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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) (revoked)

EU Regulation 2016/161 · Adopted 2 October 2015 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

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)

F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations to the whole text

Textual amendments

F1

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)

Contents

  1. Chapter I: SUBJECT MATTER AND DEFINITIONS Repealed
  2. 1Subject matter Repealed
  3. 2Scope Repealed
  4. 3Definitions Repealed
  5. Chapter II: TECHNICAL SPECIFICATIONS OF THE UNIQUE IDENTIFIER Repealed
  6. 4Composition of the unique identifier Repealed
  7. 5Carrier of the unique identifier Repealed
  8. 6Quality of the printing of the two-dimensional barcode Repealed
  9. 7Human-readable format Repealed
  10. 8Additional information in the two-dimensional barcode Repealed
  11. 9Barcodes on the packaging Repealed
  12. Chapter III: GENERAL PROVISIONS ON THE VERIFICATION OF THE SAFETY FEATURES Repealed
  13. 10Verification of the safety features Repealed
  14. 11Verification of the authenticity of the unique identifier Repealed
  15. 12Unique identifiers which have been decommissioned Repealed
  16. 13Reversing the status of a decommissioned unique identifier Repealed
  17. Chapter IV: MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY MANUFACTURERS Repealed
  18. 14Verification of the two-dimensional barcode Repealed
  19. 15Record keeping Repealed
  20. 16Verifications to be performed before removing or replacing the safety features Repealed
  21. 17Equivalent unique identifier Repealed
  22. 18Actions to be taken by manufacturers in case of tampering or suspected falsification Repealed
  23. 19Provisions applicable to a manufacturer distributing his products by wholesale Repealed
  24. Chapter V: MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY WHOLESALERS Repealed
  25. 20Verification of the authenticity of the unique identifier by wholesalers Repealed
  26. 21Derogations from Article 20(b) Repealed
  27. 22Decommissioning of unique identifiers by wholesalers Repealed
  28. 23Provisions to accommodate specific characteristics of Member States' supply chains Repealed
  29. 24Actions to be taken by wholesalers in case of tampering or suspected falsification Repealed
  30. 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 Repealed
  31. 25Obligations of persons authorised or entitled to supply medicinal products to the public Repealed
  32. 26Derogations from Article 25 Repealed
  33. 27Obligations when applying the derogations Repealed
  34. 28Obligations when supplying only part of a pack Repealed
  35. 29Obligations in case of inability to verify the authenticity and decommission the unique identifier Repealed
  36. 30Actions to be taken by persons authorised or entitled to supply medicinal products to the public in case of suspected falsification Repealed
  37. Chapter VII: ESTABLISHMENT, MANAGEMENT AND ACCESSIBILITY OF THE REPOSITORIES SYSTEM Repealed
  38. 31Establishment of the repositories system Repealed
  39. 32Structure of the repositories system Repealed
  40. 33Uploading of information in the repositories system Repealed
  41. 34Functioning of the hub Repealed
  42. 35Characteristics of the repositories system Repealed
  43. 36Operations of the repositories system Repealed
  44. 37Obligations of legal entities establishing and managing a repository which is part of the repositories system Repealed
  45. 38Data protection and data ownership Repealed
  46. 39Access by national competent authorities Repealed
  47. Chapter VIII: OBLIGATIONS OF MARKETING AUTHORISATION HOLDERS, PARALLEL IMPORTERS AND PARALLEL DISTRIBUTORS Repealed
  48. 40Products recalled, withdrawn or stolen Repealed
  49. 41Products to be supplied as free samples Repealed
  50. 42Removal of unique identifiers from the repositories system Repealed
  51. Chapter IX: OBLIGATIONS OF THE NATIONAL COMPETENT AUTHORITIES Repealed
  52. 43Information to be provided by national competent authorities Repealed
  53. 44Supervision of the repositories system Repealed
  54. Chapter X: LISTS OF DEROGATIONS AND NOTIFICATIONS TO THE COMMISSION Repealed
  55. 45Lists of derogations from bearing or not bearing the safety features Repealed
  56. 46Notifications to the Commission Repealed
  57. 47Evaluation of the notifications Repealed
  58. Chapter XI: TRANSITIONAL MEASURES AND ENTRY INTO FORCE Repealed
  59. 48Transitional measures Repealed
  60. 49Application in Member States with existing systems for the verification of the authenticity of medicinal products and for the identification of individual packs Repealed
  61. 50Entry into force Repealed
  62. Signature
  63. Annex IList of medicinal products or product categories subject to prescription that shall not bear the safety features, referred to in Article 45(1) Repealed
  64. Annex IIList of medicinal products or product categories not subject to prescription that shall bear the safety features, referred to in Article 45(2) Repealed
  65. Annex IIIAnnex III Repealed
  66. Annex IVAnnex IV Repealed

1Subject matterF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2ScopeF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3DefinitionsF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4Composition of the unique identifierF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5Carrier of the unique identifierF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6Quality of the printing of the two-dimensional barcodeF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7Human-readable formatF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8Additional information in the two-dimensional barcodeF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9Barcodes on the packagingF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10Verification of the safety featuresF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11Verification of the authenticity of the unique identifierF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

12Unique identifiers which have been decommissionedF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13Reversing the status of a decommissioned unique identifierF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14Verification of the two-dimensional barcodeF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15Record keepingF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16Verifications to be performed before removing or replacing the safety featuresF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

17Equivalent unique identifierF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18Actions to be taken by manufacturers in case of tampering or suspected falsificationF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19Provisions applicable to a manufacturer distributing his products by wholesaleF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

20Verification of the authenticity of the unique identifier by wholesalersF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

21Derogations from Article 20(b)F1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

22Decommissioning of unique identifiers by wholesalersF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

23Provisions to accommodate specific characteristics of Member States' supply chainsF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

24Actions to be taken by wholesalers in case of tampering or suspected falsificationF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

25Obligations of persons authorised or entitled to supply medicinal products to the publicF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

26Derogations from Article 25F1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

27Obligations when applying the derogationsF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

28Obligations when supplying only part of a packF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

29Obligations in case of inability to verify the authenticity and decommission the unique identifierF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

30Actions to be taken by persons authorised or entitled to supply medicinal products to the public in case of suspected falsificationF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

31Establishment of the repositories systemF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

32Structure of the repositories systemF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

33Uploading of information in the repositories systemF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

34Functioning of the hubF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

35Characteristics of the repositories systemF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

36Operations of the repositories systemF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

37Obligations of legal entities establishing and managing a repository which is part of the repositories systemF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

38Data protection and data ownershipF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

39Access by national competent authoritiesF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

40Products recalled, withdrawn or stolenF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

41Products to be supplied as free samplesF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

42Removal of unique identifiers from the repositories systemF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

43Information to be provided by national competent authoritiesF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

44Supervision of the repositories systemF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

45Lists of derogations from bearing or not bearing the safety featuresF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

46Notifications to the CommissionF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

47Evaluation of the notificationsF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

48Transitional measuresF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

49Application in Member States with existing systems for the verification of the authenticity of medicinal products and for the identification of individual packsF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

50Entry into forceF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Signature

F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annex IList of medicinal products or product categories subject to prescription that shall not bear the safety features, referred to in Article 45(1)F1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annex IIList of medicinal products or product categories not subject to prescription that shall bear the safety features, referred to in Article 45(2)F1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annex IIIF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annex IVF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .