Nordic Countries Specific Pharmaceutical Requirements

Regulatory affairs (RA) in the Nordic countries – Denmark, Finland, Iceland, Norway, and Sweden, have many similarities due to their shared membership in the European Economic Area (EEA) and close collaboration in healthcare regulation.

Moreover, as proof of good collaboration and harmonization of principles, safety standards, efficacy, and quality, the Nordic Pharmaceutical Forum was created in 2015. This collaboration was primarily thought to ensure timely and affordable access to new and old medicines for patients and create a framework and space for Nordic cooperation in pharmaceuticals. ^[1]

As each Nordic country represents a small market, the manufacture of Nordic packages has been agreed upon. As mentioned before, harmonization due to shared membership helps create Nordic packages. It is related to authorization type (CP, MRP, and DCP products – harmonization already exists, except for blue-box requirements). For pure national developments, the Nordic package option will depend on the grade of the dossier harmonization in the Nordic countries. ^[2]

The Nordic countries are frequently considered a potential single market for therapeutic products since, for example, blue-box requirements for inner packages are mostly the same  (VNR, 2D barcode, etc.). All Nordic countries follow the Readability Guideline, the QRD template, and the excipients guideline, and the recommendation of these guidelines should be reflected in the labeling and PIL, together with the national requirements, which can be found on national authorities’ websites. ^[3]

Of course, when it comes to regulatory submissions, depending on the procedure type, some particularities can easily be found on National Authorities websites:

Denmark: https://laegemiddelstyrelsen.dk/

Finland: https://www.fimea.fi/

Iceland: https://www.ima.is/

Norway: https://legemiddelverket.no/english

Sweden: https://www.lakemedelsverket.se/en

Denmark Regulatory body: Danish Medicines Agency – (DKMA) [4]

• There is no need to notify the authorities of any changes in artwork.
• If medicines are sold to Danish hospitals via Amgros, a barcode is needed in the secondary and primary packages (Danish-specific requirement). Amgros requires a bar code on the primary packaging for all pharmaceuticals for oral use, external use, and injection and infusion. However, this requirement does not apply to tablets or capsules in blister sheets or similar packaging in which tablets/capsules are single-dosed individually and not sold via Amgros. The bar code must either be an EAN 13 bar code or a 2D (GS1 DataMatrix) bar code and contain an identification key as a minimum.
• PIs can be submitted by email only for “End of procedure” or “RFIs.”

Norway Regulatory body: Norwegian Medicines Agency – (NoMA) [5]

• National submissions of PIs can be submitted by email only for “End of procedure” or “RFIs” and 61(3) notifications for medicinal products authorized through the NP.
• The corrections to the SmPC/PIL should be submitted as much as possible as part of an ongoing or upcoming procedure amending the product information (type I or type II). An update of the SmPC to implement changes in the SmPC not already covered by the classification guideline and for which no new data are required should be submitted as a C.I.z, type IB variation (CMDh Q&A on variations). ​​
• Article 61(3) notifications are changes to the package leaflet (PIL) and/or the labeling not affecting the Summary of Product Characteristics (SmPC). 61(3) notifications for medicinal products authorized through the NP are submitted to [email protected] with the filled-in form attached.
• Some changes to the labeling listed on the NoMA website can be submitted for information only with immediate implementation. Still, some need to be silently approved 90 days from the submission date (no email from the authority is received in this case).
• For the MRP variation application and art 61 (3) notification fromthe 1^st of October 2022, the (NoMA) will approve Norwegian labeling when standard labeling is revised.

Finland Regulatory body: Finnish Medicines Agency (Fimea) [6]

• Samples are not required with the application. However, they should be made available on any request by Competent Authorities within their specific timeframe and quantities.
• For initial registration, colored clean mock-ups of the packaging material in PDF format are required by FIMEA.
• For variations impacting the packaging materials, currently approved and clean mock-ups of the packaging material in PDF format are required by FIMEA and must be submitted for all procedures.
• For renewals, if no product information is revised during the procedure, no texts or mock-ups are required by FIMEA.
• Proof of payment does not need to be included in the application.
• For products registered via the national procedure, package labeling or package leaflet changes can be made via so-called 90-day notifications, which are not subject to a handling fee and do not require an application form. The changes may be implemented after 90 days if FIMEA has not commented on the suggested change.
• FIMEA does not require notification of, for example, changes to barcodes or minor changes to the size of the packaging/label if these do not affect text size or positioning. Labeling changes that require notification include proposals for a new layout, changes in font size and appearance, changes in images, colors, and logos, changes to the text, changes in text positioning, and changes regarding local representatives. An electronic version of the package leaflets and labels must be submitted along with the variation application (no fees and no EU application form are required).
• For products approved through national, mutual recognition, and decentralized procedures, approved SmPC and package leaflets in Finnish and Swedish are published on FIMEA’s website. Since the 9th of February 2022, all SmPCs must also be in Swedish.
• Product information is published on the European Medicines Agency (EMA) website for products approved through the centralized procedure.
• PIs can be submitted by email only for “End of procedure” or “RFIs.”

