My bookmarksSign up free

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

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

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

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’

Other acts of the same type
Regulation (EU) 2020/1543 of the European Parliament and of the Council of 21 October 2020 amending Regulation (EU) No 514/2014 as regards the decommitment procedureCommission Delegated Regulation (EU) 2020/2175 of 20 October 2020 amending Delegated Regulation (EU) 2020/256 establishing a multiannual rolling planningCommission Implementing Regulation (EU) 2020/1524 of 19 October 2020 imposing a definitive anti-dumping duty and definitively collecting the provisional duty imposed on imports of certain heavyweight thermal paper originating in the Republic of KoreaCommission Delegated Regulation (EU) 2021/525 of 19 October 2020 amending Annexes II and III to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (Text with EEA relevance)Council Implementing Regulation (EU) 2020/1505 of 16 October 2020 implementing Regulation (EU) No 36/2012 concerning restrictive measures in view of the situation in SyriaCouncil Implementing Regulation (EU) 2020/1507 of 16 October 2020 implementing Article 9 of Regulation (EC) No 1183/2005 imposing certain specific restrictive measures directed against persons acting in violation of the arms embargo with regard to the Democratic Republic of the CongoCommission Implementing Regulation (EU) 2020/1510 of 16 October 2020 concerning the authorisation of cinnamyl alcohol, 3-phenylpropan-1-ol, 2-phenylpropanal, 3-(p-cumenyl)-2-methylpropionalde-hyde, alpha-methylcinnamaldehyde, 3-phenylpropanal, cinnamic acid, cinnamyl acetate, cinnamyl butyrate, 3-phenylpropyl isobutyrate, cinnamyl isovalerate, cinnamyl isobutyrate, ethyl cinnamate, methyl cinnamate and isopentyl cinnamate as feed additives for all animal species except for marine animals (Text with EEA relevance)Commission Implementing Regulation (EU) 2020/1511 of 16 October 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances amidosulfuron, bifenox, chlorotoluron, clofentezine, clomazone, cypermethrin, daminozide, deltamethrin, dicamba, difenoconazole, diflufenican, fenoxaprop-P, fenpropidin, fludioxonil, flufenacet, fosthiazate, indoxacarb, lenacil, MCPA, MCPB, nicosulfuron, paraffin oils, picloram, prosulfocarb, sulphur, triflusulfuron and tritosulfuron (Text with EEA relevance)Commission Implementing Regulation (EU) 2020/1538 of 16 October 2020 entering a name in the register of protected designations of origin and protected geographical indications (‘Pampepato di Terni’/‘Panpepato di Terni’ (PGI))Commission Implementing Regulation (EU) 2020/1539 of 16 October 2020 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications ‘Sainte-Maure de Touraine’ (PDO)Commission Delegated Regulation (EU) 2020/2173 of 16 October 2020 amending Annexes I, II and III to Regulation (EU) 2019/631 of the European Parliament and of the Council to update the monitoring parameters and clarify certain aspects relating to the change in the regulatory test procedure (Text with EEA relevance)Commission Implementing Regulation (EU) 2020/1497 of 15 October 2020 concerning the authorisation of L-methionine produced by Corynebacterium glutamicum KCCM 80184 and Escherichia coli KCCM 80096 as a feed additive for all animal species (Text with EEA relevance)

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

Contents

What to look at next

Browse all EU Legal ActsEvery instrument by type and year, full text free to read section by sectionEuropean Union legislationEU Legal Acts by type and yearGrouped by instrument type and year of enactment, so you can find others of the same kindBrowse by type and yearEuropean Union: what this database coversWhich datasets are here, which official source they come from, and how current they areEuropean Union overview