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False directive: what will change in the fight against counterfeit medicines?

On 9 February 2019, the so-called False Directive will come into force.  It aims to tighten the distribution chain of pharmaceutical products by serialising their packaging. This will protect patients from counterfeit medicines. The directive will cover all prescription products and omeprazole-based OTC drugs. What awaits pharmaceutical market participants?

The new rules are changes not only for pharmaceutical manufacturers, but also for all other market players. They will cover parallel distributors and importers, but also pharmacies, hospitals and healthcare institutions, right up to the patient. In the light of the new rules, manufacturers, wholesalers and persons authorised or entitled to supply patients with medicinal products will verify the authenticity of the unique identifier. They will also check the integrity of the non-infringement element of the packaging.

It is worth noting that pharmacies face several technical challenges in connection with the counterfeiting directive. These include the implementation of mobile systems and solutions integral with the FMD database, the purchase of 2D/QR scanners, obtaining and installing a certificate, training of employees, changing procedures and hiring additional staff. It is worth noting that until the end of 2018, the purchase of scanners by pharmacies is reimbursed.

These issues were discussed during the 8th Parallel Import Forum, during which changes concerning the security of the drug distribution chain were discussed. It was held on 6 December in Warsaw.

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