Open consultations
The list below includes the European Medicines Agency's (EMA) open public consultations.
To reply to a consultation, please use the form for comments (which is also linked within each consultation document):
Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see:
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Second draft - Revision 1: Public statement on the use of herbal medicinal products containing estragole (PDF/270.4 KB)
Reference numberEMA/HMPC/137212/2005 Rev. 1StatusDraft: consultation openFirst published14/02/2020Consultation dates15/02/2020 to 15/05/2020
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Call for scientific data for the periodic review of the monograph on Agropyron repens (L.) P. Beauv., rhizoma - Revision 1 (PDF/83.07 KB)
Reference numberEMA/HMPC/47033/2020StatusDraft: consultation openFirst published31/01/2020
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Call for scientific data for the periodic review of the monograph on Syzygium aromaticum (L.) Merill et L. M. Perry (Eugenia caryophyllus (C. Spreng.) Bull. et Harr.), aetheroleum - Revision 1 (PDF/80.05 KB)
Reference numberEMA/HMPC/47048/2020StatusDraft: consultation openFirst published31/01/2020Consultation dates01/02/2020 to 30/04/2020Email address for submissionsSummaryThe 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 that the HMPC should consider at the periodic review of the monograph on Syzygium aromaticum (L.) Merill et L. M. Perry (Eugenia caryophyllus (C. Spreng.) Bull. et Harr.), aetheroleum towards a possible revision of the monograph and supporting documents. The publication of this call is the first step in the procedure established by the committee so that adopted monographs remain up-to-date (scientific state of the art).
To avoid submission of data which were already evaluated during the initial assessment work, interested parties are invited to carefully check the published ‘List of references supporting the assessment’ and ‘Overview of comments received during the public consultation’.
The HMPC is looking to receive scientific literature published since the end date of the public consultation on the monograph and supporting documents. Scientific contributions should be sent in electronic format by e-mail or Eudralink to hmpc.secretariat@ema.europa.eu
or by post to
European Medicines Agency
Domenico Scarlattilaan 6
1083 HS Amsterdam
The Netherlands
Att.: HMPC secretariatIf an interested party intends to send scientific contributions in response to several calls for scientific data, response should be sent separately to each call.
A list of all scientific contributions and their references should be enclosed.
The name and contact details of the interested party providing the scientific contributions is required.
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Call for scientific data for the periodic review of the monograph on Carum carvi L., aetheroleum - Revision 1 (PDF/78.54 KB)
Reference numberEMA/HMPC/47463/2020StatusDraft: consultation openFirst published31/01/2020Consultation dates01/02/2020 to 30/04/2020Email address for submissionsSummaryThe 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 that the HMPC should consider at the periodic review of the monograph on Carum carvi L., aetheroleum towards a possible revision of the monograph and supporting documents. The publication of this call is the first step in the procedure established by the committee so that adopted monographs remain up-to-date (scientific state of the art).
To avoid submission of data which were already evaluated during the initial assessment work, interested parties are invited to carefully check the published ‘List of references supporting the assessment’ and ‘Overview of comments received during the public consultation’.
The HMPC is looking to receive scientific literature published since the end date of the public consultation on the monograph and supporting documents.
Scientific contributions should be sent in electronic format by e-mail or Eudralink to hmpc.secretariat@ema.europa.euor by post to
European Medicines Agency
Domenico Scarlattilaan 6
1083 HS Amsterdam
The Netherlands
Att.: HMPC secretariatIf an interested party intends to send scientific contributions in response to several calls for scientific data, response should be sent separately to each call.
A list of all scientific contributions and their references should be enclosed.
The name and contact details of the interested party providing the scientific contributions is required.
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Call for scientific data for the periodic review of the monograph on Carum carvi L., fructus - Revision 1 (PDF/78.48 KB)
Reference numberEMA/HMPC/47469/2020StatusDraft: consultation openFirst published31/01/2020Consultation dates01/02/2020 to 30/04/2020Email address for submissionsSummaryThe 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 that the HMPC should consider at the periodic review of the monograph on Carum carvi L., fructus towards a possible revision of the monograph and supporting documents. The publication of this call is the first step in the procedure established by the committee so that adopted monographs remain up-to-date (scientific state of the art).
To avoid submission of data which were already evaluated during the initial assessment work, interested parties are invited to carefully check the published ‘List of references supporting the assessment’ and ‘Overview of comments received during the public consultation’.
