News about GMP/cGMP

27.09.2021

EU: Amendment to Delegated Regulation (EU) 2016/161 on safety features

EU: Amendment to Delegated Regulation (EU) 2016/161 on safety features

On 21 September 2021, an amendment to Delegated Regulation (EU) 2016/161 was published in the Official Journal of the European Union. Article 47 "Evaluation of notifications" was adapted and in Annex I, containing the list of medicinal products exempted from the obligation to bear the safety features, a new entry has been added.


Basically, the purpose of Article 47 is to force rapid action to protect public health in the event of exposure to falsified medicinal products. Therefore, corresponding reports (according to Article 46) are to be evaluated by the Commission without delay and within 45 days at the latest.

In Annex I, which lists product categories or APIs that in principle may not bear safety features, "Cicatrizants with ATC code D03AX - dosage form fly larvae" has been newly included. Since their shelf life is limited, the risk of counterfeiting is negligible, according to the justification for the inclusion.

The amendments will enter into force on the twentieth day after publication.


Source:

EU: EUR-Lex


 

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