tag:blogger.com,1999:blog-6377401824680246858.post1853423203551609265..comments2024-03-05T15:49:16.751+00:00Comments on The SPC blog: Special approval exemptions in a nutshell: a request for helproberthttp://www.blogger.com/profile/03575489215896576032noreply@blogger.comBlogger4125tag:blogger.com,1999:blog-6377401824680246858.post-86090240563561377252014-09-05T19:26:16.174+01:002014-09-05T19:26:16.174+01:00I guess the question is primarily related to Artic...I guess the question is primarily related to Article 3(1), 5(1) of Dir. 2001/83 and Article 3(2) Dir. 2001/82. From this regulatory point of view I'd like to stress that there is no such thing as a de facto marketing authorisation. So the answer to the question would be in the negative.<br />This holds also true with respect to the wording of Article 3(d)of the SPC Regulation. However, a purely restrictive approach seems to be hardly consistent with Neurim (judgment of 19 July 2012, Case C-130/11 where the European Court, by interpreting Article 3(d) of the SPC Regulation,<br />came to the conclusion that the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product, provided that the application is within thelimits of the protection conferred by the basic patent. So, there might be some ambiguity if a teleological approach to interpretation of the SPC Regulation is to be employed ...Ulrich M. Gassnernoreply@blogger.comtag:blogger.com,1999:blog-6377401824680246858.post-17573489513280890872014-08-28T17:44:01.672+01:002014-08-28T17:44:01.672+01:00The (8 year) data exclusivity provisions in Direct...The (8 year) data exclusivity provisions in Directive 2001/83 include the requirement for the product to be "authorised under Article 6". Article 6 then refers to MAs under Dir. 2001/83 and Reg. 726/2004. <br /><br />Thus, the answer to the question above would seem to be "no" - as access under a "named patient" programme is very unlikely to count as an authorisation under Dir. 2001/83 or Reg. 726/2004.Mike Snodinnoreply@blogger.comtag:blogger.com,1999:blog-6377401824680246858.post-4019986903954087322014-08-27T07:52:31.800+01:002014-08-27T07:52:31.800+01:00A good follow-up question is whether "named p...A good follow-up question is whether "named patient" programmes (which I believe is a synonym for special approval exemption) also trigger the start of the 8+2+1 data exclusivity period.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-6377401824680246858.post-57446546535861703642014-08-20T15:31:39.758+01:002014-08-20T15:31:39.758+01:00It may be worthwile to consider applying for a tra...It may be worthwile to consider applying for a traineeship at the EFTA Court (Case E-16/14 - http://www.eftacourt.int/uploads/tx_nvcases/16_14_Req_Adv_Op_OJ.pdf).Anonymousnoreply@blogger.com