Tag Archives: herbal medicinal products

EMA publishes community herbal monograph on Urtica dioica L., Urtica urens L., their hybrids or their mixtures, radix

The EMA has published this community herbal monograph on herbal medicinal products, HMPC, community herbal monographs, traditional use,Urtica dioica L., Urtica urens L. This is now the standard for use in registered herbal medicinal products in Europe.

EMA Publishes Public Statement on Allium Cepa L., bulbus

EMA Publishes Public Statement on Allium Cepa L., bulbus

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The HMPC/MLWP decided to prepare a Community herbal monograph on Allium cepa L., bulbus as announced in the meeting report from the January 2010 HMPC meeting.
After reviewing information on the products containing Allium cepa L., bulbus and preparations thereof marketed in the Community, it appears that very few products (single-ingredient and combination) are available.
A comprehensive literature search was conducted and available data, including information on products on the market in the Community, are assessed vis-à-vis the requirements laid down in Directive 2001/83/EC and its Annex I, in particular Article 1, Article 10a and Chapter 2a.
The HMPC/MLWP concluded that the following requirements for the establishment of a Community herbal monograph on traditional and well-established herbal medicinal products containing Allium cepa L., bulbus are 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”

Based on the above-mentioned information, the HMPC is of the opinion that a Community herbal monograph on Allium cepa L., bulbus cannot be established.
To read more about the assessment carried out, a link is provided to the page where to access the draft assessment report on Allium cepa L., bulbus and its list of references.



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EMA Publishes Herbal Monograph for Glycyrrhiza glabra L.,

EMA Publishes Herbal Monograph for Glycyrrhiza glabra L.,

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Glycyrrhiza glabra L. and/or Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch, radix (liquorice root)
i) Herbal substance Not applicable.
ii) Herbal preparations

a) Comminuted herbal substance

b) Soft extract (DER 1:0.4-0.5), extraction solvent water

c) Soft extract (DER 3:1), extraction solvent water

Comminuted herbal substance as a herbal tea for oral use.
Herbal preparations in liquid dosage forms for oral use.
The pharmaceutical form should be described by the European Pharmacopoeia full standard term.


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EMA Publishes Comments Received on Herbal Monograph, Symphytum Officinale L., radix

EMA Publishes Comments Received on Herbal Monograph, Symphytum Officinale L., radix

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Symphytum officinale L., radix (comfrey root)
i) Herbal substance Not applicable.
ii) Herbal preparations Liquid extract (DER 2:1), extraction solvent ethanol 65% V/V.

Herbal preparations in semi-solid dosage forms for cutaneous use.
The pharmaceutical form should be described by the European Pharmacopoeia full standard term.

Traditional herbal medicinal product used for the symptomatic treatment of minor sprains and bruises.
The product is a traditional herbal medicinal product for use in the specified indication



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EMA Publish Community Herbal Monograph on Fraxinus Excelsior L

EMA Publish Community Herbal Monograph on Fraxinus Excelsior L

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Fraxinus excelsior L. and Fraxinus angustifolia Vahl, folium (ash leaf)
i) Herbal substance
Not applicable.
ii) Herbal preparations
Comminuted herbal substance

Comminuted herbal substance as herbal tea (decoction or infusion) for oral use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term.



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EMA Publish Procedure on Publication of HMPC Statements with Community Herbal Monographs are not Established

EMA Publish Procedure on Publication of HMPC Statements with Community Herbal Monographs are not Established.

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This procedure has been prepared to clarify the conditions when the Committee on Herbal Medicinal Products (HMPC) shall establish a public statement on an herbal substance which was on the HMPC priority list, in the situation where it does not establish a Community herbal monograph on that herbal substance and preparations thereof.
The publication of this procedure is part of the European Medicines Agency’s initiatives to improve transparency in the regulatory and scientific processes followed by the HMPC in fulfilling its tasks as defined by the European legislation.

This procedure does not address the situations where:
a Community list entry cannot be established
a herbal preparation is not included in a Community herbal monograph
The justification as to why a Community list entry cannot be established together with the relevant Community herbal monograph can be found in the assessment report (AR). For the assessment works carried out so far which had led to the publication of final monographs, the absence of adequate genotoxicity data, as part of the evidence required to demonstrate a safe use, has been the primary justification to the non-establishment of a Community list entry on a herbal substance and/or preparations thereof.
The justification as to why a given herbal preparation is not included in a monograph can be found in the AR and/or in the ‘Overview of comments received during the public consultation’. It cannot be expected that such a justification is available for every possible preparation. Current practice is that justification is provided for preparations which can be found on the market of one or several Member States of the European Union and made known to the Rapporteur either by members of the HMPC/Working Party on Community Monographs and Community List (MLWP) or by interested parties via their comments on draft monographs.



