Category Archives: Herbal

EMA Publishes Procedures on the Systematic Review of Community Herbal Monographs and Supporting Documents

Posted on September 19, 2011 by admin| Leave a comment

EMA Publishes Procedures on the Systematic Review of Community Herbal Monographs and Supporting Documents

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The systematic review (assessment of the need for revision) by the Committee on Herbal Medicinal Products (HMPC) of its Community herbal monographs is laid down in section 3.2 of the ‘Reflection paper on the reasons and timelines for revision of final Community herbal monographs and Community list entries’ (EMA/HMPC/326440/2007). The need for a revision will be considered every 5 years in order to ensure that Community herbal monographs remain up-to-date (scientific state of the art).
This procedure addresses the scope, timelines and documenting aspects of the review and possible subsequent revision. The purpose of this document is to enable a consistent process for all monographs adopted by the HMPC.
The same procedure applies to Community list entries as implied in Article 16f(3) of Directive 2004/24/EC. The revision of Community list entries will take place in parallel to or shortly after the revision of related monographs. When a Community list entry is revised, the Comitology procedure will be followed at the European Commission level after transmission by the EMA.



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EMA Publishes Guidance on Companies Seeking Scientific advice on Traditional Herbal Medicinal Products

Posted on September 15, 2011 by admin| Leave a comment

EMA Publishes Guidance on Companies Seeking Scientific advice on Traditional Herbal Medicinal Products

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The HMPC adopts its scientific recommendations on the medicinal uses of herbal substances and herbal preparations (laid down in Community herbal monographs) by either consensus or a majority vote. The members of the HMPC (chosen for their role and experience in the evaluation of herbal medicinal products and representing the national competent authorities) express their divergent position when they do not support the entire content of a monograph. The divergent positions are published on the Agency website, as an appendix to the HMPC opinion. These positions may be valuable information for companies as to the specific approaches taken by some regulatory authorities on a national level. The names of the members who expressed the divergent positions can be obtained upon submission of a request for access to documents according to the ‘EMA Policy on access to documents (related to medicinal products for human and veterinary use).

Note: It should be noted that this document has been produced for guidance only and should be read in conjunction with the relevant legislation and guidance, including:
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004
Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Regulation (EC) No 1905/2005 of the European Parliament and of the Council of 14 November 2005 amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency
Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures (EMA/MB/818152/2009)
HMPC rules of procedures (EMA/HMPC/139800/2004 Rev.2)
EMA policy on the appropriate coordination between the scientific committees of the Agency (Policy 0009, EMA/124704/2005 Rev.1)



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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 Guidance on Systematic Review of Community Herbal Monograph Supporting Documents

Posted on September 14, 2011 by admin| Leave a comment

EMA Publish Guidance on Systematic Review of Community Herbal Monograph Supporting Documents

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The systematic review (assessment of the need for revision) by the Committee on Herbal Medicinal Products (HMPC) of its Community herbal monographs is laid down in section 3.2 of the ‘Reflection paper on the reasons and timelines for revision of final Community herbal monographs and Community list entries’ (EMA/HMPC/326440/2007). The need for a revision will be considered every 5 years in order to ensure that Community herbal monographs remain up-to-date (scientific state of the art).
This procedure addresses the scope, timelines and documenting aspects of the review and possible subsequent revision. The purpose of this document is to enable a consistent process for all monographs adopted by the HMPC.
The same procedure applies to Community list entries as implied in Article 16f(3) of Directive 2004/24/EC. The revision of Community list entries will take place in parallel to or shortly after the revision of related monographs. When a Community list entry is revised, the Comitology procedure will be followed at the European Commission level after transmission by the EMA.



