Does Article 37(d) require that a National Medicine Verification Organisation (NMVO) directly alerts the relevant national competent authorities, the EMA and the Commission about a falsification? Is there is a time limit for such alerting?
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.