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
There is no longer a requirement for Blue box wording in the Norwegian PL's, starting February 12 2020. The MAH's should submit a variation to make sure that the text in the PL is adapted to their product.
The change in Blue box standard wording shall be submitted as 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.
MRP/DCP
For MRP/DCP the Norwegian PL should be a faithful translation of the common text approved in the procedure, i.e. the purely national Blue box wording must be removed from the PL.
National procedure
Blue box wording under section 1 in the PL shall be removed.
In cases where there is aneed to retain important content from the Blue box standard wording, the sentences should be reformulated with adjusted text in accordance withsection 4.7 and 4.9 in the SmPC, respectively:
Information under "Kjøring og bruk av maskiner"
- Shall be adapted to each individual medicinal product
Information under "Dersom du tar for mye av X"
- Shall be adapted to each individual medicinal product
- It is possible to refer to the NorwegianPoison InformationCentrewhen relevant to the medicinal product. If so, the existing Blue box wording can be kept.
For nationally authorised products the proposed wording will be assessed by NoMA.
The Blue box standard wordingwhich wasapplicable until February 2020:
-
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, typeIB 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 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".
Packaging - Management and guideline (version 2.1 - 12/2022)
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 notificationwill benoted and no approval will be issued. See
changesto packaging for human medicinal products for information only.
Blue box requirements
Blue boxis 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
Thereare 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, seehttp://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.
Readability testing and bridging
User consultation of patient leaflet for human medicinal products
The patient leaflet (PL) must be clearly worded and understandable for the users. Readability of the PL shall be tested with a target group of patients to ensure that the PL is legible, clear and easy to use.
What is the purpose of a readability test?
PL is written for the users of the medicinal product. The PL must be of good quality enabling the users to apply the information. Patients who are potential users of the medicinal products have the best ability to answer questions and to give feedback on the readability and usefulness of the package leaflet. User consultation is a method that involves potential patients.
The interview should be conducted in a structured manner. The participants should be able to find the information, to answer in their own words and act approproately in an imagined situation. The patients shall also give specific comments on design and layout.
The patients experience how the PL function in practice . The consultation itself does not improve the PL, but indicates where there are sections which should be rectified. It is important that the interviewer takes the suggestions from the paticipants into consideration and utilise these to improve the quality of the PL.
In which situations are user testing required?
User-consultation is a requirement for marketing authorisation applications (MA), line extensions, variations concerning change in legal status (OTC/Rx), medicinal product with a new presentation and medicinal products with critical safety issues.
User consultation is not a requirement for veterinary medicinal products.
At what time during a procedure should the user test be submitted?
Results from user test or justification for not performing such consultation is to be included in all new applications for marketing authorisations, variations for change in the legal status from Rx to OTC in the national procedure and other applications where user test is required.
The following is only applicable for MA applications: The application can contain a statement where the applicant states that the user test will be included in the response to the first assessment report
How to achieve a package leaflet easy to read and with a patient friendly language
It is crucial that the applicant does a review of the language in the package leaflet. Ensure that the latest QRD template is used and that the language used is active.
Use short words and sentences to achieve a clear leaflet that is easy to read. Make sure that the most important information comes first and avoid long paragraphs. Bullet points are recommended where suitable (preferably not more than 5-6).
Use terms and expressions that people in general understand. Alternatively, terms that are easy to understand can be followed by the advanced medical term, for example in brackets.
The package leaflet shall be user friendly. Make sure that the information is sufficiently detailed for the user to recognise possible adverse effects and make the appropriate measures and actions.
What are the requirements for font/layout/design?
Applicant has to choose a font that is easily read. Make sure that i, l, and 1 are easily distinguished from each other. Do not usenarrowed fonts as they are difficult to read.
Large font size makes the text easy to read Times New Roman does not qualify as an easily read font, however, a font size of 9 points as measured in font Times New Roman is considered as a minimum.
Bold font may be used for headlines and subheadings. Do not use underlining. Italics shall only be considered when using Latin terms. Avoid excessive use of capital letters.
The space between lines shall be minimum 3 mm.
The meaning of the pictogram shall be clear and aid correct use of the medicine. Pictograms must be accompanied by a text.
How to recruit participants for user test?
Before the test, applicant has to decide how to recruite participants in addition to describe inclusion- and exclusion criterias.
Recruit participants who are relevant users (age, gender) of the particular medicine. The participants should neither have too high educatuion level, a profession where they use written material on a daily basis nor have used the medicine in the past. Be sure to exclude people who are directly involved with medicines such as doctors, nurses and pharmacists.
How to outline questions?
Before the questions are made, review the package leaflet and identify the information considered crucial for safe use. The questions should be open, hence not yes/no questions. Further, the questions should not have long answers.
