Product-information (QRD) templates - Human

The European Medicines Agency (EMA) provides Quality Review of Documents (QRD) templates for human medicines, aiding applicants and marketing authorization holders in preparing product information.

Key features:

• Standardized Templates: Offers annotated templates for product information in English and other languages.
• Regulatory Compliance: Ensures alignment with EU legislation and guidelines.
• Public Consultations: Involves stakeholders in template revisions, improving clarity and relevance.
• Specific Appendices: Includes appendices for statements on pregnancy, lactation, and adverse drug reaction reporting.
• ATMP Templates: Provides specific templates for advanced therapy medicinal products.

Use cases:

• Marketing Authorization Applications: Assists companies in preparing compliant product information for new medicines.
• Product Information Updates: Guides marketing authorization holders in updating existing product information.
• Regulatory Submissions: Facilitates the submission of standardized documents to regulatory authorities.
• Public Consultation Participation: Enables stakeholders to provide feedback on template revisions.