19 mar 2014 Con la base del. Acuerdo del CMDh la Comisión Europea emitirá una “Decisión de. Ejecución”. Medicamentos y. Productos Sanitarios. Page 3. b) ...
De acuerdo con las conclusiones científicas para vancomicina el CMDh considera que el balance beneficio-riesgo del medicamento o medicamentos que
The CMDh reaches the position that the marketing authorisation(s) of products in the scope of this single PSUR assessment should be varied. To the extent that
The CMDh agrees with the scientific conclusions made by the PRAC. Grounds for the variation to the terms of the Marketing Authorisation(s). On the basis of the
De acuerdo con las conclusiones científicas para la hidroclorotiazida/espironolactona el CMDh considera que el balance beneficio-riesgo del medicamento o
The CMDh reaches the position that the marketing authorisation(s) of products in the scope of this single PSUR assessment should be varied. To the extent that
The CMDh agrees with the scientific conclusions made by the PRAC. Grounds for the variation to the terms of the Marketing Authorisation(s).
28 nov 2021 CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) containing valproic acid sodium valproate
The CMDh agrees with the scientific conclusions made by the PRAC. Grounds for the variation to the terms of the Marketing Authorisation(s).
The CMDh agrees with the scientific conclusions made by the PRAC. Grounds for the variation to the terms of the Marketing Authorisation(s).
The CMDh started its activities in November 2005 replacing the informal Mutual Recognition Facilitation Group ( MRFG ) which was in operation over 10
CMDh Guidance Document for Submission of Summary of the Pharmacovigilance System CMDh SOP on decision-making process for new active substance status or
2005 – CMDh established under revised Pharmaceutical Legislation (Directive 2001/83/EC) ? 2012 – Responsibilities of CMDh extended
Le CMDh approuve les conclusions scientifiques formulées par le PRAC Motifs de la modification des termes de la/des autorisation(s) de mise sur le marché Sur
Informations du C M D H Sur la situation des droits de l'Homme au Maroc Au titre de Année 2006 - 2007 L'an 2006 et les quatre premiers mois de 2007 se
The provisions detailed in this CMDh paper to provide additional information about the medicinal product through a QR code are also applicable in case the
1 nov 2020 · CMDh/004/2005 Rev 18 CMDh Best Practice Guide on the processing of renewals in the Mutual Recognition and Decentralised Procedures
PDF Portable Document Format PhV WSP Working Party Pharmacovigilance Work Sharing Procedures Working Party PI Product Information
CMDh/399/2019 Public consultation 2 3 Recommendations on common regulatory approaches 4 for allergen products 5 Draft 6 Table of Contents
CMDh Best Practice Guide on the processing of renewals in the Mutual Recognition and Decentralised Procedures Table of contents 1 Introduction