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:

(a) 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;

(b) the modalities for the verification of the safety features;

(c) the provisions on the establishment, management and accessibility of the repositories system where the information on the safety features shall be contained;

(d) the list of medicinal products and product categories subject to prescription which shall not bear the safety features;

(e) the list of medicinal products and product categories not subject to prescription which shall bear the safety features;

(f) 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;

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

Article 2

Scope

This Regulation applies to:

(a) 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;

(b) medicinal products not subject to prescription included in the list set out in Annex II to this Regulation;

(c) 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.

Article 3

Definitions

The following definitions shall apply:

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

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

(c) ‘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;

(d) ‘active unique identifier’ means a unique identifier which has not been decommissioned or which is no longer decommissioned, and which has not been identified as a ‘non-Union pack’ as referred to in Article 36, point (p);

(e) ‘active status’ means the status of an active unique identifier stored in the repositories system referred to in Article 31;

(f) ‘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

The manufacturer shall place on the packaging of a medicinal product a unique identifier which complies with the following technical specifications:

(a) The unique identifier shall be a sequence of numeric or alphanumeric characters that is unique to a given pack of a medicinal product.

(b) The unique identifier shall consist of the following data elements: (i) a code allowing the identification of at least the name, the common name, the pharmaceutical form, the strength, the pack size and the pack type of the medicinal product bearing the unique identifier (‘product code’); (ii) a numeric or alphanumeric sequence of maximum 20 characters, generated by a deterministic or a non-deterministic randomisation algorithm (‘serial number’); (iii) a national reimbursement number or other national number identifying the medicinal product, if required by the Member State where the product is intended to be placed on the market; (iv) the batch number; (v) the expiry date.

(c) The probability that the serial number can be guessed shall be negligible and in any case lower than one in ten thousand.

(d) The character sequence resulting from the combination of the product code and the serial number shall be unique to a given pack of a medicinal product until at least one year after the expiry date of the pack or five years after the pack has been released for sale or distribution in accordance with Article 51(3) of Directive 2001/83/EC, whichever is the longer period.

(e) Where the national reimbursement number or other national number identifying the medicinal product is contained in the product code, it is not required to be repeated within the unique identifier.

Article 5

Carrier of the unique identifier

Article 6

Quality of the printing of the two-dimensional barcode

Manufacturers shall evaluate the quality of the printing of the Data Matrix by assessing at least the following Data Matrix parameters:

(a) the contrast between the light and dark parts;

(b) the uniformity of the reflectance of the light and dark parts;

(c) the axial non-uniformity;

(d) the grid non-uniformity;

(e) the unused error correction;

(f) the fixed pattern damage;

(g) the capacity of the reference decode algorithm to decode the Data Matrix.

Article 7

Human-readable format

Manufacturers shall print the following data elements of the unique identifier on the packaging in human-readable format:

(a) the product code;

(b) the serial number;

(c) the national reimbursement number or other national number identifying the medicinal product, if required by the Member State where the product is intended to be placed on the market and not printed elsewhere on the packaging.

Article 8

Additional information in the two-dimensional barcode

Manufacturers may include information other than the unique identifier in the two-dimensional barcode carrying the unique identifier, where permitted by the competent authority in accordance with Title V of Directive 2001/83/EC.

Article 9

Barcodes on the packaging

Medicinal products having to bear the safety features pursuant to Article 54a of Directive 2001/83/EC shall not bear on their packaging, for the purpose of their identification and verification of their authenticity, any other visible two-dimensional barcode than the two-dimensional barcode carrying the unique identifier.

CHAPTER III

GENERAL PROVISIONS ON THE VERIFICATION OF THE SAFETY FEATURES

Article 10

Verification of the safety features

When verifying the safety features, manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public shall verify the following:

(a) the authenticity of the unique identifier;

(b) the integrity of the anti-tampering device.

Article 11

Verification of the authenticity of the unique identifier

When verifying the authenticity of a unique identifier, manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public shall check the unique identifier against the unique identifiers stored in the repositories system referred to in Article 31. A unique identifier shall be considered authentic when the repositories system contains an active unique identifier with the product code and serial number that are identical to those of the unique identifier being verified.

