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.
The Delegated Regulation allows for aggregation but does not stipulate the need for pack aggregation. The EMVS / NMVS system does not support aggregation.
It is not recommended. It is necessary for the person registering to accept the terms and conditions of the EULA, which could not be justified without an agreement in place.
For those organisations who do not have an IT software provider, or who seek to find companies providing solutions, SecurMed has published the following list of providers.
Please find below links to public sites which provide useful information for the implementation of the Falsified Medicines Directive. MHRA have provided guidance for the implementation and compliance of the Safety Features Regulation: Implementing the Falsified Medicines Directive: Safety Features.
No. The Delegated Regulation asserts that all parties that are connected to the repositories system, including manufacturers, wholesalers and pharmacies, have sole responsibility, ownership and access to any data that they generate.
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