Educational material - guidance for submission and distribution
- : Amended recommendation for the distribution of educational material for generic products
Marketing authorisation holders may be required to make material for the training of healthcare professionals, patients and relatives for medicines which have a special risk of adverse drug reactions. The purpose of the material is to reduce these risks.
Educational material is a type of additional risk minimisation measure (aRMM), and the requirements for these aRMMs is given during the processing of the application for the marketing authorization. For medicinal products in central procedure, the requirements are given in Annex II, for other procedures they are described in the risk management plan (RMP).
This figure gives an overview of when the MAH should submit material to the Norwegian Medicines Agency:
Submission of material
Material for non-prescription medicines with additional risk minimsation measures
When the material is intended for non-prescription medicines, the material must be assessed and accepted by the Norwegian Medicines Agency before it is used. This means that MAH must send all material including cover letters, layout, target groups and distribution method to the Norwegian Medicines Agency for acceptance, before distribution:
The MAH should submit:
- opinion or Commission Decision (including Annex II)
- latest version of Risk Management Plan (RMP)
- material in word format (use "track changes" for later updates)
- PDF version of material with suggestions for image use and layout if available
- if a cover letter is to be included with the dispatch, this must also be assessed by NoMA
- suggested target groups
Send the material to email@example.com or firstname.lastname@example.org
Educational material for prescription medicines
From 10 November 2020, the MAH must before distribution submit final Norwegian versions of educational material for medicines that is not non-prescription medicines with additional risk minimsation measures. The Norwegian Medicines Agency does not assess and accept the material before use. The material is archived internally and the Norwegian Medicines Agency conducts random-based inspections of the material. The background and evaluation of this procedure can be found here (norwegian).
The Norwegian Medicines Agency has developed an online course (found at the bottom of the page, in Norwegian). The course describes the background for educational material, and what the MAH should be aware of when designing the material. You can also find a checklist that serves as a summary of the online course, and a glossary that can be used during the development of educational material.
Submit the following before the use and distribution of educational material:
- Final Norwegian PDF versions of material with final layout (and possibly cover letter)
- Latest version of the risk management plan (RMP) part V (for CP-products can annex IID of SmPC also be used)
- Target groups (MAH determines this themselves)
- Distribution plan including schedule for distribution
In addition, submit the following when updating material:
- justification for updating the material
Send the material to email@example.com or firstname.lastname@example.org
Medicinal products that is already marketed, and receives a new aRMM-requirement
For products that are already marketed, and receives a new aRMM-requirement, ie. an update to the Annex IID, the submission deadline for educational materials are 30 days after approval.
Random sample based inspections
The Norwegian Medicines Agency will carry out random inspections of material not used for non-prescription medicines with additional risk minimisation measures. The inspection is performed to ensure that educational material are in line with recommendations from EMA and to ensure that educational material meet individual requirements for each material. If the Norwegian Medicines Agency finds deviations from EMA's recommendations or individual requirements for each medicine, we will contact the MAH.
Guidance for the development of educational material:
Guideline on good pharmacovigilance practices (GVP) Module XVI Addendum I - Educational materials
Overall description of various risk minimization measures and educational material:
Text and language
The educational material should be written in clear and comprehensible Norwegian, and preferably without heavy and complicated sentences. If the quality of the language is poor or incomprehensible, the MAH will be asked to improve the language during an assessment/sample based inspection. Proofreading of patient material is generally given higher priority than material for health personnel.
The material should not contain more or less than the points described in the RMP part V/ Annex IID (bullet list for what aRMM should contain). All unnecessary text in educational materials not described in RMP Part V/annex IID should generally be deleted as the purpose of educational material is to describe selected risks of using the medicinal product.
Examples of this can be mechanisms of action, pathology, etc. sometimes described in the material. This should only be written if it is specifically described in RMP/annex IID.
Use of color, image and logo
Educational material shall not contain colors that are commercially related, i.e. colors that are related to the marketing of the product. However, it is allowed to use the MAH's colors in the material.
Companies are allowed to use the MAH logo in one place on each document (e.g. on either the front or back).
The educational material shall not contain pictures or illustrations unless this contributes to an increased understanding of the content, e.g. a specific procedure, different injection sites / techniques for administration or the like.
The use of color must not contribute to poor readability with reduced contrast.
Signature from prescriber/patient
The Norwegian Medicines Agency does not want educational material to contain requirements for a signature from the prescriber and/or patient unless this has been approved by the EMA/Commission. A signature may give the wrong impression that it comes with additional obligations for the patient or healthcare professional who signs. This does not prevent contact information to the treating doctor/clinic from being applied to the patient material when the intention is to inform other health personnel about contact information in the event of a crisis situation for the patient.
The MAH must have some form of version number on the educational material to enable the overview of different versions. MAH should put this on, if missing.
It is recommended that the MAH enclose a cover letter explaining the purpose of, or the updates in the educational material if the material is to be distributed to the recipient, and not only published online. Companies should be encouraged to mark the cover letter with our standard logo for safety information.
The cover letter must also always contain information about where the educational material can be found, e.g. on Felleskatalogen.no:
See updated Summary of Product Characteristics (SPC) and educational materials at www.felleskatalogen.no.
Safety information logo
The Norwegian Medicines Agency's new safety information logo is mandatory on educational material, cover letters and envelopes. The MAH can consider applying the logo on patient cards if there is enough space.
