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  1. health.ec.europa.eu › medicinal-products › eudralexEudraLex - Volume 4 - European Commission - Public Health

    8. Okt. 2003 · Find the latest guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use in the EU. Download the PDF documents for each chapter, annex and related document.

  2. www.ema.europa.eu › en › human-regulatory-overviewGood manufacturing practice | European Medicines Agency

    These legal instruments lay down the principles and guidelines of GMP in the EU: Regulation No. 1252/2014 applying to active substances for human use; Directive 2001/83/EC and Directive (EU) 2017/1572, applying to medicines for human use; Directive 91/412/EEC and Regulation (EU) 2019/6 applying to medicines for veterinary use.

  3. www.bundesgesundheitsministerium.de › gmpGute Praxis bei der Herstellung von Arzneimitteln | BMG

    31. Aug. 2023 · EU-GMP Leitfaden. Den EG -GMP-Leitfaden mit Anhängen zu § 2 Nr. 3 der AMWHV finden Sie hier. Stand: 31. August 2023. Die Europäische Kommission hat Grundsätzen und Leitlinien für eine Gute Herstellungspraxis (GMP) von Arzneimitteln formuliert.

  4. health.ec.europa.eu › latest-updates › eudralex-volume-4-euEudralex Volume 4 - EU Guidelines for Good Manufacturing Practice...

    21. Feb. 2022 · Eudralex Volume 4 - EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. 21 FEBRUARY 2022. vol4_annex21_en.pdf. English. (451.32 KB - PDF) Download. Details. Publication date. 21 February 2022. Author. Directorate-General for Health and Food Safety. Share this page.

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  6. www.ema.europa.eu › en › human-regulatory-overviewGuidance on - European Medicines Agency

    The guidance provided by the working group in the form of questions and answers (Q&As) provides additional interpretation of the European Union (EU) GMP guidelines and GDP guidelines published by the European Commission. The working group prepares these Q&As as the need arises.

  7. www.ema.europa.eu › en › documentsGood Manufacturing Practice - European Medicines Agency

    This document (Guide) is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements

  8. eur-lex.europa.eu › legal-content › ENDirective - 2003/94 - EN - EUR-Lex

    Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (Text with EEA relevance) OJ L 262, 14.10.2003, p. 22–26 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)