Summary of product characteristics (SmPC)

The target audience for the SmPC are healthcare professionals with medical professional background. The applicant must ensure that the SmPC is of high quality. The concept of plain language should be used.
 
How to write a good text:

1.    Write in Norwegian

It is important that the translated Norwegian text has the same meaning as the English text (faithful translation). There are differences between English and Norwegian grammar. Sentence structure and word order are often different. Direct translation from English to Norwegian can lead to complicated wording and incorrect translation. Split long sentences if possible.

2.    Write clearly

Use short sentences and write in an active voice. Avoid using extra nouns. Use verbs instead of nouns where possible. The message should not be disturbed by ambiguous and unclear language.

3.    Write to healthcare professionals

Use well-established Norwegian medical terms as much as possible. Some medical terms are identical in English and Norwegian.

4.    Standardised translations and abbreviations

The following translations should always be used in the SmPC.

Standardised translations:

  • active substance – virkestoff
  • adverse effects/adverse drug reactions – bivirkninger
  • adverse events – uheldige hendelser
  • drug/substance – legemiddel
  • efficacy/effectivity – effekt
  • herbal medicinal product – plantebasert legemiddel
  • medicinal product – legemiddel
  • patient alert card /patient reminder card – pasientkort

Abbreviations:

  • QD – én gang daglig
  • BID – to ganger daglig
  • TID – tre ganger daglig
  • QID – fire ganger daglig

Package leaflet (PIL)

Applicants must ensure that the package leaflet (PIL) always is of high quality. The target audience for the PIL is the patient, therefore the PIL should be easy to read and understand (written in plain language).

How to write a good text:

1.    Write in Norwegian

It is important that the translated Norwegian text has the same meaning as the English text (faithful translation). There are differences between Norwegian and English grammar. Sentence structure and word order are often different. Direct translation from English to Norwegian can lead to complicated wording and incorrect translation. Split long sentences if possible.

2.    Write clearly

Use short sentences and write in an active voice. Use verbs instead of nouns where possible. The message should not be disturbed by ambiguous and unclear language.

3.    Write to the patient

Foreign words are used to a greater extent in the English language, than in Norwegian. Medical terms should always be translated into patient friendly terms and language. The medical term may in some cases be kept in brackets.

Excipients guideline with Norwegian translations

Excipients in medicinal products should be listed qualitatively in the package leaflet. Several of these should be accompanied by information that is of importance to the patient. Such excipients are listed in the

New MAs shall comply with this guideline. Existing MAs must update the package leaflet in the next variation concerning the product information or renewal procedure.

Blue box

The Blue box standard wording in the Norwegian package leaflets must be removed or reformulated (MRP, DCP and national procedure) starting from 12 February 2020. 

  • The Blue box standard wording must be removed or reformulated by applying for a type IB C.I.z or a type II variation that affects the product information. Type IA or a 61(3) notification are not applicable for this matter.
  • For MRP/DCP the Norwegian PIL should be a faithful translation of the common text approved in the procedure. 
  • For nationally authorised products the proposed wording shall be assessed by NoMA. The information under the headings "Dersom du tar for mye av X" and "Kjøring og bruk av maskiner" in the Norwegian package leaflet should be adjusted to each medicinal product accordingly, reflecting the content of section 4.7 and 4.9 in the SmPC.

The following Blue box standard wording must be removed or reformulated

  • Legal status Under punkt 1: Hvis preparatet er unntatt fra reseptplikt må det fremgå av pakningsvedlegget. Tilhørende indikasjonsområde og dosering inkluderes.
  • Under punkt 1: "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 overskriften: Kjøring og bruk av maskiner: "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 overskriften: Dersom du tar for mye av X: "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."

High quality Norwegian product information

The product information has to be easy to read and understand for the users. A higher quality of the product information will improve the patient information and contribute to safe use of medicines.

This section will give you some advices on how to create a Norwegian product information of high quality. This includes information about the marketing authorisation holder (MAH) responsibilites, choice of translators, resources, high quality translations of new marketing authorisations (MA) and improving excisting product informations.

Templates, guidelines and other resources on how to write a high quality Norwegian product information can be found under Resources.

MAH responsibilites

The MAH is responsible for the product information and its high quality. The product information includes summary of product characteristics (SmPC), package leaflet (PL) and labelling .

Adequate principles of plain language shall be applied. The MAH is responsible for ensuring that the Norwegian product information is updated in accordance with today's requirements and guidelines before submission.

