prop · H603106 · 2019-04-09 00:00:00 — (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. 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. 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: (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 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)‘unique identifier’ means a unique identifier which has not been decommissioned or which is no longer decommissioned; (e)‘status’ means the status of an 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. TECHNICAL SPECIFICATIONS OF THE UNIQUE IDENTIFIER 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-determi nistic randomisation algorithm (‘serial number’); (iii)a national reimbursement number or other national number identifying the medicinal product, if required by the where the product is intended to be placed on the market; L 32/8 (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. of the unique identifier 1.Manufacturers shall encode the unique identifier in a two-dimensional barcode. 2.The barcode shall be a machine-readable Data Matrix and have error detection and correction equivalent to or higher than those of the Data Matrix ECC200. Barcodes conforming to the ation/International Electrotechnical Commission standard (‘ISO/IEC’) 16022:2006 shall be presumed to fulfil the requirements set out in this paragraph. 3.Manufacturers shall print the barcode on the packaging on a smooth, uniform, low-reflecting surface. 4.When encoded in a Data Matrix, the structure of the unique identifier shall follow an internationally-recognised, standardised data syntax and semantics (‘coding scheme’) which allows the identification and accurate decoding of each data element of which the unique identifier is composed, using common scanning equipment. The coding scheme shall include data identifiers or application identifiers or other character sequences identifying the beginning and the end of the sequence of each individual data element of the unique identifier and defining the information contained in those data elements. Unique identifiers having a coding scheme conforming to ISO/IEC 15418:2009 shall be presumed to fulfil the requirements set out in this paragraph. 5.When encoded in a Data Matrix as data element of a unique identifier, the product code shall follow a coding scheme and begin with characters specific to the coding scheme used. It shall also contain characters or character sequences identifying the product as a medicinal product. The resulting code shall be less than 50 characters and be globally unique. Product codes which conform to the ISO/IEC 15459-3:2014 and ISO/IEC 15459-4:2014 shall be presumed to fulfil the requirements set out in this paragraph. 6.Where necessary, different coding schemes may be used within the same unique identifier provided that the decoding of the unique identifier is not hindered. In that case, the unique identifier shall contain standardised characters permitting the identification of the beginning and the end of the unique identifier as well as the beginning and the end of each coding scheme. Where containing multiple coding schemes, unique identifiers which conform to ISO/IEC 15434:2006 shall be presumed to fulfil the requirements set out in this paragraph. Quality of the printing of the two-dimensional barcode 1.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; L 32/9 (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. 2.Manufacturers shall identify the minimum quality of the printing which ensures the accurate readability of the Data Matrix throughout the supply chain 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. 3.When printing the Data Matrix, manufacturers shall not use a quality of the printing lower than the minimum quality referred to in paragraph 2. 4.A quality of printing rated at least 1,5 in accordance with ISO/IEC 15415:2011 shall be presumed to fulfil the requirements set out in this Article. 1.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 where the product is intended to be placed on the market and not printed elsewhere on the packaging. 2.Paragraph 1 shall not apply where the sum of the two longest dimensions of the packaging equals or is less than 3.Where the dimensions of the packaging allow it, the human-readable data elements shall be adjacent to the two- dimensional barcode carrying the unique identifier. 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. 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. L 32/10 GENERAL PROVISIONS ON THE VERIFICATION OF THE SAFETY FEATURES 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. 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 unique identifier with the product code and serial number that are identical to those of the unique identifier being verified. 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. Reversing the status of a decommissioned unique identifier 1.Manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public may only the status of a decommissioned unique identifier to an 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; L 32/11 (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. 2.Medicinal products bearing a unique identifier which cannot be reverted to an status because the conditions set out in paragraph 1 are not fulfilled shall not be returned to saleable stock. MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE 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. 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. Verifications to be performed before removing or replacing the safety features 1.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. 