Counterfeiting of pharmaceutical products
Issued by TracePack - Jul 26th 2018, 16:11
The counterfeiting of pharmaceutical products is an enormous risk for consumers’ health and a major economic loss for the pharmaceutical industry.
The safety of pharmaceutical products is a necessity for the final consumer and it requires an utmost control of the flow of products, from the manufacturing to the distribution.
In this context, many countries have decided to adopt new regulations with the aim to introduce safety elements for the packaging of medicinal products for human use. This is a significant change that will ensure the authenticity of medicines and safety for patients (and also for the pharmaceutical industry) and will strengthen the security of the supply chain.
The Falsified Medicines Directive (Directive 2011/62/EU) establishes solutions to combat counterfeit medicines. It is a key priority in the Medical and Pharmaceutical Sector as all pharmaceutical laboratories with prescription medicines must comply with the EU-FMD before the deadline of 9th February 2019. This new directive introduces measures to reinforce the security of the supply chain of prescription medicines, with the obligation to include a serial number on the outer packaging of each product, in the form of a unique, individual and readable number, using a 2Ddata Matrix barcode, added to anti-tampering devices which will allow the verification of medicines before being dispensed to patients.
This directive concerns manufacturers of pharmaceuticals, importers, third-party packers and wholesale distributors of medicines within the EU, as well as manufacturers of active ingredients (API’s) which are supplied to EU companies.
The regulations affect all levels of packaging:
Although encoding blisters is not obligatory by law, it is still advisable to identify them individually. This option is especially useful for hospital medicine control, in which single doses are administered to patients. The blisters are identified with the batch number and the expiry date. The ideal equipment for encoding blisters is laser coders and large character high-resolution inkjet technology. The marking is done on the aluminium film before it is applied on the blister and both technologies allow the marking process to take place at the high production rates required by the manufacturing lines.
Each individual case must be marked with codes that ensure a globally unique product classification made of a serial number optionally combined with a “tamper-evident” label that ensures that the case has not been handled in any way. This serialisation ensures transparency of the origin of the product to the retail point of sale.
This first level of aggregation contains pre-serialised cases. The coding of this level allows the consolidation of the serial numbers of the cases it contains into a new independent serial number for the whole set.
This last aggregation level contains several levels of pre-serialised packaging. Labelling pallets allow the serial numbers of the products comprising the pallet to be consolidated into a single SSCC pallet registration.
Tracepack can offer many solutions to help with making sure that everyone within the supply chain of the pharmaceutical industry is compliant with the new regulations by offering label applicators, TIJ pharma inks, special coatings used on primary and secondary packaging, pharma-grade particles.
The Pharma tamper-evident labelling system has been specifically developed for high-speed tamper evident label application on pharmaceutical packets in order to guarantee the secure conditions imposed by the Directive 2011/62/EU. The Pharma track labelling system provides a solution for serialisation and tamper-evident seal which allows ink-jet to laser marking on the top of the product labelling as well as on crucial sealing points.
Our PharmaTIJ inks are available as a solvent based ink which offers superior print performance on Bopp film, PET film, aluminium foil & varnished stock with a fast-drying time and adhesion as well as an aqueous-based ink which is suitable for security coding of porous substrates such as cardboard and paper, which when exposed to blacklight the ink changes colour as a result this ink is ideal for customers seeking a low cost-effective option.
Special coatings which are applied onto primary and secondary packaging and direct food contact applications such as pharmaceutical tablets when used in conjunction with laser coding systems.
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