Quality & Compliance
Safety & Vigilance
26 july 2023
Educational material for medicinal products is crucial in providing accurate and reliable information to Health Care Professionals (HCPs: doctors, pharmacists and nursing staff) and/or patients and caregivers, facilitating informed decision-making, and promoting the safe and effective use of medicinal products. Following regulatory guidelines and requirements and ensuring scientific accuracy, balance, clarity, and relevance to the target audience is essential when developing educational material for medicinal products.
Educational materials are additional risk minimisation measures intended to promote medicinal products’ safe and effective use. Educational materials focus on specific safety concerns related to medicinal product use to provide clear information on these specific risks and describe what actions are required to prevent and minimise such risks.
Regulatory authorities typically determine the requirement to create educational material for a medicinal product which may vary depending on the specific region.
In most cases, regulatory authorities may request educational material for medicinal products during the approval process or after the product has been granted marketing authorisation. The timing and specific requirements for educational material may be influenced by factors such as the nature of the medicinal product, its intended use, potential risks, and the target patient population.
The educational material is typically developed by the pharmaceutical company or the marketing authorisation holder (MAH) per applicable guidelines and regulations. Only when the educational material has been reviewed and approved by the national competent authority the medicinal product can be launched in this respective country.
The MAH submits the educational material to the national competent authority in each EEA country where the medicinal product is intended to be marketed.
The national competent authority reviews the educational material to ensure it complies with relevant regulatory requirements (such as the European Union (EU) legislation on medicinal products).
Once the educational material is deemed compliant with applicable regulations, it is approved by the national competent authority.
The MAH may be required to make revisions or provide additional information during the review process, and the approval may be subject to conditions or restrictions.
After approval, the educational material may be subject to post-approval monitoring by the national competent authorities to ensure ongoing compliance with regulations and guidelines. Any updates or changes to the material may require additional approval.
It’s important to note that the approval process for medicinal products’ educational material varies slightly across different EEA countries, as each country has specific requirements and procedures. Overall, the process is designed to ensure that educational material for medicinal products is accurate, reliable, and compliant with regulatory standards to safeguard patient safety and promote appropriate use of medicinal products.
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