9.2.2016   

EN

Official Journal of the European Union

L 32/1

(1)

Directive 2001/83/EC, as amended, provides for measures to prevent the entry into the legal supply chain of falsified medicinal products by requiring the placing of safety features consisting of a unique identifier and an anti-tampering device on the packaging of certain medicinal products for human use for the purposes of allowing their identification and authentication.

(2)

Diverging authentication mechanisms for medicinal products based on different national or regional traceability requirements may limit the circulation of medicinal products across the Union and increase costs for all players in the supply chain. It is therefore necessary to establish Union-wide rules for the implementation of the safety features for medicinal products for human use, with particular regard to the characteristics and technical specifications of the unique identifier, the modalities for the verification of the safety features, and the establishment and management of the repository system containing information on the safety features.

(3)

In accordance with Article 4 of Directive 2011/62/EU of the European Parliament and of the Council (2) and Article 54a(2) and (3) of Directive 2001/83/EC, the Commission has assessed the benefits, costs and cost-effectiveness of different policy options for the characteristics and technical specifications of the unique identifier, the modalities for the verification of the safety features and the establishment and management of the repository system. The policy options identified as the most cost-effective have been introduced as core elements of this Regulation.

(4)

This Regulation sets out a system where the identification and the authentication of medicinal products is guaranteed by an end-to-end verification of all medicinal products bearing the safety features, supplemented by the verification by wholesalers of certain medicinal products at higher risk of falsification. In practice, the authenticity and integrity of the safety features placed on the packaging of a medicinal product at the beginning of the supply chain should be verified at the time the medicinal product is supplied to the public, although certain derogations may apply. However, medicinal products at higher risk of falsification should be additionally verified by wholesalers throughout the supply chain, to minimise the risk of falsified medicinal products circulating undetected for lengthy periods of time. The verification of the authenticity of a unique identifier should be performed by comparing that unique identifier with the legitimate unique identifiers stored in a repositories system. When the pack is supplied to the public, or is distributed outside the Union, or in other specific situations, the unique identifier on that pack should be decommissioned in the repositories system so any other pack bearing the same unique identifier could not be successfully verified.

(5)

It should be possible to identify and verify the authenticity of an individual pack of a medicinal product for the entire time the medicinal product stays on the market and the additional time necessary for returning and disposing of the pack after it has expired. For this reason, the character sequence resulting from the combination of the product code and the serial number sequence should be unique to a given pack of a medicinal product until at least one year after the expiry date of that pack or five years after the product has been released for sale or distribution in accordance with Article 51(3) of Directive 2001/83/EC, whichever is the longer period.

(6)

The inclusion of the product code, the national reimbursement and identification number, the batch number and expiry date in the unique identifier contributes to patient safety by facilitating recall, withdrawal and return procedures and pharmacovigilance in this sector.

(7)

In order to have a negligible probability that a serial number can be guessed by falsifiers, the serial number should be generated according to specific randomisation rules.

(8)

Compliance with certain international standards, while not mandatory, can be used as proof that certain requirements of this Regulation are fulfilled. Where it is not possible to prove compliance with international standards, it should be the responsibility of the persons to whom the obligations are addressed to prove, by verifiable means, that they comply with those requirements.

(9)

The unique identifier should be encoded using a standardised data structure and syntax so that it can be correctly recognised and decoded throughout the Union by commonly-used scanning equipment.

(10)

The global uniqueness of the product code not only contributes to the unambiguity of the unique identifier but also facilitates the decommissioning of a unique identifier when this operation takes place in a Member State different from the Member State where the medicinal product was initially intended to be placed on the market. A product code which conforms to certain international standards should be presumed to be globally unique.

(11)

To facilitate the verification of the authenticity and decommissioning of a unique identifier by wholesalers and persons authorised or entitled to supply medicinal products to the public, it is necessary to ensure that the structure and printing quality of the two-dimensional barcode encoding the unique identifier allow for high-speed reading and minimisation of reading errors.

(12)

The data elements of the unique identifier should be printed on the packaging in human-readable format so to allow the verification of the authenticity of the unique identifier and its decommissioning in case the two-dimensional barcode is unreadable.

