UX + SEO in
generating sales; Maximizing sales on Amazon; New rules in Poland for
calculating VAT in E-commerce; Machine Learning at tantis.pl; Progressive Web Apps
– an online store available anytime and anywhere.
The team of KIELTYKA GLADKOWSKI dedicated to clients operating in life science sector actively advises on all aspects of in vitro diagnostics, including regulatory, corporate and investments matters. For the purposes of such clients this text analyses the bullet points of REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Regulation 2017/746/EU (IVDR) replaces the existing Directive 98/79 / EC on in vitro diagnostic medical devices (IVDD), which was adopted in 1998.
With the
publication of the IVDR, the five-year transition period from the In Vitro
Diagnostic Medical Devices Directive (98/79/EC) (IVDD) to the new regulation
has started. The IVDR regulation will apply from the date of application, i.e.
from May 26, 2022, with some provisions, including Notified Bodies and the
Medical Device Coordination Group will enter into force sooner. Until the date
of application of the IVDR, the laws and regulations adopted by the Member
States under the IVDD will continue to apply. Under Art. 22 of the 1998 IVDD
directive, the member states were obliged to prepare and introduce the national
laws, regulations and administrative provisions necessary to comply with this
directive by December 7, 1999 (IVDD) at the latest. The provisions of the
directive were to apply with effect from 7 June 2000. As the provisions of the
directive could be interpreted differently in different countries, it was
possible for national provisions to differ. In the case of EU regulations, the
provisions contained therein do not have to be transposed and adapted to
national law. In May 2017, the European Parliament and the Council of the
European Union published two new regulations on medical devices (2017/745/EU)
(MDR) and in vitro diagnostic medical devices (2017/746/EU) (IVDR). Regulation
2017/746/EU (IVDR) replaces the existing Directive 98/79/EC on in vitro
diagnostic medical devices (IVDD), which was adopted in 1998.