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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 List of references supporting the assessment of Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix

Posted on September 7, 2011 by admin| Leave a comment

EMA Publish List of references supporting the assessment of Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix

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The Agency acknowledges that copies of the underlying works used to produce this monograph were provided for research only with exclusion of any commercial purpose.
Agbabiaka TB, Guo R, Ernst E. Pelargonium sidoides for acute bronchitis: A systemic review and meta-analysis. Phytomedicine 2008, 15:378-385.
Bachert C, Schapowal A, Funk P, Kieser M. Treatment of acute rhinosinusitis with the preparation from Pelargonium sidoides EPs® 7630: a randomized, double-blind, placebo-controlled trial. Rhinology 2009, 47:51-58.
Beil W, Kilian P. EPs® 7630, an extract from Pelargonium sidoides roots inhibits adherence of Helicobacter pylori to gastric epithelial cells. Phytomedicine 2007, 14:5-8.
Bereznoy VV, Riley DS, Wassmer G, Heger M. Efficacy of extract of Pelargonium sidoides in children with acute non-group A beta-haemolytic streptococcus tonsillophyaryngitis: a randomized, double-blind, placebo-controlled trial. Altern Ther Health Med 2003, 9:68-78.
Bladt S, Wagner H. “Umckaloabo”-Droge der afrikanischen Volksmedizin. Dtsh Apoth Ztg 1977, 117:1655-1660.
Bladt S, Wagner H. Cumarindrogen: Qualitatsprüfung der Umcka-Droge und ihrer Zubereitungen. Dtsh Apoth Ztg 1988, 128:292-296.
Bladt S, Wagner H. From the Zulu medicine to the European phytomedicine Umckaloabo®. Phytomedicine 2007, 14:2-4.
Blochin B, Haidvogl M, Heger M. Umckaloabo im Vergleich zu Acetylcystein bei Kindern mit acuter Bronchitis: prospective, randomisierte, kontrollierte, offene Studie zur Wirksamkeit und Vertraglichkeit. Der Kassenarzt 1999, 49:46-50.
Brendler T, van Wyk BE. A historical, scientific and commercial perspective on the medicinal use of Pelargonium sidoides (Geraniaceae). J Ethnopharmacol 2008, 119:420-433….



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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 Assessment report on Olea europaea L., folium

Posted on September 7, 2011 by admin| Leave a comment

EMA Publish Assessment report on Olea europaea L., folium

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Herbal substance(s) (binomial scientific name of the plant, including plant part)
Olea europaea L. folium (olive leaf)
Herbal preparation(s)
Herbal substance
Fresh or dried leaves
Herbal preparations
Comminuted dried leaves for herbal tea
Pharmaceutical forms
Herbal substance and comminuted herbal substance as herbal tea for oral use.


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EMA Publishes Assessment report on Tanacetum parthenium (L.) Schulz Bip., herba

Posted on September 6, 2011 by admin| Leave a comment

EMA Publishes Assessment report on Tanacetum parthenium (L.) Schulz Bip., herba

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Herbal substance(s) (binomial scientific name of the plant, including plant part)
Tanacetum parthenium (L.) Schulz Bip., herba
Herbal preparation(s) Powdered herbal substance
Pharmaceutical forms Herbal preparation in solid dosage forms for oral use.
Rapporteur Prof Gioacchino Calapai
Assessors Prof Gioacchino Calapai/Marisa Delbò



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EMA Publish List of references supporting the assessment of Oenothera biennis L.; Oenothera lamarckiana L., oleum

Posted on September 6, 2011 by admin| Leave a comment

EMA Publish List of references supporting the assessment of Oenothera biennis L.; Oenothera lamarckiana L., oleum

