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18:49 Apr 29, 2011 |
Greek to English translations [PRO] Medical - Medical: Pharmaceuticals | |||||||
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| Selected response from: Anna Spanoudaki-Thurm Germany Local time: 19:40 | ||||||
Grading comment
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Summary of answers provided | ||||
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4 +2 | παρέκκλιση σε/για κατηγορία προϊόντων/φαρμάκων |
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παρέκκλιση σε/για κατηγορία προϊόντων/φαρμάκων Explanation: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLE... γ) απόφαση του Οργανισμού που χορηγεί παρέκκλιση σε κατηγορία προϊόντων σύμφωνα με το άρθρο 11, Μόλις γνωμοδοτήσει η Παιδιατρική Επιτροπή, εφαρμόζεται η διαδικα- σία του άρθρου 25. Σε περίπτωση παρέκκλισης για κατηγορία φαρμά- κων εφαρμόζονται μόνον οι παράγραφοι 6 και 7 του άρθρου 25. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLE... (c) a decision of the Agency granting a class waiver pursuant to Article 11; As soon as the Paediatric Committee adopts an opinion, the procedure laid down in Article 25 shall apply. In the case of a class waiver, only paragraphs 6 and 7 of Article 25 shall apply. |
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