Article 12

Unique identifiers which have been decommissioned

A medicinal product bearing a unique identifier which has been decommissioned shall not be further distributed or supplied to the public except in any of the following situations:

(a) the unique identifier was decommissioned in accordance with Article 22(a) and the medicinal product is distributed for the purpose of exporting it outside the Union;

(b) the unique identifier was decommissioned earlier than the time of supplying the medicinal product to the public, pursuant to Articles 23, 26, 28 or 41;

(c) the unique identifier was decommissioned in accordance with Article 22(b) or (c) or Article 40, and the medicinal product is provided to the person responsible for its disposal;

(d) the unique identifier was decommissioned in accordance with Article 22(d) and the medicinal product is provided to the national competent authorities.

Article 13

Reversing the status of a decommissioned unique identifier

Manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public may only revert the status of a decommissioned unique identifier to an active status if the following conditions are fulfilled:

(a) the person performing the reverting operation is covered by the same authorisation or entitlement and operates in the same premises as the person that decommissioned the unique identifier;

(b) the reverting of the status takes place not more than 10 days after the unique identifier was decommissioned;

(c) the pack of medicinal product has not expired;

(d) the pack of medicinal product has not been registered in the repositories system as recalled, withdrawn, intended for destruction or stolen and the person performing the reverting operation does not have knowledge that the pack is stolen;

(e) the medicinal product has not been supplied to the public.

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

The manufacturer placing the safety features shall verify that the two-dimensional barcode carrying the unique identifier complies with Articles 5 and 6, is readable and contains the correct information.

Article 15

Record keeping

The manufacturer placing the safety features shall keep records of every operation he performs with or on the unique identifier on a pack of medicinal product for at least one year after the expiry date of the pack or five years after the pack has been released for sale or distribution in accordance with Article 51(3) of Directive 2001/83/EC, whichever is the longer period, and shall provide those records to competent authorities on request.

Article 16

Verifications to be performed before removing or replacing the safety features

Before removing or covering, either fully or partially, the safety features in accordance with Article 47a of Directive 2001/83/EC, the manufacturer shall verify the following:

(a) the integrity of the anti-tampering device;

(b) the authenticity of the unique identifier and decommission it if replaced.

Article 17

Equivalent unique identifier

When placing an equivalent unique identifier for the purposes of complying with Article 47a(1)(b) of Directive 2001/83/EC, the manufacturer shall verify that the structure and composition of the unique identifier placed on the packaging complies, with regard to the product code and the national reimbursement number or other national number identifying the medicinal product, with the requirements of the Member State where the medicinal product is intended to be placed on the market, so that that unique identifier can be verified for authenticity and decommissioned.

Article 18

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

Where a manufacturer has reason to believe that the packaging of the medicinal product has been tampered with, or the verification of the safety features shows that the product may not be authentic, the manufacturer shall not release the product for sale or distribution and shall immediately inform the relevant competent authorities.

Article 19

Provisions applicable to a manufacturer distributing his products by wholesale

Where a manufacturer distributes his products by wholesale, Article 20(a), and Articles 22, 23 and 24 shall apply to him in addition to Articles 14 to 18.

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

A wholesaler shall verify the authenticity of the unique identifier of at least the following medicinal products in his physical possession:

(a) medicinal products returned to him by persons authorised or entitled to supply medicinal products to the public or by another wholesaler;

(b) medicinal products he receives from a wholesaler who is neither the manufacturer nor the wholesaler holding the marketing authorisation nor a wholesaler who is designated by the marketing authorisation holder, by means of a written contract, to store and distribute the products covered by his marketing authorisation on his behalf.

A wholesaler established in Northern Ireland, Cyprus, Ireland or Malta shall perform adequate verifications to ensure that shipments of medicinal products manufactured and labelled for the United Kingdom market comply with the requirement to bear safety features under Article 54a(1) of Directive 2001/83/EC when received from the manufacturer, the marketing authorisation holder or a wholesaler who is designated by the marketing authorisation holder, by means of a written contract, to store and distribute the products covered by his marketing authorisation on his behalf.

