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. 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 …

MHRA PUBLIC ASSESSMENT REPORT - GOV.UK

Webb14 feb. 2024 · MHRA medicines portal. For enquiries about registering and submitting product licence applications using MHRA portal. Telephone: 020 3080 7100. … Webbwhom the medicine is indicated followed - when necessary – by specific information for any relevant special population (e.g. children or elderly). - Public Assessment Reports provide detailed information on medicinal products and are available on the website of the European Medicines Agency, of Heads of medicines Agencies or other National on serious mass vs whey protein

New guidance and information for industry from the MHRA

WebbThe European Medicines Agency's (EMA) Working Group on Quality Review of Documents (QRD) develops, reviews and updates templates for product information for use by … 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 … Webb25 okt. 2011 · 1. Where can I find further information on this subject? The following FAQs are presented below: 2. What is an investigational medicinal product (IMP)? 3. Who is … ioannis michos