EMA/HMPC/244313/2016 EMA/HMPC/M/H/187 Committee on Herbal Medicinal Products (HMPC)
Opinion of the HMPC on a European Union herbal monograph on Polygonum aviculare L., herba Opinion The HMPC, in accordance with Article 16h(3) of Directive 2001/83/EC, as amended, and as set out in the appended assessment report, establishes by a majority of 25 out of 26 votes a European Union herbal monograph on Polygonum aviculare L., herba which is set out in Annex I. The divergent position is appended to this opinion. The Norwegian HMPC member agrees with the above-mentioned recommendation of the HMPC. This opinion is forwarded to Member States, to Iceland and Norway, together with its Annex I and appendices. The European Union herbal monograph and assessment report will be published on the European Medicines Agency website.
London, 5 April 2016
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
Opinion of the HMPC on a European Union herbal monograph on Polygonum aviculare L., herba EMA/HMPC/244313/2016
Page 3/5
Appendix II: Divergent positions
Opinion of the HMPC on a European Union herbal monograph on Polygonum aviculare L., herba EMA/HMPC/244313/2016
Page 4/5
The member of the HMPC mentioned below did not agree with the HMPC’s opinion for the following reason: Regarding the EU Herbal Monograph for Polygonum avicularis herba, I have to take a divergent position regarding the following parts of the indication: From a Dutch point of view, for indication 2, “Traditional herbal medicinal product for symptomatic treatment of mild irritations in the mouth or throat.”
should be preferable.
And for indication 3 “Traditional herbal medicinal product used to achieve flushing of the urinary tract as an adjuvant in minor urinary tract complaints” is considered acceptable.
Emiel van Galen, HMPC member from the Netherlands London, 5 April 2016
Opinion of the HMPC on a European Union herbal monograph on Polygonum aviculare L., herba EMA/HMPC/244313/2016
Opinion of the HMPC on a European Union herbal monograph on ...
Send a question via our website www.ema.europa.eu/contact ... The HMPC, in accordance with Article 16h(3) of Directive 2001/83/EC, as amended, and as set ...
Jul 18, 2016 - products in applications for marketing authorisation (bibliographical and mixed ... and supporting documents', proposals on update of existing template for EU herbal monographs, ... E-mail: [email protected].
Feb 22, 2018 - The committee welcomed Erika Svedlund as new member from Sweden and Katarzyna Tomaszewska as new Polish alternate. Revised European Union herbal monographs. Upon recommendation from the MLWP, the HMPC adopted after systematic review th
Feb 6, 2017 - The drafting group started the review of the herbal specification guideline in line with the quality guideline revision as well as of the reflection ...
Feb 2, 2016 - mild symptoms of mental stress and to aid sleep. The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use. 4.2. Posology and method of administration4. Well-estab
Mar 28, 2017 - EMA/HMPC/750269/2016. Committee on ... November 2016. January 2017 .... In absence of sufficient data, the use during lactation is not ...
Jun 14, 2016 - Call for scientific data (systematic monograph review). In April the HMPC had agreed to initiate the systematic review of 13 herbal substances ...
Mar 27, 2018 - Upon recommendation from the MLWP, the HMPC adopted after systematic review the following final revised EU herbal monographs: â¢. Revised EU herbal monograph on Agni casti fructus (by majority). â¢. Revised EU herbal monograph on Cal
Reading summary reports and the assessment report that was prepared for the current procedure, the following can be summarised: â¢. We do not have accessible any relevant scientific information concerning the behaviour and fate of fluazuron in milk,
The CVMP has estimated the safe level based on a mathematic calculation only (even if the conclusion is that exposure does not represent a sizable part of the ...
Sep 20, 2016 - (R6) What kinds of safety data are required for applications ..... has to be demonstrated by using appropriate analytical data, for example.
Dec 15, 2017 - This sequential methodological approach actually carried out was ... For the QT, this fact constituted a minor deficiency in the PROs development ...... for both tools, the D-PPAC and the C-PPAC, item selection/optimization was.
On 12 April 2017, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted an opinion2 recommending the inclusion of alarelin in all food ...
institutional development of EU-Russia relations from three perspectives: European studies, Russian studies and International. Relations, including Foreign ...
trade or business establishment[s] as legitimate exercise of their corporate. and/or proprietary power[s]. I. FACTUAL BACKGROUND. The City Government of ...