Educational material as a condition

Educational material is intended to reinforce the information that is provided in the product information, with the aim of minimising the risks associated with the use of a medicinal product, and/or maximising the benefit-risk balance. Educational materials are an example of an additional risk minimisation measure (aRMM) and must be described in the risk management plan (RMP).

The material must be prepared and distributed by the marketing authorisation holder (MAH). It may be aimed at for example prescribers, other healthcare professionals, pharmacists and/or patients.

When are conditions set?

Conditions regarding educational material can be a part of the new marketing authorisation for a medicinal product but they can also be added later, for example in connection with a periodic safety report, a referral or following a variation application.

The conditions can be found:

• In case of centrally authorised products, the conditions are described in Annex IID to the End of Procedure Assessment Report (EPAR), which is available on the European Medicines Agency’s website.
• In the case of nationally authorised products (Nat, MRP, DCP), the conditions are formulated in the assessment report or in an ‘End of procedure’ document, where one is prepared.
• The conditions may also be described in a Commission Decision following, for example, a referral procedure.

National review of educational material

The review of the educational material is always performed at a national level.

Other Member States’ educational materials are managed by the competent authority in the concerned country. This also applies to cases and procedures where Sweden is acting as reference Member State.

The Swedish MPA can only answer questions concerning the national handling of educational material in accordance with the applicable regulations in Sweden.

Educational materials not specified as a condition

Educational material for products that does not have a condition in the marketing authorisation, but merely an activity in the risk management plan (RMP), is not reviewed by the Swedish MPA and is not required to be submitted for review.

Regardless of whether educational material is specified as a condition in the marketing authorisation or if it is only an activity in the RMP, the material must be drawn up and distributed as specified in the RMP or as agreed. The management of risk minimisation measures from the RMP may be subject to review in a pharmacovigilance inspection.

These educational materials, as they are found in the RMP, do not constitute a condition and no review will be performed by the MPA.

Distribution plan

The MAH shall propose and submit a distribution plan. Unless stipulated otherwise, distribution should take place prior to launch and in the event of updates of the conditions in the marketing authorisation.

The distribution plan must include:

• target groups
• means of distribution
• frequency of distribution.

The distribution plan must ensure that no one in the target group is excluded from the distribution. This means that the material can be distributed via email and/or via regular mail depending on which method is deemed the best way to reach everyone in the target group.

In cases where the conditions state that the summary of product characteristics, the package leaflet and/or the labelling constitute part of the educational material, a reference to current versions at the Swedish MPA's Läkemedelsfakta can often replace distribution in paper form for these documents. The reference should then be placed in the introduction of the other documents of the educational material, with the intended recipient of each document taken into consideration. It should be clear that the educational material is intended to be read together with the part of the product information to which reference is made.

The MAH can, if they so choose, publish the educational material on a webpage that provide healthcare providers, pharmacies, patients, relatives, and the public with current information about medicinal products. If this is done, all the different parts of the educational material must be made available on the webpage. The publication is deemed a complement to the direct distribution that is done via email or mail.

Updated educational material or amended distribution plan

I the conditions in the marketing authorisation are amended, the marketing authorisation holder must, as soon as possible, submit the updated and version controlled educational material to the MPA for review.

If an update to the educational material is made for any other reason, the material must only be submitted if the amendment or alteration impacts the fulfilment of the condition. Thus, changes made in the material may result in the need for a new review, even if the conditions have not changed.

In the event of a change in an agreed distribution plan, the new plan must be submitted to the MPA for review.

Controlled distribution as a condition

If it is stated in the marketing authorisation that controlled distribution is a condition, this must be stated in the application and be reflected in the distribution plan. This will also be reviewed at a national level.

In Sweden, national legislations do not allow for a system with controlled distribution that is based on identifying connections between prescriber and patient on an individual level. For a distribution plan pertaining to a medicinal product with conditions for controlled distribution to be considered acceptable, the MAH must provide a plan of following-up that the target group has access to the educational material. This follow-up system can, for example, consist of regularly performed emails or phone calls to ensure that the educational material is accessible to the target group.

Application for review of educational material

During the review, MAH can be asked to submit additional documentation if it is considered necessary for the assessment.

Applications for the review of educational material must include:

• an application form
• the educational material, in Word format, written in Swedish (version with 'Track Changes', if the material has been updated, along with a clean version)
• the document setting out the relevant condition (see the heading ‘When are conditions set?’)
• a distribution plan.

Applications for the review of sound- and/or video based educational material must include:

• an application form
• the script for the sound- and/or video material, in Word format, written in Swedish (version with 'Track Changes', if the material has been updated, along with a clean version)
• the document setting out the relevant condition (see the heading ‘When are conditions set?’)
• a distribution plan.

During the review, the Swedish MPA will evaluate the need to hear/see the finished sound-/video material. If it is considered necessary, the MAH will be notified that the finished product also is to be submitted for review. The video material is, in these cases, to be submitted in MPEG-4 format.

