Swissmedic, the Swiss Agency for Therapeutic Products, has introduced its updated guidance on "Product Information for Human Medicinal Products", effective 15 November 2024. This guide not only aligns with Switzerland’s rigorous regulatory standards but also streamlines the preparation, submission, and approval processes for pharmaceutical companies. For applicants, the document is intended to clarify the specific requirements that must be fulfilled so that the product information texts can be processed as quickly and efficiently as possible.
Product information serves as the bridge between pharmaceutical companies and healthcare providers, ensuring the safe and effective use of medicinal products. It consists of two critical parts:
Healthcare Professional Information: Targeted toward physicians and pharmacists, providing in-depth details on a product's composition, use, and risks.
Patient Information: Simplified guidance to help individuals understand how to use a medicinal product safely.
Swissmedic’s guidance emphasizes clarity, compliance, and multilingual accessibility, ensuring that the information meets the needs of diverse users while adhering to regulatory requirements.
The guidance applies to medicinal product information texts for human medicinal products, including complementary medicines, herbal medicinal products and radiopharmaceuticals.
The guidance provides a structured framework for preparing product information, addressing:
Medicinal Products: Including complementary medicines, herbal remedies, and radiopharmaceuticals.
Legal Requirements: Aligning with the Therapeutic Products Act (TPA) and related ordinances.
Swissmedic’s updated document simplifies the process for pharmaceutical companies, offering:
Templates: Ready-to-use structures for product information.
Clarity: Clear definitions and requirements reduce guesswork.
Efficiency: Aligning with Swiss standards minimizes delays in the approval process.
Additionally, the multilingual requirement (German, French, and Italian) ensures inclusivity, catering to Switzerland’s diverse population.
The guidance also explains the requirements and provisions for producing medicinal product information for patients ("Patient information"). Part A of the guidance document contains information on the Patient information for allopathic medicines, while parts B, C and D deal with the Patient information texts for complementary and herbal medicines.
A. Requirements for the medicinal product information for patients ("Patient information")
B. Requirements for the Patient information for complementary medicinal products
C. Requirements for the Patient information for phytotherapeutic products
D. Requirements for the Patient information for medicinal products used in Asian medicine with no indication
Want to know more? Dive into the full guidance document on the Swissmedic website here.
Also check out this "Information sheet" about the "Mandatory reporting of adverse reactions during a clinical trial with ATMPs, other products (bacteriophages, etc.)" and procedures that were released last week (11 November, 2024).
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