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Nový príspevok v sekcii zahraničná judikatúra!


 | 20.6.2013 | komentárov: 294

Upozorňujeme Vás na uverejnenie rozhodnutia Súdneho dvora Európskych spoločenstiev (dnes Súdny dvor Európskej únie) vo veci C-249/2009 týkajúcej sa reklamy liekov konkrétne výkladu článku 87 ods. 2 smernice 2001/83/ES o právnych predpisoch spoločenstva týkajúcich sa liekov na humánne použitie.

Obrazok Vnútroštátny súd (Správny súd v tartu, Estónsko) prerušil konanie vo veci Novo Nordisk AS proti Ravimiamet a položil súdu dve prejudiciálne otázky

„1. Má sa článok 87 ods. 2 smernice 2001/83… vykladať v tom zmysle, že sa vzťahuje aj na citáty z lekárskych časopisov alebo iných vedeckých prác, ktoré sú uvedené v reklame na liek určenej pre osoby oprávnené na jeho predpisovanie?
2. Má sa článok 87 ods. 2 smernice 2001/83… vykladať v tom zmysle, že zakazuje v reklame na liek uverejniť tvrdenia, ktoré sú v rozpore so súhrnom charakteristických vlastností výrobku, ale nevyžaduje, aby sa všetky tvrdenia, ktoré sú obsiahnuté v reklame na liek, museli nachádzať v súhrne charakteristických vlastností výrobku alebo aby ich bolo možné z údajov uvedených v tomto súhrne odvodiť?“

Súd rozhodol, že vo vzťahu

- k prvej otázke sa článok 87 ods. 2 článok smernice 2001/83 musí vykladať v tom zmysle, že sa týka aj citácií pochádzajúcich z lekárskych časopisov alebo vedeckých diel, ktoré sa nachádzajú v reklame na liek určenej osobám oprávneným na predpisovanie alebo vydávanie liekov, a preto sa aj reklama v odborných časopisoch musí v každej časti zhodovať s údajmi uvedenými v súhrnnej charakteristike  výrobku
- k druhej otázke o tom, že sa predmetný článok musí vykladať v tom zmysle, že zakazuje uverejnenie tvrdení, ktoré sú v rozpore so súhrnom charakteristických vlastností výrobku v reklame na liek určenej osobám oprávneným na jeho predpisovanie alebo vydávanie, ale nevyžaduje, aby sa všetky tvrdenia uvedené v tejto reklame nachádzali v uvedenom súhrne alebo ich bolo možné z neho vyvodiť. Takáto reklama môže zahŕňať tvrdenia doplňujúce informácie uvedené v článku 11 uvedenej smernice pod podmienkou, že tieto tvrdenia:
– potvrdzujú alebo spresňujú uvedené informácie – a sú s nimi zlučiteľné – bez toho, aby ich skresľovali, a
– sú v súlade s požiadavkami uvedenými v článku 87 ods. 3 a článku 92 ods. 2 a 3 tejto smernice.


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