New product code functionality starting Multiple product codes for each article number

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1 To our submitters of medicines New product code functionality starting Multiple product codes can be added to each article number in VareWeb Product codes for inner packs can be registered in VareWeb for use in hospitals and hospital pharmacies. As a result, the documentation requirements during submission have increased to allow comparison between registered product codes and the corresponding barcode on the package. The changes apply to medicines with marketing authorization and pharmacy produced medicines, but not for medicines without marketing authorization. Terms: Product code: a series of digits, NTIN or GTIN, used as a unique identifier of products in master data systems. The term barcode has inaccurately been used as a synonym for product code. This will now be changed in VareWeb. Barcode: an optical, machine-readable data carrier on the package that provides unique identification upon scanning. The term barcode includes used both one-dimensional, linear barcodes (EAN-13) and two-dimensional barcodes, 2D Data Matrix, that carry multiple features of information. Multiple product codes for each article number Starting , it will be possible to change the barcode/product code on an active/marketed product without changing the article number. This one-to-many functionality allows a smooth transition from the NTIN to the GTIN format for product codes. Many companies wish to employ GTIN in preparation of the future requirements for a 2D Data Matrix that will apply according to the Falsified Medicines Directive starting In practice, this means that you can add multiple product codes to each article number. This new functionality is located under the heading called Product codes in VareWeb. You can add multiple product codes from , but the wholesalers and pharmacies will not be able to handle physical packages with new barcodes until Information regarding existing and new product codes will be submitted to the users via data files, thereby allowing wholesalers and pharmacies to scan packages with different barcodes/ product codes that identify the same article number. To ensure that a product code is linked to the correct product, you should upload a mock-up or an image of the package with a visible barcode during registration of new products and during registration of new product codes. It will not be possible to submit a new product code without uploading documentation. As a quality control measure, Farmalogg will compare the registered product code with the uploaded mock-up/image. The uploaded mock-up/image therefore needs to be of high quality and the text (i.e. GTIN presented as digits) human readable. Registering a correct product code is however still the responsibility of the company. Importantly, it is the responsibility of the company to comply to the guidelines for product codes, GTIN: GS1_Healthcare_GTIN_Allocation_Rules_ Also see CHANGE SITUATIONS VNR vs. GTIN 1

2 Product codes for inner packs for use in hospitals and hospital pharmacies. Background Hospitals and hospital pharmacies collaborate on bedside scanning, where identification of medications is of crucial importance. To allow electronic identification of medications before administering them to patients, it is necessary to be able to scan the barcode of the individual medication dose. This requires both that a barcode exists on the individual dose, and corresponding product code in master data systems/article registers that handles scanning of barcodes regardless of the packaging level being scanned (primary-, secondary or tertiarypackaging). Starting , it will be possible to register product codes for inner packs at different packaging levels in VareWeb. VareWeb has been upgraded with new functionality to meet the needs of hospital pharmacies and hospitals, both for internal logistics and for bedside scanning. The information registered for inner packs will be integrated in a packaging hierarchy that will be transmitted to wholesalers and pharmacies. The organization of this hierarchy is based on the GTIN guidelines and ISO-standard 16791:2014. In practice, companies can now add product codes to inner packs by using the heading Product codes in VareWeb. When registering a new product, you can register product codes both for the consumer unit and for the inner pack at the same time. This functionality will be available in VareWeb from , but product codes for inner packs will not be submitted to hospital pharmacies/hospitals until at the earliest. We expect that hospitals and hospital pharmacies will be ready to employ product codes for inner packs during first half of To ensure that a product code for an inner pack is linked to the correct product, a mock-up or an image of the barcode needs to be uploaded during product code registration. It will not be possible to submit a new product code for inner packs without uploading documentation. As a quality control measure, Farmalogg will compare the registered product code to the uploaded mock-up/image. The uploaded mock-up/image therefore needs to be of high quality and the text (i.e. GTIN presented as digits) human readable. Registering a correct product code is however still the responsibility of the company. It is the responsibility of the company to comply to the guidelines for product codes, GTIN GS1_Healthcare_GTIN_Allocation_Rules_ The organization of the packaging hierarchy is described in the ISO-standard 16791:2014 and is mentioned in the GS1 Healthcare GTIN Allocation Rules. Attachments: 1) New functionality for product codes - medicines (complementary practical information) 2) Product codes for multiple packaging levels - medicines (complementary information with illustration of packaging hierarchy, terms etc.). 2

