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of important news :

Loading of data in the NMVS before releasing medicinal packs to the market

Dear MAH,

We would like to draw your attention to a critical issue related to the serialisation of medicines and the uploading of batch and serial number data into the French NMVS.

As the stabilisation period nears its end, it is crucial to adhere to best practices in serialisation. Once this period concludes, any pack that generates an alert will need to be quarantined for investigation and cannot be dispensed to patients.

Risks of Late Data Uploads to the NMVS

When batches are released to the market without their data being uploaded into the NMVS, systematic alerts may be triggered during dispensing by end users. These alerts directly affect:

• The ability of end users to provide your products to patients.

• Your sales, as non-compliant packs may be quarantined and rendered unsellable.

Recommendations to Ensure Batch Compliance

To prevent these situations, we recommend:

Ensuring full batch data uploads into the NMVS before market release:

• Data uploads must occur at the time of QP release validation (batch release).

• No batch should be distributed until this step has been successfully confirmed.

Implementing strict internal controls to verify successful data uploads into the NMVS before any market release.

Using a single pack to verify a batch upload to avoid generating alerts for every pack in the batch if the data has not been uploaded.

Adhering to these best practices will ensure the availability of your products on the market and help prevent delays or losses caused by avoidable alerts. You will also contribute to maintaining the smooth flow of the supply chain and strengthening the trust of pharmacies and patients in your products.

We remain at your disposal for any questions or clarifications and thank you in advance for your attention to this matter.

See you soon!

The France MVO Team
France Medicines Verification Organisation
www.france-mvo.fr

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