The HMPC is looking to receive scientific literature published since the end date of the public consultation on the monograph and supporting documents. Scientific contributions should be sent in electronic format by e-mail or Eudralink to hmpc.secretariat@ema.europa.eu
or by post to
European Medicines Agency
Domenico Scarlattilaan 6
1083 HS Amsterdam
The Netherlands
Att.: HMPC secretariatIf an interested party intends to send scientific contributions in response to several calls for scientific data, response should be sent separately to each call.
A list of all scientific contributions and their references should be enclosed.
The name and contact details of the interested party providing the scientific contributions is required.
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Call for scientific data for the periodic review of the monograph on Zingiber officinale Roscoe, rhizoma - Revision 1 (PDF/78.69 KB)
Reference numberEMA/HMPC/47493/2020StatusDraft: consultation openFirst published31/01/2020Consultation dates01/02/2020 to 30/04/2020Email address for submissionsSummaryThe 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 that the HMPC should consider at the periodic review of the monograph on Zingiber officinale Roscoe, rhizoma towards a possible revision of the monograph and supporting documents. The publication of this call is the first step in the procedure established by the committee so that adopted monographs remain up-to-date (scientific state of the art).
To avoid submission of data which were already evaluated during the initial assessment work, interested parties are invited to carefully check the published ‘List of references supporting the assessment’ and ‘Overview of comments received during the public consultation’.
The HMPC is looking to receive scientific literature published since the end date of the public consultation on the monograph and supporting documents. Scientific contributions should be sent in electronic format by e-mail or Eudralink to hmpc.secretariat@ema.europa.eu
or by post to
European Medicines Agency
Domenico Scarlattilaan 6
1083 HS Amsterdam
The Netherlands
Att.: HMPC secretariatIf an interested party intends to send scientific contributions in response to several calls for scientific data, response should be sent separately to each call.
A list of all scientific contributions and their references should be enclosed.
The name and contact details of the interested party providing the scientific contributions is required.
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Call for scientific data for the periodic review of the monograph on Chamaemelum nobile (L.) All. (Anthemis nobilis L.), flos - Revision 1 (PDF/78.99 KB)
Reference numberEMA/HMPC/50752/2020StatusDraft: consultation openFirst published31/01/2020Consultation dates01/02/2020 to 30/04/2020Email address for submissionsSummaryThe 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 that the HMPC should consider at the periodic review of the monograph on Chamaemelum nobile (L.) All. (Anthemis nobilis L.), flos towards a possible revision of the monograph and supporting documents. The publication of this call is the first step in the procedure established by the committee so that adopted monographs remain up-to-date (scientific state of the art).
To avoid submission of data which were already evaluated during the initial assessment work, interested parties are invited to carefully check the published ‘List of references supporting the assessment’ and ‘Overview of comments received during the public consultation’.
The HMPC is looking to receive scientific literature published since the end date of the public consultation on the monograph and supporting documents.
Scientific contributions should be sent in electronic format by e-mail or Eudralink to hmpc.secretariat@ema.europa.euor by post to
European Medicines Agency
Domenico Scarlattilaan 6
1083 HS Amsterdam
The Netherlands
Att.: HMPC secretariatIf an interested party intends to send scientific contributions in response to several calls for scientific data, response should be sent separately to each call.
A list of all scientific contributions and their references should be enclosed.
The name and contact details of the interested party providing the scientific contributions is required.
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Call for scientific data for the periodic review of the monograph on Cola nitida (Vent.) Schott et Endl. (C. vera K. Schum.); Cola acuminata (P. Beauv.) Schott et Endl. (Sterculia acuminata P. Beauv.), semen - Revision 1 (PDF/80.17 KB)
Reference numberEMA/HMPC/50864/2020StatusDraft: consultation openFirst published31/01/2020Consultation dates01/02/2020 to 30/04/2020Email address for submissionsSummaryThe 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 that the HMPC should consider at the periodic review of the monograph on Cola nitida (Vent.) Schott et Endl. (C. vera K. Schum.); Cola acuminata (P. Beauv.) Schott et Endl. (Sterculia acuminata P. Beauv.), semen towards a possible revision of the monograph and supporting documents. The publication of this call is the first step in the procedure established by the committee so that adopted monographs remain up-to-date (scientific state of the art).
To avoid submission of data which were already evaluated during the initial assessment work, interested parties are invited to carefully check the published ‘List of references supporting the assessment’ and ‘Overview of comments received during the public consultation’.
The HMPC is looking to receive scientific literature published since the end date of the public consultation on the monograph and supporting documents.
Scientific contributions should be sent in electronic format by e-mail or Eudralink to hmpc.secretariat@ema.europa.euor by post toEuropean Medicines Agency
Domenico Scarlattilaan 6
1083 HS Amsterdam
The Netherlands
Att.: HMPC secretariatIf an interested party intends to send scientific contributions in response to several calls for scientificdata, response should be sent separately to each call.
