Public consultationshttps://www.ema.europa.eu/en/homepagePublic consultationsen-gbCopyright: (C) European Medicines AgencyTue, 14 May 2024 18:04:26 +0200Fri, 03 May 2024 09:50:00 +0200Reflection paper on use of real-world data in non-interventional studies to generate real-world evidencehttps://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-real-world-data-non-interventional-studies-generate-real-world-evidence_en.pdfReflection paper on use of real-world data in non-interventional studies to generate real-world evidencehttps://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-real-world-data-non-interventional-studies-generate-real-world-evidence_en.pdfFri, 03 May 2024 09:50:00 +0200Public consultationsGuideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal productshttps://www.ema.europa.eu/en/documents/scientific-guideline/guideline-stability-testing-applications-variations-marketing-authorisation-veterinary-medicinal-products_en.pdfGuideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal productshttps://www.ema.europa.eu/en/documents/scientific-guideline/guideline-stability-testing-applications-variations-marketing-authorisation-veterinary-medicinal-products_en.pdfThu, 02 May 2024 09:25:30 +0200Public consultationsConcept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labellinghttps://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-risk-assessment-medicinal-products-human-reproduction-lactation-data-labelling_en.pdfConcept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labellinghttps://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-risk-assessment-medicinal-products-human-reproduction-lactation-data-labelling_en.pdfThu, 02 May 2024 09:10:57 +0200Public consultationsKetoprofen : call for scientific data for use in CVMP assessment work of ketoprofen: review of the CVMP opinion for the establishment of maximum residue limitshttps://www.ema.europa.eu/en/documents/mrl-report/ketoprofen-call-scientific-data-use-cvmp-assessment-work-ketoprofen-review-cvmp-opinion-establishment-maximum-residue-limits_en.pdfKetoprofen : call for scientific data for use in CVMP assessment work of ketoprofen: review of the CVMP opinion for the establishment of maximum residue limitshttps://www.ema.europa.eu/en/documents/mrl-report/ketoprofen-call-scientific-data-use-cvmp-assessment-work-ketoprofen-review-cvmp-opinion-establishment-maximum-residue-limits_en.pdfTue, 30 Apr 2024 16:24:59 +0200Public consultationsConcept 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 authorisationshttps://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-guideline-safety-nanoparticles-context-establishment-maximum-residue-limits-veterinary-marketing-authorisations_en.pdfConcept 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 authorisationshttps://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-guideline-safety-nanoparticles-context-establishment-maximum-residue-limits-veterinary-marketing-authorisations_en.pdfFri, 26 Apr 2024 14:30:00 +0200Public consultationsDraft template for assessment report for the development of European herbal monographs and European Union list entries - Revision 6https://www.ema.europa.eu/en/documents/template-form/draft-template-assessment-report-development-european-herbal-monographs-european-union-list-entries-revision-6_en.pdfDraft template for assessment report for the development of European herbal monographs and European Union list entries - Revision 6https://www.ema.europa.eu/en/documents/template-form/draft-template-assessment-report-development-european-herbal-monographs-european-union-list-entries-revision-6_en.pdfThu, 18 Apr 2024 11:45:09 +0200Public consultationsDraft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-agricultural-collection-practice-gacp-starting-materials-herbal-origin-revision-1_en.pdfDraft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-agricultural-collection-practice-gacp-starting-materials-herbal-origin-revision-1_en.pdfThu, 18 Apr 2024 11:31:51 +0200Public consultationsTemplate for a European Union herbal monographhttps://www.ema.europa.eu/en/documents/template-form/template-european-union-herbal-monograph_en.pdf-0Template for a European Union herbal monographhttps://www.ema.europa.eu/en/documents/template-form/template-european-union-herbal-monograph_en.pdf-0Mon, 15 Apr 2024 09:49:48 +0200Public consultations