Educational material - guidance for submission and distribution

When the material is intended for non-prescription medicines, the material must be assessed and accepted by the Norwegian Medical Products 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 Medical Products 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 opplaeringsmateriell@dmp.no or educationalmaterial@noma.no

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 Medical Products Agency does not assess and accept the material before use. The material is archived internally and the Norwegian Medical Products Agency conducts random-based inspections of the material. The background and evaluation of this procedure can be found here (norwegian).​

The Norwegian Medical Products 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 opplaeringsmateriell@dmp.no or educationalmaterial@noma.no

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.

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.

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.

The Norwegian Medical Products 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.

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.​

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.dmp.no/meldeskjema.

Text for material to patients

Bivirkninger kan meldes på elektronisk skjema til DMP: www.dmp.no/pasientmelding.

For medicinal products labelled with black triangle the standard text to report adverse drug reactions comes after the black triangle and explanatory text about additional monitoring. See section about black triangle below. 

Exception is patient cards where the black triangle and explanatory text should not be included. Here you can use the following standard sentence to encourage reporting of adverse drug reactions: 

Du kan bidra ved å melde enhver mistenkt bivirkning, se www.dmp.no/pasientmelding

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:

Healthcare professionals

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.dmp.no/meldeskjema.

Patients

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.dmp.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. However the standard sentence to report adverse drug reactions should be on the patient card. 

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 redaksjonen@felleskatalogen.no with the subject field "E-post apotek til utsendelse av opplæringsmateriell".

The email to the pharmacies should contain the text "Sikkerhetsinformasjon i samarbeid med DMP” 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 Medical Products 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 Medical Products 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.​

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 Medical Products 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.