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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)

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)

CHAPTER I SUBJECT MATTER AND DEFINITIONS

Article 1 Subject matter

This Regulation lays down:

  1. the characteristics and technical specifications of the unique identifier that enables the authenticity of medicinal products to be verified and individual packs to be identified;

  2. the modalities for the verification of the safety features;

  3. the provisions on the establishment, management and accessibility of the repositories system where the information on the safety features shall be contained;

  4. the list of medicinal products and product categories subject to prescription which shall not bear the safety features;

  5. the list of medicinal products and product categories not subject to prescription which shall bear the safety features;

  6. the procedures for the notification to the Commission by national competent authorities of non-prescription medicinal products judged at risk of falsification and prescription medicinal products not deemed at risk of falsification in accordance with the criteria set out in Article 54a(2)(b) of Directive 2001/83/EC;

  7. the procedures for a rapid evaluation of and decision on the notifications referred to in point (f) of this Article.

Article 2 Scope

1.

This Regulation applies to:

  1. medicinal products subject to prescription which shall bear safety features on their packaging pursuant to Article 54a(1) of Directive 2001/83/EC, unless included in the list set out in Annex I to this Regulation;

  2. medicinal products not subject to prescription included in the list set out in Annex II to this Regulation;

  3. medicinal products to which Member States have extended the scope of application of the unique identifier or of the anti-tampering device in accordance with Article 54a(5) of Directive 2001/83/EC.

2.

For the purposes of this Regulation, where reference is made to the packaging in a provision of this Regulation, the provision shall apply to outer packaging or to the immediate packaging if the medicinal product has no outer packaging.

Article 3 Definitions

1.

For the purposes of this Regulation, the definitions in Article 1 of Directive 2001/83/EC shall apply.

2.

The following definitions shall apply:

  1. ‘unique identifier’ means the safety feature enabling the verification of the authenticity and the identification of an individual pack of a medicinal product;

  2. ‘anti-tampering device’ means the safety feature allowing the verification of whether the packaging of a medicinal product has been tampered with;

  3. ‘decommissioning of a unique identifier’ means the operation changing the active status of a unique identifier stored in the repositories system referred to in Article 31 of this Regulation to a status impeding any further successful verification of the authenticity of that unique identifier;

  4. ‘active unique identifier’ means a unique identifier which has not been decommissioned or which is no longer decommissioned;

  5. ‘active status’ means the status of an active unique identifier stored in the repositories system referred to in Article 31;

  6. ‘healthcare institution’ means a hospital, in- or outpatient clinic or health centre.

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

ANNEX II

ANNEX III

ANNEX IV