Labelling requirements for investigational medicinal
Found 7 free book(s)Labelling Requirements for Investigational Medicinal ...
dgra.deDr. Astrid Weyermann Labelling requirements for IMPs in multinational CTs Page 6 / 71 1 EXECUTIVE SUMMARY The purpose of regulatory labelling requirements for investigational medicinal
EU GMP Requirements
www.ema.europa.euTMH, Ankara, 20-21 Oct 2009 Bernd Boedecker 3 Trade & Industry Inspection Agency of Lower Saxony / Germany, Hannover office Contents covered Legislation related to Investigational Medicinal …
NIMPs (v IMPs): Definitions and Practical Approaches
www.csdg.co.uk4 Current Status Regulatory Environment • Currently no regulations around NIMPS • Guidance from the European Commission* — Defines nIMPs, provides examples, and required filing documentation Non-Investigational Medicinal Product (NIMP) * A medical product not defined within the description of …
DIRECTIVE FOR IMPORTATION AND RELEASE OF …
www.who.intdraft template document [name of national regulatory authority] directive for importation and release of investigational medicinal products for clinical trials to be conducted in (name of the country)
swissethics
www.swissethics.chStudy ID, Version xx of date (DD/MM/YYYY) Page 3 of 45 <<Protocol template: Interventional study with investigational medicinal product (IMP) / medical device (MD)>> Clinical Study Protocol
The supply of unlicensed medicinal products (“specials”)
assets.publishing.service.gov.uk2 The supply of unlicensed medicinal products (“specials”) Contents Page 1 Introduction 3 2 Special needs 4 3 Persons authorised to procure “specials” in the UK 5 4 Manufacture and assembly in the UK 6 5 Importation into the UK 7
2005 12 14 Annex 19 Final - Trends
academy.gmp-compliance.org2 1. Scope 1.1 This Annex to the Guide to Good Manufacturing Practice for Medicinal Products (“the GMP Guide”) gives guidance on the taking and holding of reference samples of …