The packaging of a product serves many different purposes: Inform the customer about the content, protect the product during transport, storage and handling processes, convince customers to buy it and also keep the product safe from tampering.
Nigeria 1990: A cough syrup is "stretched" with a toxic solvent. Over 100 children die.
Haiti 1996: At least 59 people die after taking a fake fever syrup.
United States 2008: The active ingredient of the blood thinner heparin is replaced with a cheaper substance that caused patients to have adverse reactions.
Pakistan 2011: Over 200 people die after taking contaminated heart medication.
...but how are those examples related to your packaging? How does this affect your business? And what can you do to avoid a growing number of counterfeit products?
According to a research from the American Society for Microbiology in 2015 around 10% of all drugs in circulation are counterfeit. This number is even higher looking at developing countries in which 30-40% of all products are affected. The customers are paying the price for that by (usually unknowingly) consuming those products and putting health and safety at risk, as shown by the examples above.
Therefore as of February 9th, 2019 it is mandatory that the packaging of pharmaceutical products is tamper evident. The Medicinal Product Directive 2001/83/EC as amended by the Falsified Medicines Directive 2011/62/EU (FMD) mandates the verification of the authenticity of medicinal products with introduction of Serialization and Tamper Evident Packaging and defines requirements on how to reach compliance. Article 54(o) of Directive2001/83/EC and Article 3(2)(2) of Regulation (EU) No 2016/161 give some more details on the mandatory specifications as “...an anti-tampering device has to allow the verification of whether the packaging of the medicinal product has been tampered with.”
According to the regulations of the Food and Drug Administration (21 CFR § 211.132), Tamper Evident Packaging (TEP) "is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred." This means a visible and irreversible damage on the product packaging showing the customer whether the packaging has been opened/altered/tampered since it left the manufacturer.
The examples below show different ways to meet the requirements and reach compliance with the EU FMD.
Here compliance does not necessarily mean an increase of cost and a difficult implementation phase but definitely a higher safety for people using the product and therefore satisfied and happy customers trusting it.
What kind of packaging are you using? In case you cannot answer this question with “tamper evident packaging” and/or want to learn more about this topic and what would be the best solution for your products, contact us and we will be happy to support you.
It is Child’s Safety Week from June 7 – June 13 2021 and we would like to raise awareness for this very important topic as well. This year’s slogan of the event “Share because you care” is why we would like to share our knowledge with you.
In our last article, we discussed the confusing situation regarding remote audits and the strategies that manufacturers can follow in order to qualify for this type of inspection under the MDR. In this article we focus on analysing Notified Bodies’ experience while conducting remote audits under the MDD and giving you practical advice for successfully going through it and try to devise the future of remote audits.