# 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) (revoked) EU Regulation 2016/161 ยท adopted 2 October 2015 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) ## Introductory text 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) (revoked) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Chapter I: SUBJECT MATTER AND DEFINITIONS ## 1 Subject matter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Chapter II: TECHNICAL SPECIFICATIONS OF THE UNIQUE IDENTIFIER ## 4 Composition of the unique identifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Carrier of the unique identifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Quality of the printing of the two-dimensional barcode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Human-readable format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Additional information in the two-dimensional barcode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Barcodes on the packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Chapter III: GENERAL PROVISIONS ON THE VERIFICATION OF THE SAFETY FEATURES ## 10 Verification of the safety features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 Verification of the authenticity of the unique identifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 12 Unique identifiers which have been decommissioned . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 13 Reversing the status of a decommissioned unique identifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Chapter IV: MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY MANUFACTURERS ## 14 Verification of the two-dimensional barcode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 15 Record keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 16 Verifications to be performed before removing or replacing the safety features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 17 Equivalent unique identifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 18 Actions to be taken by manufacturers in case of tampering or suspected falsification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 19 Provisions applicable to a manufacturer distributing his products by wholesale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Chapter V: MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY WHOLESALERS ## 20 Verification of the authenticity of the unique identifier by wholesalers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 21 Derogations from Article 20(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 22 Decommissioning of unique identifiers by wholesalers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 23 Provisions to accommodate specific characteristics of Member States' supply chains . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 24 Actions to be taken by wholesalers in case of tampering or suspected falsification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Chapter VI: MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY PERSONS AUTHORISED OR ENTITLED TO SUPPLY MEDICINAL PRODUCTS TO THE PUBLIC ## 25 Obligations of persons authorised or entitled to supply medicinal products to the public . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 26 Derogations from Article 25 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 27 Obligations when applying the derogations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 28 Obligations when supplying only part of a pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 29 Obligations in case of inability to verify the authenticity and decommission the unique identifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 30 Actions to be taken by persons authorised or entitled to supply medicinal products to the public in case of suspected falsification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Chapter VII: ESTABLISHMENT, MANAGEMENT AND ACCESSIBILITY OF THE REPOSITORIES SYSTEM ## 31 Establishment of the repositories system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 32 Structure of the repositories system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 33 Uploading of information in the repositories system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 34 Functioning of the hub . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 35 Characteristics of the repositories system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 36 Operations of the repositories system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 37 Obligations of legal entities establishing and managing a repository which is part of the repositories system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 38 Data protection and data ownership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 39 Access by national competent authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Chapter VIII: OBLIGATIONS OF MARKETING AUTHORISATION HOLDERS, PARALLEL IMPORTERS AND PARALLEL DISTRIBUTORS ## 40 Products recalled, withdrawn or stolen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 41 Products to be supplied as free samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 42 Removal of unique identifiers from the repositories system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Chapter IX: OBLIGATIONS OF THE NATIONAL COMPETENT AUTHORITIES ## 43 Information to be provided by national competent authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 44 Supervision of the repositories system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Chapter X: LISTS OF DEROGATIONS AND NOTIFICATIONS TO THE COMMISSION ## 45 Lists of derogations from bearing or not bearing the safety features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 46 Notifications to the Commission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 47 Evaluation of the notifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Chapter XI: TRANSITIONAL MEASURES AND ENTRY INTO FORCE ## 48 Transitional measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 49 Application in Member States with existing systems for the verification of the authenticity of medicinal products and for the identification of individual packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 50 Entry into force . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Annex I List of medicinal products or product categories subject to prescription that shall not bear the safety features, referred to in Article 45(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Annex II List of medicinal products or product categories not subject to prescription that shall bear the safety features, referred to in Article 45(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Annex III . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Annex IV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . --- Source: https://www.legislation.gov.uk/eur/2016/161 (the official version) Page: https://openlegislation.uk/eu-regulation-2016-161 Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.