Pharmacy · Regulatory Affairs
When submitting a herbal medicinal product for marketing authorization in Europe requiring efficacy comparable to conventional medicines, which guideline applies?
Verified Solution4 OptionsUpdated: October 2026👁️1 View
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- 1EU Regulation 536/2014 on clinical trials
- 2ICH S7A Safety Pharmacology Studies
- 3ICH Q10 Pharmaceutical Quality System
- 4EU Directive 2001/83/EC as amended by Directive 2004/24/EC✓
Correct answer
EU Directive 2001/83/EC as amended by Directive 2004/24/EC
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