Regulation 1235/2010 of the EU Parliament and the Council of 15 Dec 2010
Regulation 1235/2010 of the EU Parliament and the Council
TOPICS
Pharmacovigilance
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
“Pharmacovigilance and Public Health: The Stakeholders and their contribution to the safe use of medicines”
Regulation N 658/2014 of the European Parliament
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