Educational materials

The marketing authorisation of medicinal product can be subject to additional risk minimisation measures, which are conditions or restrictions to ensure safe and effective use of the medicinal product.

 

Often these conditions involve distributing educational materials for healthcare professionals and patients. All materials distributed to fulfill such conditions must be reviewed by the Icelandic Medicines Agency. Educational materials 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 educational materials 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 educational materials.

The IMA then has up to 60 days to review the educational materials.

Instructions for submitting educational materials

Educational materials are a part of the Risk Management Plan (RMP), as set out in conditions of the marketing authorisation and are classified as additional risk minimisation measures (aRMM). This refers to aRMM based on the requirements set out in Annex II D (for CAP).
Educational materials must fulfil the requirements set forth in Annex II D and/or the RMP and be in line with GVP V Rev.2, GVP XVI – Risk minimisation measures: selection of tools and effectiveness indicators and GVP XVI Addendum I – Educational materials. The Icelandic Medicines Agency (IMA) reviews the submitted material based on those requirements and will suggest changes as required.
The IMA would like to point out that while preparing the educational materials it can be beneficial to seek out specialist in the specific area. It is also important that the educational materials are localized as needed, they are clear, concise, and easily understood and wording is consistent with the approved SmPC.

If new requirements for educational materials are added after the initial authorisation, or if the requirements are changed, the marketing authorisation holder (MAH) is responsible for fulfilling the new/updated requirements.

The IMA would like to point out that laws and regulation regarding data protection and the processing of personal data must be adhered to while preparing and distributing educational materials. See the website of The Data Protection Authority, www.personuvernd.is. The IMA does not review information that may be included in the educational materials regarding data protection. This information is the responsibility of the MAH.

When preparing educational materials for generic medicinal products and educational materials for a reference medicinal product are available (either the innovator or another generic medicinal product), the wording, goal, content, and layout of the educational materials shall not differ from the reference medicinal product, unless this can be justified. This is to minimise the health care system burden, ensure consistency and increase patient safety.

New educational materials should always be submitted to the IMA for review.

When educational materials are updated, the general rule is that the material should be submitted to the IMA for review. The request for review should explain the changes made, and all changes from the previous version should be identified using Track changes.

The table below explains when and if a review of the educational materials is required, and if distribution is required.

EDUMAT changes Review required Distribution required
New educational materials Reviewed by the IMA. Materials and/or cover letter distributed according to IMAs instructions.
Changes made to the content according to PI/RMP Reviewed by the IMA. Materials and/or cover letter distributed according to IMAs instructions.
MAH holder changed, no other changes to the materials Reviewed by the IMA. If contact information have changed, including how to report adverse reactions, the cover letter must be distributed. If the material includes materials for patients/caregivers, it must be distributed again.
Product no longer subject to additional monitoring (▼), no other changes to the materials Review not required. The date of approval does not change. If the material is published on serlyfjaskra.is, a request for publishing the updated materials must be submitted. No further distribution required.
Previously approved materials re-distributed (e.g. new recipients or request for additional copies of the materials) Materials should not be updated/changed and therefore there is no need for review or notifying IMA. Materials that have been approved can be distributed to new recipients the same as if healthcare professionals request additional copies of the materials.

Additional educational materials prepared by the MAH (i.e. website, videos, materials not required in the RMP/Annex IID) are not reviewed by the IMA. The MAH is responsible for ensuring those materials reflect the educational materials that have been reviewed by the IMA.

The IMA has up to 60 days to review educational materials. The applicant should follow the instructions below when submitting a request for review of educational materials to the IMA.

  • MAH/representative shall submit to the IMA a completed Application form for request of review of educational materials. Care must be taken to ensure that the currently valid version of the form is used.
  • The educational materials submitted for review shall be in Word format (.doc/docx).
  • The currently approved requirements for additional risk minimisation measures for the medicinal product (Annex II D and/or RMP) must be submitted with the application.
  • The IMA recommends using the active ingredient in the educational materials instead of the brand name as much as possible. This will minimise confusion for the users of the medicine.
  • Only the Icelandic version of the educational material shall be submitted, not the English/original version. The IMA may request the original materials if required.
  • The educational materials shall not include or be in any way connected to advertising.
  • The educational materials shall only include the requirements listed in Annex II/RMP. Additional information will distract from the important safety concerns the materials are intended to address.
  • If the educational material will include images (pictures, drawings, graphs etc.) it must be included in the materials submitted to the IMA for review. Images cannot be added to the materials following IMA’s review.
  • Product logos are not allowed. The logo of the MAH or representative can be placed once in each component of the educational materials on the front or back page, however it may not be larger than the title of the material.
  • When submitting updated educational materials, all changes compared with the previously approved version must be identified using Track changes.
  • In cases where the SmPC is required as a part of the educational materials, it does not need to be distributed. The cover letter or specific components of the educational material should include instructions stating that the SmPC can be accessed on www.serlyfjaskra.is.

