Educational material as a condition in the marketing authorisation - FAQ

What is educational material?

For some medicinal products, educational material is a condition in the marketing authorisation and the marketing authorisation holder (MAH) must develop and distribute the educational material to relevant target groups. Educational material can for example be developed for prescribing doctors, nurses, pharmacists, or patients.

Educational material as a condition is always assessed at a national level, regardless of which approval procedure the medicinal product has been approved through. It is the matter of each national competent authority to determine the appropriate review process of educational material. The Swedish Medical Products Agency’s procedure for educational material might differ from other member states’ procedures. For details regarding other member states’ procedures, you are referred to each country’s competent authority (even in those situations where Sweden has the role of reference member state). Hence, the Swedish Medical Products Agency can only answer questions regarding national management of educational material in Sweden.

Which educational materials are reviewed by the Swedish Medical Products Agency?

Only educational material listed as a condition according to art 21 a directive 2001/83/EG in the marketing authorisation is reviewed by the Swedish Medical Products Agency. (See questions below for more information on where you can determine if a product has a condition including educational material).

Educational material not listed as a condition according to art. 21 a directive 2001/83/EG should not be evaluated and should consequently not be sent to the Swedish Medical Products Agency.

Educational material as a condition according to art 21 a directive 2001/83/EG should be described in the risk management plan (RMP).

Note that educational material not considered a condition, but merely an activity in the RMP, will not be reviewed by the Swedish Medical Products Agency.

In conclusion, if educational material is an activity in the RMP and is written as a condition in the marketing authorisation, it should be reviewed by the Swedish Medical Products Agency.

Flödesschema

What should the MAH include in the submission to the Swedish Medical Products Agency?

  • Educational material in Swedish language (include a tracked-changed version if the material has been updated as well as a clean version).
  • Document where the condition is stated.
           - For centrally approved products: the European commission’s decision including Annex II.
           - For nationally approved products, MRP, or DCP: the final assessment report where the condition is included.
  • Information on target groups for the educational material and the distribution frequency (distribution plan).

Where can I find information about the condition for educational material?

For centrally approved products, the conditions are described in EPAR annex IID which can be found on EMA’s website for each product.

For nationally approved products, MRP, or DCP, the conditions are included in the assessment report or in the End of Procedure document, usually listed under conditions according to art 21 a directive 2001/83/EG. The conditions can also be included in a European commission decision if the product has for example been subjected to a referral process.

For nationally approved products, MRP or DCP, how do you know if educational material is a condition in the marketing authorisation?

Conditions can either be part of the original marketing authorisation or added at a later time point, for example in a PSUSA, referral or a variation. Conditions are included in the assessment report or End of Procedure document (see question above).

For centrally approved medicinal products, the conditions are included in annex IID to the European commission decision.

Is there a situation where educational material is not a condition but described in the RMP?

GVP module V clarifies that only the additional risk minimisation efforts that are defined as conditions to the marketing authorisation should be included in the RMP. However, for non-centrally approved products, the RMP may include descriptions of additional risk minimisation efforts that are not defined as conditions to the marketing authorisation. These educational materials, although included in the RMP, should not be reviewed by the Swedish Medical Products Agency when lacking a condition.

Regardless of whether the educational material is a condition to the marketing authorisation or simply an activity in the RMP, is should be developed and distributed according to the RMP or other agreements.

It is important to note that even if the educational material is not a condition and therefore should not be reviewed by the Swedish Medical Products Agency, it should still be handled in accordance with the description in the most current RMP. Note that the management of aRMM from the RMP can be the subject of a pharmacovigilance inspection.

How is the educational material reviewed?

The Swedish Medical Products Agency reviews if the educational material fulfils the condition in the marketing authorisation. If the educational material submitted includes information other than what is listed as a condition, it is not included in the review. Hence, the Swedish Medical Products Agency reviews if the educational material fulfils the conditions.

The MAH should design the educational material in a way so that it clearly fulfils the specifics in the condition.

