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Tag Archives: EMA Marketing Authorisation amendment

UPDATED EMA GUIDANCE ON MAINTENANCE OF INFORMATION REQUIREMENTS

The European Medicines Agency (“EMA”) has updated its guidance documents to reflect new European Union (“EU”) requirements which require Marketing Authorisations Holders (“MAHs”) to update the information they submitted to the EMA on authorised medicinal products in the EU. Background Under the new EU pharmacovigilance rules, MAHs are, since July 2012, required to electronically submit