See instructions for different components of the educational material in the following sections.

Short cover letter addressed to the relevant recipients of the educational materials (generally the healthcare professionals) must always be included with the educational materials, and must include at minimum:

  • The logo identifying important safety information. The IMA encourages MAHs to join the agreement on use of the logo. See below.
  • Statement that these materials include important information regarding safe and effective use of the product and that this information is provided at the request of the authorities. The following text may be used as applicable: Fræðsluefnið er útbúið og því miðlað/dreift til að uppfylla kröfur lyfjayfirvalda, en markmiðið er að auka öryggi og tryggja rétta notkun lyfsins.
  • Brief purpose of the educational materials (i.e. what safety concern and/or risk does it address)
  • If the product is subject to additional monitoring (▼), the black triangle should be placed next to the product/chemical name the first time it is mentioned along with the accompanying information.
  • A reminder to report any adverse reactions to the IMA. The following text may be used: Heilbrigðisstarfsmenn eru hvattir til að tilkynna allar aukaverkanir sem grunur er um að tengist lyfinu til Lyfjastofnunar: http://www.lyfjastofnun.is eða í gegnum eyðublað (Tilkynning um aukaverkun) sem er að finna í Sögukerfinu.
  • A list of all components of the educational material (ensure to keep titles consistent) and how each one can be accessed.
  • If the educational material is not distributed on print the cover letter shall clearly explain where the material can be accessed (list the website address, e.g. www.serlyfjaskra.is).
  • If the educational material has been updated the cover letter should briefly explain what changes have been made and why.
  • If the educational material has been updated and previous version was distributed (on print or in email) the cover letter should include a reminder for the recipient to discard previous version of the educational materials.
  • The cover letter shall list the recipients of the educational materials and a request that other healthcare professionals be notified of the educational materials. The following text may be used: Viðtakendur þessa fræðsluefnis eru: Allir sérfræðingar í xxx (sérgrein) og lyfjafræðingar í lyfjabúðum/sjúkrahúsapótekum. Viðtakendur eru hvattir til að láta aðra heilbrigðisstarfsmenn vita um fræðsluefnið eftir því sem við á.

Educational materials for healthcare professionals should at minimum contain the following:

  • The logo identifying important safety information. See below.
  • Statement that these materials include important information regarding safe and effective use of the product and that this information is provided at the request of the authorities. The following text may be used as applicable: Fræðsluefnið er útbúið og því miðlað/dreift til að uppfylla kröfur lyfjayfirvalda, en markmiðið er að auka öryggi og tryggja rétta notkun lyfsins.
  • If the product is subject to additional monitoring (▼), the black triangle should be placed next to the product/chemical name the first time it is mentioned along with the accompanying information.
  • All requirements according to the aRMM (AnnexII/RMP) should be addressed in the educational material. The material should not contain other information than relevant safety information or information that is already adequately presented in the SmPC.
  • The reader should be referred to the SmPC for further information.
  • If the indication for use is included in the educational material, it should be verbatim from the SmPC.
  • The titles of the components should be descriptive.
  • Date of IMA approval shall at minimum be provided on the first and last page of the educational material. The IMA provides the approval date in the format of <month><year> during review and this date cannot be changed by the applicant.
  • Version number should be included on every page of the educational material.

Educational materials for patients/caregivers should at minimum contain the following:

  • The logo identifying important safety information. See below.
  • Statement that these materials include important information regarding safe and effective use of the product and that this information is provided at the request of the authorities. The following text may be used as applicable: Fræðsluefnið er útbúið og því miðlað/dreift til að uppfylla kröfur lyfjayfirvalda, en markmiðið er að auka öryggi og tryggja rétta notkun lyfsins. This is not required for patient cards.
  • If the product is subject to additional monitoring (▼), the black triangle should be placed next to the product/chemical name the first time it is mentioned along with the accompanying information.
  • All requirements according to the aRMM (AnnexII/RMP) should be addressed in the educational material. The material should not contain other information than relevant safety information or information that is already adequately presented in the SmPC.
  • The reader should be referred to the patient information leaflet for further information.
  • If information needs to be written into the material (e.g., date of administration or if patient needs to contact specific doctor if specific symptoms appear) it needs to be stated who should fill in this information. The following text may be used: Fyllist út af lækni/heilbrigðisstarfsmanni (changed as applicable).
  • The titles of the components should be descriptive.
  • Date of IMA approval shall at minimum be provided on the first and last page of the educational material. The IMA provides the approval date in the format of <month><year> during review and this date cannot be changed by the applicant.
  • Version number should be included on every page (or slide) of the educational material.

