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TS EN 16679

Packaging - Tamper verification features for medicinal product packaging

This European Standard specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.

Standard by TSE, 18.02.2015

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  • Language: English
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About This Item

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TS EN 16679 is a packaging standard focused on features used to verify whether medicinal product packaging has been tampered with. It also gives guidance for the application, use and check of those features, so the emphasis is on the package as a protective and inspectable system rather than on the medicine itself.

What tamper verification features are meant to do

In general technical terms, tamper verification features are visible or structural elements that help users detect whether a pack has been opened or interfered with after sealing. Typical concepts in this area include breakable closures, tear strips, seals, foil structures or other security-oriented packaging elements. Their purpose is to provide an evident check on package integrity; they do not, by themselves, solve counterfeiting or all supply-chain risks.

How the standard frames application and checking

The standard’s scope is centred on how tamper verification features are applied to medicinal product packaging, how they are used, and how they are checked. In practice, this matters because medicinal packaging must combine product protection, clear user communication and reliable integrity control. Tamper-evident design is therefore part of the overall packaging function, supporting both handling confidence and the visual confirmation of intact closure.

TS EN 16679 is not a product monograph or a medicine-performance standard; it addresses the verification features on the pack. For packaging and quality professionals, it serves as a technical reference for understanding how tamper verification elements are organised and assessed in the context of medicinal products.

SKU: 78596a4f6b48

  • Publication Date: 18.02.2015
  • Standard Status: H (İptal Edilmiş Standard/Withdrawn standard)
  • Publisher: TSE
  • Document Language: en
  • ICS Classification: 03.120.10 Kalite Yönetimi ve Kalite Güvencesi; 11.120.10 İlaçlar; 55.020 Ambalajlama ve Malların Dağıtımı (Genel)
  • Pages: 20
  • Source Standard: EN 16679:2014
  • International Equivalents:

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