DS/EN 16679:2015

Emballage - Forsegling af lægemiddelemballage til verifikation af, at emballagen er ubrudt


Status:
Gældende
Type:
Standard
Sprog:
EN
Kategori:
Under revision:
Pris fra:
kr. 423,00

Beskrivelse

This European Standard specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.
NOTE – The packaging of medicinal products placed on the market and incorporating tamper verification features in accordance with this European Standard meets the requirements of Directive 2001/83/EC as amended by Directive 2011/62/EU. Article 54(o) of the Directive stipulates, that on the outer packaging of certain medicinal products or, where there is no outer packaging, on the immediate packaging shall appear, among others, "a device allowing verification of whether the outer packaging has been tampered with".
The principles in this European Standard can be applied in other countries and sectors, as appropriate.

Under revision


Antal sider: 20

Udgivet: 2015-01-22

Godkendelsesdato: 2015-01-16

Internationale relationer: EN 16679:2014 IDT

ICS: 03.120.10 - Kvalitetsstyring 11.120.10 - Medikamenter 55.020 - Emballage og varedistribution. Generelt

Varenummer: M274909


Udvalg og komiteer

Komite

  • CEN/TC 261
  • CEN/TC 261/SC 5/WG 12

Dansk udvalg

DS/S-269