Upon completion of IMA’s review the agency will send the educational material including amendments/correction and comments to the applicant.

  • If further review is not required, the IMA will clearly state so in the response and the educational material should not be sent back to the IMA for further review.
  • If further review is required, the IMA will clearly state so in the response and request a response within 30 days.
  • If the applicant disagrees with the comments/amendments made by the IMA, the applicant shall send their objections within 30 days.

The IMA will add their own procedure number on the cover letter, in the format of V-xxxxxxxx. The applicant may not change the V-number. The applicant may change the placement of the number, and the applicant may also use the same V-number on the other components.

  • The IMA will add the approval date on all component of the educational material apart from the cover letter, in the form of: Samþykkt af Lyfjastofnun mán ár. This date should at minimum appear on the first and last page of each component, but the applicant may otherwise decide the placement. The applicant may not change the approval date.
    • If educational materials are updated and no review is required (see above), the approval date will not be changed.

  • The logo identifying important safety information shall be placed on the envelopes when educational materials are distributed via mail, and in a prominent place close to the top when educational materials are distributed via email.
  • Educational materials approved by the IMA may not be distributed with other materials not reviewed by the IMA.
  • Educational materials intended for patients/caregivers must always be distributed in a printed version to the recipients, even if it is also available on www.serlyfjaskra.is.
      1. The only exception is patient cards included in the medicine packaging. However, healthcare professionals should be notified of the patient cards and informed if they need to instruct patients on how to fill out the card.
      2. Ability to carry the patient alert card with ease (e.g. it can be fitted in a wallet) should be a key design feature of the patient card. In addition, the patient card should be printed on a paper that is suitable for such use. The patient card should be easily identifiable by the patient when it is included in the package.
  • A copy of the final educational materials shall be sent to the IMA at the same time and in the same way it is distributed to other recipients. Printed materials should be sent to IMA’s address. Materials distributed via email should be sent to [email protected]. When sending the copy, a reference should be made to the V-number.

IMA encourages MAHs to publish educational materials on its medicinal product information website, www.serlyfjaskra.is. See instructions below.

If educational materials are to be published on MAH’s website, the following should be adhered to:

  • Distribution of the materials via the website shall be approved by the IMA.
  • Link to the website shall be included in the application for review of the educational materials.
  • The website may not include links or reference to other documents or website unless approved by the IMA.
  • The website may not include references to or information about medicinal product not marketed in Iceland.

Instructions on electronic publication and removal of educational materials

The Icelandic Medicines Agency (IMA) only publishes educational materials that have been approved by IMA on its medicinal product information website: www.serlyfjaskra.is.

Educational material is published once a month.

Please follow these instructions:

  • Request for publication needs to be sent to IMA at least 7 days before the material is to be published.
  • The request should be sent by email to IMAs e-mail address: [email protected].
  • The subject line needs to be clear and specific e.g.: Educational material for [product name] for publication on [date].
  • All documents for publication must accompany the e-mail.
  • The e-mail must include:
    • Formal request for publication on www.serlyfjaskra.is.
    • V-number.
    • Month, when the material should be published.
    • Title to be displayed on the webpage
    • The order the components should appear in on the website
    • Version (example: New material, 1st edition or updated content 3rd edition).
    • When submitting updated materials, it must be clearly explained if it should replace currently published materials, which ones and if any materials are to be removed.
    • Confirmation that all files are enclosed and that they are the correct documents.

The Icelandic Medicines Agency requests that the following table is used when request for publication on Sérlyfjaskrá is submitted. Additionally, a confirmation that all files are enclosed and that they are correct must be included.

Month for publication:
V-number:
Order Title to be displayed on the Sérlyfjaskrá File name Version Replaces the following,
if applicable

  • Layout and design of the educational material must be clear and user-friendly.
  • Files should be in pdf format.
    • The documents need to be searchable (“Find” function).
    • Documents to be downloaded (e.g. checklists) are recommended to be in live pdf format.

  • The name of each file must be descriptive of the content, (note this only applies to the file name, not the title that is displayed on the website).
    • File names must not exceed 50 characters.
    • File names must not contain symbols (except underscore _).
    • File name must not contain space.
    • File names must not contain uniquely Icelandic letters.
    • Example of a file name: HCP_checklist_followup.

Titles of material components that appear on the website can be up to 50 characters. In case more space is needed, a comment field can be added below the title.