(13)

A two-dimensional barcode can store more information than the data elements of the unique identifier. It should be possible to use that residual storage capacity to carry further information and avoid the placing of additional barcodes.

(14)

The presence of multiple two-dimensional barcodes on the packaging can engender confusion with regard to which barcode should be read for the purpose of verifying the authenticity of and identifying a medicinal product. This may lead to mistakes in the verification of the authenticity of medicinal products and to falsified medicinal products being inadvertently supplied to the public. For this reason, the presence of multiple two-dimensional barcodes on the packaging of a medicinal product for the purposes of identification and verification of the authenticity should be avoided.

(15)

The verification of both safety features is necessary to ensure the authenticity of a medicinal product in an end-to end verification system. The verification of the authenticity of the unique identifier aims at ensuring that the medicinal product originates from the legitimate manufacturer. The verification of the integrity of the anti-tampering device shows whether the packaging has been opened or altered since it left the manufacturer, thereby ensuring that the content of the packaging is authentic.

(16)

The verification of the authenticity of the unique identifier is a critical step to ensure the authenticity of the medicinal product bearing it and should only be based on the comparison with trusted information on the legitimate unique identifiers uploaded in a secure repositories system by verified users.

(17)

It should be possible to revert the status of a unique identifier that has been decommissioned in order to avoid the unnecessary waste of medicinal products. It is however necessary to subject the reverting of the status to strict conditions to minimise the threat to the security of the repositories system that such operation could generate if abused by counterfeiters. Those conditions should apply regardless of whether the decommissioning operation took place at the moment of supply to the public or at an earlier point in time.

(18)

Competent authorities should be able to access information on the safety features of a medicinal product while this product is in the supply chain or after it has been supplied to the public, recalled or withdrawn from the market. To this end, manufacturers should retain records of operations with or on the unique identifier of a given medicinal product after the identifier has been decommissioned from the repositories system for a minimum of one year after the expiry date of that medicinal product 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.

(19)

Past incidents of falsification show that certain medicinal products, such as those returned by persons authorised or entitled to supply medicinal products to the public or wholesalers, or medicinal products distributed by persons who are neither the manufacturer nor a wholesaler holding the marketing authorisation nor a designated wholesaler, are at higher risk of being falsified. The authenticity of those medicinal products should therefore be subject to additional verifications by wholesalers throughout the supply chain to minimise the risk that falsified products entering the legal supply chain freely circulate in the Union territory until they are verified at the time of supply to the public.

(20)

The verification by wholesalers of the authenticity of medicinal products at higher risk of being falsified would be equally effective whether performed by scanning individual unique identifiers or an aggregated code allowing the simultaneous verification of multiple unique identifiers. In addition, the verification could be performed at any time between the reception of the medicinal product by the wholesaler and its further distribution, to equal results. For those reasons, it should be left to the choice of the wholesaler whether to scan individual unique identifiers or aggregated codes, where available, or the timing of the verification, provided that the wholesaler ensures the verification of all unique identifiers of those products at higher risk of falsification in his physical possession, as required by this Regulation.

(21)

In the complex Union supply chain, it may happen that a medicinal product changes ownership but remains in the physical possession of the same wholesaler, or that a medicinal product is distributed within the territory of a Member State between two warehouses belonging to the same wholesaler or the same legal entity, but no sale takes place. In those cases, the wholesalers should be exempted from performing a verification of the unique identifier as the risk of falsification is negligible.

(22)

As a general principle, in an end-to-end verification system, the decommissioning of the unique identifier in the repository system should be performed at the end of the supply chain when the medicinal product is supplied to the public. Certain packs of medicinal products, however, may not eventually be supplied to the public and it is therefore necessary to ensure the decommissioning of their unique identifiers at a different point of the supply chain. This is the case of products which, inter alia, are to be distributed outside the Union, intended for destruction, requested as samples by competent authorities, or are returned products which cannot be returned to saleable stock.

(23)

Although Directive 2011/62/EU introduced provisions to regulate the sale of medicinal products at a distance to the public and mandated the Commission to establish the modalities of verification of the safety features by persons authorised or entitled to supply medicinal products to the public, the supply of medicinal products to the public is still mostly regulated at national level. The end of the supply chain may be organised differently in the different Member States and involve specific healthcare professionals. It should be possible for the Member States to exempt specific institutions or persons authorised or entitled to supply medicinal products to the public from the obligation of verification of the safety features, in order to accommodate the particular characteristics of the supply chain in their territory and ensure that the impact of the verification measures on those parties is proportionate.