A list of all scientific contributions and their references should be enclosed.
The name and contact details of the interested party providing the scientific contributions is required.
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Call for scientific data for the revision of the monograph on Pelargonium sidoides DC; Pelargonium reniforme Curt., radix - Revision 1 (PDF/79.81 KB)
Reference numberEMA/HMPC/47573/2020StatusDraft: consultation openFirst published31/01/2020Consultation dates01/02/2020 to 30/04/2020Email address for submissions
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Draft European Union list entry on Achillea millefolium L., herba - Revision 1 (PDF/104.05 KB)
Reference numberEMA/HMPC/376417/2019StatusDraft: consultation openFirst published31/01/2020Consultation dates01/02/2020 to 30/04/2020Email address for submissions
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Draft European Union herbal monograph on Achillea millefolium L., herba - Revision 1 (PDF/133.58 KB)
Reference numberEMA/HMPC/376416/2019StatusDraft: consultation openFirst published31/01/2020Consultation dates30/01/2020 to 30/04/2020Email address for submissions
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Reflection paper on good manufacturing practice and marketing authorisation holders (PDF/467.99 KB)
Reference numberEMA/457570/2019StatusDraft: consultation openFirst published20/01/2020Consultation dates17/01/2020 to 17/04/2020Email address for submissions
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Draft European Union herbal monograph on Herniaria glabra L., H. hirsuta L., H. incana Lam., herba (PDF/124.16 KB)
Reference numberEMA/HMPC/554043/2018StatusDraft: consultation openFirst published19/12/2019Consultation dates19/12/2019 to 15/03/2020Email address for submissions
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Draft guideline on good pharmacovigilance practices: Product- or population-specific considerations III: Pregnant and breastfeeding women (PDF/475.52 KB)
Reference numberEMA/653036/2019StatusDraft: consultation openFirst published11/12/2019Consultation dates11/12/2019 to 28/02/2020Email address for submissionsSummaryThis product- and population- specific considerations chapter P.III of the good pharmacovigilance practices (GVP) aims to provide guidance to marketing authorisation applicants/holders, competent authorities of Member States and the Agency for facilitating appropriate pharmacovigilance for medicinal products that may be used in pregnant or breastfeeding women.
Comments should be provided using
this template
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Open call for data on use of antimicrobials in animals (PDF/277.78 KB)
Reference numberEMA/536558/2019StatusDraft: consultation openFirst published10/12/2019Consultation dates10/12/2019 to 06/03/2020SummaryRegulation (EU) 2019/6 on veterinary medicinal products allows medicinal products to be used outside the terms of their marketing authorisation under certain conditions when no suitable authorised product is available. This is often often referred to as ‘cascade use’. However, in the specific case of antimicrobials, Article 107(6) of the regulation makes provisions for a list of antimicrobials that may not be used under the cascade, or may only be used subject to certain conditions.
The European Commission has asked the European Medicines Agency (EMA) to provide scientific advice on how to address these provisions in forthcoming additional legislation.
The Committee for Medicinal Products for Veterinary Use (CVMP) invites all interested parties, including pharmaceutical industry, veterinarians, professional groups, learned societies, governmental institutions as well as EU and EEA Member States to submit information on cascade use of antimicrobials in animals and any scientific evidence of an impact on public and animal health that the CVMP should consider in the preparation of its scientific advice.
The consultation will close on 6 March 2020.
To submit information, use below questionnaire:
https://ec.europa.eu/eusurvey/runner/OpenCallUseofantimicrobialsinanimals
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Draft VICH GL59 Harmonisation of criteria to waive laboratory animal batch safety testing for vaccines for veterinary use (PDF/370.09 KB)
StatusDraft: consultation openFirst published18/11/2019Consultation dates18/11/2019 to 10/04/2020Email address for submissionsSummaryThis document provides internationally harmonised recommendations for criteria on data requirements to waive laboratory animal batch safety testing of veterinary vaccines in regions where it is required.
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CVMP reflection paper on promoting the authorisation of alternatives to antimicrobials in the EU (PDF/308.04 KB)
Reference numberEMA/CVMP/461776/2017StatusDraft: consultation openFirst published18/10/2019Consultation dates18/10/2019 to 30/04/2020Email address for submissionsSummaryThe CVMP has adopted a draft reflection paper on ‘Promoting the authorisation of alternatives to antimicrobials in the EU’. This draft reflection paper has been developed to identify additional measures that could be implemented to promote the authorisation of alternatives to antimicrobials in the EU and is available for public consultation until 30 April 2020.
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