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Safety features for medicinal products for human use – Questions and Answers – Versions 11 & 12

EU

Versions 11 & 12 of the Q&A on Safety features for medicinal products for human use have been published in October and November of 2018. Following these updates, multiple questions have been revised (1.20; 1.23; 2.21; 7.15; 8.4; 8.7) and some new questions have been added (5.8; 6.8; 8.8).

Compared to the previous version, the placing of safety features by means of stickers has been defined more in detail. Stickers must be placed under GMP conditions and the outer packaging on which the identifier is placed as a sticker must meet all applicable labelling requirements. Moreover, the use of stickers is not acceptable when the readability of compulsory regulatory information is limited.

More information can be found here.

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