Europe – EudraVigilance registration documents for Production

Registration of the headquarter for MAHs

• A cover letter signed by the qualified person for pharmacovigilance or a responsible person within the pharmacovigilance department of the organisation. The cover letter should be printed on the organisation’s headed paper and should indicate that the undersigned is the ‘qualified person for pharmacovigilance’. The name and OMS ORG ID of the new organisation should also be provided once it has been successfully created by EMA

• EMAIL confirmation from the OMS Data Stewards acknowledging the successful creation of the organisation

• A copy of the ID card or driver’s license or passport of the qualified person for
pharmacovigilance at headquarter level

− We require that the full name and signature are visible. You may black out any other
information contained on the ID document

− This information will be used to verify the identity of the registering person and will be treated as confidential and will not be published or included in any user list…