Requirements regarding safety features for packages for medicinal products

Wednesday, September 28, 2016

A new framework regarding requirements for a unique identifier for human medicinal products packages will come into force in Sweden February 9th 2019. Packages concerned by the requirements shall bear a unique identifier and an anti-tampering device allowing the verification of whether the packaging has been tampered with.

A unique identifier shall be introduced on packages for human medicinal products according to the Commission Delegated Regulation (EU) 2016/161. The unique identifier shall consist of a 2D-code together with the information also in a human-readable format.

The Regulation also states that the concerned packages shall bear an anti-tampering device allowing the verification of whether the packaging of a medicinal product has been tampered with.

Marketing authorization holders for the concerned Swedish medicinal products shall follow the guidelines published by CMDh and EMA with the purpose to update the labelling and the QRD-template.

All prescription only products, except the ones stated in Annex I of the Regulation, are affected by the new requirements.

Some products not subject to prescription are also affected by the new requirements. They are listed in Annex II.

The implementation may be done in connection with other variations affecting the product information. More information can be found in the guidelines published by CMDh and EMA.

For applications for new products the QRD-template shall be updated with the relevant information when the application is submitted.

The framework will apply in Sweden from February 9th 2019.

 

Please note the news item’s date of publishing. The Medical Products Agency does not update news.

 

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Contact us

Ylva Satrell
Senior Expert, Department of Product Information
+ 46 18-17 46 00 (phone)

Ulrika Björnsson
Assessor, Department of Product Information
+ 46 18-17 46 00 (phone)

   
 

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