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Tag Archives: Poland

Poland: New Medical Research Agency

On Monday, March 4, the President signed a bill on the establishment of a new institution, the Medical Research Agency (ABM). The new Agency will be a specialized body of experts who will work on innovation in Polish medicine, focusing on areas related to oncology, haematology and rare diseases. The activities of the Agency will

Poland: official position of the competent authority on consequences for medical devices in the event of a no-deal brexit

On 1 March 2019[1], the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issued yet another communique concerning consequences of Brexit, this time with respect to the medical devices. It is announced that in the event of a “no-deal” Brexit, as from 30 March 2019, the United Kingdom

Poland: Post-registration changes required in case of no-deal Brexit

On 25 February 2019[1], the President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued a communique concerning the necessary post-registration changes in the event of a “no-deal” Brexit. In the event of a “no-deal” Brexit, the President of the Office has recommended that companies immediately introduce post-registration

Effects of Brexit on reimbursement decisions concerning medicinal products in Poland

The President of the Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL) estimates that approximately 20% of all the 10,000 medicinal products registered in Poland will be affected by the effects of Brexit. Out of this number, according to media reports, new reimbursement decisions will need to be issued for

Overhaul of Polish consumer law

Important amendments to Polish consumer protection law have been introduced which increase the risk of doing business in Poland. Please see our e-alert summarising the principal changes.