2.Manufacturers holding both a manufacturing authorisation according to Article 40 of Directive 2001/83/EC and an authorisation to manufacture or import investigational medicinal products to the Union as referred to in Article 61 of Regulation (EU) No 536/2014 of Parliament and of the Council (1) shall verify the safety features and decommission the unique identifier on a pack of medicinal product before repackaging or re-labelling it for the purpose of using it as authorised investigational medicinal product or authorised auxiliary medicinal product. (1) Regulation (EU) No 536/2014 of Parliament and of the Council of on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. L 32/12 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 where the medicinal product is intended to be placed on the market, so that that unique identifier can be verified for authenticity and decommissioned. 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. 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. MODALITIES OF VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE 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. 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 between two warehouses belonging to the same wholesaler or the same legal entity, and no sale takes place. 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; L 32/13 (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. 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 practitioners; (f)armed forces, and other governmental institutions maintaining stocks of medicinal products for the purposes of civil protection and disaster control; (g)universities and other higher education 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. 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. 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 Obligations of persons authorised or entitled to supply medicinal products to the public 1.Persons authorised or entitled to supply medicinal products to the public shall verify the safety features and decommission the unique identifier of any medicinal product bearing the safety features they supply to the public at the time of supplying it to the public. 2.Notwithstanding paragraph 1, persons authorised or entitled to supply medicinal products to the public operating within a healthcare institution may carry out that verification and decommissioning at any time the medicinal product is in the physical possession of the healthcare institution, provided that no sale of the medicinal product takes place between the delivery of the product to the healthcare institution and the supplying of it to the public. L 32/14 3.In order to verify the authenticity of the unique identifier of a medicinal product and decommission that unique identifier, persons authorised or entitled to supply medicinal products to the public shall connect to the repositories system referred to in Article 31 through the national or supranational repository serving the territory of the in which they are authorised or entitled. 4.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. Derogations from Article 25 1.Persons authorised or entitled to supply medicinal products to the public are exempted from the obligation to verify the safety features and decommission the unique identifier of medicinal products provided to them as free samples in accordance with Article 96 of Directive 2001/83/EC. 2.Persons authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy are exempted from the obligation to verify the safety features and decommission the unique identifier of medicinal products where that obligation has been placed on wholesalers by national legislation in accordance with Article 23. 3.Notwithstanding Article 25, Member States may decide, where necessary to accommodate the particular character istics 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. 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. Obligations when supplying only part of a pack Notwithstanding Article 25(1), where persons authorised or entitled to supply medicinal products to the public supply only part of a pack of a medicinal product the unique identifier of which is not decommissioned, they shall verify the safety features and decommission that unique identifier when the pack is opened for the first time. L 32/15 Obligations in case of inability to verify the authenticity and decommission the unique identifier Notwithstanding Article 25(1), where technical problems prevent persons authorised or entitled to supply medicinal products to the public from verifying the authenticity of and decommissioning a unique identifier at the time the medicinal product bearing that unique identifier is supplied to the public, those persons authorised or entitled to supply medicinal products to the public shall record the unique identifier and, as soon as the technical problems are solved, verify the authenticity of and decommission the unique identifier. Actions to be taken by persons authorised or entitled to supply medicinal products to the public in case of suspected falsification Where persons authorised or entitled to supply medicinal products to the public have reason to believe that the packaging of the medicinal product has been tampered with, or the verification of the safety features of the medicinal product indicates that the product may not be authentic, those persons authorised or entitled to supply medicinal products to the public shall not supply the product and shall immediately inform the relevant competent authorities. , MANAGEMENT AND ACCESSIBILITY OF THE REPOSITORIES SYSTEM of the repositories system 1.The repositories system where the information on the safety features shall be contained, pursuant to Article 54a(2)(e) of Directive 2001/83/EC, shall be set up and managed by a non-profit legal entity or non-profit legal entities established in the Union by manufacturers and marketing authorisation holders of medicinal products bearing the safety features.