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CMDh: Phvwp and Cmd(H) Best Practice Guide for Work Sharing Concerning The Assessment Of Psurs of Products for Which an EU Harmonised Virtual Birth Date and Related Harmonised Data Lock Point Have Been Agreed

18.12.2009
This document sets outs the responsibilities of the P-RMS and P-CMS with respect to work sharing in the assessment of PSURs. The responsibilities of the MAHs are set out in a separate guidance ...

EMEA: Substances considered as not falling within the scope of Regulation (EC) No 470/20091, with regard to residues of veterinary medicinal products in foodstuffs of animal origin

18.12.2009
Regulation (EC) 470/2009 of 6 May 2009 lays down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin. The Regulation ...

EMEA: Explanatory note on fees payable to the European Medicines Agency

18.12.2009
Following the publication of the Rules for the implementation of Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures1 as last adopted by the Agency’s ...

EMEA: Mandate, Objectives And Rules of Procedure for the Pharmacovigilance Inspectors Working Group

18.12.2009
The PhV IWG will address all matters related directly or indirectly to PhV inspections and carry out the tasks described under section II. The key to its role is the development and implementation ...

Transitional provisions for implementation of Variation Regulation (EC) No 1234/2008

18.12.2009
Further to discussions between the EMEA, European Commission and the CMD(h), the following practical guidance on the transitional provision and entry into force of the Variation Regulation, as ...

Proposal for a Revision of the European Commission Guideline on Summary of Product Characteristics

18.12.2009
Overview of comments received on draft revision 2 of the smpc guideline ...

EMEA: Guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension

09.12.2009
This guideline is intended to provide guidance for the evaluation of new medicinal products or drugs used in combination in the treatment of pulmonary arterial hypertension PAH. ...