Product information should always be submitted in an electronic format. SmPC and PIL should be submitted in word format (with tracked changes for variations) and mock-ups in pdf format.
Templates for the Norwegian translation of the product information are available below:
The Best Practice Guide on the submission of high quality national translations (published by CMDh) aims to improve the quality of translations of the agreed product information submitted during the national implementation phase of the procedures.
The warning triangle
All medicinal products for human use containing an active substance stated in the warning triangle list from the NoMA, shall bear the warning triangle. The requirement applies regardless of what type of procedure the medicinal product has been approved in.
Naming of medicinal products
Guideline for the naming of medicinal products
Blue box requirements for the PIL
If the medicinal product is fully or partially exempted from prescription, the indication and posology approved for OTC status should be clearly stated under the respective heading. In addition to the below Blue Box texts there might be additional requirements concerning the OTC status. As the legal status may differ between MSs, there is a need for the possibility to make additional amendments and/or delete information about indications, dosage and also important warnings approved for OTC.
Under the heading in section 1 (May be omitted for products intended for hospital use only, and administered by health care professionals)
«Vær oppmerksom på at legen kan ha foreskrevet legemidlet til en annen bruk og/eller med en annen dosering enn angitt i pakningsvedlegget. Følg alltid legens forskrivning som er angitt på apoteketiketten.»
Under the heading “Driving and using machines” (Applies to all products except mineral and/or vitamin containing products and most products for topical use)
«Du må bare kjøre bil eller utføre risikofylt arbeid når det er trygt for deg. Legemidler kan påvirke din evne til å kjøre bil eller utføre risikofylt arbeid. Les informasjonen i pakningsvedlegget nøye. Er du i tvil må du snakke med lege eller apotek.»
Under the heading ”If you take more X than you should”
«Kontakt lege, sykehus eller Giftinformasjonen (tlf. 22 59 13 00) hvis du har fått i deg for mye legemiddel eller hvis barn har fått i seg legemiddel ved et uhell. For andre spørsmål om legemidlet, kontakt lege eller apotek.»
The NoMA has a guideline for applicants to use when designing the mock-ups (in Norwegian). The guideline is based on the Norwegian Regulation (Forskrift om legemidler) § 3-29-§ 3-41.
Some changes to the labelling can be submitted for information only (in Norwegian). This applies to some 61(3)-notifications and the requirements for such notifications are listed in this document.
Please note that the NoMA requires mock-ups of the labelling in pdf format for approval. The translation of the labelling text in word format (QRD template) is not appropriate when submitting labelling for approval.
Information about the implementation of the unique identifier on labelling/mock-ups (human) in connection with the Falsified Medicines Directive:
Questions and Answers - Unique identifier
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 Medicines 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.
- 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 email@example.com. 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.
Guidance 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.
Any batch QP released 6 months or more after an approval must contain the changes.
Blue box requirements for the labelling
There is no requirement 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»
The local representative may be indicated in the “blue box” on the labeling, by name, telephone number and/or e-mail address and logo (optional). Postal address may be included if space permits (should not interfere with the legibility of the EU text on the outer packaging) and if mentioned in the leaflet.
Identification and Authenticity
The Nordic commodity number for Norway is required on the outer labelling of all medicinal products. It is written as “Vnr XX XX XX”. For further information and application for Nordic Commodity Numbers, please refer to http://wiki.vnr.fi/.
The EAN code (bar code) is accepted but not required on the labelling.
Symbols and Pictograms
Products containing inflammable material must bear the international warning symbol.
Products which reduce the ability to drive or operate machines must have a warning triangle on the outer and inner packaging. The products concerned are defined by the Norwegian Medicines Agency. The tip of the triangle points upwards. It is a red triangle on a white background. Its size is adapted to fit the labelling; its sides are usually 10 mm long and the width of the frame is usually 2 mm.
Particular warning on the labelling for medicinal products containing glucosamine when extracted from shrimp or other shellfish
Norwegian text required on the labelling: «Skal ikke brukes av skalldyrallergikere.»
Warning statements for excipients in the labelling and PIL
Annex to Excipients guideline in English and Norwegian.