Patient QA on Biosimilars EMA ... - European Commission - europa.eu 2025

1. Click ‘Get Form’ to open it in the editor.
2. Begin by entering your company name and the name of the manufacturer or authorized representative in the designated fields.
3. Fill in the postal address, including street, postcode, and city. Ensure all information is accurate for proper identification.
4. Provide your telephone number and email address for contact purposes.
5. In the section for apparatus model/product, specify the type and include any relevant batch or serial numbers.
6. Describe the object of the declaration clearly, ensuring it allows for traceability. You may include a color image if necessary.
7. List applicable Union harmonization legislation such as EMC Directive 2014/30/EU and any other relevant directives.
8. Document any harmonized standards and technical specifications that have been applied, including titles and dates.
9. If applicable, provide details about the notified body, including its name and four-digit notified body number.
10. Finally, sign off on behalf of your organization by entering the place of issue, date of issue, and your name along with function and signature.

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