(24)

The verification of the authenticity of a unique identifier is not only paramount to the authentication of a medicinal product but also informs the person performing the operation of whether that product is expired, recalled, withdrawn or indicated as stolen. Persons authorised or entitled to supply medicinal products to the public should verify the authenticity and decommission a unique identifier at the time the medicinal product is supplied to the public so to access the most up-to-date information concerning the product and avoid that products which are expired, recalled, withdrawn or indicated as stolen are supplied to the public.

(25)

In order to avoid an excessive impact on the daily operations of healthcare institutions, it should be possible for the Member States to allow persons authorised or entitled to supply medicinal products to the public operating within healthcare institutions to perform the verification of the authenticity and the decommissioning of a unique identifier earlier than the time the medicinal products is supplied to the public, or exempt them from such an obligation, subject to certain conditions.

(26)

In certain Member States, the persons authorised or entitled to supply medicinal products to the public are allowed to open a pack of a medicinal product in order to supply part of that pack to the public. It is therefore necessary to regulate the verification of the safety features and the decommissioning of the unique identifier in this specific situation.

(27)

The effectiveness of an end-to-end verification system in preventing falsified medicinal products from reaching the public depends upon the systematic verification of the authenticity of the safety features and the subsequent decommissioning of the unique identifier of every supplied pack, so that that unique identifier cannot be re-used by traffickers. It is therefore important to ensure that such operations, should they not be performed at the time the medicinal product is supplied to the public due to a technical problem, are performed as soon as possible thereafter.

(28)

An end-to-end verification system requires the setting up of a repositories system which stores, inter alia, the information on the legitimate unique identifiers of a medicinal product and can be queried for the purposes of verifying the authenticity of and decommissioning a unique identifier. This repositories system should be established and managed by the marketing authorisation holders, since they are responsible for placing the product on the market, and by the manufacturers of medicinal products bearing the safety features, since they bear the costs of the repositories system in accordance with Article 54a(2)(e) of Directive 2001/83/EC. However, wholesalers and persons authorised or entitled to supply medicinal products to the public should be entitled to participate to the establishment and management of the repositories system, should they wish to, as their daily work will depend upon the correct functioning of the repositories system. In addition, national competent authorities should be consulted in the setting up of the repositories system as their early involvement will benefit their subsequent supervision activities.

(29)

Limiting the use of the repository system should not be used for the purpose of gaining market advantage. For this reason, membership of specific organisations should not be a prerequisite for using the repository system.

(30)

The structure of the repositories system should be such as to ensure that medicinal product verification is possible throughout the Union. This may require the transfer of data and information on a unique identifier between repositories within the repositories system. In order to minimise the number of necessary connections between repositories and ensure their interoperability, each national and supranational repository part of the repositories system should connect to and exchange data through a central repository acting as information and data router.

(31)

The repositories system should comprise the necessary interfaces providing access, either directly or by means of software, to wholesalers, persons authorised or entitled to supply medicinal products to the public and national competent authorities so that they can comply with their obligations under this Regulation.

(32)

Given the sensitive nature of the information on the legitimate unique identifiers and the potential negative impact on public health should such information fall in the hands of traffickers, the responsibility for ensuring the upload of such information in the repositories system should be placed on the marketing authorisation holder or the person responsible for placing the product bearing the unique identifier on the market. The information should be retained for a period of time sufficiently long to allow the appropriate investigation of incidents of falsification.

(33)

In order to harmonise the data format and data exchange across the repositories system and guarantee the interoperability of the repositories as well as the readability and the accuracy of the transferred data, each national and supranational repository should exchange information and data using the data format and data exchange specifications defined by the central repository.

(34)

To ensure medicinal product verification without hindering the movement of medicinal products within the single market, it should be possible for wholesalers and persons authorised or entitled to supply medicinal products to the public to verify the authenticity of and decommission a unique identifier in any Member State, regardless of where in the Union the medicinal product bearing that unique identifier was originally intended to be placed on the market. To this end, the status of a unique identifier should be synchronised between repositories and, where necessary, verification queries should be redirected by the central repository to the repositories serving the Member States where the product was intended to be placed on the market.