Why is there a second review of the educational material on a national level when the educational material has already been reviewed within the risk management plan?

In the RMP, it is assessed if educational material is requested and which main points it should cover. However, the final content of the educational material is a national matter for each competent authority.

How long is the review process?

The review process takes approximately 30 days. If the Swedish Medical Products Agency issues question or comments on the material, it may take longer.

Can I submit educational material ahead of European Commission decision?

Yes, for non-approved products submitted through the centralised procedure, educational material based on CHMP opinion can be submitted to the Swedish Medical Products Agency ahead of European Commission decision. This is also applicable for already approved medicinal products when educational material has been added as a condition in the marketing authorisation.

The Swedish Medical Products Agency can provide feedback on the educational material but will not issue the final statement until after the European Commission decision and after the MAH has submitted a copy of the decision to the Swedish Medical Products Agency. After MAH has received the final statement from the Swedish Medical Products Agency, the educational material may be distributed.

In regards to medicinal products approved via MRP, DCP or national procedures where educational material is a condition, the educational material can be submitted for review after the procedure has been concluded but before the national approval has been received. The Swedish Medical Products Agency will provide feedback on the material and send the final statement after the national approval has been sent.

Should updated educational material be re-submitted?

The MAH is requested to submit updated educational material if the condition in the marketing authorisation has changed. Follow the same procedure as outlined above and submit the updated material in Swedish language together with a copy of the new European Commission decision (centralised procedure) or assessment report (Nat, MRP, DCP) where the updated condition is stated.

If the educational material has been updated but the condition is unchanged, the MAH does not have to send in the revised material except in those instances where the updates affects language that has been defined as a condition in the marketing authorisation, so called key messages. In summary, updates to the educational material might warrant a new review even if the condition is unchanged. See flow chart above.

How do I submit the educational material?

General question regarding educational material not connected to a specific medicinal product should be sent to: registrator@lakemedelsverket.se

Educational material that should be reviewed by the Swedish Medical Products Agency, or questions regarding educational material for a specific product, should be sent to RIC@lakemedelsverket.se
It can also be submitted via eudralink or CESP.

Can a condition for educational material be removed or can educational material be removed from the RMP?

If there are reasons to change a condition or aRMM in the RMP, you may submit appropriate variation application according to the variations regulation and the submitted application will be reviewed through this procedure.

If this question concerns a condition for a generic product where the reference product has a condition including educational material, the condition of the reference product has to be reviewed first.

According to GVP module XVI Addendum I, the "date of approval by the competent authority the Member State" should be included in the material. How should this be handled if sections in the educational material that are not subjected to a condition defined in the marketing authorisation are updated? Per definition, these types of updates do not warrant review by the Swedish Medical Products Agency.

The Swedish Medical Products Agency does not approve educational material per say, but issues a statement if the educational material fulfils the criteria set out in the marketing authorisation. The issue date of the final statement should be included in the educational material. If sections in the educational material not subjected to a condition (and subsequently will not be reviewed by the Swedish Medical Products Agency) are updated, the issue date of the final statement should still be used “last reviewed by the Medical Products Agency [date]”.

Can educational material be web-based?

Educational material should be in paper format unless otherwise stated in the condition in the marketing authorisation. The MAH is free to provide web-based material in addition to the regular paper format material but this is not reviewed by the Swedish Medical Products Agency.

Note that the Swedish Medical Products Agency reviews educational material as a whole. If additional web-based material is provided and is labelled as educational material, the Swedish Medical Products Agency recommends that all parts of the educational material are made available.

Should the product information be attached to the educational material?

Educational material usually consists of a combination of documents where product information may be one. The art 21 a directive 2001/83/EG condition in the marketing authorisation should specify if product information is part of the educational material. If product information is included in the condition, it should be distributed as part of the educational material. It is not acceptable to only refer to a website.

Is there a logo/stamp for educational material or a special envelope that should be used?

No, there is no specific logo, stamp or envelope that should be used.

 
 

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Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information