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EMA Publish Procedure for Calls for Scientific Data for Use in HMPC Assessment Work

EMA Publish Procedure for Calls for Scientific Data for Use in HMPC Assessment Work

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In accordance with Directive 2001/83/EC amended as regards traditional herbal medicinal products through Directive 2004/24/EC (1), it is the task of the Committee on Herbal Medicinal Products (HMPC) to establish a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (Article 16f). Furthermore, the HMPC shall establish Community herbal monographs for herbal medicinal products (Article 16h(3)). The HMPC has also undertaken to ensure that monographs and list entries remain up-to-date (scientific state of the art) by assessing regularly the need for their revision (5, 6).
The legislation does not specify how scientific data relating to the assessment work for the monographs and list entries should be identified and compiled. The HMPC discussed a number of possibilities and agreed on a practice subject to 3 conditions:
1. The compilation of data will be a public procedure; and
2. The compilation will take place within a framework of criteria to be predefined by the HMPC (e.g. in relation to literature search strategy); and
3. The compilation shall seek to ensure that a complete set of bibliographic references and/or scientific data will be available to the Rapporteur(s).

No requirements for scientific standards are provided in the legislation and submission by interested parties of bibliographic references and/or scientific data is voluntary. However, some guidance as to the scope of data requested can be provided through the application of Directive 2001/83/EC:
Bibliographic data submitted in relation to well-established medicinal use should provide evidence that the constituent or the constituents of the medicinal product has or have a well-established medicinal use with recognised efficacy and an acceptable level of safety within the meaning of Directive 2001/83/EC as amended (Recital 2 of Directive 2004/24/EC).
Bibliographic data submitted in relation to traditional-use should provide evidence that the medicinal product in question, or a corresponding product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the Community (Article 16c(1)(c)).
In addition, the contributor is expected to submit both favorable and unfavorable data as well as to ensure that the newest publications are taken into account.
Further guidance on the requirements can be found in the HMPC ‘Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorisation (bibliographical and mixed applications) and in applications for simplified registration’ (2) and the HMPC ‘Guideline on the assessment of clinical safety and efficacy in the preparation of Community herbal monographs for well-established and of Community herbal monographs/entries to the Community list for traditional herbal medicinal products/substances/preparations’ (3).


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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publishes Community herbal monograph on Tanacetum parthenium (L.) Schulz Bip., herba

EMA Publishes Community herbal monograph on Tanacetum parthenium (L.) Schulz Bip., herba

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Traditional use
With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Tanacetum parthenium (L.) Schulz Bip., herba (feverfew)
i) Herbal substance Not applicable.
ii) Herbal preparations Powdered herbal substance

Herbal preparation in solid dosage forms for oral use.
The pharmaceutical form should be described by the European Pharmacopoeia full standard term.

 

Traditional herbal medicinal product for the prophylaxis of migraine headaches after serious conditions have been excluded by a medical doctor.
The product is a traditional herbal medicinal product for use in specified indication exclusively



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EMA Publishes Concept Paper on using CTD Format in Traditional Herbal Medical Products Applications

EMA Publishes Concept Paper on using CTD Format in Traditional Herbal Medical Products Applications

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This concept paper is concerned with the revision of the guideline on the use of the Common Technical Document (CTD) format in the preparation of a registration application for traditional herbal medicinal products (EMEA/HMPC/71049/2007).
This revision pertains to the presentation and content of the Module 3 on Quality (chemical, pharmaceutical and biological information) for traditional herbal medicinal products (THMPs) to help future applicants in their submission.

This guideline is applicable to applications for traditional use registration of THMPs for human use.
The compilation of dossiers for marketing authorisation applications for HMPs is not covered by this guideline. However, guidance provided on modules 2.3 and 3 are also applicable to HMPs applications for marketing authorisation for human and veterinary use.

In the light of experience, there is a need to update this guideline to provide further clarification on the exact location of quality data requirements in the Module 3 on Quality of the CTD and to provide further explanations on the kind of information that is required from applicants at time of application.
Minor changes in the body of the current guideline will be introduced and two annexes will be added. The first annex will be a best practice guide describing the exact location of relevant parts of the documentation and the corresponding guidelines in the CTD Module 3 sections and the second annex will be a Module 3 mock-up.

