Joint development and distribution of educational materials

Holders of marketing authorisations of medicinal products containing the same active substance/combination of active substances should cooperate in the development and distribution of joint EM, i.e. to create EM of uniform content, graphic layout, format, without company logos, and stating only the active substance/combination of active substances.

In case there are several MA holders who have medicinal products with the same active substance and who have identical or very similar obligations regarding EM development and distribution or any other measures to minimise risks (in particular, but not limited to medicinal products legally based on Art. 10(1), 10(3), and 10(4) of Directive 2001/83/EC), SÚKL usually requires all of these MA holders to develop and distribute joint EM.

Joint EM development

These EM shall be developed for a particular active substance/combination of active substances without giving the names of individual medicinal products. There may be a space reserved for the entry of the name of the medicinal product upon hand-over to the patient or his/her carer within the EM; this concerns primarily Patient Alert Cards. The method of providing the names of medicinal products depends on the specific situation and is subject to agreement with SÚKL.

The following courses of action may be applied:

1. Educational materials for the original medicinal product have already been approved in compliance with this Guideline.

• The previously approved text shall be used and amendments in terms of deleting the name of the original medicinal product and its replacement with the name of the active substance/combination of active substances shall be made.
• The title of the EM shall be amended so as to clearly reflect that they are applicable to all medicinal products with the same indication(s) containing the same active substance/combination of active substances.
• SÚKL shall inform the representative of the original medicinal product on the receipt of application for EM approval for a product with the same active substance/combination of active substances and on the decision regarding joint EM development.
• SÚKL shall ensure the sharing of contact information among the concerned MA holders.
• Where there are several MA holders entering the market, their representatives shall appoint a contact person for further communication with SÚKL from amongst themselves. Such contact person shall thereafter represent all of the parties involved, including the representative of the original medicinal product(s), unless he/she is the contact person.
• The appointed contact person shall get the approved EM from SÚKL´s website. In case of problems with editing in the PDF format, the contact person may request these EM from the MA holder of the original medicinal product. SÚKL suggests that the MA holder of the original medicinal product provide the materials without unnecessary delay.
• If necessary and having regard to the up-to-datedness of the previously approved EM, SÚKL may request further text and format amendments thereof.

2. There are no approved EM for the original product or generic products, or there are several approved educational materials

• SÚKL shall inform the representatives of MA holders of the necessity to develop joint EM.
• SÚKL shall ensure the sharing of contact information among the concerned MA holders.
• The representatives of MA holders shall appoint a contact person for further communication with SÚKL from amongst themselves. Such contact person shall thereafter represent all of the parties involved, including the representative of the original medicinal product(s), unless he/she is the contact person.
• The representatives of MA holders shall draft a joint EM proposal which shall be submitted by the contact person to SÚKL for assessment.
• SÚKL shall provide its opinion on the submitted joint EM proposal.
• On the basis of this opinion, the representatives shall then prepare the final joint EM proposal which shall be submitted by the contact person to SÚKL for approval.

The following course of action is usually common for both categories:

Typically, the text shall not give the names of individual medicinal products or MA holders´ contact addresses. This ensures that in case another medicinal product is placed onto the market or any of the products is no longer distributed, it will not be necessary to update and redistribute the EM.

Instead, the EM shall encourage healthcare professionals to study the SmPC and find the MA holder´s contact data in the SmPC of the respective medicinal product, ideally by including the following text:

<Aktuálně platný SmPC lze vyhledat na webových stránkách Státního ústavu pro kontrolu léčiv v sekci Databáze léků na adrese https://www.sukl.cz/modules/medication/search.php. Kontaktní údaje jednotlivých držitelů rozhodnutí o registraci léčivých přípravků obsahujících (vložit název účinné látky/látek) lze nalézt v části Kontakty, která se objeví po kliknutí na název léčivého přípravku.>

<The currently affective SmPC may be obtained from the website of the State Institute for Drug Control under the database of medicinal products section at https://www.sukl.cz/modules/medication/search.php. Contact data of individual holders of marketing authorisation of medicinal products containing (enter the name of the active substance(s)) are available from the Contacts sections, which will came up if click on the name of the medicinal product.>

The procedure for PIL retrieval and an invitation to study the PIL for patients or their carers shall be handled likewise, ideally using the method outlined under chapter 3 (Content of educational materials for patients).

