(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.
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)
Modified by
- Commission Delegated Regulation (EU) 2021/457of 13 January 2021amending Delegated Regulation (EU) 2016/161 as regards a derogation from the obligation of wholesalers to decommission the unique identifier of products exported to the United Kingdom(Text with EEA relevance), 32021R0457, March 17, 2021
(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: (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.
(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 Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (OJ L 159, 20.6.2012, p. 5 ).(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 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1 ).(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): (i) wholesalers and persons authorised or entitled to supply medicinal products to the public, for the purposes of verifying the authenticity of the unique identifier and decommissioning it in case of failure of their own software; (ii) national competent authorities, for the purposes referred to in Article 39;
(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.
| Name of active substance or product category | Pharmaceutical form | Strength | Remarks |
|---|---|---|---|
| Homeopathic medicinal products | Any | Any | |
| Radionuclide generators | Any | Any | |
| Kits | Any | Any | |
| Radionuclide precursors | Any | Any | |
| Advanced therapy medicinal products which contain or consist of tissues or cells | Any | Any | |
| Medicinal gases | Medicinal gas | Any | |
| Solutions for parenteral nutrition having an anatomical therapeutical chemical ("ATC") code beginning with B05BA | Solution for infusion | Any | |
| Solutions affecting the electrolyte balance having an ATC code beginning with B05BB | Solution for infusion | Any | |
| Solutions producing osmotic diuresis having an ATC code beginning with B05BC | Solution for infusion | Any | |
| Intravenous solution additives having an ATC code beginning with B05X | Any | Any | |
| Solvents and diluting agents, including irrigating solutions, having an ATC code beginning with V07AB | Any | Any | |
| Contrast media having an ATC code beginning with V08 | Any | Any | |
| Tests for allergic diseases having an ATC code beginning with V04CL | Any | Any | |
| Allergen extracts having an ATC code beginning with V01AA | Any | Any |
| Name of active substance or product category | Pharmaceutical form | Strength | Remarks |
|---|---|---|---|
| omeprazole | gastro-resistant capsule, hard | 20 mg | |
| omeprazole | gastro-resistant capsule, hard | 40 mg |
| Notification to the European Commission of medicinal products not subject to prescription judged to be | |||||
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| Notification to the European Commission of medicinal products judged | |||||
| Member State: | Name of competent authority: | ||||
| Entry No | Active substance (Common Name) | Pharmaceutical form | Strength | Anatomical Therapeutical Chemical (ATC) Code | Comments/Complementary information |
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