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Commission Delegated Regulation (EU) 2021/1686 of 7 July 2021 amending Delegated Regulation (EU) 2016/161 as regards the evaluation of notifications by national competent authorities to the Commission and the inclusion of cicatrizants with ATC code D03AX and pharmaceutical form fly larvae in the list of medicinal products that shall not bear the safety features (Text with EEA relevance)

CELEX
32021R1686
Document type
REG_DEL
Sector
Legislation
Date of document
2021-07-07
In force since
2021-10-11
Status
In force

Text

Article-level text, parsed from the formex manifestation.

Article 47 Evaluation of the notifications

Where, following a notification as referred to in Article 46, the Commission or a Member State considers, on the basis of casualties or hospitalisations of persons in the Union due to exposure to falsified medicinal products, that rapid action is required to protect public health, the Commission shall assess the notification without delay and at the latest within 45 days.’;

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

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