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EMA Publishes Community Herbal Monograph on Valeriana Officinalis L., Radix and Humulus Lupulus L., flos

EMA Publishes Community Herbal Monograph on Valeriana Officinalis L., Radix and Humulus Lupulus L., flos

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Well-established use

With regard to the marketing authorisation application of Article 10a of Directive 2001/83/EC as amended
Fixed combinations of Valeriana officinalis L., radix (valerian root) and Humulus lupulus L., flos (hop strobiles)
i) Herbal substances
Not applicable
ii) Herbal preparations used in fixed combinations of
a) Dry extracts of valerian root (DER 4-8:1, methanol 45-51% m/m) and hop strobiles (DER 3-10:1, methanol 40-51% m/m)
b) Dry extracts of valerian root (DER 4-7:1, ethanol 70% v/v) and hop strobiles (DER 4-8:1, methanol 40% v/v)

Traditional use

With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Fixed combinations of Valeriana officinalis L., radix (valerian root) and Humulus lupulus L., flos (hop strobiles)
i) Herbal substances
Not applicable
ii) Herbal preparations used in fixed combinations of
– Liquid extract (DER 1:6.3) from a mixture of valerian root-hop strobiles (1:1), extraction solvent ethanol 40% v/v
– Liquid extract from a mixture (1:1) of valerian root tincture (DER 1:10), extraction solvent ethanol 53% m/m and hop strobiles liquid extract (DER 1:2.2), extraction solvent ethanol 53% m/m
– Dry extracts
a) Dry extracts of valerian root (DER 4-6:1), extraction solvent water and hop strobiles (DER 3-6:1), extraction solvent water
b) Dry extracts of valerian root (DER 5-7:1), extraction solvent methanol 45% m/m and hop strobiles (DER 5-7:1), extraction solvent water
c) Dry extracts of valerian root (DER 4-5:1), extraction solvent ethanol 60% v/v and hop strobiles (DER 5-9:1), extraction solvent water

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EMA Publishes Community herbal monograph on Lavandula angustifolia P. Mill., flos

EMA Publishes Community herbal monograph on Lavandula angustifolia P. Mill., flos

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended Lavandula angustifolia P. Mill., flos
(lavender flower)
i) Herbal substance
As defined in the Ph. Eur. monograph.
ii) Herbal preparations
a) Comminuted herbal substance
b) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 50-60% v/v

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EMA Publishes Community Herbal Monograph for Hamamelis virginiana L., cortex

EMA Publishes Community Herbal Monograph for Hamamelis virginiana L., cortex

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended Hamamelis virginiana L., cortex; Hamamelidis cortex (hamamelis bark)
i)
Herbal substance
Not applicable
ii)
Herbal preparations
-Dried comminuted herbal substance
-Tincture (Ratio of herbal substance to extraction solvent 1:10), extraction solvent ethanol 45% v/v
-Dry extract (DER 5-7.7:1), extraction solvent ethanol 30% m/m

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publish Community Herbal Monograph on Comicifuga racemosa (L.) Nutt., rhizoma

EMA Publish Community Herbal Monograph on Comicifuga racemosa (L.) Nutt., rhizoma

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Well Established Use

With regard to the marketing authorisation application of Article 10(a) of Directive 2001/83/EC as amended
Cimicifuga racemosa (L.) Nutt., rhizoma (black cohosh)
i) Herbal substance
Not applicable.
ii) Herbal preparations
a) Dry extract (DER 5-10:1), extraction solvent ethanol 58% (V/V)
b) Dry extract (DER 4.5-8.5:1), extraction solvent ethanol 60% (V/V)
c) Dry extract (DER 6-11:1), extraction solvent propan-2-ol 40% (V/V)

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EMA Publish Community Herbal Monograph on Pelargonim Sidoides DC and/or Pelargonium Reniforme Curt.,radix

EMA Publish Community Herbal Monograph on Pelargonim Sidoides DC and/or Pelargonium Reniforme Curt.,radix

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix (pelargonium root)
i) Herbal substance
Not applicable.
ii) Herbal preparations
Liquid extract (DER 1:8-10), extraction solvent ethanol 11% m/m

For Assistance with the regulation of a herbal produt in the EU, UK or USA Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publish Community herbal monograph on Cola nitida (Vent.) Schott et Endl. and its varieties and Cola acuminata (P. Beauv.) Schott et Endl., semen

EMA Publish Community herbal monograph on Cola nitida (Vent.) Schott et Endl. and its varieties and Cola acuminata (P. Beauv.) Schott et Endl., semen