Please note that the logo is different from the safety information logo previously used on educational material.
The purpose of the logo is to clarify the importance of the information for the recipient. The Norwegian Medicines Agency believes that standardized labeling can contribute to important safety information being read.
- Letter template (word) with security logo at the top left. Standardized template with logo in header
- Letter template (word) with security logo at the top right. Standardized template with logo in header
Reporting of adverse drug reactions
The following standard sentences can be used in cover letters and educational material where it is encouraged to report adverse drug reactions:
Text for material to healthcare professionals
Helsepersonell bes melde nye, uventede og alvorlige mistenkte bivirkninger på elektronisk meldeskjema: www.legemiddelverket.no/meldeskjema.
Text for material to patients
Bivirkninger kan meldes på elektronisk skjema til Legemiddelverket: www.legemiddelverket.no/pasientmelding.
Standard statement of where educational material can be found online
It should be stated in the educational material and cover letter, if applicable, where the educational material and the SmPC can be found online. Use the following default statement:
Se oppdatert preparatomtale (SPC) og opplæringsmateriell på www.felleskatalogen.no.
Educational materials for medicinal products on the common European watch list shall contain a black triangle in one place on all documents (except for patient cards*) with explanatory text. Place the black triangle in front of the product name (▼product name) at the beginning of the educational material, and have the same height as the letters in the product name it appears in front of. On the same page, there should be an explanatory text for the black triangle. Explanatory text for material to:
Dette legemidlet er underlagt særlig overvåking for å oppdage ny sikkerhetsinformasjon så raskt som mulig. Helsepersonell oppfordres til å melde enhver mistenkt bivirkning på elektronisk meldeskjema: www.legemiddelverket.no/meldeskjema.
Dette legemidlet er underlagt særlig overvåking for å oppdage ny sikkerhetsinformasjon så raskt som mulig. Du kan bidra ved å melde enhver mistenkt bivirkning, se www.legemiddelverket.no/pasientmelding
* EMA wants the black triangle including explanatory text not to be included in patient cards since there often is little space on patient cards. The space should therefore be saved to increase the readability of other information on the patient card.
The MAH must always submit a plan for whether material should be distributed and/or published on Felleskatalogen. The MAH must also propose a schedule for publication and/or dissemination. Educational material shall normally be distributed to selected recipient groups when the educational material is new or when there is significant changes/updates in existing educational material. In the event of minor changes, it should be considered to only publish on Felleskatalogen.
Educational material for generic medicines does not in principle need to be distributed. The MAH of the origin product has often already distributed the educational material, and the material/risks described in the educational material are therefore most often already known by the health professionals. However, the MAH must ensure that prescribers are aware of the existence of educational material for their product, and that physical copies of the material can be distributed upon request from the prescribers or patients, for example via e-mail.
Educational materials for HCPs in pharmacies are sent by email. An overview of email addresses for pharmacies is available from the Norwegian Pharmaceutical Product Compendium (Felleskatalogen). To receive the lists, send an e-mail to email@example.com with the subject field "E-post apotek til utsendelse av opplæringsmateriell".
The email to the pharmacies should contain the text "Sikkerhetsinformasjon i samarbeid med Legemiddelverket” in the subject field. Attach the educational material to the email in pdf format.
Educational material should not be sent to GPs on paper. The Norwegian Medicines Agency instead disseminates the information through notifications in the electronic patient journal (EPJ).
Updated material is only notified through this system if the update is required by the authorities. It is therefore important that it is clearly stated in the submission to the Norwegian Medicines Agency whether the update is required by the authorities. In addition, clearly state in the email that GPs are the recipient group for the material.
Other doctors/other healthcare professionals
Educational materials for other groups of health personnel must be sent by post mail.
Publication at Felleskatalogen
We strongly encourage publishing all educational material in the Norwegian Pharmaceutical Product Compendium (Felleskatalogen). The reason for this is that almost all health personnel use Felleskatalogen, and there is a greater probability that educational material will be used if it is easily accessible. It will therefore increase patient safety if all educational materials are available to healthcare professionals and patients through Felleskatalogen.
There are three categories of educational materials on Felleskatalogen:
- Educational material and instructions for use
- Pregnancy prevention program
- Educational material and pregnancy prevention program
Felleskatalogen groups the material into the correct category when the material is submitted to them.
- Educational material (RMP material) is published on www.felleskatalogen.no
- Use FK SHARE for uploading, https://share.felleskatalogen.no/
- Are you a new FK SHARE user? Send e-mail to firstname.lastname@example.org to be registered
NB! RMP material should always be marked with ‘RMP’ in the file name. Assessment of RMP is done by the Norwegian Medicines Agency, and Felleskatalogen's editorial staff will not assess this material further.
Educational material for generic products
Where the conditions for generic products are identical to the original product, the educational material should be harmonised with the existing approved material for the original product.
Joint material and distribution
Marketing authorization holders for different products with the same substance and identical conditions concerning educational materials are encouraged to collaborate on the preparation of the educational material. The MAH should submit only one version for the educational material to the Norwegian Medicines Agency. We also recommend that the marketing authorization holders collaborate on the dissemination of the educational material to make sure that the recipients on the distribution list receive the same common educational material.
The courses are only available in Norwegian.
The courses will take you through the most important aspects to remember when preparing the educational material.