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RegisterNo EU originator available: bad luck [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2016-04-27 13:38 (3714 d 10:54 ago) – Posting: # 16247
Views: 3,491
Hi nobody,
Too bad. See the BE-GL Section 4.1.2 and the referred Directive 2001/83/EC Article 8.
I once succeeded with a reference product which was registered in a member state of the EEA (Switzerland) – but it was a hell of paper work and a hybrid application (PK + clinical study). Don’t think that it would be acceptable in ‘pure’ BE.
❝ Wanna do a BE trial for EU, but there is no orignator's product on the market (any more), what is the solution?
Too bad. See the BE-GL Section 4.1.2 and the referred Directive 2001/83/EC Article 8.
I once succeeded with a reference product which was registered in a member state of the EEA (Switzerland) – but it was a hell of paper work and a hybrid application (PK + clinical study). Don’t think that it would be acceptable in ‘pure’ BE.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- EU reference product - no originator available nobody 2016-04-27 09:22
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- No EU originator available: bad luckHelmut 2016-04-27 11:38
- No EU originator available: bad luck nobody 2016-04-27 12:01
- no originator = no generic Dr_Dan 2016-04-27 15:42
- no originator = no generic nobody 2016-04-27 16:31
- No EU originator available: bad luckHelmut 2016-04-27 11:38
Ing. Helmut Schütz