Draft Public Statement On Adhatoda Vasica Nees, Folium
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
15 January 2013
EMA/HMPC/681468/2012
Committee on Herbal Medicinal Products (HMPC)
Public statement on Adhatoda vasica Nees, folium
Draft
Keywords
Herbal medicinal products; HMPC; Public statements; Adhatoda vasica Nees, folium; Adhatodae vasicae folium; Malabar nut leaf
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Discussion in Working Party on Community Monographs and Community |
May 2012 |
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List (MLWP) |
November 2012 |
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Adoption by HMPC for release for consultation |
15 January 2013 |
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End of consultation (deadline for comments). Comments should be provided using this template. The completed comments form should be sent to hmpc.secretariat@ema.europa.eu |
15 April 2013 |
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Rediscussion in MLWP | |
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Adoption by HMPC |
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© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.
Public statement on Adhatoda vasica Nees, folium
PROBLEM STATEMENT
The HMPC/MLWP decided to prepare a Community herbal monograph on Adhatoda vasica Nees, folium as announced in the July 2011 HMPC meeting report. A call for the submission of scientific data was published on the EMA website with a submission period from 15 July 2011 until 15 November 2011.
A comprehensive literature search was conducted and available data, including information on products on the market in the European Union, were assessed in relation to the requirements laid down in Directive 2001/83/EC and its Annex I, in particular Article 1, Article 10a and Chapter 2a.
Evidence of traditional use originates mainly from India, where A. vasica has been used in the Ayurvedic tradition for a very long time. Detailed information on extraction solvents and/or posology for preparations used in the Indian traditional medicine is, however, incomplete.
No medicinal products containing A. vasica as a single active ingredient have been found within the EU. Although medicinal combination products containing A. vasica have been marketed in the EU for more than 15 years, it is not considered sufficient as basis for the establishment of a Community herbal monograph on A. vasica as a single active ingredient. European handbooks confirm the use of A. vasica in India, but no specific evidence of traditional medicinal use in Europe has been found.
During the assessment of the medicinal use of A. vasica information relating to possible abortive/anti-implantation and uterotonic effects was found. Further information on reproductive toxicity of A. vasica preparations is therefore considered necessary.
The HMPC/MLWP concluded that the following requirement for the establishment of a Community herbal monograph on traditional herbal medicinal products containing Adhatoda vasica Nees, folium is not fulfilled:
- the requirement laid down in Article 10a of Directive 2001/83/EC that the active substance has a recognised efficacy and an acceptable level of safety and that the period of well-established medicinal use has elapsed
- the requirement laid down in Article 16a(1)(d) of Directive 2001/83/EC that "the period of traditional use as laid down on Article 16c(1)(c) has elapsed"
- the requirement laid down in Article 16a(1)(b) of Directive 2001/83/EC that the herbal substance or herbal preparation is "exclusively for administration in accordance with a specified strength and posology"
- the requirement laid down in Article 16a(1)(e) of Directive 2001/83/EC that "the data on the traditional use of the medicinal product are sufficient; in particular the product proves not to be harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long-standing use and experience"
Based on the currently available information on traditional use and concerns regarding reproductive safety, the HMPC is of the opinion that a Community herbal monograph on Adhatoda vasica Nees, folium cannot be established unless additional information is made available.
A link is provided to the page where to access the draft list of references available on Adhatoda vasica, Nees, folium.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/herbal/medicines/herbal med 0001 80.isp&mid=WC0b01ac058001fa1d
Public statement on Adhatoda vasica Nees, folium
EMA/HMPC/681468/2012
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