(35)

In order to ensure that the functioning of the repositories system supports an end-to-end verification of the authenticity of medicinal products, it is necessary to set out the characteristics and operations of the repositories system.

(36)

The investigation of suspected or confirmed incidents of falsification would benefit from knowing as much information as possible on the product subject to the investigation. For this reason, records of all operations concerning a unique identifier, including the users performing those operations and the nature of the operations should be stored in the repositories system, be accessible for the purpose of investigating events flagged as potential incidents of falsification in the repositories system, and be made immediately available to competent authorities upon request.

(37)

In accordance with Article 54a(3) of Directive 2001/83/EC, it is necessary to ensure the protection of personal data as provided for in Union law, the legitimate interests to protect information of a commercially confidential nature and the ownership and confidentiality of the data generated by the use of the safety features. For this reason, manufacturers, marketing authorisation holders, wholesalers and persons authorised or entitled to supply medicinal products to the public should only have ownership of and access to the data they generate when they interact with the repositories system. Although the present delegated Regulation does not require any personal data to be stored in the repositories system, the protection of personal data should be ensured in case users of the repositories use the repositories system for purposes which are outside the scope of this Regulation.

(38)

The information referred to in Article 33(2) of this Regulation and the information on the status of a unique identifier should stay accessible to all parties required to verify the authenticity of medicinal products, as such information is necessary for the proper performing of those verifications.

(39)

In order to avoid potential ambiguities and authentication errors, no unique identifiers having the same product code and serial number should be present in the repositories system at the same time.

(40)

In accordance with Article 54a(1) of Directive 2001/83/EC, medicinal products subject to prescription are to bear the safety features while medicinal products not subject to prescription are not allowed to. However, whether a medicinal product is subject to prescription is most often decided nationally and may vary across Member States. In addition, Member States may extend the scope of application of the safety features in accordance with Article 54a(5) of Directive 2001/83/EC. As a result, the same medicinal product may be required to bear the safety features in one Member State but not in another. In order to ensure the correct application of this Regulation, national competent authorities should, when requested, make available the information on the medicinal products placed on the market on their territory which shall bear the safety features, including those for which the scope of application of the unique identifier or of the anti-tampering device has been extended in accordance with Article 54a(5) of Directive 2001/83/EC, to the marketing authorisation holders, manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public.

(41)

Since a repository may use servers physically located in different Member States, or may be physically located in a Member State which is not the Member State it serves, national competent authorities should be allowed to perform or observe inspections in other Member States, subject to certain conditions.

(42)

The lists containing the medicinal products or product categories which, in the case of prescription medicinal products shall not bear the safety features, and in the case of non-prescription medicinal products shall bear the safety features, should be established considering the risk of and the risk arising from falsification of the medicinal products or product categories, in accordance with Article 54a(2)(b) of Directive 2001/83/EC, as amended. Those risks should be assessed on the basis of the criteria referred to in the said Article.

(43)

In order to avoid disruptions in the supply of medicinal products, transitional measures for medicinal products which have been released for sale or distribution without the safety features before the date of application of this Regulation in the Member State or Member States where the product is placed on the market are necessary.

(44)

At the time of entry into force of Directive 2011/62/EU of the European Parliament and of the Council, Belgium, Greece and Italy already had systems in place for the verification of the authenticity of medicinal products and for the identification of individual packs. Directive 2011/62/EU granted such Member States an additional transitional period for adapting to the harmonised Union system for safety features introduced by that Directive for the same purposes, by allowing them to defer their application of the Directive as regards that system. In order to ensure consistency between the national transposition measures adopted pursuant to the Directive, on the one hand, and the rules of this Regulation, on the other hand, those Member States should be allowed the same additional transitional period for the application of the rules of this Regulation regarding that system.

(45)

In the interest of legal certainty and legal clarity with regard to the applicable rules in those Member States which benefit from an additional transitional period in accordance with this Regulation, each of those Member States should be required to notify the Commission of the date from which the provisions of this Regulation subject to the additional transitional period apply in its territory in order for the Commission to publish the date of application in that Member State in the Official Journal of the European Union sufficiently in advance,

(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.