3 Attachment 1 New functionality for product codes in VareWeb - medicines A product code is a series of digits, usually in the GTIN format, used as a unique identifier of products in master data systems. The term barcode has inaccurately been used as a synonym for product code, and the field heading called barcode is now changed to product code in VareWeb. A barcode is a machine-readable carrier of information printed on the package that provides unique identification upon scanning. Starting , it will be possible to change the barcode on a package without changing the article number (Vnr). In addition, it will be possible to register product code to inner packs for medicines. In practice, this means that you can add multiple product codes to each article number. These new functionalities are located under the heading called Product codes in VareWeb. Please note the following changes in VareWeb when submitting a new product or a new product code for consumer unit or inner pack: 1. Registration of a new product In addition to registering product codes for the consumer unit, you may now register product codes for inner packs of the consumer unit, given that this inner pack has a barcode. Registering product codes for inner packs will be possible for medicines with marketing authorization and pharmacy produced medicines. Similar as before, you should upload a mock-up or high-quality image of the package with a visible product code. This is also required when registering product codes for inner packs. To ensure that the product code is linked to the correct product, Farmalogg will compare the uploaded mockup/image with the registered product code. After your submission has been evaluated by Farmalogg, it will not be possible to change the product code, please see point 3 below. 2. Add product code to consumer unit or inner pack to an existing product When adding a new product code for a costumer unit or for an inner pack, you need to upload a mock-up or high-quality image of the package with a visible product code. To ensure that the product code is linked to the correct package, Farmalogg will compare the uploaded mock-up/image with the registered product code. If the wrong product code is submitted, it will not be possible to correct this, please see point 3 below. 3. Submitted product code is incorrect If the submitted product code contains incorrect digits, these digits cannot be corrected by Farmalogg. In such a case, the submitted product code must be cancelled and you must submit the product code over again. The reason that it is not possible to change submitted product codes is a new functionality and validation when registering product codes for inner packs for medicines. 4. Product code overview At the site Product code Consumer Unit, you will have access to all consumer unit product codes registered for a product, and this overview can be exported to Excel. Product codes for inner packs will not be shown at this site. At the site Product code Inner Pack, you will have access to all product codes for both the consumer unit and inner pack for a given product, and this overview can be exported to Excel. 3

4 Attachment 2 Product codes for multiple packaging levels - medicines With the new functionality in VareWeb, it will be possible to register product codes on multiple packaging levels for inner packs linked to Consumer Unit, in a packaging hierarchy, see illustration below. For example: Antibiotic X, solution for injection, 4x3x4x2ml In this example, the packaging levels are: Primary level 2ml Secondary level 4x2ml Tertiary level 3x4x2ml Quaternary level 4x3x4x2ml Note: terms like secondary package relates to the level in the packaging level in the hierarchy, not to the packaging material. Illustration from GS1_Healthcare_GTIN_Allocation_Rules_ See next page for an illustration of the packaging hierarchy. Note: All packaging levels in the hierarchy need a product code that unambiguously identifies the package. The hospital pharmacies state that companies that currently print the same barcode/product code on different packaging levels need to correct this as soon as possible. If changing the product code on an inner pack, the product code on higher packaging levels in the hierarchy needs to be changed as well. When changing the product code of a secondary package, you can keep the old inner pack product code, and link it to the new secondary package product code. Incorrect product codes will be declined by Farmalogg. Incorrect product codes that are cancelled after being approved cannot be reused for the same product. 4

5 Terms Packaging hierarchy The hierarchically organized relations between different packaging levels of a product. According to the GS1-standard, all packages in a packaging hierarchy should have a unique barcode. See the illustration below. Packaging hierarchy from single dose to transport pallet. Source: GS1 Denmark. Article number (Vnr): Article number for the consumer unit package, used as an information carrier in the article register and by the Norwegian authorities to link marketed packages to prices, refunds and interchangeability of generics. Product code: a series of digits, NTIN or GTIN, used as a unique identifier of products in master data systems. The term barcode has inaccurately been used as a synonym for product code. Barcode: an optical, machine-readable data carrier on the package that provides unique identification upon scanning. The term barcode includes used both one-dimensional, linear barcodes (EAN-13) and two-dimensional barcodes, 2D Data Matrix, that carry multiple features of information. One-dimensional (or linear) barcode: For example, EAN-13, in practice GTIN or NTIN (see below). Two-dimensional barcode: For example, 2D Data Matrix where the product code is one of several features of information. NTIN (National Trade Item Number): NTIN is a GTIN with a common Nordic prefix that is owned by the Nordic Number Centre in Finland (NNC). As a result, the prefix does not identify the marketing authorization holder. The NTIN contains the Nordic article number and can therefore only be changed if the article number changes. The NTIN does not make distinction between packages to the same extent as the GTIN, and is not always a unique identifier. An article number can only have one NTIN, but multiple GTINs. 5

6 GTIN (Global Trade Item Number): the GTIN is used for the unique identification of trade items worldwide. The GTIN normally consists of 13 digits and contains a countryspecific prefix, the company number, an internal item reference number and a check digit. F-pak: The consumer unit with an article number. Bedside scanning: A digital system for handling medications where all information from prescription to administration is communicated seamlessly between different systems. All documentation throughout the process is electronic and traceable. The system follows the individual medication throughout the process. Clinical package: Several consumer units packed together and registered with its own article number. Thus, the clinical package is by definition also a consumer unit. Meant for sales to hospitals, hence the name. All packaging levels in the hierarchy needs a barcode/product code that uniquely identifies the package and separates it from other packaging levels. Multipackage or multiple package: A package similar to a clinical package. This is a more generic term used for a package that consists of several packages. The multipackage may or may not have its own article number. Primary level: The smallest packaged unit. This could be a box of tablets, an ampoule, a pre-filled syringe etc. Secondary level: Package that contains defined units, inner packs. Often this is the consumer unit with its own article number. As an example, this could be ten vials packaged in a carton. Tertiary level: a package that contains secondary level packs. This is often the clinical package with its own article number or a retail package. Quaternary level: a package that contains multiple tertiary level packs. This is often an assembly of retail packages or a transport pallet. 6