For a better user experience please update your browser or use Chrome or Firefox browser.
Utilities
Publication detail
Home
Guideline on aspects of the application of Article 8(1) and (3) of Regulation (EC) No 141/2000: Assessing similarity of medicinal products versus authorised orphan medicinal products benefiting from market exclusivity and applying derogations from that market exclusivity
Publication metadata
- Published:
- Corporate author(s): Council of the European Union , European Parliament
- Subject: application of EU law , derogation from EU law , drugs classification , exclusive distribution agreement , market approval , medicinal product , pharmaceutical legislation
- OJ : JOC_2008_242_R_0012_01
- CELEX : 52008XC0923(03)
Document viewer
Note:
The publication cannot be displayed in the document viewer. Open web version
You may access it from: Download and languages