Commission Delegated Regulation (EU) 2016/161Show full title

1. Introductory Text

2. CHAPTER I SUBJECT MATTER AND DEFINITIONS

   1. Article 1. Subject matter

   2. Article 2. Scope

   3. Article 3. Definitions

3. CHAPTER II TECHNICAL SPECIFICATIONS OF THE UNIQUE IDENTIFIER

   1. Article 4. Composition of the unique identifier

   2. Article 5. Carrier of the unique identifier

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

   4. Article 7. Human-readable format

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

   6. Article 9. Barcodes on the packaging

4. CHAPTER III GENERAL PROVISIONS ON THE VERIFICATION OF THE SAFETY FEATURES

   1. Article 10. Verification of the safety features

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

   3. Article 12. Unique identifiers which have been decommissioned

   4. Article 13. Reversing the status of a decommissioned unique identifier

5. CHAPTER IV MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY MANUFACTURERS

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

   2. Article 15. Record keeping

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

   4. Article 17. Equivalent unique identifier

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

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

6. CHAPTER V MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY WHOLESALERS

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

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

   3. Article 22. Decommissioning of unique identifiers by wholesalers

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

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

7. 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

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

   2. Article 26. Derogations from Article 25

   3. Article 27. Obligations when applying the derogations

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

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

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

8. CHAPTER VII ESTABLISHMENT, MANAGEMENT AND ACCESSIBILITY OF THE REPOSITORIES SYSTEM

   1. Article 31. Establishment of the repositories system

   2. Article 32. Structure of the repositories system

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

   4. Article 34. Functioning of the hub

   5. Article 35. Characteristics of the repositories system

   6. Article 36. Operations of the repositories system

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

   8. Article 38. Data protection and data ownership

   9. Article 39. Access by national competent authorities

9. CHAPTER VIII OBLIGATIONS OF MARKETING AUTHORISATION HOLDERS, PARALLEL IMPORTERS AND PARALLEL DISTRIBUTORS

   1. Article 40. Products recalled, withdrawn or stolen

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

   3. Article 42. Removal of unique identifiers from the repositories system

10. CHAPTER IX OBLIGATIONS OF THE NATIONAL COMPETENT AUTHORITIES

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

    2. Article 44. Supervision of the repositories system

11. CHAPTER X LISTS OF DEROGATIONS AND NOTIFICATIONS TO THE COMMISSION

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

    2. Article 46. Notifications to the Commission

    3. Article 47. Evaluation of the notifications

12. CHAPTER XI TRANSITIONAL MEASURES AND ENTRY INTO FORCE

    1. Article 48. Transitional measures

    2. 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

    3. Article 50. Entry into force

13. Signature

14. 1. 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)

    2. 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)

    3. ANNEX III

    4. ANNEX IV