Repeat use mutual recognition procedure
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Public Assessment Report Repeat-Use Mutual Recognition ...
www.mhra.gov.ukPublic Assessment Report . Repeat-Use Mutual Recognition Procedure . VERSATIS 5% MEDICATED PLASTER . LIDOCAINE 5% MEDICATED PLASTER (Lidocaine) Procedure No: UK/H/1040-1041/001/E03
Public Assessment Report Repeat-Use Mutual Recognition ...
www.mhra.gov.ukPAR SolarazeTM 3% Gel UK/H/0226/001/E022 2 LAY SUMMARY This Repeat-Use Mutual Recognition Procedure (UK/H/0226/001/E02) granted a Marketing Authorisation to Almirall SA for the medicinal product Solaraze™ 3% Gel (PL 16973/0012) in
CMDv/BPG/003 Best Practice Guide For The Repeat Use ...
www.hma.eu1. Introduction 2. Aim and Scope 3. Description of Procedure 3.1. Before submitting the application 3.1.1. Case of withdrawal of the application during an earlier procedure
CMD(h) BEST PRACTICE GUIDES FOR THE SUBMISSION AND ...
www.hma.euCMD(h) BPGs for the submission and processing of Variations in the MRP June 2006 Page 3/28 CHAPTER 1 CMD(h) BEST PRACTICE GUIDE FOR THE ALLOCATION OF THE MUTUAL RECOGNITION VARIATION
Harmonised Technical Guidance for Non-eCTD electronic ...
esubmission.ema.europa.euThis Guidance Document is intended to assist pharmaceutical companies with the submission of regulatory information in electronic format to the National Competent Authorities in the EEA (hereafter referred to as NCAs).