Often these conditions involve distributing safety advice tools for healthcare professionals and patients. All tools distributed to fulfill such conditions must be reviewed by the Icelandic Medicines Agency. Safety advice tools that fulfill such conditions are identified using a specific logo, see below.
It is essential that healthcare professionals who prescribe or administer the relevant medicinal product and patients/caregivers who use the medicinal product familiarize themselves with the safety advice tools and the relevant instructions.
Attention marketing authorization holders
The Icelandic Medicines Agency takes two weeks to ensure that all required documents have been received with the request for review of safety advice tools .
The IMA then has up to 60 days to review the safety advice tools.
Instructions for preparing and submitting safety/educational advice tools
Safety advice tools are a part of the Risk Management Plan (RMP) as set out in the conditions of the marketing authorisation and is classified as additional risk minimisation measures (aRMM). Safety advice tools must comply with the require and GVP Module XVI Addendum II – Methods for evaluation effectiveness of risk minimisation measures.
The Icelandic Medicines Agency reviews safety advice tools based on these requirements and the Icelandic health care system, suggesting changes as needed. If new or changed requirements for safety advice tools arise the marketing authorisation is issued, the marketing authorisation holder (MAH) must fulfil these new/changed conditions.
When preparing safety advice tools for a generic medicinal product, and the reference medicinal product already has safety advice tools, the wording, objectives, content, and presentation of the generic product’s safety advice tools must not be different unless there are clear reasons for this. This ensures consistency, reduces the burden on the healthcare system, ensure consistency, and enhances patient safety. MAHs are encouraged to prepare joint safety advice tools for the same active substance when requirements are comparable. For joint safety advice tools covering multiple products, the active substance should be used instead of product names.
The Icelandic Medicines Agency may require user-testing of safety advice tools with healthcare professionals and/or patients to ensure they are understood and user-friendly. MAHs are encouraged to conduct user-testing whenever possible and should consider consulting specialists in the relevant field during the creation of the safety advice tools.
The MAH/representative must submit a dissemination plan for evaluation by the Icelandic Medicines Agency. The dissemination plan, which is a part of the application form, must specify for each component (including cover letter to HCPs):
- Recipients: e.g. patients, physicians (by specialty), pharmacists.
- Dissemination method: How the component will reach recipients.
- Number of copies: For paper format, specify the number of copies based on realistic estimates (use of the product, purposes of the component).
- Re-dissemination: Whether and how the safety advice tools will be re-disseminated regularly or as needed. When safety advice tools are re-dissemination, no changes to the components are permitted.
- User-testing information: Whether any user-testing has been conducted.
An updated dissemination plan must be submitted each time the safety advice tools are updated, either as a part of the application form or as a separate document. The application is invalid without a completed plan.
No application is needed for assessment of safety advice tools consisting solely of a patient card included in the product’s packaging and approved product information. However, a dissemination plan must be submitted when changes are made to patient cards that are part of the pack or when a patient card is added to a pack already on the market. The dissemination plan must detail when new/updated cards will reach patients, and how distribution will be managed until packs with cards reach patients, considering stock and sale figures. This is to ensure that patients receive the safety advice tools required.
Compliance with laws and regulations on processing personally identifiable information is required, see more on the website of the Data Protection Authority www.personuvernd.is. The Icelandic Medicines Agency does not review data protection information in safety advice tools, this is the responsibility of the MAH/representative.
New safety advice tools must be submitted to the Icelandic Medicines Agency for approval, except for patient cards included in product packaging and product information. Updated tools must also be submitted for approval, with changes detailed and visible in Track Changes.
Re-dissemination is permitted in accordance with the approved dissemination plan. No changes to the safety advice tools are permitted during re-dissemination (including date in cover letter to HCPs).
The Icelandic Medicines Agency will not assess safety advice tools if no changes have been made to the safety information.
Distribution of Safety Advice Tools
For patients: Ensure all recipients have access to appropriate components. Must be distributed in paper format.
For healthcare professionals: Electronic distribution is encouraged unless patient components are included. When checklist or forms that are to be filled out are included, they should be fillable electronically, otherwise a paper version must be distributed.
If safety advice tools for a generic product align with those for a reference medicinal product already published in Sérlyfjaskrá, this may suffice for distribution, except when patient components are included.
If applicant wishes to publish the safety advice tools on their own website, it must only contain the safety advice tools without additional information or links.
The Icelandic Medicines Agency aims to assess safety advice tools within 60 days after confirming receipt of the application. Follow these guidelines when submitting an application for assessment:
- Submit a completed application form for the assessment of safety advice tools. Ensure you use the latest version of the form by downloading it from the website each time.
- Documents should be submitted in WORD format (.doc/docx).
- Include currently approved conditions for additional risk minimisation measures (Annex II and/or RMP) with the application.
- Use the active substance name in the safety advice tools instead of the product name whenever possible to minimise confusion for patients using generic medicinal products.
- Submit only the Icelandic translation of the safety advice tools. Do not submit the English version unless requested by the Icelandic Medicines Agency.
