FarmavitaR+

1. Difficulty in readability testing
(Regulatory Affairs/European Union)

... then of course, one must present all this in a clear, logical manner in the PL final report. Author:   Ryan Smith Arriello sro Vinohradska 1188/58 Prague 3, 13 000, Czech Republic (Tel)       ...

2. New Czech guideline
(eSubmissions/eSubmissions)

... renewals for medicinal products which cannot be therapeutically interchanged, applications for marketing authorisation of products containing new active substances in the Czech Republic, applications for ...

3. Czech Republic-yearly maintenance fees
(Regulatory Affairs/European Union)

Czech Republic introduced yearly maintenance fees for medicinal products With the new law on Pharmaceuticals 378/2007 Coll. valid from December 31st 2007 Czech Republic introduced yearly  maintenance ...

4. Update on e-CTD submission in Czech Republic
(Regulatory Affairs/European Union)

Update on e-CTD submission in Czech Republic „Special cases“ according to updated guideline REG-84- submission in eCTD format, released 02.10.2008. The following shall be considered special cases: ...

5. CZECH - INFORMATION FOR M.A.H.
(Regulatory Affairs/Regulatory Affairs News)

OTC Medicinal Products Subject to Sales Restriction - Implementation of a New Category The State Institute for Drug Control (SÚKL) in Czech Republic has been preparing the implementation of ...

6. First FarmavitaR+ / regulanet conference
(Regulatory Affairs/Regulatory Affairs News)

... associates from Bulgaria, Croatia, Czech Republic, Romania, Serbia, Slovakia, Slovenia and Turkey. FarmavitaR+ can immediately offer a wide range of services including regulatory submissions in ...

7. Administrative Fees - Romania
(Regulatory Affairs/European Union)

... "repeat use" procedure for harmonisation with the initial mutual recognition procedure 1720 Please, contact us for regulatory affairs support in Czech R., Slovak R., Hungary, Croatia, ...

8. Administrative Fees - The Czech R.
(Regulatory Affairs/European Union)

New Guidelines about Administrative fees in the Czech Republic As of December 1 2007 this new guideline for admistraive fees supersedes guideline UST 29 published in January 2007. Please, contact us ...

9. New RA Alliance
(Regulatory Affairs/Regulatory Affairs News)

... covered by FarmavitaR+ are Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Hungary, Macedonia, Montenegro, Romania, Serbia, Slovakia, and Turkey. FarmavitaR+ will also provide ...

10. CEE Overview
(Reports/Market Report)

Central and Eastern Europe Pharmaceutical Industry - An Overview The Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Slovak Republic and Slovenia are the new Central and Eastern European ...

11. Membership
(AboutUs/AboutUs)

Membership and Use of  FarmavitaR+ - Regulatory Affairs Network Registration is key to your business development with FarmavitaR+ Community. Please, register as the member and log in with your user name ...

12. CEFTA
(Regulatory Affairs/Europe not-EU)

... the Czech Republic, Slovakia, Hungary and Slovenia. CEFTA was established by Poland, Hungary and Czechoslovakia on 21 December 1992 in Kraków, Poland. Slovenia joined CEFTA in 1996, Romania in 1997, ...

13. IP case - Atorvastain
(Pharmaceutical product/Pharmaceutical product)

... will expire in Nov. 2011 in number of EU countries. However, in Slovenia, Czech R., Bulgaria, Hungary, Poland and Slovakia there is no national patents with link to  EP-00247633 as primary patent. The ...

14. New CADREAC
(Regulatory Affairs/General Gulielines)

Simplified MRP procedure for EU candidates  For the Czech R., Slovak R., Hungary, Croatia, Romania and Bulgaria there is simplified MRP procedure, also known as CADREAC prcedure. Because of simplicity ...

15. About us
(AboutUs/AboutUs)

... network of RA associates in Czech R, Slovak R., Hungary,  Serbia, Bosnia and Herzegovina, FYR Macedonia, Kosovao, Albania, Bulgaria, Romania and Turkey. FarmavitaR+ is offering range of regulatory affairs ...

16. Czech Republic -Brach Office
(Contact / Contacts)

Czech Republic -Brach Office, Prague, Hradec Kralove,  ...

17. Croatia - Farmavita Regulanet Ltd.
(Contact / Contacts)

... employing a few people in Croatia and the network of RA associates in Czech R, Slovak R., Hungary, Serbia, Bosnia and Herzegovina, FYR Macedonia, Kosovao, Albania, Bulgaria, Romania and Turkey. FarmavitaR+ ...

18. Bulgaria - Branch Office
(Contact / Contacts)

... a few people in Croatia and the network of RA associates in Czech R, Slovak R., Hungary, Serbia, Bosnia and Herzegovina, FYR Macedonia, Kosovao, Albania, Bulgaria, Romania and Turkey. FarmavitaR+ is ...

19. Czech Republic
(Category)

Articles and news related to Czech Republic  ...