Get Validation Checklist For Initial Maas - Pharmaceuticals - European ... - Ema Europa

This guide provides comprehensive, step-by-step instructions on completing the Validation Checklist for initial marketing authorization applications for pharmaceuticals. It aims to assist users in accurately filling out each section and field of the online form to ensure compliance with EMA requirements.

Follow the steps to accurately complete the validation checklist.

1. Click ‘Get Form’ button to obtain the form and open it in your editor.
2. Begin with section one, 'Background on the product.' Fill in the invented name, procedure number, International Nonproprietary Name (INN) or common name, and the indication applied for.
3. Proceed to the 'Pharmaceutical Form' table, ensuring consistency with the Summary of Product Characteristics (SPC). Confirm pharmaceutical form and strength per the European Directorate for the Quality of Medicines and Healthcare.
4. In ‘Background documentation,’ cross-check the links and ensure required documents such as GMP guidelines and e-submission guidelines are attached where necessary.
5. In 'Checklist Part 1a,' verify the application form details including product name, addresses, and confirm that the correct version of the application form is used.
6. Ensure all annexes required by the checklist are completed and consistent across all sections of the form. Double-check names, addresses, and contact information for accuracy.
7. Finalize by reviewing each checklist item for validation criteria compliance. If any required documents are missing, indicate them accordingly and note down actions.
8. After completing all fields, save your changes. You can then download, print, or share the completed form as needed.

Complete your documents online today to ensure a smoother evaluation process!