(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.

(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;

(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.

(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:

(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.

(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.

(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.

(a)

the authenticity of the unique identifier;

(b)

the integrity of the anti-tampering device.

(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.

(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.

(a)

the integrity of the anti-tampering device;

(b)

the authenticity of the unique identifier and decommission it if replaced.

(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)

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.

(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.

(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.

(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.

(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.

(a)

a central information and data router (‘hub’);

(b)

repositories which serve the territory of one Member State (‘national repositories’) or the territory of multiple Member States (‘supranational repositories’). Those repositories shall be connected to the hub.

(a)

upload, collate, process, modify and store the information on the safety features that enables the verification of the authenticity and identification of medicinal products;

(b)

identify an individual pack of a medicinal product bearing the safety features and verify the authenticity of the unique identifier on that pack and decommission it at any point of the legal supply chain.

(a)

the data elements of the unique identifier in accordance with Article 4(b);

(b)

the coding scheme of the product code;

(c)

the name and the common name of the medicinal product, the pharmaceutical form, the strength, the pack type and the pack size of the medicinal product, in accordance with the terminology referred to in Article 25(1)(b) and (e) to (g) of the Commission Implementing Regulation (EU) No 520/2012 (4);

(d)

the Member State or Member States where the medicinal product is intended to be placed on the market;

(e)

where applicable, the code identifying the entry corresponding to the medicinal product bearing the unique identifier in the database referred to in Article 57(1)(l) of Regulation (EC) No 726/2004 of the European Parliament and the Council (5);

(f)

the name and address of the manufacturer placing the safety features;

(g)

the name and address of the marketing authorisation holder;

(h)

a list of wholesalers who are 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)

it shall be physically located in the Union;

(b)

it shall be set up and managed by a non-profit legal entity established in the Union by manufacturers and marketing authorisation holders of medicinal products bearing the safety features and, where they have chosen to participate, wholesalers and persons authorised or entitled to supply medicinal products to the public;

(c)

it shall be fully interoperable with the other repositories composing the repositories system; for the purposes of this Chapter, interoperability means the full functional integration of, and electronic data exchange between repositories regardless of the service provider used;

(d)

it shall allow the reliable electronic identification and authentication of individual packs of medicinal products by manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public, in accordance with the requirements of this Regulation;

(e)

it shall have application programming interfaces able to transfer and exchange data with the software used by wholesalers, persons authorised or entitled to supply medicinal products to the public and, where applicable, national competent authorities;

(f)

when wholesalers and persons authorised or entitled to supply medicinal products to the public query the repository for the purposes of verification of authenticity and decommissioning of a unique identifier, the response time of the repository, not considering the speed of the internet connection, shall be lower than 300 milliseconds in at least 95 % of queries. The repository performance shall allow wholesalers and persons authorised or entitled to supply medicinal products to the public to operate without significant delay;

(g)

it shall maintain a complete record (‘audit trail’) of all operations concerning a unique identifier, of the users performing those operations and the nature of the operations; the audit trail shall be created when the unique identifier is uploaded to the repository and be maintained until at least one year after the expiry date of the medicinal product bearing the unique identifier or five years after the product has been released for sale or distribution in accordance with Article 51(3) of Directive 2001/83/EC, whichever is the longer period;

(h)

in accordance with Article 38, its structure shall be such as to guarantee the protection of personal data and information of a commercially confidential nature and the ownership and confidentiality of the data generated when manufacturers, marketing authorisation holders, wholesalers and persons authorised or entitled to supply medicinal products to the public interact with it;

(i)

it shall include graphical user interfaces providing direct access to it to the following users verified in accordance with Article 37(b):

(a)

the repeated verification of the authenticity of an active unique identifier in accordance with Article 11;

(b)

the triggering of an alert in the system and in the terminal where the verification of the authenticity of a unique identifier is taking place when such verification fails to confirm that the unique identifier is authentic in accordance with Article 11. Such an event shall be flagged in the system as a potential incident of falsification except where the product is indicated in the system as recalled, withdrawn or intended for destruction;

