Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Dir... (32016R0161)
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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)
- 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)
- CHAPTER I
- Article 1
- Subject matter
- Article 2
- Scope
- Article 3
- Definitions
- CHAPTER II
- Article 4
- Composition of the unique identifier
- Article 5
- Carrier of the unique identifier
- Article 6
- Quality of the printing of the two-dimensional barcode
- Article 7
- Human-readable format
- Article 8
- Additional information in the two-dimensional barcode
- Article 9
- Barcodes on the packaging
- CHAPTER III
- Article 10
- Verification of the safety features
- Article 11
- Verification of the authenticity of the unique identifier
- Article 12
- Unique identifiers which have been decommissioned
- Article 13
- Reversing the status of a decommissioned unique identifier
- CHAPTER IV
- Article 14
- Verification of the two-dimensional barcode
- Article 15
- Record keeping
- Article 16
- Verifications to be performed before removing or replacing the safety features
- Article 17
- Equivalent unique identifier
- Article 18
- Actions to be taken by manufacturers in case of tampering or suspected falsification
- Article 19
- Provisions applicable to a manufacturer distributing his products by wholesale
- CHAPTER V
- Article 20
- Verification of the authenticity of the unique identifier by wholesalers
- Article 21
- Derogations from Article 20(b)
- Article 22
- Decommissioning of unique identifiers by wholesalers
- Article 23
- Provisions to accommodate specific characteristics of Member States' supply chains
- Article 24
- Actions to be taken by wholesalers in case of tampering or suspected falsification
- CHAPTER VI
- Article 25
- Obligations of persons authorised or entitled to supply medicinal products to the public
- Article 26
- Derogations from Article 25
- Article 27
- Obligations when applying the derogations
- Article 28
- Obligations when supplying only part of a pack
- Article 29
- Obligations in case of inability to verify the authenticity and decommission the unique identifier
- Article 30
- Actions to be taken by persons authorised or entitled to supply medicinal products to the public in case of suspected falsification
- CHAPTER VII
- Article 31
- Establishment of the repositories system
- Article 32
- Structure of the repositories system
- Article 33
- Uploading of information in the repositories system
- Article 34
- Functioning of the hub
- Article 35
- Characteristics of the repositories system
- Article 36
- Operations of the repositories system
- Article 37
- Obligations of legal entities establishing and managing a repository which is part of the repositories system
- Article 38
- Data protection and data ownership
- Article 39
- Access by national competent authorities
- CHAPTER VIII
- Article 40
- Products recalled, withdrawn or stolen
- Article 41
- Products to be supplied as free samples
- Article 42
- Removal of unique identifiers from the repositories system
- CHAPTER IX
- Article 43
- Information to be provided by national competent authorities
- Article 44
- Supervision of the repositories system
- CHAPTER X
- Article 45
- Lists of derogations from bearing or not bearing the safety features
- Article 46
- Notifications to the Commission
- Article 47
- Evaluation of the notifications
- CHAPTER XI
- Article 48
- Transitional measures
- Article 49
- Application in Member States with existing systems for the verification of the authenticity of medicinal products and for the identification of individual pack
- Article 50
- Entry into force
- ANNEX I
- ANNEX II
- ANNEX III
- ANNEX IV
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