- Safety advice tools must not contain link to advertisements, either directly or indirectly.
- Include any images in the submission. No images may be added after approval.
- Medicinal logos are generally not allowed unless valid reasons are provided. The MAH’s or representative’s logo is allowed in one place on each component on the front or back cover, but it must not be larger than the title of the safety advice tool.
- The use of a registered trademark is only allowed the first time the name of the medicinal product appears.
The Icelandic Medicines Agency will add “Samþykkt af Lyfjastofnun í <month><year>” (en. Approved by the Icelandic Medicines agency in <month><year>) to confirm that the safety advice tool meets the conditions of the marketing authorisation. This sentence must be included at a minimum on the first page of each component. The marketing authorisation holder is not allowed to insert or change the date but may choose the location of the date.
See the following:
Include a short cover letter to HCPs receiving the safety advice tools, containing at least the following:
- The logo identifying important safety information.
- A concise description of the risk addressed in the safety advice tools. Do not explain legal requirements.
- The black triangle ▼ if applicable, along with the accompanying statement. The black triangle should be next to the product name/active substance the first time it is used.
- The requirement to report all suspected adverse reactions to the Icelandic Medicines Agency. The following text can be used: “Heilbrigðisstarfsmenn eru minntir á skyldur sínar til að tilkynna allar aukaverkanir sem grunur er um að tengist lyfinu. Hægt er að tilkynna til Lyfjastofnunar, eða í gegnum eyðublað (Tilkynning um aukaverkun) sem er að finna í Sögu.”
- A list of all components included in the cover letter to HCPs (ensure the titles are consistent) and how the components can be accessed.
- Specify the main changes if an update to the components has taken place.
- If the previous version of the safety advice tools has been distributed, remind recipients to discard the older version.
- Specify the recipients in accordance with the dissemination plan and recommend informing other health care professionals about the safety advice tools. The applicant is responsible for proposing the recipients, which the Icelandic Medicines Agency evaluates.
o The following sentence or a similar one can be used (depending on the relevant recipients): “Viðtakendur þessara öryggisupplýsinga eru: Allir sérfræðingar í xxx (sérgrein) og lyfjafræðingar í
lyfjabúðum/sjúkrahúsapótekum.
Viðtakendur eru hvattir til að láta aðra heilbrigðisstarfsmenn vita um innihald upplýsinganna eftir því sem við á.”
All components of the safety advice tools must contain at least the following:
- The logo identifying important safety information on all components.
o The Icelandic Medicines Agency encourages the logo to be on all patient cards whenever possible, including those part of the product information/packaging.
o If there is no space for the logo on the patient card, request an exemption. - If the black triangle ▼ is applicable, it and the accompanying statement must be displayed on the safety advice tools. The black triangle should be next to the product name/active substance the first time it is used.
- Refer the reader to the SmPC/patient leaflet as applicable, for further information.
- Ensure wording is consistent with the approved product information (SmPC and/or the patient leaflet).
- Include the version number/identifier on all pages of the safety advice tools.
The key objective of patient cards is for the patient to carry them at all times. They should be of a suitable size (e.g., fit in a wallet) and printed on durable paper. If included in the medicinal packaging, the patient must easily identify the card (it should not be printed on traditional patient leaflet paper or as part of the patient leaflet). The Icelandic Medicines Agency requests that all patient cards are published on www.serlyfjaskra.is, see guidelines for publishing of safety advice tools.
- The website may not include references to or information about medicinal product not marketed in Iceland.
When the assessment is completed, the agency sends the safety advice tools with proposed changes/corrections and comments to the applicant.
- If no further assessment is needed (i.e. all comments/changes are considered minor), the safety advice tools should not be sent back to the agency. The applicant is responsible for addressing any comments. The Icelandic Medicines Agency will not review the safety advice tool again in these cases.
- If further assessment is required, responses should be submitted within 30 days. The agency will assess the responses and changes provided.
- If the applicant disagrees with the comments/changes, this must be communicated within 30 days.
The Icelandic Medicines Agency adds a V-number related to the assessment on the cover letter to HCPs. The applicant is not allowed to change the V-number.
- Place the logo identifying important safety information on envelopes when sent by mail and prominently at the top of the email if sent electronically.
- PDF documents for publication/distribution must be searchable.
- No other material may be enclosed when distributing the safety advice tools.
- Safety advice tools intended for patients must always be sent in print version to the appropriate recipients, even if it is also available on www.serlyfjaskra.is.
o An exception is when patient cards are included in the product packaging; however, healthcare professionals must be informed where the card can be found and what needs to be discussed with the patient (e.g., recording information on the card). The Icelandic Medicines Agency requests that patient cards included in the packaging be published on Sérlyfjaskrá.
The Icelandic Medicines Agency encourages the publication of safety advice tools in Sérlyfjaskrá. See guidelines below.
If the safety advice tools are to be published on the marketing authorisation holder’s website, the following must be respected:
- The distribution via the website must be approved by the Icelandic Medicines Agency.
- Include a link to the page in the application form for the assessment.
