Commission Delegated Regulation (EU) 2016/161of 2 October 2015supplementing 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
Article 1
Subject matter
Article 2
Scope
Article 3
Definitions
CHAPTER II
TECHNICAL SPECIFICATIONS OF THE UNIQUE IDENTIFIER
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
GENERAL PROVISIONS ON THE VERIFICATION OF THE SAFETY FEATURES
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
MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY MANUFACTURERS
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
MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY WHOLESALERS
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
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
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
ESTABLISHMENT, MANAGEMENT AND ACCESSIBILITY OF THE REPOSITORIES SYSTEM
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
OBLIGATIONS OF MARKETING AUTHORISATION HOLDERS, PARALLEL IMPORTERS AND PARALLEL DISTRIBUTORS
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
OBLIGATIONS OF THE NATIONAL COMPETENT AUTHORITIES
Article 43
Information to be provided by national competent authorities
Article 44
Supervision of the repositories system
CHAPTER X
LISTS OF DEROGATIONS AND NOTIFICATIONS TO THE COMMISSION
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
TRANSITIONAL MEASURES AND ENTRY INTO FORCE
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 packs
Article 50
Entry into force
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
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)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation revoked (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(hh) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)