In case only some of these medicinal products are under additional monitoring, the declaration thereof shall be modified as follows:

For healthcare professionals:

<Některé z léčivých přípravků obsahujících (název účinné látky/látek) podléhají následnému sledování, což je vyznačeno přítomností symbolu obráceného černého trojúhelníku na balení a textech doprovázejících léčivý přípravek následujícím způsobem: Tento léčivý přípravek podléhá dalšímu sledování. To umožní rychlé získání nových informací o bezpečnosti. Žádáme zdravotnické pracovníky, aby hlásili jakákoli podezření na nežádoucí účinky.>

<Some of the medicinal products containing (name of the active substance/s) are under additional monitoring, which is indicated by the symbol of a black inverted triangle on the packaging and in the text accompanying the medicinal product as follows: This medicinal product is under monitoring. This will allow for rapid collection of new safety information. Healthcare professionals are kindly asked to reports any suspected adverse reactions.>

For patients:

<Některé z léčivých přípravků obsahujících (název účinné látky/látek) podléhají následnému sledování, což je vyznačeno přítomností symbolu obráceného černého trojúhelníku na balení a textech doprovázejících léčivý přípravek následujícím způsobem: Tento přípravek podléhá dalšímu sledování. To umožní rychlé získání nových informací o bezpečnosti. Můžete přispět tím, že nahlásíte jakékoli nežádoucí účinky, které se u Vás vyskytnou.>

<Some of the medicinal products containing (name of the active substance/s) are under additional monitoring, which is indicated by the symbol of a black inverted triangle on the packaging and in the texts accompanying the medicinal product as follows: This medicinal product is under additional monitoring. This will allow for rapid collection of new safety information. You may contribute by reporting any adverse reactions that you experience.>

Joint EM distribution

The distribution of new, i.e. joint EM shall be organised by all of the parties involved. MA holders are advised to submit a joint Distribution Plan referred to under chapter 5 (Submission of educational materials for approval). SÚKL shall not be involved in negotiations on how the costs of the development and distribution of joint EM will be shared.

The provision of additional joint EM as needed shall then be safeguarded by each MA holder individually as per the approved method further detailed in the Distribution Plan.

Should the parties involved fail to achieve consensus, SÚKL shall announce the date and venue of a joint meeting via its website or e-mail, at least 14 days in advance. The results of the joint meeting regarding the content and appearance of joint EM shall then be required by SÚKL for all holders of marketing authorisations of the concerned medicinal products. It is in the interest of the MA holders to arrange for their representatives to attend the meeting. Failure of any of the MA holders’ representatives to attend the meeting shall not constitute grounds for postponing the meeting or for non-applicability of its conclusions. Following the EM approval, such EM shall be considered the only ones effective within the territory of the Czech Republic for all of the concerned medicinal products. This will automatically result in the revocation of previously approved EM and these EM shall not be allowed to be further distributed.

3) In case of placement of another medicinal product onto the market which is subjected to the same obligation implied by its marketing authorisation, and existence of joint EM, the joint approved EM shall be applied in the following manner: 

• The MA holder shall submit the information on planned placement onto the market (at least 2 months in advance) together with the current version of the approved joint EM published on SÚKL´s website, or shall provide the exact wording of their title, version number, if applicable, and the date of their publication.
• The holder shall submit the proposal of their own Distribution Plan or the joint Distribution Plan will be shared therewith, if applicable (e.g. containing timelines for scheduled repeated mass distribution).
• SÚKL shall thereafter provide its opinion on the proposed distribution method. In most cases of this type, the course of action consisting solely of the provision of further joint EM by specialised representatives whenever necessary shall be recommended. Nevertheless, in justifiable cases only, SÚKL may require mass distribution based on the conditions set forth by the marketing authorisation.