Article 21

Derogations from Article 20(b)

Verification of the authenticity of the unique identifier of a medicinal product is not required under Article 20(b) in any of the following situations:

(a) that medicinal product changes ownership but remains in the physical possession of the same wholesaler;

(b) that medicinal product is distributed within the territory of a Member State between two warehouses belonging to the same wholesaler or the same legal entity, and no sale takes place.

Article 22

Decommissioning of unique identifiers by wholesalers

A wholesaler shall verify the authenticity of and decommission the unique identifier of the following medicinal products:

(a) products which he intends to distribute outside of the Union;

(b) products which have been returned to him by persons authorised or entitled to supply medicinal products to the public or another wholesaler and cannot be returned to saleable stock;

(c) products which are intended for destruction;

(d) products which, while in his physical possession, are requested as a sample by competent authorities;

(e) products which he intends to distribute to the persons or institutions referred to in Article 23, where required by national legislation in accordance with the same Article.

By way of derogation from point (a), until 31 December 2024, the obligation to decommission the unique identifier of medicinal products which the wholesaler intends to distribute outside of the Union shall not apply to medicinal products manufactured and labelled for the United Kingdom market or for the United Kingdom market and the markets of Cyprus, Ireland or Malta, which he intends to distribute in the United Kingdom.

Article 23

Provisions to accommodate specific characteristics of Member States' supply chains

Member States may require, where necessary to accommodate the particular characteristics of the supply chain on their territory, that a wholesaler verifies the safety features and decommissions the unique identifier of a medicinal product before he supplies that medicinal product to any of the following persons or institutions:

(a) persons authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy;

(b) veterinarians and retailers of veterinary medicinal products;

(c) dental practitioners;

(d) optometrists and opticians;

(e) paramedics and emergency medical practitioners;

(f) armed forces, police and other governmental institutions maintaining stocks of medicinal products for the purposes of civil protection and disaster control;

(g) universities and other higher education establishments using medicinal products for the purposes of research and education, with the exceptions of healthcare institutions;

(h) prisons;

(i) schools;

(j) hospices;

(k) nursing homes.

Article 24

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

A wholesaler shall not supply or export a medicinal product where he has reason to believe that its packaging has been tampered with, or where the verification of the safety features of the medicinal product indicates that the product may not be authentic. He shall immediately inform the relevant competent authorities.

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

They shall also verify the safety features and decommission the unique identifier of the following medicinal products bearing the safety features:

(a) medicinal products in their physical possession that cannot be returned to wholesalers or manufacturers;

(b) medicinal products that, while in their physical possession, are requested as samples by competent authorities, in accordance with national legislation;

(c) medicinal products which they supply for subsequent use as authorised investigational medicinal products or authorised auxiliary medicinal products as defined in Articles 2(2)(9) and (10) of Regulation (EU) No 536/2014.

Article 26

Derogations from Article 25

Notwithstanding Article 25, Member States may decide, where necessary to accommodate the particular characteristics of the supply chain on their territory, to exempt a person authorised or entitled to supply medicinal products to the public operating within a healthcare institution from the obligations of verification and decommissioning of the unique identifier, provided that the following conditions are met:

(a) the person authorised or entitled to supply medicinal products to the public obtains the medicinal product bearing the unique identifier through a wholesaler belonging to the same legal entity as the healthcare institution;

(b) the verification and decommissioning of the unique identifier is performed by the wholesaler that supplies the product to the healthcare institution;

(c) no sale of the medicinal product takes place between the wholesaler supplying the product and that healthcare institution;

(d) the medicinal product is supplied to the public within that healthcare institution.

Article 27

Obligations when applying the derogations

Where the verification of the authenticity and decommissioning of the unique identifier is carried out earlier than referred to in Article 25(1), pursuant to Articles 23 or 26, the integrity of the anti-tampering device shall be verified at the time the medicinal product is supplied to the public.

Article 28

Obligations when supplying only part of a pack