The Swissmedic released an updated guidance "Product information for Human Medicinal Products" which provides comprehensive instructions on the preparation and submission of product information for human medicinal products. This includes requirements for both healthcare professionals and patient information leaflets.
The guidance aims to ensure that the information is clear, accurate, and compliant with regulatory standards. Swissmedic uses the guidance document as a resource for applying the legal provisions in a uniform and equitable manner. For applicants, it clarifies the specific requirements needed to process product information texts quickly and efficiently.
The guidance document applies to medicinal product information texts (Information for healthcare professionals and Patients information) for human medicinal products, including complementary medicines, herbal medicinal products, and radiopharmaceuticals.
Information for Healthcare Professionals:
General Requirements: Specifies the template and requirements for preparing information tailored to healthcare professionals, including specific guidelines for different medicinal product groups and procedures.
Language Requirements: Details requirements regarding the language used in product information to ensure clarity and comprehension.
Special Considerations: Addresses aspects such as black triangle status, boxed warnings, international guidelines, and temporary authorizations, ensuring comprehensive coverage of safety and usage information.
Individual Sections of Product Information:
Covers essential sections such as the name of the medicinal product, composition, pharmaceutical form, indications, dosage/administration, contraindications, warnings, precautions, interactions, adverse reactions, pharmacokinetics, and more.
Emphasizes the importance of providing detailed and accurate information to facilitate informed decision-making by healthcare professionals and patients.
Patient Information:
Provides requirements for preparing patient information, including general requirements, specific sections like what the medicine is used for, dosage instructions, possible side effects, and safety precautions.
Ensures patient safety through clear, understandable information on the medicine's use and potential effects.
Swissmedic's guidance on product information for human medicinal products sets clear standards for pharmaceutical companies operating in Switzerland. By adhering to these guidelines, companies can ensure their product information meets regulatory requirements, facilitating the safe and effective use of medicinal products by healthcare professionals and patients alike.
For more detailed information, refer to the full Swissmedic guidance document here.
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