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The Agency acknowledges that copies of the underlying works used to produce this monograph were provided for research only with exclusion of any commercial purpose.
Abou El-Ela SH, Prasse KW, Carroll R, et al. Effects of dietary primrose oil on mammary tumorigenesis induced by 7,12-dimethylbenz(a)anthracene. Lipids 1987; 22(12): 1041-1044
Abou El-Ela SH, Prasse KW, Carroll R, et al. Eicosanoid synthesis in 7,12-dimethylbenz(a)anthracene-induced mammary carcinomas in sprague-dawley rats fed primrose oil, menhaden oil or corn oil diet. Lipids 1988; 23(10): 948-954
Aman MG, Mitchell EA, Turbott SH. The effects of essential fatty acid supplementation by Efamol in hyperactive children. J Abnorm Child Psychol 1987; 15(1): 75-90
Al-Shabanah OA. Effect of evening primrose oil on gastric ulceration and secretion induced by various ulcerogenic and necrotizing agents in rats. Food Chem Toxicol 1997; 35(8): 769-775
Anonymous. Surgical research society abstracts. Br J Surg 1981; 68: 801-824
Anstey A, Quigley M, Wilkinson JD. Topical evening primrose oil as treatment for atopic eczema. J Dermatol Treat 1990; 1: 199-201
Bamford JTM, Gibson RW, Renier CM. Atopic eczema unresponsive to evening primrose oil (linoleic and -linolenic acids). J Am Acad Dermatol 1985; 13(6): 959-965
Barnes J, Anderson LA, Phillipson JD. Herbal Medicines. Pharmaceutical Press, London 2007, 251-255
Bédard M. Evening primrose oil – still promising, but unproven. Can Pharm J 2003; 136(10): 41-42
Belch JJF, Shaw B, O’Dowd A, et al. Evening primrose oil (Efamol) as a treatment for cold-induced vasospasm (Raynauds phenomenon). Prog Lipid Res 1986; 25: 335-340


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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 List of references supporting the assessment of Tanacetum parthenium (L.) Schulz Bip., herba

Posted on September 5, 2011 by admin| Leave a comment

EMA Publish List of references supporting the assessment of Tanacetum parthenium (L.) Schulz Bip., herba

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The Agency acknowledges that copies of the underlying works used to produce this monograph were provided for research only with exclusion of any commercial purpose.
Anderson D, Jenkinson PC, Dewdney RS, Blowers SD, Johnson ES, Kadam NP. Chromosomal aberrations and sister chromatid exchanges in lymphocytes and urine mutagenicity of migraine patients: a comparison of chronic feverfew users and matched non-users. Hum Toxicol 1988, 7:145-152.
Anderson KN, Bejcek BE. Parthenolide induces apoptosis in glioblastomas without affecting NF-kappaB. J Pharmacol Sci 2008, 106:318-320.
Awang DVC. Prescribing therapeutic feverfew (Tanacetum parthenium (L.) Schultz bip., syn. Chrysanthemum parthenium (L.) Bernh.). Elsevier Science Inc 1998, 1(1):11-13.
Bamford CC, Tepper SJ. Daily pharmacologic prophylaxis of episodic migraine. Tech Reg Anesth Pain Manag 2009, 13:20-27.
Barnes J, Anderson LA, Philipson JD. Herbal Medicines. 3rd ed. Pharmaceutical Press, London 2007.
Barsby RW, Knight DW, McFadzean I. A chloroform extract of the herb feverfew blocks voltage-dependent potassium currents recorded from single smooth muscle cells. J Pharm Pharmacol 1993, 45:641-645.
Barsby RW, Salan U, Knight DW, Hoult JR. Feverfew extracts and parthenolide irreversibly inhibit vascular responses of the rabbit aorta. J Pharm Pharmacol 1992, 44:737-740.
Bejar E. Parthenolide inhibits the contractile responses of rat stomach fundus to fenfluramine and dextroamphetamine but not serotonin. J Ethnopharmacol 1996, 50:1-12.
British Herbal Pharmacopoeia. British Herbal Medicine Association, Bournemouth 1990.
British Herbal Pharmacopoeia. 4th ed. British Herbal Medical Association, London 1996…….



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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 Assessment report on Arctostaphylos uva-ursi (L.) Spreng., folium

Posted on September 5, 2011 by admin| Leave a comment

EMA Publish Assessment report on Arctostaphylos uva-ursi (L.) Spreng., folium

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Herbal substance(s) (binomial scientific name of the plant, including plant part)
Arctostaphylos uva-ursi (L.) Spreng., folium (bearberry leaf)
Herbal preparation(s)
A) Comminuted herbal substance
B) Powdered herbal substance
C) Dry extract (DER 3.5 – 5.5:1), extraction solvent ethanol 60% (V/V) containing 23.5 – 29.3% of hydroquinone derivatives calculated as anhydrous arbutin (spectrophotometry)
D) Dry extract (DER 2.5 – 4.5:1), extraction solvent water containing 20 – 28% of hydroquinone derivatives calculated as anhydrous arbutin (spectrophotometry)
Pharmaceutical forms
Herbal substance or herbal preparations in solid dosage forms or as herbal tea/macerate for oral use.