(c)

the decommissioning of a unique identifier in accordance with the requirements of this Regulation;

(d)

the combined operations of identification of a pack of a medicinal product bearing a unique identifier and verification of the authenticity and decommissioning of that unique identifier;

(e)

the identification of a pack of a medicinal product bearing a unique identifier and the verification of the authenticity and the decommissioning of that unique identifier in a Member State which is not the Member State where the medicinal product bearing that unique identifier was placed on the market;

(f)

the reading of the information contained in the two-dimensional barcode encoding the unique identifier, the identification of the medicinal product carrying the barcode and the verification of the status of the unique identifier, without triggering the alert referred to in point (b) of this Article;

(g)

without prejudice to Article 35(1)(h), the access by verified wholesalers to the list of wholesalers referred to in Article 33(2)(h) for the purposes of determining whether they have to verify the unique identifier of a given medicinal product.

(h)

the verification of the authenticity of a unique identifier and its decommissioning by manually querying the system with the data elements of the unique identifier;

(i)

the immediate provision of information concerning a given unique identifier to the national competent authorities and the European Medicines Agency, upon request;

(j)

the creation of reports that allow competent authorities to verify compliance of individual marketing authorisation holders, manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public with the requirements of this Regulation or to investigate potential incidents of falsification;

(k)

the reverting of the status of a unique identifier from decommissioned to active, subject to the conditions referred to in Article 13;

(l)

the indication that a unique identifier has been decommissioned;

(m)

the indication that a medicinal product has been recalled, withdrawn, stolen, exported, requested as a sample by national competent authorities, indicated as a free sample by the marketing authorisation holder, or is intended for destruction;

(n)

the linking, by batches of medicinal products, of the information on unique identifiers removed or covered to the information on the equivalent unique identifiers placed on those medicinal products for the purposes of complying with Article 47a of Directive 2001/83/EC.

(o)

the synchronisation of the status of a unique identifier between the national or supranational repositories serving the territory of the Member States where that medicinal product is intended to be placed on the market.

(a)

inform the relevant national competent authorities of its intention to physically locate the repository or part of it in their territory and notify them once the repository becomes operational;

(b)

put in place security procedures ensuring that only users whose identity, role and legitimacy has been verified can access the repository or upload the information referred to in Article 33(2);

(c)

continuously monitor the repository for events alerting to potential incidents of falsification in accordance to Article 36(b);

(d)

provide for the immediate investigation of all potential incidents of falsification flagged in the system in accordance with Article 36(b) and for the alerting of national competent authorities, the European Medicines Agency and the Commission should the falsification be confirmed;

(e)

carry out regular audits of the repository to verify compliance with the requirements of this Regulation. Audits shall take place at least annually for the first five years after this Regulation becomes applicable in the Member State where the repository is physically located, and at least every three years thereafter. The outcome of those audits shall be provided to competent authorities upon request;

(f)

make the audit trail referred to in Article 35(1)(g) immediately available to competent authorities upon their request;

(g)

make the reports referred to in Article 36(j) available to competent authorities upon their request.

(a)

supervising the functioning of the repositories and investigating potential incidents of falsification;

(b)

reimbursement;

(c)

pharmacovigilance or pharmacoepidemiology.

(a)

ensure the decommissioning of the unique identifier of a medicinal product which is to be recalled or withdrawn, in every national or supranational repository serving the territory of the Member State or Member States in which the recall or the withdrawal is to take place;

(b)

ensure the decommissioning of the unique identifier, where known, of a medicinal product which has been stolen, in every national or supranational repository in which information on that product is stored;

(c)

indicate in the repositories referred to in points (a) and (b) that that product has been recalled or withdrawn or stolen, where applicable.

(a)

the medicinal products placed on the market on their territory which shall bear the safety features in accordance with Article 54(o) of Directive 2001/83/EC and this Regulation;

(b)

the medicinal products subject to prescription or subject to reimbursement for which the scope of the unique identifier is extended for the purposes of reimbursement or pharmacovigilance, in accordance with Article 54a(5) of Directive 2001/83/EC;

(c)

the medicinal products for which the scope of the anti-tampering device is extended for the purpose of patient safety, in accordance with Article 54a(5) of Directive 2001/83/EC.