Státní ústav pro kontrolu léčiv http://www.sukl.cz Copyright © 2001-2008 webmaster@sukl.cz webmaster@sukl.cz en Thu, 9 Sep 2010 18:02:07 +0200 21. Sunset clause and export? Thu, 26 Aug 2010 17:38:50 +0200 http://www.sukl.cz/21-jak-je-to-se-sunset-clause-a-vyvozem-leciv?source=rss http://www.sukl.cz/21-jak-je-to-se-sunset-clause-a-vyvozem-leciv Sunset clause – A list of medicinal products Mon, 16 Aug 2010 17:06:05 +0200 http://www.sukl.cz/sunset-clause-a-list-of-medicinal-products?source=rss http://www.sukl.cz/sunset-clause-a-list-of-medicinal-products Question and answer Mon, 16 Aug 2010 17:04:15 +0200 http://www.sukl.cz/question-and-answer?source=rss http://www.sukl.cz/question-and-answer 20. How we should proceed when we are the RMS, the product has no consumption here and the only CMS country to which we could transfer the concerned marketing authorisation does not respond to our e-mails? Mon, 16 Aug 2010 14:17:26 +0200 http://www.sukl.cz/20-how-would-you-recommend-proceeding-when-we-are-the-rms?source=rss http://www.sukl.cz/20-how-would-you-recommend-proceeding-when-we-are-the-rms 19. In the case of code-adjusted MA numbers, will compliance with the quantity conditions be considered on the basis of individual codes or on the basis of the master MA number stated in the marketing authorisation? Mon, 16 Aug 2010 14:17:02 +0200 http://www.sukl.cz/19-in-the-case-of-code-adjusted-ma-numbers-will-compliance?source=rss http://www.sukl.cz/19-in-the-case-of-code-adjusted-ma-numbers-will-compliance 18. If we have a medicinal product where the MA number has been or should be code-adjusted, how will the periods for individually code-adjusted MA numbers be calculated? Mon, 16 Aug 2010 14:16:31 +0200 http://www.sukl.cz/18-if-we-have-a-medicinal-product-where-the-ma-number-has?source=rss http://www.sukl.cz/18-if-we-have-a-medicinal-product-where-the-ma-number-has 17. Is it possible to consider patent protection a relevant reason for granting the exemption? Mon, 16 Aug 2010 14:16:12 +0200 http://www.sukl.cz/17-is-it-possible-to-consider-patent-protection-a-relevant?source=rss http://www.sukl.cz/17-is-it-possible-to-consider-patent-protection-a-relevant 16. Is it possible to grant an exemption for marketing reasons? Mon, 16 Aug 2010 14:15:53 +0200 http://www.sukl.cz/16-is-it-possible-to-grant-an-exemption-for-marketing?source=rss http://www.sukl.cz/16-is-it-possible-to-grant-an-exemption-for-marketing 15. Is it possible to grant an exemption on the ground of the medicinal products being subject to another administrative procedure (price determination)? Mon, 16 Aug 2010 14:15:34 +0200 http://www.sukl.cz/15-is-it-possible-to-grant-an-exemption-on-the-ground-of-the?source=rss http://www.sukl.cz/15-is-it-possible-to-grant-an-exemption-on-the-ground-of-the 14. Is any application form for granting the exemption available on the SÚKL website? Mon, 16 Aug 2010 14:15:12 +0200 http://www.sukl.cz/14-is-any-application-form-for-granting-the-exemption?source=rss http://www.sukl.cz/14-is-any-application-form-for-granting-the-exemption