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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)

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)

Delegated Regulation (EU) 2021/1686 · Regulation · 3 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Evaluation of the notifications

Article 1

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Delegated Regulation (EU) 2016/161 is amended as follows: (1) Article 47 is replaced by the following: ‘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.’; (2) Annex I is amended as set out in the Annex to this Regulation.

Article 2

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

Supplementary provisions

ANNEXSupplementary provisions

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ANNEX In Annex I to Delegated Regulation (EU) 2016/161, the following entry is added: Name of active substance or product category Pharmaceutical form Strength Remarks ‘Cicatrizants with ATC code D03AX Fly larvae’

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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