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 opplaeringsmateriell@legemiddelverket.no or educationalmaterial@noma.no

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. This arrangement will operate in a pilot period until 31.01.2022 where the Norwegian Medicines Agency will assess whether it works as intended. The background for the arrangement can be read here.

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 (and possibly Annex IID)
  • 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@legemiddelverket.no or educationalmaterial@noma.no

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.

Guides

Guidance for the development of educational material:

Overall description of various risk minimization measures and educational material:

Security information logo

We recommend using the Norwegian Medicines Agency's new safety information logo on material, cover letters and envelopes. 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 templates:

Standard texts

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.

Black triangle

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.legemiddelverket.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.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.

Distribution

Pharmacy

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 Legemiddelverket” in the subject field. Attach the educational material to the email in pdf format.

General practitioners

From 1 February 2020, the Norwegian Medicines Agency initiated a pilot project where educational material would 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.

The pilot period lasts until 1 February 2021, where after an evaluation, a decision will be made on whether this way of disseminating safety material will be permanent. Read more about the pilot project here.

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.

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.

Online courses

The courses are only available in Norwegian.

The courses will take you through the most important aspects to remember when designing educational material.

Publisert: 16.11.2020

​Fant du det du lette etter?