There’s a new EN 16679 that’s just been published. Titled “Packaging – Tamper verification features for medicinal product packaging,” it’s available from Document Center Inc. now. You’ll use this standard if you sell certain medicinal products in the Eurozone.
The standard itself provides you with the requirements for the packaging of medicinal products. It also provides guidance for the application, usage and checking of tamper verification features. You’ll see a wide variety of national editions for this publication as it gets adopted in each of the EU countries.
You’ll be glad to know that by using the EN 16679 you’ll meet the requirements of Directive 2001/83/EC as amended by Directive 2011/62/EU. This is especially important since the amended directive requires that on the outer packaging or the immediate packaging of certain medicinal products need “a device allowing verification of whether the outer packaging has been tampered with” or not.
FYI: You should also note that there will be no formal adoption of the EN 16679 as a harmonized standard.
You have a number of options when you purchase your copy from Document Center Inc. Of course, you can always purchase the BS EN 16679 English language edition in paper format. And the German adoption is expected to be released in March. But you may prefer to use the SS-EN-16679. The Swedish adoption is available in English and may be purchased in both paper format and for pdf download. You’ll also be able to include it in our Standards Online multi-user subscription service. And the price is significantly lower!
Just head to the Document Center webstore at www.document-center.com and place your order. Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Should you have any questions about what edition is best for you, our staff can help you make that decision. And if you need additional support services to improve your use of these compliance documents, we’re here for you on that as well!
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