WebbThe Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for regulating the effectiveness and safety of medicines and medical … WebbMHRA PUBLIC ASSESSMENT REPORT Statins: updates to product safety information November 2009 Executive summary 2 1. Introduction 4 2. Summary of data 8 2.1 Sleep disturbances 8 2.2 Memory loss 12 2.3 Micturition disorders 15 2.4 Sexual disturbance 17 2.5 Depression 20 2.6 Interstitial pneumopathy 23
Electronic product information: From principles to actions
WebbMHRA produced FAQs for Pharmacovigilance You will need to register or login above with your username to post on this forum. If you require further help please view our quick start guide WebbA medicine’s product information is regulated, scientifically validated information that assists healthcare professionals in prescribing and dispensing and informs patients and consumers about their medicine and its safe use.. The development of electronic product information (ePI) is intended to improve access to up-to-date product information on … the west wing cardiff accommodation
Medicines and Healthcare products Regulatory Agency
WebbThe Information for healthcare professionals document is a description of a medicinal product’s properties and the conditions attached to its use. It explains how to use and … WebbAESGP, EFPIA and Medicines for Europe are pleased to share their reflections on EMA-HMA-EC Key principles for electronic Product Information (ePI). This paper aims to highlight key asks and identify key actions in order to move the ePI project from principles to action. It also stresses the fact that all stakeholders would benefit from an ePI … Webb9 feb. 2024 · products authorised through MRP/DCP may not be submitted via a national application. 2 If this is the first submission of label mock-ups, documentation as described in section 4.1 relating to the product information for marketed products is required. This information should be submitted by way of a national Article 61(3) notification. the west wing boutique hotel tampa fl