European Commission 2 October 2015, 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)

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European Union · · · Cited by 162 · 02-10-2015

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)

9.2.2016

Official Journal of the European Union

L 32/1

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)

THE EUROPEAN COMMISSION,

Having

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