Chapter 35 Pharmacovigilance
Found 4 free book(s)
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euGuideline on good pharmacovigilance practices (GVP) – Chapter P.III EMA/653036/2019 DRAFT FOR PUBLIC CONSULTATION Page 3/27 43 P.III.A. Introduction 44 The need for guidance on pharmacovigilance specifically for the use of medicinal products in pregnancy 45 is widely recognised.
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euGuideline on good pharmacovigilance practices (GVP) – Module VI EMA/873138/2011 Page 5/84 124 VI.A. Introduction 125 VI.A.1. Scope 126 This Module addresses the legal requirements detailed in Title IX of Directive 2001/83/EC and Chapter 127 3 of Regulation (EC) No 726/2004, which are applicable to competent authorities in Member States,
The Human Medicines Regulations 2012 - Legislation.gov.uk
www.legislation.gov.ukGrant or refusal of licence 35 24. Standard provisions of licences 35 25. Duration of licence 35 ... Authorisations granted under Chapter 4 of Title III of the 2001 Directive 59 71. Withdrawal of medicinal product from the market 59 ... 86. EU marketing authorisations: breach of pharmacovigilance condition etc 64 Offences relating to advanced ...
A Guide to Managing Medicines Supply and Shortages
www.england.nhs.ukChapter 1: National Processes − DHSC Medicines Supply Team − NHSE&I Commercial Medicines Unit − NHSE&I Patient Safety Team − NHSE&I Community Pharmacy Commissioning Team − Medicines and Healthcare products Regulatory Agency (MHRA) − Medicines Shortage Response Group Chapter 2: Secondary Care Processes