Retained EU Law
2015
United Kingdom
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)
At a glance
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
Browse 50 other sections — procedural / definitional / commencement
Scope
Definitions
Composition of the unique identifier
Carrier of the unique identifier
Quality of the printing of the two-dimensional barcode
Human-readable format
Additional information in the two-dimensional barcode
Barcodes on the packaging
Verification of the safety features
Verification of the authenticity of the unique identifier
Unique identifiers which have been decommissioned
Reversing the status of a decommissioned unique identifier
Verification of the two-dimensional barcode
Record keeping
Verifications to be performed before removing or replacing the safety features
Equivalent unique identifier
Actions to be taken by manufacturers in case of tampering or suspected falsification
Provisions applicable to a manufacturer distributing his products by wholesale
Verification of the authenticity of the unique identifier by wholesalers
Derogations from Article 20(b)
Decommissioning of unique identifiers by wholesalers
Provisions to accommodate specific characteristics of Member States' supply chains
Actions to be taken by wholesalers in case of tampering or suspected falsification
Obligations of persons authorised or entitled to supply medicinal products to the public
Derogations from Article 25
Obligations when applying the derogations
Obligations when supplying only part of a pack
Obligations in case of inability to verify the authenticity and decommission the unique identifier
Actions to be taken by persons authorised or entitled to supply medicinal products to the public in case of suspected falsification
Establishment of the repositories system
Structure of the repositories system
Uploading of information in the repositories system
Functioning of the hub
Characteristics of the repositories system
Operations of the repositories system
Obligations of legal entities establishing and managing a repository which is part of the repositories system
Data protection and data ownership
Access by national competent authorities
Products recalled, withdrawn or stolen
Products to be supplied as free samples
Removal of unique identifiers from the repositories system
Information to be provided by national competent authorities
Supervision of the repositories system
Lists of derogations from bearing or not bearing the safety features
Notifications to the Commission
Evaluation of the notifications
Transitional measures
Application in Member States with existing systems for the verification of the authenticity of medicinal products and for the identification of individual packs
Entry into force
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