Get Medicinal Products For Human Use Volume 2b Module 12 Administrative Information Revision 10

This guide provides comprehensive instructions for filling out the Medicinal Products For Human Use Volume 2b Module 12 Administrative Information Revision 10 form online. By following these steps, users can ensure that they accurately complete the necessary information required for the marketing authorization of a medicinal product.

Follow the steps to effectively complete the form.

1. Press the ‘Get Form’ button to obtain the form and display it for editing.
2. Begin filling out the administrative data section. This includes details such as the product name, strength, pharmaceutical form, and active substances. Ensure accuracy as this information is crucial for the application.
3. Move to the declaration and signature section. Fill in the applicant's details, including their title, address, and the person authorized for communication. Make sure to complete the confirmation statement regarding the quality, safety, and efficacy of the medicinal product.
4. In the type of application section, specify if the application concerns a centralized procedure, mutual recognition procedure, or decentralized procedure. Select the applicable options as instructed in the form.
5. Proceed to the marketing authorization application particulars. Here, provide the product’s name, ATC code, strength, route of administration, and packaging details accurately.
6. Complete the sections regarding manufacturers and legal status. Make sure to include all relevant details about the marketing authorization holder and any manufacturing authorizations.
7. If applicable, provide any relevant annexed documents requested in the form, including proof of payment and letters of authorization.
8. After all sections are filled out, review the form for completeness and accuracy. Save any changes made.
9. Finally, download, print, or share the completed form as required by the submission guidelines.

Complete your application forms online to ensure a smooth submission process.