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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
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)
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