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Committee on Herbal Medicinal Products (HMPC)
Questions & Answers on the European Union framework
for (traditional) herbal medicinal products, including those
from a ?non-European? tradition
Table of Content
1.
- European Pharmacopoeia
SAWP
Scientific Advice Working Party
SmPC
Summary of Product Characteristics
THMP
Traditional Herbal Medicinal Product
TUR
Traditional Use Registration
WEU
Well-Established Use
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
- Terminology of herbal medicinal products (Q&A 1-4)
Question 1
What are herbal substances, herbal preparations, and herbal medicinal products?
- Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
- Question 4
Are food supplements regulated under the European Union (EU) pharmaceutical legislation
for (traditional) herbal medicinal products ((T)HMPs)?
- Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
- Regulation of herbal medicinal products in the European Union (Q&A 511)
Question 5
Where to find the pharmaceutical legislation and dossier requirements for herbal medicinal
products (HMPs), including traditional herbal medicinal products (THMPs), in the European
Union (EU)?
- Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
- These countries have,
through the EEA agreement, adopted the complete Union acquis on medicinal products and are
consequently parties to the Union procedures.
- Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
- Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
- Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
- Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
- Specific provisions for traditional herbal medicinal products (Q&A 1221)
Question 12
Which indications can be granted for traditional herbal medicinal products (THMPs)?
- Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
- Nov. 2023
Answer 17
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
- Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
- Question 29
Does the Committee on Herbal Medicinal Products (HMPC) hold a specific database on
(registered) authorised (traditional) herbal medicinal products ((T)HMPs)?
- Discussion with Member States intended to be
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
- Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
