EUROPEAN COMMISSION Brussels 03 February 2010 EudraLex
3 févr. 2010 EU Guidelines to. Good Manufacturing Practice. Medicinal Products for Human and Veterinary Use. Annex 13. Investigational Medicinal Products.
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CHMP Minutes and Annex 13-16 December 2021
8 févr. 2022 EMA/CHMP/782804/2021. Human Medicines Division. Committee for medicinal products for human use (CHMP). Minutes for the meeting on 13-16 ...
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EU GMP Requirements
Focal points of inspections at IMP manufacturing sites. ▫ Revision of Annex 13 – current status. ▫ GMP level of Active Ingredients for Use in IMPs
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Annual report of the Good Manufacturing and Distribution Practice
12 sept. 2016 Send a question via our website www.ema.europa.eu/contact ... GMP Guide: Annex 13 (Manufacture of Investigational Medicinal Products) .
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Annex 19 Reference and Retention Samples
14 déc. 2005 This Annex to the Guide to Good Manufacturing Practice for Medicinal ... for investigational medicinal products are given in Annex 13 to the.
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Reflection paper on the use of interactive response technologies
10 déc. 2013 Send us a question Go to www.ema.europa.eu/contact ... expiry date expiry update labelling
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Reflection paper on the use of interactive response technologies
10 déc. 2013 Send us a question Go to www.ema.europa.eu/contact ... expiry date expiry update labelling
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Reflection Paper on Good Manufacturing Practice and Marketing
10 janv. 2022 Annex 12 Paragraph 33). Page 10. EMA/INS/3094/2022. Page 10/29.
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guide to good manufacturing practice for medicinal products annexes
1 févr. 2022 Annex 13 (Manufacture of investigational medicinal products) ... Annex 18 [GMP Guide for active pharmaceutical ingredients]**.
Guideline on the Investigation of Bioequivalence
1 août 2010 E-mail: mail@ema.europa.eu http://www.ema.europa.eu ... in accordance with good manufacturing practice including Annex 13 to the EU.
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