Packaging of medicinal products

Marketing Authorisation Holders may apply for common Nordic packs for medicinal products for humans and animals.

The Guideline on Nordic Packages contains information on the way Marketing Authorisation Holders may form mock-ups for common Nordic packs. Guidelines and application forms may be found on the MPA’s website, Sweden. All Marketing Authorisation Holders are expected to continuously stay updated on:

• Guideline on Nordic Packages 
• Q&A Nordic Packages 
• Request for Nordic mock-up cooperation (updated 02.09.2024)

 All documents are published on the MPA website(External link)(External link).

Marketing Authorisation Holders may submit enquiries regarding Nordic packages by using the Question to the Nordic Package group. 

From 1st of January 2025 a pilot on English-language common Nordic packages will start.

The pilot will explore the use of English language on common Nordic packages, on the pack itself and the printed package leaflet. Medicinal products produced in low volumes, administrated by healthcare personnel and listed on the shared Nordic list to be exempt from Nordic language requirements.

Norwegian package leaflet will be available in digital format.

The pilot will last for 5 years and MAH are encouraged to apply if they have medicinal products that fulfills the criteria. The pilot concerns the Nordic countries Denmark, Finland, Iceland, Norway and Sweden.

See application form, guideline, the Nordic list and more information about the pilot on the MPAs website.  

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/(External link).

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 farmalogg@apotek.no

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.

For information about the unique identifier on labelling/mock-ups (human) in connection with the Falsified Medicines Directive.

Questions and Answers - Unique identifier (pdf)

For some medicinal products, LIS (Sykehusinnkjøp HF, divisjon legemidler) requires the inclusion of a 2D code 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 code on the immediate packaging. The legislation does not prohibit the use of a 2D code on the immediate packaging. However, the inclusion of a 2D code is not a requirement in the legislation.
• The 2D code 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 code 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 code in all procedures. For medicinal products approved through the purely national procedure and the MRP/DCP a 61(3) notification can be submitted to pi@noma.no. 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.

Industry standard for product codes