Applications should be sent by email to: RIC@lakemedelsverket.se

Applications may also be sent via EudraLink or CESP.

When the application has been submitted, a receipt of acknowledgement will be sent to the applicant.

Reporting of adverse reactions in educational materials

Information on adverse reaction reporting included in the educational material aimed at healthcare professionals must state that adverse reaction reports shall be submitted to the Swedish MPA.

Products with identical conditions regarding educational material

Where the conditions for generic products are identical to the originator product, the educational material should follow the existing approved material for the originator product. MAH for different products with the same substance and identical conditions regarding educational materials may propose joint educational material and distribution plan. However, this is not coordinated by the Swedish MPA and is entirely optional for those that wish to follow this approach.

The review process

The review of educational material is always performed nationally. The Swedish MPA reviews the educational material to ensure that it meets the condition stated in the marketing authorisation. The material must be formulated in such a way that the requirements regarding the content are clear.

In Sweden, a pilot study is currently ongoing where randomised selection for review is applied on certain types of educational material. After approximately one year, the pilot study will be evaluated.

As per the pilot study, randomized selection is used to determine which new or updated educational materials for products with marketing authorisation of generic, hybrids and biosimilars will be selected for review. This also applies to updated educational materials with marketing authorisations of NCE/KAS, WEU, fixed combination and informed consent. When the Swedish MPA has received the application, the MAH will be notified if the educational material has been selected for review or if distribution of the material can be initiated immediately.

Educational material for products with marketing authorisation of NCE/KAS, WEU, fixed combination and informed consent that is submitted to the Swedish MPA for review for the first time will always go through the review process. This also applies when an indication has been added/removed and there has been a change in the distribution plan. The educational material for a product with conditions regarding controlled distribution shall also go through the review process if the educational material is new and/or there has been an update to the distribution plan.

The review of educational material is estimated to approximately 30 days. However, if the Swedish MPA has any remarks concerning the material, this period may exceed 30 days. The review process begins when the application is complete.

Educational material that has not been selected for review is received by the Swedish MPA for information and distribution can begin as soon as the MAH receives the notification.

Legal basis for educational material chosen through randomized selection

• Art. 10(1) – generic
• Art. 10(3) – hybrid
• Art. 10(4) – biosimilar
• Updated educational material

Legal basis for educational material that is not part of the randomized selection

• Art. 8(3) – New Active Substance (NCE)/Known Active Substance (KAS)
• Art. 10a – Well Established Use (WEU)
• Art. 10b – Fixed combination
• Art. 10c – Informed consent
• Updated distribution plan when an indication has been added
• Conditions for Controlled distribution

Version number

During the duration of the pilot study for randomized selection, educational material submitted to the Swedish MPA shall contain a version number to make it clear to the recipient which version it is they have received. The version number replaces the phrase “Granskad av Läkemedelsverket” and is to be written as follows: version xx/month-year.

Preliminary review of educational materials

Medicinal products authorised via the centralised procedure

For medicinal products authorised via the centralised authorisation procedure, the application for the review of educational material may be submitted once the opinion of the Committee for Medicinal Products for Human Use (CHMP) has been received. This sometimes occur before the Commission Decision is received, and in those cases, a preliminary statement is issued. The final statement is issued after the MAH has provided the Swedish MPA with a copy of the Commission Decision, and once the MAH has received the final statement, the educational material may be distributed.

Where an update to previously reviewed educational material is carried out as a result of a variation application, distribution of the material may take place after receiving a preliminary statement, as it can take up to 12 months to receive a Commission Decision following a centralised variation procedure (information on when Commission Decisions can be expected is normally provided in CHMP’s opinion). The final statement will be issued when the Swedish MPA receives a copy of the Commission Decision from the MAH.

Medicinal products authorised by national procedure

In the case of a medicinal product authorised by national procedure or MRP/DCP where there are conditions regarding educational material, it may be submitted after completion of the procedure, but before national authorisation has been obtained. The MPA provides feedback on the material and sends a final statement after national authorisation has been issued.

Removal of conditions concerning educational materials

In the event of changes to conditions or additional risk minimisation measures, avariation application must be submitted.

When conditions for educational material are removed, the distribution of the material can be discontinued whenever the procedure (where the condition is removed) is finalised. There is no requirement to notify the Swedish MPA when distribution of educational material stops.

Parallel distribution

General questions concerning educational material should be sent by email to: registrator@lakemedelsverket.se

Questions concerning educational material for a specific product should be sent to: RIC@lakemedelsverket.se

Regulatory framework

Chapter 6. Second paragraph, Medicinal products act (2015:315)

Article 21(a) of Directive 2001/83/EC

Article 21(a) of Directive 2001/83/EC regulates the scope to impose conditions concerning the issuing of authorisation. Educational material which is a condition of the marketing authorisation must be reviewed and be covered by an opinion from the Swedish MPA before the material can be used in Sweden.

Article 10 of Regulation (EC) No 726/2004

Article 10 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.