05.01.2011 | In English | Dodaj komentarz
On 22 December 2010, the European Court of Justice (“ECJ”) issued a judgment in European Commission v. The Republic of Poland (C-385/08) in which it found that Poland was in breach of European Union law. The breach involved generics of the medicine Plavix being introduced to trade and marketed after Poland’s accession to the European Union. These generics were not covered by the transitional period and their marketing authorisations issued prior to 1 May 2004 had not been “harmonised”. czytaj więcej »
30.09.2010 | In English | Dodaj komentarz
In the evening of 9 September 2010, a proposed act on the reimbursement of drugs, foodstuffs intended for particular nutritional purposes and medical devices was sent for interministerial and public consultation (bill of 8 September 2010; further: the Reimbursement Act).
The proposed amendments are revolutionary and could lead to a radical and fundamental change in existing business models and in the rules on marketing activities, and could even affect sales structure. This primarily applies to manufacturers of drugs, foodstuffs intended for particular nutritional purposes and medical devices, and wholesalers, etc. The new regulation will also influence the professional practice of and the level of legal risk for doctors and pharmacists. czytaj więcej »