Criteria for choice of translators

The Norwegian Medicines Agency (NoMA) emphasizes the importance of choosing Norwegian translators with relevant scientific background* and sufficient regulatory knowledge**. MAH is responsible for finding translators that deliver translations of high quality. It is important that the translated Norwegian text has the same meaning as the English text (faithful translation).

*Relevant scientific background with regard to knowledge of the medical terminology and the correct scientific translations for this class of medicinal product.

**Regulatory knowledge with regard to QRD templates, appendices, reference documents and guidelines.

How to create a new Norwegian product information

New marketing authorisations and line extensions:

Start with the current Norwegian version of the QRD template. Then add standard wording from templates and relevant appendices where applicable. Further, add mandatory text from referral, PSUSA to the product information and highly recommended text from PRAC signal. See list under resources (not exhaustive).

For generic/biosimilar medicinal products approved in the centralized procedure:

If the medicinal product is approved as a generic, hybrid, biosimilar or through an informed consent procedure the Norwegian product information shall be a true copy of the reference product. Note that this is not applicable for product specific sections, as well as when the reference product is not updated according to the current templates and guidelines.

How to improve an existing Norwegian product information

Renewals

The complete product information shall be revised with focus on plain language and updates according to current templates and guidelines.

It is important to get an overview of the text and which parts that need to be updated and/or made more understandable.

Check if these parts are included in the standard template wording from the QRD template, the excipients guideline etc. or if they are mandatory texts taken from referral, PSUSA or highly recommended text from PRAC signal. If the text that needs updating is not from one or more of the sources above, then apply the plain language principles  under "MAH responsibilities" when translating/updating.

For generic/biosimilar medicinal products approved in the centralized procedure: see information above under "How to create a new Norwegian product information".

Resources

The MAH should focus on readability, harmonised and consistent language when translating to Norwegian. Templates, reference and guidance documents that are instrumental for the preparation of a high quality product information are listed below (not exhaustive):
For general reference guidelines on how to create a product information
Terms that are approved/preferred for use

Recommendations on updating the product information

QRD templates

Norwegian QRD product information templates for all procedures for both human and veterinary medicinal products.

Updating Norwegian product information by new QRD template 

Common practice for updating the product information of nationally authorised medicinal products (MRP/DCP and purely national procedure):

  • The product information should be updated according to the current template at the time of submission, i.e. applications submitted before the new template was published are processed according to the old template. If not other is advised by Reference member state (RMS) or national authority.
  • The product information should be updated with the next variation that affect the product information.
  • If no variation concerning the product information is planned, the MA-holder may submit a C.I.z, type IB variation (CMDh Q&A on variations) within 2-3 years.

For medicinal products authorised through centralized procedures, please see EMA's website.

Revision of Human QRD template – Version 10.1, 06/2019

Version 10.1, 06/2019 of the human QRD template was published on the EMA's website on 28 June, 2019.

Among the changes, new requirements for the traceability of biological medicinal products has been introduced under section 4.4 Warnings and precautions.

Please note that in addition some linguistics updates have been made in the Norwegian translation.

For detailed information on the implementation of the new version, see EMA's website.

Reporting of adverse reactions in SmPC and PIL

For medicinal products authorised through MRP/DCP and national procedure the texts below shall be included in both printed and electronic version of the product information.

For medicinal products authorised through CP the texts below shall be included in the printed version of the product information only.

SmPC Reporting of suspected adverse reactions (section 4.8):

Melding av mistenkte bivirkninger

Melding av mistenkte bivirkninger etter godkjenning av legemidlet er viktig. Det gjør det mulig å overvåke forholdet mellom nytte og risiko for legemidlet kontinuerlig. Helsepersonell oppfordres til å melde enhver mistenkt bivirkning. Dette gjøres via meldeskjema som finnes på nettsiden til Statens legemiddelverk: www.legemiddelverket.no/meldeskjema.

Package leaflet Reporting of side effects (section 4):

Melding av bivirkninger

Kontakt   <,>   dersom du opplever bivirkninger. Dette gjelder også bivirkninger som ikke er nevnt i pakningsvedlegget. Du kan også melde fra om bivirkninger direkte via meldeskjema som finnes på nettsiden til Statens legemiddelverk: www.legemiddelverket.no/pasientmelding. Ved å melde fra om bivirkninger bidrar du med informasjon om sikkerheten ved bruk av dette legemidlet.

Packaging

The national guideline on packaging is based on the Norwegian regulation (Forskrift om legemidler) § 3-29-§ 3-41 and applies to human and veterinary medicinal products.