Sweden Regulatory body: Swedish Medicinal Products Agency (MPA) [7]

• MPA requires samples with a new MA application. The other type of procedure samples are unnecessary, but they should be made available on any request by Competent Authorities within their specific timeframe and quantities.
• Mock-ups should be submitted in PDF version 1.4 or higher (one PDF for each mock-up). For the assessment of Nordic packages, the form “Request for a Nordic mock-up cooperation” should be enclosed with the submission. Information regarding what updates have been made should be clear, and the currently approved mock-ups should be enclosed.
• For renewals, when no changes to the product information have been made, there is no need to submit Swedish texts or mock-ups. The Swedish MPA must confirm that the product information has not been changed.
• Proof of payment does not need to be included in the application. There is no need to attach a specific letter for MPA. PLG needs to fill in the information in the electronic application form for MRP and national products and mention fees in the Cover letter.
• For IA- and IB-variations in the mutual recognition procedure and for Art 61(3)- both English and Swedish versions of the product information should be submitted.
• Submissions of PIs can be made by email only for “End of procedure” or “RFI.”
• Labeling changes can be submitted as 61(3) notifications or for information only.
• The labeling changes that do not, or only partly fulfill the criteria for a notification for information, should be submitted to the Swedish MPA for assessment and approval. Standard timetables are, in that case, applied, and the changes should not be introduced until a letter of approval has been received from the Swedish MPA.

  Iceland Regulatory body: Icelandic Medicines Agency – (IMA) [8]

• For products not in Worksharing, additional submission in IS is needed to inform IMA

that national DK approval is obtained. Submission should be made as soon as DK approval is obtained

, and approval timelines are one month after submission.

• MAH needs to ensure that labeling on packages and the text of the printed leaflet follows IMA’s approved product information and that conditions set out in Regulation No. 545/2018 are fulfilled. From the 26th of May 2021, neither package leaflets nor technical updates on mock-ups need to be sent to the IMA. Following the processing of variation application that leads to change in the labeling document, an updated, clean mock-up must be submitted regarding the relevant case [email protected] or [email protected]
• Mock-ups should be submitted to the Icelandic Medicines Agency no later than one month before the medicinal product is marketed or when publication of information in the Drug Catalogue and the Price List is requested.

What to expect in the Nordic and Global markets

At ProductLife Group we work in the Nordic market daily as well as global markets with over 1000 different clients. Our Danish presence not only provides us a firm understanding of the market but our personal contacts allow us to also support with complex requests. Trust PLG to support your existing portfolio of products in the Nordic market and consider us for your expansion activities. Contact us to learn more about how we can further support your products and company.

Bibliography

1. https://amgros.dk/media/3790/nlf-strategy-final.pdf accessed 23.06.2023

2.https://legemiddelverket.no/Documents/English/Regulatory%20affairs/Guideline_final_pub_coll_19.2.20.pdf accessed 14.07.2023

3. https://www.fimea.fi/documents/160140/741488/Guideline+on+Nordic+packages+-+19+February+2014.pdf/e68fda4e-3c78-411e-b248-53da97774ef9 accessed 25.06.2023
4. CLIENT-WPD-RA-LBK-023 V 4.0 – Lundbeck Denmark WPD
5. CLIENT-WPD-RA-LBK-054 V 3.0 – Lundbeck Norway WPD
6. CLIENT-WPD-RA-LBK-052 V 3.0 – Lundbeck Finland WPD
7. CLIENT-WPD-RA-LBK-055 V 3.0 – Lundbeck Sweden WPD
8. CLIENT-WPD-RA-LBK-053 V 3.0 – Lundbeck Iceland WPD