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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 Overview of comments received on Community herbal monograph on Juniperus communis L., aetheroleum

Posted on September 4, 2011 by admin| Leave a comment

EMA Publishes Overview of comments received on Community herbal monograph on Juniperus communis L., aetheroleum

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Organisations and/or individuals that commented on the draft Community herbal monograph> on Juniperus communis L., aetheroleum as released for public consultation on 15 March 2010 until 15 August 2010.
Organisations and/or individuals
1 European Scientific Cooperative on Phytotherapy (ESCOP)



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EMA Publish List of references supporting the assessment of Arctostaphylos uva-ursi (L.) Spreng., folium

Posted on September 4, 2011 by admin| Leave a comment

EMA Publish List of references supporting the assessment of Arctostaphylos uva-ursi (L.) Spreng., folium

Full Text Here

The Agency acknowledges that copies of the underlying works used to produce this
monograph were provided for research only with exclusion of any commercial purpose.
Adesunloye BA. Acute renal failure due to the herbal remedy CKLS. Am J Med 2003, 115(6):506-7.
Ahn KS, Moon KY, Lee J, Kim YS. Downregulation of NF-kappaB activation in human keratinocytes by
melanogenic inhibitors. J Dermatol Sci 2003, 31(3):193-201.
Albrecht J, Kreyes G. Langzeitbehandlung von Dauerkatheterpatienten: Chemoprophylaxe oder
Phytotherapie? Extr Urol 1988, 11(5):277-80.
Alvarado F. The relationship between Na+ and the active transport of arbutin in the small intestine.
Biochim Biophys Acta 1965, 109:478-94.
Alvarado F, Monreal J. Na+-Dependent active transport of phenylglucosides in the chicken small
intestine. Comp Biochem Physiol 1967, 20:471-88.
Annuk H, Hirmo S, Türi E, Mikelsaar M, Arak E, Wadström T. Effect on cell surface hydrophobicity and
susceptibility of Helicobacter pylori to medicinal plant extracts. FEMS Microbiol Lett 1999, 172:41-5.
Assaf MH, Makboul MA, Beck JP, Anton R. Preliminary study of phenolic glycosides from Origanum
majorana; quantitative estimation of arbutin, cytotoxic activity of hydroquinone. Planta Med 1987,
53(4):343-5.
Barnes J, Anderson L, Phillipson D. Herbal Medicines: A guide for healthcare professionals. 3rd ed.
Pharmaceutical Press, London 2002, 577-9.
Bartleby J. Effects of Bearberry: Uva ursi for urinary infections. Potent herbal for pee problems.
Associated content. 2006. Available at:
www.associatedcontent.com/article/19953/effects_of_bearberry_uva_ursi_for_urinary_infections.htm
Accessed 3/9/2009…………..



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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 Assessment report on Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix

Posted on September 3, 2011 by admin| Leave a comment

EMA Publish Assessment report on Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix

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This draft Assessment Report is published to support the release for public consultation of the draft Community herbal monograph on Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix. It should be noted that this document is a working document, not yet fully edited, and which shall be further developed after the release for consultation of the monograph. Interested parties are welcome to submit comments to the HMPC secretariat, which the Rapporteur and the MLWP will take into consideration but no ‘overview of comments received during the public consultation’ will be prepared in relation to the comments that will be received on this assessment report. The publication of this draft assessment report has been agreed to facilitate the understanding by Interested Parties of the assessment that has been carried out so far and led to the preparation of the draft monograph.


