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Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010
Directive 2010/84/EU of the European Parliament and of the Council
Pharmacovigilance
Regulation 1235/2010 of the EU Parliament and the Council of 15 Dec 2010
Regulation 1235/2010 of the EU Parliament and the Council
The rules governing Medicinal Products in the European Union Volume 10 – Guidance Documents applying to Clinical Trials
The rules governing Medicinal Products in the European Union
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
PhVWP and CMD(h) Best Practice Guide for Work Sharing
Guidance Document for Marketing Authorisation Holders on submissions of PSURs under the EU PSUR work sharing scheme
Guidance Document for Marketing Authorisation Holders on submissions of PSURs