IMA can publish education materials as video or audio files on www.serlyfjaskra.is. The file can be sent with email or if the file is large a website where the file can be found can be cited.

  • All educational material is published once a month
  • Please send the educational material to IMA seven days before requested date of publication.
  • Please note that educational material will not be published on public holidays.
  • The applicant is responsible for checking that everything is in order following the publication on www.serlyfjaskra.is. Please contact IMA if the publication is not correct.

  • The applicant should send a request for removal of educational materials from www.serlyfjaskra.is to [email protected].
  • The email must include:
    • The name and strength of the product
    • What components of the educational materials should be removed, and when (use exactly the same title as is published)
    • Updated requirements for risk minimisation (RMP/Annex II) supporting the request must be provided
    • The subject should be “EDUMAT request for removal from the website” and [product name]
    • Educational material is removed from www.serlyfjaskra.is once a month

Instructions for submitting educational materials and on electronic publication and removal of education materials were last updated in July 2023.

When applying for evaluation of educational material

Please always use the current form to apply for review of educational materials. The current valid form was updated in July 2023. Marketing authorization holders are asked to refrain from using outdated version of the same.

Agreement on specific labelling of educational materials

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/educational material 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.:

  • Educative material 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,
  • Educative material published for medicinal products following a referral, in accordance with a Commission Decision,
  • Educative material 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 educational material.

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]

Abbott
Abbvie
Accord
Actavis
Actelion Registration
Alcon
ALK-Abelló
Allergan Norden
Allergan Pharmaceuticals International Ltd.
Allergen Pharmaceuticals Ireland
Alvetra GmbH
Alvogen IPCo S.à.r.l.
Amgen
Arthropharm Europe Limited
Astellas
AstraZeneca
Baxter
Bayer
Bayer Animal Health GmbH
Bene-Artzneimittel GmbH
BGP Products AB
BGP Products Aps
BGP Products Ltd
Biogen Idec
Bioglan Pharma AB
BioMarin International Limited
BMS
Boeringer Ingelheim
CCS
Celgene
Celltrion
Ceva Sante Animale
Chanelle UK Limited
Cheplapharm Arzneimittel
Chiesi Farmaceutici SpA
Clintec Parenteral SA
Colgate Palmolive A/S
CSL Behring AB
Daiichi Sankyo Europe GmbH
Dentsply De Trey
Desitin Arzneimittel
Diurnal
Dopharma Research B.V.
Eisai
Elan Pharma International Ltd.
Elanco Animal Health A/S
Eli Lilly
Expanscience
Ferring
Fresenius Kabi
Fresenius Medical Care
Galderma
GE Healthcare
Gedeon Richter Nordics AB
Generics Ltd UK
Genzyme Europe B.V.
Gilead
Grünenthal GmbH
GSK
Hospira
Intendis GmbH Berlin
Intercept
Janssen Biologics B.V.
Janssen-Cilag
JSC Grindeks
Kela Laboratories NV
Kyowakirin
LEO Pharma
Les Laboratories Servier
Linde Healthcare – ÍSAGA
Lohmann Animal Health
Lundbeck
LYFIS
Martindale Pharmaceuticals
Medical Valley Invest AB
The Medicines Company UK Limited
MEDA
medac Gesellschaft für klinische Spezialpräparate GmbH
Medical
Medice Arzneimittel Pütter GmbH & Co. KG
Medilink
Medimpex UK Limited
Menarini International Operations Luxembourg S.A.
Mentholatum Company Ltd.
Merck
MercuryPharma
Moderna
MSD
Mylan AB
Mylan Hospital AS
Mylan SAS
Norbrook
Nordic Drugs
Norpharma A/S
Novartis
Novo Nordisk
Octapharma Nordic
Orifarm Generics A/S
Orion Corporation
Otsuka
Pfizer
Pfizer Oy Animal Health
PharmaCoDane
Pharmacosmos A/S
Pharma Nord ApS
Pierre Fabré
Raptor Pharmaceuticals Europe B.V.
ratiopharm GmbH
Reckitt Benckiser Healthcare
Roche
Sandoz GmbH
Sanofi
Sanofi-Pasteur MSD
Santen Oy
Shire Pharmaceuticals Ltd.
SkyePharma PLC
Smith & Nephew
STADA Arzneimittel AG
Swedish Orphan Biovitrum (Sobi)
Takeda
TEVA
Thea
Therakind Ltd
Tillotts Pharma AB
UCB
United Therapeutics Europe Ltd.
Vétoquinol
Vian S.A.
Vifor Pharma
Zogenix ROI Ltd.
Williams & Halls ehf.

Last updated: November 24, 2023
Var efnið hjálplegt Yes No

Hvað þarf að laga?