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)
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CHAPTER I

SUBJECT MATTER AND DEFINITIONS

Subject matter
Article 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Scope
Article 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Definitions
Article 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHAPTER II

TECHNICAL SPECIFICATIONS OF THE UNIQUE IDENTIFIER

Composition of the unique identifier
Article 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Carrier of the unique identifier
Article 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Quality of the printing of the two-dimensional barcode
Article 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Human-readable format
Article 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Additional information in the two-dimensional barcode
Article 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Barcodes on the packaging
Article 9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHAPTER III

GENERAL PROVISIONS ON THE VERIFICATION OF THE SAFETY FEATURES

Verification of the safety features
Article 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Verification of the authenticity of the unique identifier
Article 11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Unique identifiers which have been decommissioned
Article 12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Reversing the status of a decommissioned unique identifier
Article 13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHAPTER IV

MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY MANUFACTURERS

Verification of the two-dimensional barcode
Article 14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Record keeping
Article 15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Verifications to be performed before removing or replacing the safety features
Article 16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Equivalent unique identifier
Article 17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Actions to be taken by manufacturers in case of tampering or suspected falsification
Article 18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Provisions applicable to a manufacturer distributing his products by wholesale
Article 19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHAPTER V

MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY WHOLESALERS

Verification of the authenticity of the unique identifier by wholesalers
Article 20. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Derogations from Article 20(b)
Article 21. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Decommissioning of unique identifiers by wholesalers
Article 22. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Provisions to accommodate specific characteristics of Member States' supply chains
Article 23. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Actions to be taken by wholesalers in case of tampering or suspected falsification
Article 24. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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

Obligations of persons authorised or entitled to supply medicinal products to the public
Article 25. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Derogations from Article 25
Article 26. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Obligations when applying the derogations
Article 27. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Obligations when supplying only part of a pack
Article 28. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Obligations in case of inability to verify the authenticity and decommission the unique identifier
Article 29. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Actions to be taken by persons authorised or entitled to supply medicinal products to the public in case of suspected falsification
Article 30. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHAPTER VII

ESTABLISHMENT, MANAGEMENT AND ACCESSIBILITY OF THE REPOSITORIES SYSTEM

Establishment of the repositories system
Article 31. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Structure of the repositories system
Article 32. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Uploading of information in the repositories system
Article 33. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Functioning of the hub
Article 34. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Characteristics of the repositories system
Article 35. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Operations of the repositories system
Article 36. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Obligations of legal entities establishing and managing a repository which is part of the repositories system
Article 37. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Data protection and data ownership
Article 38. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Access by national competent authorities
Article 39. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHAPTER VIII

OBLIGATIONS OF MARKETING AUTHORISATION HOLDERS, PARALLEL IMPORTERS AND PARALLEL DISTRIBUTORS

Products recalled, withdrawn or stolen
Article 40. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Products to be supplied as free samples
Article 41. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Removal of unique identifiers from the repositories system
Article 42. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHAPTER IX

OBLIGATIONS OF THE NATIONAL COMPETENT AUTHORITIES

Information to be provided by national competent authorities
Article 43. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Supervision of the repositories system
Article 44. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHAPTER X

LISTS OF DEROGATIONS AND NOTIFICATIONS TO THE COMMISSION

Lists of derogations from bearing or not bearing the safety features
Article 45. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Notifications to the Commission
Article 46. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Evaluation of the notifications
Article 47. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHAPTER XI

TRANSITIONAL MEASURES AND ENTRY INTO FORCE

Transitional measures
Article 48. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Application in Member States with existing systems for the verification of the authenticity of medicinal products and for the identification of individual packs
Article 49. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Entry into force
Article 50. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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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)
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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)
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ANNEX III. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ANNEX IV. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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)