To reply to a consultation, please use the dedicated EUSurvey link included in the relevant consultation document.
In case this link is not available, you can use the form below for comments:
Form for submission of comments on scientific guidelines
English (EN) (232 KB - DOC)
To submit comments specifically on ICH draft guidelines under consultation, use the form below:
Submission of comments on ICH guidelines
English (EN) (208.69 KB - XLSX)
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:
Draft guideline on the conduct of efficacy studies for intramammary products for use in cattle
This guideline provides guidance on design, conduct and reporting of pre-clinical studies and clinical trials or veterinary medicinal products for intramammary use in dairy cattle. The current revision consists of changes made to align the guideline with the relevant provisions of Regulation (EU) 2019/6.
Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu.
English (EN) (368.46 KB - PDF)
Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Revision 2
This guideline provides recommendations for the design and conduct of pre-clinical studies and clinical trials for veterinary medicinal products containing antimicrobial substances. The current revision consists of changes made to align the guideline with the relevant provisions of Regulation (EU) 2019/6.
Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu.
English (EN) (415.61 KB - PDF)
Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (135.57 KB - PDF)
Methylphenidate, prolonged-release tablet 18 mg, 27 mg, 36 mg and 54 mg and modified release capsule 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg product-specific bioequivalence guidance
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (155.3 KB - PDF)
Budesonide, gastro-resistant hard capsules with prolonged release properties, 3 mg, product-specific bioequivalence guidance
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (178.83 KB - PDF)
Budesonide, prolonged release tablets, 9 mg product-specific bioequivalence guidance
Comments should be provided using this EUSurvey form . For any technical issues, please contact the EUSurvey Support.
English (EN) (158.87 KB - PDF)
Budesonide, gastro-resistant hard capsules, 3 mg, gastro-resistant granules, 9 mg product-specific bioequivalence guidance
Comments should be provided using this EUSurvey form . For any technical issues, please contact the EUSurvey Support.
English (EN) (178.77 KB - PDF)
Draft public statement on Tribulus terrestris L., herba - First version
Comments should be provided using this template to hmpc.secretariat@ema.europa.eu
English (EN) (121.1 KB - PDF)
Draft European Union herbal monograph on Zingiber officinale Roscoe, rhizoma - Revision 1
Comments should be provided using this template to hmpc.secretariat@ema.europa.eu
English (EN) (212.85 KB - PDF)
Draft European Union herbal monograph on Urtica dioica L.; Urtica urens L., herba - Revision 1
Comments should be provided using this template to hmpc.secretariat@ema.europa.eu
English (EN) (280.16 KB - PDF)
Draft European Union herbal monograph on Prunus avium L.; Prunus cerasus L., peduncle - First version
Comments should be provided using this template to hmpc.secretariat@ema.europa.eu
English (EN) (265.34 KB - PDF)
Draft European Union herbal monograph on Urtica dioica L.; Urtica urens L., radix - Revision 1
Comments should be provided using this template to hmpc.secretariat@ema.europa.eu
English (EN) (216.05 KB - PDF)
European Commission guidelines on variations categories and procedures: Proposal for stakeholder consultation - clean version
The proposed amendments and an executive summary are available on the EMA corporate website at Variations guidelines: Proposed amendments to the European Commission guidelines on variations categories and procedures. Please consolidate your comments at your EU trade industry association / organisation level and submit them through the dedicated EU survey tool only: EU survey: Submission of comments on the revision of Variation Guidelines.
English (EN) (1.45 MB - PDF)
ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines Step 2b
Comments should be provided using this template. The completed comments form should be sent to ich@ema.europa.eu
English (EN) (1.48 MB - PDF)
Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (408.25 KB - PDF)
Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (298.63 KB - PDF)
Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (399.77 KB - PDF)
Ketoprofen : call for scientific data for use in CVMP assessment work of ketoprofen: review of the CVMP opinion for the establishment of maximum residue limits
Pursuant to Article 11 of Regulation (EC) No 470/2010 the European Commission requested the CVMP to review its previous opinion for the establishment of maximum residue limits (MRLs) for ketoprofen in view of concerns relating to residue concentrations in tissues from the target populations (i.e. bovine, porcine and Equidae) that may exceed the ADI.
The CVMP invites all interested parties such as pharmaceutical industry, learned societies, governmental institutions as well as EU and EEA-EFTA Member States to submit scientific data for use in the review of the residue assessment of ketoprofen.
The CVMP is seeking to obtain any relevant data, not already reported when a “No MRL required” status was agreed by the CVMP for ketoprofen in the aforementioned species (please refer to EMEA/MRL/020/95 and EMEA/MRL/076/96-FINAL), that may be available on the pharmacokinetics, residue depletion, analytical methods and monitoring results of ketoprofen in bovine, porcine and Equidae and that could impact the final conclusions.
Scientific contributions should be sent to: mrl@ema.europa.eu
English (EN) (147.59 KB - PDF)
Concept paper for the development of a guideline on the safety of nanoparticles – in the context of the establishment of maximum residue limits and veterinary marketing authorisations
This concept paper addresses the need for a specific guideline on the establishment of maximum residue limits (MRLs) for pharmacologically active nanoparticles, as well as on safety for veterinary medicinal products (VMPs) containing nanoparticles.
Comments should be provided using this template. The completed comments form should be sent to Vet-Guidelines@ema.europa.eu
English (EN) (140.62 KB - PDF)
Draft template for assessment report for the development of European herbal monographs and European Union list entries - Revision 6
Comments should be provided using this template. The completed comments form should be sent to hmpc.secretariat@ema.europa.eu
English (EN) (499.78 KB - PDF)