Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (Text with EEA relevance)
- In force
- CELEX number: 32016R0161
- Official Journal: JOL_2016_032_R_0001
- Form: Regulation
- Procedure number: --
- Languages:
- bg
- cs
- da
- de
- el
- en
- et
- fi
- fr
- hr
- hu
- it
- lv
- lt
- mt
- nl
- pl
- pt
- ro
- sk
- sl
- es
- sv
Dates
Date of document: - October 2, 2015
- February 9, 2016
- February 29, 2016
- Entry into force - Date pub. +20 See Art 50
- February 9, 2019
- Application - See Art 50
- February 9, 2025
- Application - Partial application See Art 50
- January 1, 2021
- See Art 22.2
- December 31, 2021
- See Art 22.2
Modified by
Modified by:
- Règlement délégué (UE) 2022/315 de la Commission du 17 décembre 2021 modifiant le règlement délégué (UE) 2016/161 en ce qui concerne la dérogation à l’obligation incombant aux grossistes de désactiver l’identifiant unique des médicaments exportés vers le Royaume-Uni (Texte présentant de l’intérêt pour l’EEE) - detail
- Règlement délégué (UE) 2021/457 de la Commission du 13 janvier 2021 modifiant le règlement délégué (UE) 2016/161 en ce qui concerne une dérogation à l’obligation incombant aux grossistes de désactiver l’identifiant unique des produits exportés vers le Royaume-Uni (Texte présentant de l’intérêt pour l’EEE) - detail
- Règlement délégué (UE) 2021/1686 de la Commission du 7 juillet 2021 modifiant le règlement délégué (UE) 2016/161 en ce qui concerne l’évaluation des notifications faites à la Commission par les autorités compétentes nationales et l’inscription des cicatrisants dont le code ATC est D03AX et la forme pharmaceutique «larves de mouches» sur la liste des médicaments qui ne doivent pas être dotés des dispositifs de sécurité (Texte présentant de l’intérêt pour l’EEE) - detail
Modifies
Affected by case
- Judgment of the Court (Seventh Chamber) of 26 January 2023. Consejo General de Colegios Oficiales de Farmacéuticos de España (CGCOF) v Administración General del Estado. Request for a preliminary ruling from the Tribunal Supremo. Reference for a preliminary ruling – Medicinal products for human use – Delegated Regulation (EU) 2016/161 – Repositories system containing information on safety features – Creation of an interface integrated into the national repository and managed by the public authorities – Obligation to use a specific application for certain medicinal products. Case C-469/21.
- A31
- A32
- A35
- A36
- A25
- A44
- Judgment of the Court (Fifth Chamber) of 17 November 2022. Novartis Pharma GmbH v Abacus Medicine A/S. Request for a preliminary ruling from the Landgericht Hamburg. Reference for a preliminary ruling – Intellectual property – EU trade mark – Regulation (EU) 2017/1001 – Article 9(2) – Rights conferred by a mark – Article 15 – Exhaustion of the rights conferred by a trade mark – Parallel import of medicinal products – Repackaging of the product bearing the mark – New outer packaging – Opposition by the proprietor of the mark – Artificial partitioning of the markets between Member States – Medicinal products for human use – Directive 2001/83/EC – Article 47a – Safety features – Replacement – Equivalent features – Delegated Regulation (EU) 2016/161 – Article 3(2) – Anti-tampering device – Unique identifier. Case C-147/20.
- Case C-224/20: Request for a preliminary ruling from the Sø- og Handelsretten (Denmark) lodged on 29 May 2020 — Merck Sharp & Dohme B.V., Merck Sharp & Dohme Corp., MSD DANMARK ApS, MSD Sharp & Dohme GmbH, Novartis AG, FERRING LÆGEMIDLER A/S and H. Lundbeck A/S v Abacus Medicine A/S, Paranova Danmark A/S, 2CARE4 ApS
- article 30
- article 25
- article 10 point (b)
- article 16
- Case C-147/20: Request for a preliminary ruling from the Landgericht Hamburg (Germany) lodged on 23 March 2020 — Novartis Pharma GmbH v Abacus Medicine A/S
- article 24
- article 3 paragraph 2 point (a)
- article 30
- article 5 paragraph 3
- article 10
- Case C-469/21: Request for a preliminary ruling from the Tribunal Supremo (Spain) lodged on 29 July 2021 — Consejo General de Colegios Oficiales de Farmacéuticos de España v Administración General del Estado
- article 35
- article 31
- article 32
- article 44
- article 36
- article 25
- Case C-204/20: Request for a preliminary ruling from the Landgericht Hamburg (Germany) lodged on 13 May 2020 — Bayer Intellectual Property GmbH v kohlpharma GmbH
EuroVoc Vocabulary
- Internal market - Principles
- Labelling
- Technical barriers
- Exchange of information
- Technical specification
- Industrial counterfeiting
- Proprietary medicinal products
- Medicinal product
- Medicinal products
- Pharmaceutical legislation