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EMA Publishes Assessment report on Juniperus communis L., Aetheroleum

Posted on September 3, 2011 by admin| Leave a comment

EMA Publishes Assessment report on Juniperus communis L., Aetheroleum

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Herbal substance(s) (binomial scientific name of the plant, including plant part) – Juniperus communis L., aetheroleum

Herbal Preperation Essential oil

Pharmaceutical form – herbal preperations in liquid dosage forms for oral and cutaneouse use


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EMA Publish Overview of comments received on Community herbal monograph on Tanacetum parthenium (L) Schulz Bip., herba

Posted on September 2, 2011 by admin| Leave a comment

EMA Publish Overview of comments received on Community herbal monograph on Tanacetum parthenium (L) Schulz Bip., herba

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Organisations and/or individuals that commented on the draft Community herbal monograph on Tanacetum parthenium (L) Schulz Bip., herba as released for public consultation on 6 May 2010 until 15 August 2010.
Organisations and/or individuals
1 European Scientific Cooperative on Phytotherapy (ESCOP)
2 Kooperation Phytopharmaka (KOOP PHYTO)
3 NATUREX S/A



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EMA Publishes List of references supporting the assessment of Juniperus communis L., aetheroleum

Posted on September 2, 2011 by admin| 1 Comment

EMA Publishes List of references supporting the assessment of Juniperus communis L., aetheroleum

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The Agency acknowledges that copies of the underlying works used to produce this monograph were provided for research only with exclusion of any commercial purpose.
Anonymous. Final report on the safety assessment of Juniperus communis extract, Juniperus oxycedrus extract, Juniperus oxycedrus tar, Juniperus phoenica extract and Juniperus virginiana extract. Int J Toxicol 2001, 20(2):41-56.
Anonymous. Royal Decree of 29 August 1997 concerning the manufacturing and commercialising of food supplements with plants or plant preparations. Belgian State Journal 21 November 1997.
Barnes J, Anderson LA, Phillipson JD. Herbal Medicines. 3rd ed. Pharmaceutical Press, London 2007, 386-388.
Bruneton J. Pharmacognosie. Phytochimie des Plantes médicinales. 3rd ed. Editions Tec & Doc, Paris 1999, 586-588.
De Smet PAGM, Keller K, Hänsel R, Chandler RF. Adverse Effects of Herbal Drugs Vol. 2. Springer-Verlag, Berlin / Heidelberg 1993, 217-228.
Delfosse M. Drogues végétales et plantes médicinales. APB, Brussels 1998, 221-222.
Duke JA. CRC Handbook of Medicinal Herbs. CRC Press, Boca Raton 1988, 256-258.
Emami SA, Asili J, Mohaghegi Z, Hassanzadech MK. Antioxidant activity of leaves and fruits of Iranian conifers. Evid Based Complement Altern Med 2007, 4:313-319.
ESCOP monographs 2nd ed. Juniperi pseudo-fructus – Juniper. European Scientific Cooperative on Phytotherapy, editor. Thieme Verlag, Stuttgart 2003, 282-285.
European Pharmacopoeia 6th ed. Juniperi pseudo-fructus. Council of Europe 01/2008: 1532; 2206-2207.
European Pharmacopoeia 6th ed. Juniperi aetheroleum. 01/2008: 1832; 2207-2208….



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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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MHRA approves THR for Lamberts Devils Claw Tablets

Posted on September 2, 2011 by admin| Leave a comment

MHRA approves THR for Lamberts Devils Claw Tablets

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MHRA approves THR for Lamberts Devils Claw Tablets

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

Posted on September 1, 2011 by admin| Leave a comment

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 Overview of comments received on Community herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium

Posted on September 1, 2011 by admin| Leave a comment

EMA Publishes Overview of comments received on Community herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium

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Organisations and/or individuals
1 European Scientific Cooperative on Phytotherapy (ESCOP)
2 The European Botanical Forum (EBF)
3 Association of the European Self-Mediacation Industry (AESGP)



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

Posted on July 22, 2011 by admin| Leave a comment

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 Call for Scientific Data for Use in HMPC Assessment work on Eucalyptus globulus Labill., follium

Posted on July 20, 2011 by admin| Leave a comment

EMA Call for Scientific Data for Use in HMPC Assessment work on Eucalyptus globulus Labill., follium

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The HMPC invites all interested parties such as pharmaceutical industry associations, health care professional groups, learned societies, consumers and patients’ associations, governmental institutions as well as EU and EEA-EFTA Member States to submit any scientific data, which may be used in the assessment of Eucalyptus globulus Labill., folium as part of the establishment of Community herbal monographs and/or Community list entries.

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