Assure that the questions covers crucial safety information. The PL should include general information regarding what the patient should do if a dose is missed or a specific adverse event occurs. A user test should also focus on the instructions on adminitration and dosing. The questions should also consider pictograms if applicable. Also make sure to receive feedback on th PL’s layout and design.
Generally, 12-15 questions will be sufficient. In certain instances when comprehensive information is necessary to ensure safe use, additional questions might be needed.
What is the purpose of a pilot?
It is recommended to perfom a pilot before the user test. The main purpose of a pilot is to review whether the questions can be considered suitable. If the pilot test indicates that the language or design aren’t pasient friendly, the Applicant should consider the feedback to improve the package leaflet.
How to perform a user test in practice?
The participants are given mock-ups of the package leaflet and read this.
The interviewer asks the questions orally. For each question, the participant shall locate the information in the package leaflet and answer in their own words.
- Register if the participant is able to find the information. Note down the time the participant used to find the information for each question. (More than 2 minutes is often categorized as not found).
- Record if the paticipant is able to understand the information. Note down the participant`s answer to each question. The answers is usually separated in categories as for example correct answer, wrong answer or incomplete answer.
It is important to have questions to prove that the particant is able to use the information i.e. question about how the participant will act in an imagined situation.
There should be clear instructions for the interviewer. An instruction should decribe what the interviewer should do if the participant does not find the answer. For example the interviewer can be allowed to read the question again, but not help the participant to find the answer.
A total of 10 persons in the first round is usual. Review the results and make use of the participant`s feedback to improve the package leaflet before the next round.
The second round should verify the result from the first round.
How to present the results?
Describe the recruitment of the target patient group and present demographic data of participants.
Present results of each round separately. The number of participants able to find the information and the number of participants who have understood the information, should be presented. The aim of the user test is to ensure that the package leaflet is legible and easy to use. The applicant should discuss the results, and suggestions from the partcipants shoud be taken into considerations. Any weaknesses inditified, should be addressed in an approriate way to improve the readability for the user.
The criteria is that 90% of test participants can find the information , of whom 90% can show that they understand it, i.e. each and every question meets criterion of 81 % correct answers. This means to have 16 out of 20 participants should been able to find the information and have answered each question correctly and shown that they can use the information.
How long is the user test valid?
The user test is valid until a new is required, cf. question 2.
Is it required to perform a user consultation for package leaflets that were approved before the requirement on user consultation was implemented in the regulation?
Many medicinal products were approved before the requirements on user consultation came into force. The Norwegian Medicines Agency has not required user consultation of the package leaflet for those products.
If a company applies for a line extension, i.e. a new strength or a new presentation of the medicinal product, if they apply for a change in the legal status from Rx to OTC or a major safety variation, a user consultation is required.
Is it required to perform a user consultation for package leaflets that were approved before the requirement on user consultation was implemented in the regulation?
Many medicinal products were approved before the requirements on user consultation came into force. The Norwegian Medicines Agency has not required user consultation of the package leaflet for those products.
If a company applies for a line extension, i.e. a new strength or a new presentation of the medicinal product, if they apply for a change in the legal status from Rx to OTC or a major safety variation, a user consultation is required.
Bridging – comparing a proposed package leaflet with an approved and user tested package leaflet.
What is «bridging»?
If a package leaflet are sufficiently similar both in content and layout to another package leaflet that have gone thru a successful user consultation a “bridging” may be done to demonstrate that the requirements for user consultation are met.
How to choose a package leaflet to compare against?
The applicant should make a thorough decision on which approved and user tested package leaflet it wishes to use for the comparison. The approval should be quiet recent. Information on safe use and medical terminology in need for explanation should be presented in a similar way. If there are no available approved package leaflet that are sufficient similar, the applicant may need to present a full user consultation or a focused user consultation. A focused user consultation could be use when the new package leaflet are similar to an approved package leaflet apart from e.g. a new route of administration, new safety information have been added or new pictograms are used.
Since the design and layout of the information is crucial to how the information is used and understood, the leaflets should be of the same design, layout and font. As layout and design often have an corporate design it may be necessary to compare the package leaflet with more than one approved package leaflet i.e to refer to the design and layout of one leaflet and to the content of the leaflet for another product.
How to submit a bridging proposal?
Use the QRD form for submission and assessment of user testing bridging proposal.
For centrally authorised medicinal products, you will find the QRD form on the European Medicines Agencies (EMA) homepage. The QRD form for the decentralised and mutual recognitinal procedure the form are published on the CMDhs homepage.
For purely national authorised medicinal product, please use the QRD form published on the CMDhs homepage.
What isa focus test?
A focus test isa “focused” user test, only addressing certain aspect of the package leaflet crucial for safe use of the medicinal product. Often, only a couple of questions may be sufficient for a focus test. Design the questions to make sure that the user can find, understand and use new and important information.
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
- 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.
- 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
