National guideline on packaging
The national guideline on packaging is based on the Norwegian regulation (Forskrift om legemidler til mennesker) § 3-29-§ 3-41, according to the Directive (EU) 2001/83. Further the guideline is based on the Norwegian Regulation m.v. § 2b. according to Article 10 -13 in the Directive (EU) 2019/6 on veterinary medicinal products, as well as § 5-1 - § 5-3 in the "Forskrift om legemidler til dyr".
Guideline and Q&A on Nordic packages
The Guideline on Nordic Packages document contains general information on Nordic packages, whereas the Frequently Asked Questions document gives detailed advice on different package issues. These documents apply to medicinal products for both human and veterinary use. Marketing authorisation holders may submit questions regarding issues relating to Nordic packages. For this purpose a specific form, Question to the Nordic package group should be used. All documents are published on the MPA website.
Regarding requests for common Nordic assessment for mock-ups, please use the form ”Request for a Nordic mock- up cooperation for a marketing authorisation procedure/61(3) notification (hum)/C.II.6 variation (vet)”. The request form and further information about this procedure is found on the MPA website.
Blue box requirements
Blue box is additional information on labelling that may be required or permitted nationally in accordance with Articles 58 and 64 of Directive 2001/82/EC
There are no requirements for the legal status to appear on the label, except for packages intended for dose dispensing. Norwegian text required on the labelling: «Kun til dosedispensering»
Identification and authenticity
The Nordic number is required on the outer labelling of all medicinal products. It is written as "Vnr XX XX XX". The EAN code (bar code) is accepted but not required on the labelling. For further information and application for Nordic article Numbers, please refer to http://wiki.vnr.fi/.
The EAN code (bar code) is accepted but not required on the labelling.
Symbols and pictograms
Medicinal products containing inflammable material must bear the international warning symbol (pdf).
Medicinal products which reduce the ability to drive or operate machines must have a warning triangle on the outer and inner packaging.
61(3) notifications for information only
Some changes concerning the labelling can be submitted as a 61(3) notification for information only. The notificationwill benoted and no approval will be issued. See changes to packaging for human medicinal products for information only (pdf).
Unique identifier/FMD Q&A
For information about the unique identifier on labelling/mock-ups (human) in connection with the Falsified Medicines Directive.
2D barcode on immediate packaging
For some medicinal products, LIS (Sykehusinnkjøp HF, divisjon legemidler) requires the inclusion of a 2D barcode on the immediate packaging. The Norwegian Medical Products Agency is often asked if LIS can make such a demand:
- Yes, LIS can require a 2D barcode on the immediate packaging. The legislation does not prohibit the use of a 2D barcode on the immediate packaging. However, the inclusion of a 2D barcode is not a requirement in the legislation.
- The 2D barcode can be placed on the immediate packaging, as long as the statutory information is included and the readability requirement of the statutory information is fulfilled.
- Statutory information for small immediate packaging is name, strength, pharmaceutical dose form, method of administration, active substance, expiry date, batch no. and contents by weight, by volume or by unit.
- Statutory information for blister packs included each perforated blister is name, strength, pharmaceutical dose form, active substance, expiry date, batch no. and marketing authorisation holder.
- The 2D barcode can include information already included on the labelling, e.g. PC (product code) (name, strength and pharmaceutical form), shelf life and batch number.
A mock-up of the immediate packaging must be approved with the 2D barcode in all procedures. For medicinal products approved through the purely national procedure and the MRP/DCP a 61(3) notification can be submitted to firstname.lastname@example.org. The changes can also be included in an ongoing variation including update of the mock-ups.
For centrally authorised medicinal products, the mock-ups are approved by the EMA.
Nordic article number (Varenummer (Vnr)) - general information
According to the national regulations, the outer packaging must contain a Nordic article number. Nordic Number Center in Finland is responsible for the allocation of numbers. For further information and details on how to apply for a Nordic article number, see http://wiki.vnr.fi/.
Change in trade name requires a change of Nordic article number (Vnr)
To change the Nordic article number:
- Submit an application for a new Nordic article number to PIC in Finland.
- Inform Farmalogg about the new article number. It must be registered and processed as a new product in Farmalogg.
Only two article numbers can be in sale at the same time, due to the functionality of the FEST register. If a third article number is registered for sale, the oldest article number will lose reimbursement.
The article number provides a unique identity for a specific package, which is essential when buying and selling medicinal products. Each article number carries information necessary for the proper logistics and handling of the medicinal product at pharmacies, wholesalers, suppliers and prescribers. The article number is also a prerequisite for all public statistics. All medicinal products in Farmalogg's national article register (Vareregisteret) must have an article number, and all the electronic information about a medicinal product is linked to the article number.
For information regarding Farmaloggs national article register (Vareregisteret), contact email@example.com
Change of Nordic Article Number when changing the packaging structure
The Norwegian Medical Products Agency delivers a new solution for the distribution of medicinal products data to the specialist health service. For increased data quality and better interaction between different national regulatory authorities, information must be structured according to the current international standard, ISO-IDMP (Identification of Medicinal Products) and GS1 standard (product codes). Information about the medicinal products is delivered in FHIR format, categorized into Medicinal Products, Packaged Products, Manufactured Items, Administrable Products and Ingredient.
Packages are structured according to the number of package levels. These package levels: primary, secondary and tertiary levels represent inner, intermediate and outer packaging depending on how the physical packaging looks like. The product codes can be placed on various levels where they exist, so that each level can be uniquely identified. The packaging structure in the new solution supports a closed medication loop in the hospitals, so that healthcare personnel can scan and track prepared medication to be administered to patients.
A consistent packaging structure is necessary to deliver correct information to the hospitals. The change in packaging that leads to a changed package level must trigger a change of Nordic Article number, even if the content as quantity/quantity is the same. This is to avoid the same Nordic Article number representing two different physical packages, which leads to errors in the systems in the hospitals. Such situations are unfortunate and create confusion and unnecessary extra work for healthcare personnel.
When the packaging level changes, the MA holder/representative of the medicinal product is responsible for applying for a new Nordic Article number at the Nordic Number Centre/Pharmaca Health, and then registering it as a new product at Farmalogg.