Attention! Tripping hazard "Blaue Hand"

The launch of a new medicinal product is a complex process that involves many important considerations. One aspect that is often overlooked is the importance of mandated educational materials, also known as "Blaue Hand" materials (engl. blue hand materials). If educational materials are not approved by the competent authority in a timely manner, it can potentially jeopardize the launch schedule.

What are educational materials and why are they so important?

For some medicinal products, in addition to the package leaflet and the Summary of Product Characteristics (SmPC), additional educational material is required according to the Risk Management Plan to minimize risks for patients. These educational materials are commissioned by the competent authority and created by the pharmaceutical company. They encompass various types of informational resources (printed versions, downloadable content, video/ audio files, or even hotlines) to inform patients, physicians, pharmacists, and other healthcare professionals about safety-related aspects of the new medication, describe risk mitigation measures, and ensure patient safety. Depending on the target audience, these materials can include anything from guidelines and training videos to diaries or checklists. Designing them requires the creative expertise of the involved parties and a thorough understanding of potential hazards in risk management.

Marketing departments sometimes express concerns about physicians being exposed to the risks of a new medication before its positive benefits. Here, we recommend rather highlighting the opportunities. Medicinal products that are perceived as safe are more likely to be prescribed again.

The "Blue Hand" - a symbol of approval

A mandated educational material must be marked with the symbol of the blue hand. It serves as a stamp of approval, validating the material as being of high quality, accurate, and trustworthy.

Similar to the marketing authorisation of a medicinal product that has been tested and released for sale, the "Blaue Hand" serves as a symbol indicating that the educational material meets regulatory requirements and can be safely utilized. It represents a collective symbol of knowledge and authorization. Importantly, it is not intended to have any promotional character. However, high-quality material can still be viewed as a positive differentiating factor during product launches.

Why a blue hand as logo?

The "Blaue Hand" logo was chosen based on the well-known logo of the "Rote Hand" symbol (engl. red hand) and serves to distinguish officially approved educational material at first glance from other information material published by the pharmaceutical company. The aim is to reliably reach the recipients of the educational material including physicians, pharmacists and, if applicable patients, while creating a strong sense of recognition. Furthermore, it highlights the value and importance of the material.

Why are educational materials difficult to create?

Creating educational materials is not an easy task. Medicinal products can be complex, both in terms of their mechanism of action and their application. Creating educational material therefore requires a deep understanding of the product and its application. At the same time, the information provided must be precise and written in clear and concise language to ensure easy comprehension by the respective target audience. Each target group has specific requirements, necessitating the development of tailored materials. In addition, educational materials must be up-to-date, regularly reviewed and updated.

All in all, creating educational materials requires thorough planning, expertise, and the ability to convey complex information in a clear and engaging way to ensure it serves its purpose. Finally, the question of whether the effort is having the desired effect must be answered. Evaluating the effectiveness of risk minimization activities, such as educational materials, is described in the GVP guidelines as a key element of risk management. This measurement of the Effecitveness of Risk Minimazation is used to assess the impact and optimize the measure(s) if necessary.

The stumbling block approval

To ensure that the approval of educational material does not become a stumbling block, individual requirements must be observed for each specific material. For example, the following must be taken into account:

• no launch without approval, whereby the submission modalities, deadlines, fees, etc. are country-dependent
• determination of the distribution methods and preparation of the communication plan
• if applicable, integration of a QR code in the package leaflet
  
• different countries have different requirements, so no uniform, Europe-wide educational material can be created
• timelines to approval may vary and delays should be considered
• the effort for measuring the Effectiveness of Risk Minimisation is at an adequate level and is not excessive

Educational materials must comply with regulatory requirements. This means they must meet specific requirements, including the use of certain terms and compliance with design and content guidelines. For instance, educational materials should ensure that

• no further risks or study data are described unless it has been ordered by the authorities
• there are no linguistic repetitions from the SmPC or package leaflet
  
• an active language is used
• no claims of a promotional nature and no claims of potential superiority to other therapeutic options are made
• the mention of the trade name of the medicinal product is limited to a necessary minimum

All of these points must be considered during the creation process to make the hurdle of approval easier to overcome.

No approved educational material - no launch

An initial submission of the educational material to the competent authority can only take place after a positive CHMP vote for approval. The approval process can sometimes be very lengthy and challenging. In Germany, the initial technical assessment by the competent authority takes place within a period of 4 weeks after submission. Any necessary corrections must be made by the pharmaceutical company within 2 weeks. Depending on the quality of the dossier and the associated scope of review, further assessment rounds with a deadline of 2 weeks each on both sides need to be considered (see figure 1).

Thus, the overall processing time can be prolonged, especially since regulatory processing times are sometimes not strictly adhered to or there may be a change in assessors.

As a rule, the Risk Management Plan stipulates that the educational material must be approved and disseminated prior to the initial launch of the medicinal product. This effectively causes a delay in the product launch until the approval for the educational material is granted. If the launch of the medicinal prodcuts has to be postponed as a result, this can lead to financial losses and a competitive disadvantage. Therefore, educational materials are crucial to the success of timely launches.

Our experience: the early bird gets the approval in time

Mandated educational materials play a crucial role in the marketing of new medicinal products. In our work, we have observed an increasing trend of educational material being mandated by competent authorities.

Furthermore, successful educational material represents a strategic tool and should ideally be planned at the EU level right from the beginning. Coordination with the headquarters should also not be neglected. The interdisciplinary and creative development of the material, as well as its distribution via the company website or QR codes, can significantly contribute to a positive image of a pharmaceutical company.

As the creation, approval, and potentially printing and distribution of educational material take some time, it is crucial to start early to avoid potential delays in the market launch process. It is also important to anticipate multiple rounds of revisions by the competent authority and potential delays from their side.

Think about the educational material in time to make your product launch a great success!

We are happy to support you with tips and tricks from our many years of experience!