https://www.ema.europa.eu/en/homepagePublic consultationsen-gbCopyright: (C) European Medicines AgencyFri, 10 May 2024 01:12:13 +0200Fri, 03 May 2024 09:50:00 +0200https://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 consultationshttps://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 consultationshttps://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 consultationshttps://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 consultationshttps://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 consultationshttps://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 consultationshttps://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 consultationshttps://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 consultationshttps://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-pharmaceutical-quality-inhalation-nasal-medicinal-products_en.pdfDraft guideline on the pharmaceutical quality of inhalation and nasal medicinal productshttps://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-pharmaceutical-quality-inhalation-nasal-medicinal-products_en.pdfFri, 12 Apr 2024 10:03:09 +0200Public consultationshttps://www.ema.europa.eu/en/documents/other/draft-revised-heads-medicines-agency-european-medicines-agency-guidance-document-identification-personal-data-commercially-confidential-information-within-structure-marketing-authorisation-application_en.pdfDraft revised Heads of Medicines Agency / European Medicines Agency guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossierhttps://www.ema.europa.eu/en/documents/other/draft-revised-heads-medicines-agency-european-medicines-agency-guidance-document-identification-personal-data-commercially-confidential-information-within-structure-marketing-authorisation-application_en.pdfFri, 12 Apr 2024 09:28:07 +0200Public consultationshttps://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-requirements-demonstrating-therapeutic-equivalence-between-orally-inhaled-products-oip-asthma-chronic-obstructive-pulmonary-disease-copd_en.pdfDraft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-requirements-demonstrating-therapeutic-equivalence-between-orally-inhaled-products-oip-asthma-chronic-obstructive-pulmonary-disease-copd_en.pdfFri, 12 Apr 2024 09:12:50 +0200Public consultations