- The website must not contain links or references to other documents or websites unless approved by the Icelandic Medicines Agency.
- The website must not contain references or information about medicinal products not on the market in Iceland.
Instructions for Publishing and Removal of Safety Advice Tools
Only safety advice tools approved by the Icelandic Medicines Agency are published on www.serlyfjaskra.is.
Safety advice tool for new medicines: Published simultaneously with the product in Sérlyfjaskrá. Safety advice tools are listed alphabetically, and a numbering sequence ensures documents are published in the requested order.
Updated safety advice tools: Generally published every working Monday. Requests for publication must be sent at least 7 days before the desired publication date.
Once published, the applicant is responsible for checking www.serlyfjaskra.is to ensure accuracy. Any issues should be reported to the Icelandic Medicines Agency.
The document title must be descriptive of its content to facilitate storage at the Icelandic Medicines Agency.
- The title must not exceed 50 characters.
- No symbols are allowed (except underscores _).
- No spaces are allowed.
- No special Icelandic characters are allowed.
- Example: Guide_for_HCPs.
The title or name of the component that appears on www.serlyfjaskra.is can be up to 50 characters. It does not have to match the document title. If more explanation is needed use the comment column. Titles are published alphabetically unless numbers are used at the beginning. A numbering sequence ensures the requested order.
Use the following table when sending a request for publication in Sérlyfjaskrá:
| Order | Display title for Sérlyfjaskrá | Document title | Version number | Replaces, if applicable: |
- Send the request for publication by email to: [email protected].
- The subject line should be “Safety advice tools for [product name] for publication on [publication date]”.
- Attach all documents for publication to the email.
- Include the following in the email:
o The V-number of the application (provided during the approval process)
o The desired publication date
o All products involved (name, strength, and form).
o The version of the safety advice tools (e.g., new material, 1st version, or updated material, 3rd version).
o Specify which components are to be replaced, removed, and their replacements.
o Use a numbering sequence to ensure the requested order. If no numb er is used, documents will be published alphabetically.
The Icelandic Medicines Agency can publish safety advice tools as an video or audio file on www.serlyfjaskra.is. Send the file by email, if large, provide a link to a website. Ensure files are no larger than 100 MB.
Send a request for removal by email to [email protected].
The subject line should be “Request for the removal of safety advice tools for [product name]”.
The email must include:
- All medicinal products involved (name, strength, and form).
- The exact title of the component(s) to be removed and the removal date.
- Updated conditions for risk minimisation measures (RMP/Annex II).
Instructions for submitting safety advice tools and on electronic publication and removal of safety advice tools were last updated in February 2025.
When applying for evaluation of safety advice tools
Please always use the current form to apply for review of safety advice tools. The current valid form was updated in February 2025. Marketing authorization holders are asked to refrain from using outdated version of the same.
The form valid from February 2025
Agreement on specific labelling of safety advice tools
The Icelandic Medicines Agency (IMA) and the Icelandic Association of the Pharmaceutical Industry (Frumtök) have in cooperation designed a symbol which is intended to help healthcare professionals (HCPs) distinguish between important risk communications/safety advice tools sent in agreement with IMA and other material sent by marketing authorisation holders (MAHs), e.g. promotional material.
IMA and the Icelandic Association of the Pharmaceutical Industry (Frumtök) signed an agreement regarding the use of this symbol on 29 November 2012.
All MAHs are invited and encouraged to apply for the use of this symbol by becoming part of the aforementioned agreement. In order to be allowed to use the symbol, an e-mail has to be submitted to IMA ([email protected]), where the MAH requests to be part of the agreement and thereby accepting its conditions, i.e. to use it and use it only for risk communication sent to the relevant HCPs in agreement with IMA, following the agency‘s assessment, i.e.:
- Safety advice tools published for centralised products to fulfill CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT in Annex II, C/D of their marketing authorisation,
- Safety advice tools published for medicinal products following a referral, in accordance with a Commission Decision,
- Safety advice tools published in agreement with IMA, due to commitments in a RMP approved by the rapporteur/RMS/NA,
- Risk communication sent due to requirements of EMA/IMA and in agreement with IMA, after IMA´s assessment, e.g. Direct Healthcare Professional Communication letters (DHPCs).
It is strictly forbidden to use the symbol in context with promotional material.
The symbol should be used to label envelopes (on a sticker/label or printed on the envelope itself, in colour). The location on the envelope is not specified but it should be clearly visible. The IMA also recommends the use of the symbol on Direct Healthcare Professional Communication (DHPC) letters, e.g. in the header of the first page. This also applies to any annexes to specific safety information and safety advice tools.
Notwithstanding this additional field of application the label shall always be used on envelopes, whether the contained documents are identified in the same manner or not.
The symbol can only be used for material which is distributed upon request or by special permission of the agency.
All MAHs are invited and encouraged to apply for the use of this symbol by becoming part of the aforementioned agreement. In order to be allowed to use the symbol, a request has to be submitted to the IMA using the email address [email protected]
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pharma&
PharmaCoDane
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