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Guidelines for EMVO and NMVO stakeholders: recommendations for alert handling and prevention process

February 21, 2019

The following guidelines reflect the best effort and thinking of stakeholder experts with the information available to them, on 29 January 2019.

The document has been developed by experts representing the main stakeholder associations member of EMVO (research-based manufacturers, generic manufacturers, parallel distributors, full-line wholesalers, community pharmacists and hospital pharmacists) as well as technical experts from EMVO and NMVOs. The draft recommendations are still being discussed and refined by the stakeholders and technical experts.

As the medicines verification system is not, today, systematically used by all supply chain actors, the recommendations below have been developed with a theoretical and normative view of how alerts should be prevented and managed. However, at this point in time, stakeholders recognize that real-world situations might require a pragmatic approach in managing alerts to avoid disruptions in forwards logistics.

Above and beyond their best efforts to comply with the requirements, all supply chain stakeholders maintain the goal to ensure access to safe medicines for patients in Europe. They are expressing, once again, their willingness to work closely together with national authorities to receive guidance and insights, on a case by case basis, on how to overcome the initial ‘growing pains’ of using the new system. It is their utmost desire to ensure availability of medicines to patients while working together to prevent the entry of falsified medicines in the supply chain.

Read the guidelines in full in the PDF document attached below.

Letter to stakeholders

A key measure to address falsification in the EU and protect the legal supply chain of medicines is an end-to-end verification system introduced by the Falsified Medicines Directive (FMD).

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Amount of the annual fee

HOPAL determined the amount of the annual fee for the Croatian Medicines Verification System usage by MAHs
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The Croatian Medicines Verification Organisation (HOPAL) is a non-profit organisation representing the different stakeholders, both...
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