The use of the term “provide for” in Article 37(d) of Commission Delegated Regulation (EU) 2016/161 means that an NMVO has to ensure that the National Competent Authorities (NCA), the EMA and the Commission are informed.
Industry stakeholders have worked together and there is a 2-stage process. Upon initial receipt of an alert, SecurMed UK will work with the ‘pack in hand’ organisation and the Marketing Authorisation Holder to identify if there has been a technical or procedural error. Once confirmed that this is not the case, a submission is made to MHRA via the Yellow Card website by the organisation who first raised the alert.
National Competent Authorities
GOV. UK guidance on:
FMD Safety Features
FMD Errors or Alerts
To register for the FMD Safety Features newsletter, or for any queries about the FMD, please contact the Medicines and Healthcare products Regulatory Agency (MHRA).
We recommend you contact your software supplier in the first instance, as they may have a record of your existing password, or provide the functionality to reset it. You can use the reset password function found in the UK MVS GUI.
Registration is a simple and easy process.
Please read our End User Registration Guidance first. To register, please read our guidance below and the End User Licence Agreement (EULA) carefully. For more detailed information, please see our End User Registration Process Overview.
If you have successfully logged onto the UK MVS but are having a problem logging onto your FMD software, please contact your Software Supplier.
Your reset email has been sent to the UK MVS contact email address you provided at End User Registration. Please check the Junk folder. If you provided the email address of your Software Supplier, please contact them to retrieve the reset email.