Get Des Annex 2 (variations). Electronic Application Form Data Exchange Standard 3.0 - Supplementary

The DES Annex 2 (Variations) form provides a structured approach for submitting variations to marketing authorizations. This guide will walk you through each section of the form, ensuring you understand how to complete it accurately when filling out the form online.

Follow the steps to successfully complete the DES Annex 2 (Variations) form.

1. Click the ‘Get Form’ button to access the DES Annex 2 (Variations) form and open it in your preferred electronic editor.
2. Begin by filling out the 'Application for Variation to a Marketing Authorization' section. Indicate whether it is a human or veterinary application, and provide the necessary authorization details.
3. In the 'Products Concerned by This Application' section, list the names, pharmaceutical forms, and strengths of the products involved in this application.
4. When you reach the 'Type of Change(s)' section, ensure you select the appropriate boxes for the variation types that apply to your submission.
5. If your application includes new indications or orphan medicinal product information, be prepared to provide specific details in the dedicated sections.
6. Continue to the 'Declarations of Applicant' section and clearly state your compliance with all required conditions.
7. Sign the form in the 'Signatures' section, ensuring all necessary fields are completed, including your name, title, and the date.
8. Once all sections are filled, review your information carefully for accuracy. Save your changes, and you have the option to download, print, or share the completed form.

Complete and submit your documents online today for efficient processing.