Packaging - Management and guideline

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.

61(3) notifications for information only

Some changes concerning the labelling can be submitted as a 61(3) notification for information only. The notification will be noted and no approval will be issued. See changes to packaging for human medicinal products for information only.

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

Legal status

There are 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»

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.

Medicinal products which reduce the ability to drive or operate machines must have a warning triangle on the outer and inner packaging.

The warning triangle - list and Q&A

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 procedure. The warning triangle is a national blue box element.

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. 

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 farmalogg@apotek.no

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 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 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.

Implementation date and batch-specific variations

Implementation deadline for packaging

Batches of medicinal products that are QP released 6 months or later after the approval date must have updated packaging.

Delayed implementations in the packaging, later than 6 months, shall be applied for as batch-specific variations.

Implementation deadline for package leaflet

All QP released batches for a medicinal product shall have updated package leaflet implemented at least 6 months after the date of approval. Nevertheless, the Norwegian Medicines Agency may accept a 12 months implementation deadline from the approval date, if the conditions below are fulfilled.

Delayed implementations in the package leaflet, later than 6 months, which do not fulfil the conditions below, shall be applied for as batch-specific variations

Conditions for 12-month implementation deadline

  1. Section 6 (last paragraph) in the package leaflet for human medicinal products shall contain a reference to Felleskatalogen.no . See «Q&A» below for further information.
  2. The last approved Package Leaflet shall be available on Felleskatalogen.no web site within 3 months from the approval date.

NoMA may determine a shorter implementation deadline of the updates in the package leaflet. If the updates include any safety issues for the medicinal product, NoMA may demand immediate implementation with the first produced batch or consequent withdrawal.

Questions and answers (Q&A)

Where and how to include information about Felleskatalogen.no in the package leaflet?

For human medicinal products, the hyperlink to the Felleskatalogen.no shall be inserted in Section 6 after the date of approval.

National procedure (NP)

The following sentence shall be inserted in the Norwegian package leaflet: «Detaljert informasjon om dette legemidlet er tilgjengelig på nettstedet til Felleskatalogen.no»

MRP/DCP

The following sentence shall be inserted in the Norwegian package leaflet, in the national phase of the procedure: «Detaljert informasjon om dette legemidlet er tilgjengelig på nettstedet til Felleskatalogen.no»

The following sentence shall be inserted in the English package leaflet, at the first opportunity: «Detailed information on this medicine is available on the website of (name of MA Agency (hyperlink)).

Centralised procedure (CP)

For centrally authorised medicinal products, the reference to the Felleskatalogen.no shall be found in the printed version of the package leaflet, but it may be inserted in the Norwegian electronic leaflet (e-PL).

The wording for the medicinal products in centralised procedure shall be as follows:

«Detaljert informasjon om dette legemidlet er tilgjengelig på nettstedet til Det europeiske legemiddelkontoret (the European Medicines Agency): http://www.ema.europa.eu , og på nettstedet til Felleskatalogen.no.»

When to implement the information about the Felleskatalogen.no in the package leaflet? 

The reference to the Felleskatalogen.no shall be implemented with the first variation application concerning the Norwegian package leaflet, in all four procedures for approval (Centralised, MRP/DCP and national). Consequently, the reference implementation shall not be applied for with a separate variation application/notification 61(3).

How often should updates in the package leaflet be implemented?

The implementation of the package leaflet updates shall be done as soon as possible and within 6 months from the approval date. However, if the hyperlink Felleskatalogen.no is included in the package leaflet, and the last approved package leaflet is uploaded in Felleskatalogen.no within 3 months after the date of approval, NoMA shall accept an implementation deadline for 12 months.

When to apply for a batch-specific variation?

If the package leaflet fulfils the conditions for the 12 months implementation deadline, all delays beyond 12 months shall be applied for as batch-specific variations.
In those cases where the package leaflet does not fulfil the conditions for the 12 months implementation deadline, the delays beyond 6 months shall be applied for as batch-specific variations.

Is it acceptable to include codes with URL to the Felleskatalogen.no in the package leaflet?

Codes with URL are acceptable. They have to be according to the guideline on «Mobile scanning and other technologies to be included in packaging and PL», and should refer directly to the relevant electronic leaflet (e-PL) on www.Felleskatalogen.no for the medicinal product

Links to the guideline for mobile scanning and other technologies:

Naming of medicinal products

Guideline for the naming of medicinal products

 

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