Full Text Here

With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Cola nitida (Vent.) Schott et Endl. and its varieties and Cola acuminata (P. Beauv.) Schott et Endl., semen (cola)
i) Herbal substance
Not applicable.
ii) Herbal preparations
a) Powdered herbal substance
b) Liquid extract (DER 1:1), extraction solvent ethanol 60% V/V
c)Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 60% V/V

For Assistance with Registering Herbal Products in the UK or EU Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

EMA Publish Community herbal monograph on Oenothera biennis L. & Oenothera lamarckiana L., oleum

EMA Publish Community herbal monograph on Oenothera biennis L. & Oenothera lamarckiana L., oleum

Full Text Here

With regard to the marketing authorisation application of Article 10(a) of Directive 2001/83/EC as amended
Oenothera biennis L.; Oenothera lamarckiana L., oleum (evening primrose oil)
i) Herbal substance
Not applicable.
ii) Herbal preparations
Fatty oil obtained from seeds of Oenothera biennis L. or Oenothera lamarckiana L. by extraction and/or expression.

EMA Publishes Public Statement on Syzygium Aromaticum (L.) Merill et L.M Perry, flos

EMA Publishes Public Statement on Syzygium Aromaticum (L.) Merill et L.M Perry, flos

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The HMPC/MLWP decided to prepare a Community herbal monograph on Syzygium aromaticum (L.) Merill et L.M. Perry, flos as announced in the 2011 MLWP work programme.
After reviewing information on the products containing Syzygium aromaticum (L.) Merill et L.M. Perry, flos and preparations thereof marketed in the European Union, it appears that no single-ingredient products are available. Furthermore, after consultation with interested parties on priority levels for anticipated assessment works in 2010, a low level of priority was identified for the establishment of a monograph on Caryophylli flos.
The Rapporteur has integrated relevant published data in the joint assessment report on Caryophylli aetheroleum and Caryophylli flos.

Based on the above-mentioned information, the HMPC decided that no Community herbal monograph on Syzygium aromaticum (L.) Merill et L.M. Perry, flos will be established, unless new data are provided.

EMA Publish Community Herbal Monograph on Oenothera Biennis L., Oenothera Lamarckiana L., oleum

EMA Publish Community Herbal Monograph on Oenothera Biennis L., Oenothera Lamarckiana L., oleum

Full Text Here

With regard to the marketing authorisation application of Article 10(a) of Directive 2001/83/EC as amended
Oenothera biennis L.; Oenothera lamarckiana L., oleum (evening primrose oil)
i) Herbal substance
Not applicable.
ii) Herbal preparations
Fatty oil obtained from seeds of Oenothera biennis L. or Oenothera lamarckiana L. by extraction and/or expression.

For Assistance with Registering a Herbal Product in the EU or UK Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

EMA Publish Community Herbal Monograph for Cola Nitida (Vent.) Schott et Endl.

EMA Publish Community Herbal Monograph for Cola Nitida (Vent.) Schott et Endl.

Full Text Here

With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Cola nitida (Vent.) Schott et Endl. and its varieties and Cola acuminata (P. Beauv.) Schott et Endl., semen (cola)
i) Herbal substance
Not applicable.
ii) Herbal preparations
a) Powdered herbal substance
b) Liquid extract (DER 1:1), extraction solvent ethanol 60% V/V
c)
Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 60% V/V

For Assistance with Submitting Evidence to NICE Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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  1. (required)


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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

EMA Statement on Herbal Products Containing Thujone

EMA Statement on Herbal Products Containing Thujone

Full Text Here

During the assessments of Artemisia absinthium L. (monograph EMA/HMPC/234463/2008) and Salvia officinalis L. (monograph EMA/HMPC/331653/2008), it became apparent that the risk assessment of thujone, a major component in both herbal preparations, poses considerable uncertainties and difficulties. Thujone has been regarded as a severe neurotoxicant since 1800’s, although recently differing views have been expressed. Difficulties culminated in the determination of maximum limit of daily intakes of thujone, which in the case of Absinthii herba was set at 3.5 mg/person and in the case of sage leaf preparations 5.0 mg/person, both for a maximum duration of 2 weeks. Furthermore, the HMPC has concluded that the benefits of sage essential oil do not outweigh its risks (Public statement EMA/HMPC/41843/2009). Considering that thujone is a natural constituent of the essentials oils of a number of plants widely used, the HMPC decided to prepare a public statement on the use of herbal medicinal products containing thujone.

For Assistance with Regulating Herbal Products in the UK or EU Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

Fill Out the Short Form Below…


  1. (required)


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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”