DIRECTIVE FOR IMPORTATION AND RELEASE OF …

draft 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)

  Product, Release, Medicinal, Investigational, Importation, Importation and release of, Importation and release of investigational medicinal products

The supply of unlicensed medicinal products (“specials”)

2 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

  Product, Medicinal, Medicinal products, Importation

National Drug Authority Guidelines - World Health …

Context of the Guideline NDA regulates issues related to safety, quality, efficacy, handling and use of pharmaceutical and other medical products in research.

  Product, Drug, National, Authority, National drug authority

Study Guide - Royal Society of Biology

QP Study Guide 2017 Page 3 of 15 Preface The three UK professional bodies, also known as the Joint Professional Bodies, administering the Qualified Persons scheme, the Royal Pharmaceutical Society, the Royal Society of Biology and the

  Guide, Study, Study guide

First in Human Studies - ABPI

Introduction First in Human (FIH) clinical trials are part of the exploratory phase of drug development and represent a significant milestone in the clinical development of new