Driving Change In Pharmaceutical Packaging-Newman Labelling

With the Falsified Medicines Directive coming into force in 2019, now is the time to re-evaluate the efficiency of your production lines to ensure they will cope with the extra demands the Directive will place on them.

In July 2011, the EU adopted the Falsified Medicines Directive in a concerted effort to protect patients and consumers from falsified medicines which may contain ingredients of low quality or in the wrong doses; be deliberately and fraudulently mislabelled with respect to their identity or source; have fake packaging, the wrong
ingredients, or low levels of the active ingredients. As you might expect, falsified medicines do not pass through the usual evaluation of quality, safety and efficacy, which is required for the EU authorization procedure. Because of this, they can be a very real health threat.  The Falsified Medicines Directive doesn’t comes into force until February 2019 but EU member states are under an obligation to start implementing the measures laid out in the Directive.



For pharmaceutical manufacturers, contract packers and distributors – indeed all those involved in the supply chain –
the new Directive is momentous. Whilst there have already been requirements for certain information to be included on the packaging, the Directive will require organisations to be able to proficiently handle vast amounts of extra data. That data doesn’t just need to be stored and archived, but will need to be applied to medicine packaging and read at high speeds. With the new Directive, every individual pack of medicine must be marked with a unique, non predictive serial number with information that can be read by people and machines; previously only data pertaining
to the batch was required, but the onus has now changed to each and every individual container. The unique identifier must be placed in a 2D barcode and contain the product code, a serial number, the national reimbursement number (if requested by Member States), the batch number and the expiry date. Each serial number must be registered with a pan European database.

Read more here: http://www.newman.co.uk/download_pdf/Driving-Change-In-Pharmaceutical-Packaging.pdf

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