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Poland
Hogan Lovells
In preparation for situations of crisis caused by a potential spread of the coronavirus, the Polish Parliament has adopted a draft bill that introduces certain new obligations upon...
Hogan Lovells
In March 2019, the new law creating a Medical Research Agency ("the Agency") entered into force in Poland. This new entity is intended to play a similar role to institutions like the UK's Medical
Schoenherr Attorneys at Law
On 15 May 2017 the President of Poland executed the Act of 7 April 2017 amending the Pharmaceutical Law (the "Amending Act"), which changes the current regulations of the Act of 6 September 2001 Pharmaceutical Law ..
CMS Cameron McKenna Nabarro Olswang LLP
From 1 January 2012, doctors will only be able to obtain a medicinal product sample for 2 years after first requesting it, and will be limited to a maximum of 4 samples per year.
CMS Cameron McKenna Nabarro Olswang LLP
The Polish Parliament adopted a new law governing the reimbursement of medicinal products, medical devices and food for special medical purposes.
CMS Cameron McKenna Nabarro Olswang LLP
Changes may be made to the way clinical trials are financed, supervised and conducted following an inspection of 13 clinical hospitals by the Supreme Audit Office (NIK).
CMS Cameron McKenna Nabarro Olswang LLP
The data exclusivity period applicable to pharmaceuticals for human use is to be extended by the introduction of an 8+2+1 rule to replace the current 6-year exclusivity period.
CMS Cameron McKenna Nabarro Olswang LLP
From 4 June 2010, new rules apply to the composition and labeling of dietary supplements.
CMS Cameron McKenna Nabarro Olswang LLP
From 22 March 2010, the period for which sponsors must keep basic documentation of a clinical trial will be extended from two to five years.
CMS Cameron McKenna Nabarro Olswang LLP
Foodstuffs such as dietary supplements may be subject to amended procedure where there are concerns whether they meet the criteria for medicinal products.
CMS Cameron McKenna Nabarro Olswang LLP
The interim period for borderline products will expire on 31 December 2009 after attempts to extend it failed.
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