Get the free EU Module 1 - eSubmission - Europa.eu

EUModule1Specification Version1.4 August2009 DocumentControl ChangeRecord Version Date Author’s) Comments 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 0.91 0.92 0.93 0.95.1 0.95.2 0.95.3 1.0 1.1 1.2 1.2.1

How to fill out eu module 1

How to fill out EU Module 1:

1. Start by gathering all necessary information such as the product name, its intended use, and the manufacturer's details.
2. Identify the applicable EU Directives and Regulations that are relevant to your product, as this will determine the specific requirements for Module 1.
3. Begin filling out the EU Declaration of Conformity form, which is typically used for Module 1. Provide all required information and make sure it is accurate and up-to-date.
4. Include any relevant test reports, technical documentation, or other supporting documents that demonstrate your product's compliance with the applicable EU requirements.
5. Clearly state the product's conformity assessment procedure and any relevant standards or technical specifications that have been followed.
6. Sign and date the EU Declaration of Conformity, indicating your responsibility for ensuring the product meets all relevant EU regulations.
7. Keep a copy of the completed EU Declaration of Conformity, along with all supporting documentation, for future reference and potential audits.

Who needs EU Module 1:

1. Manufacturers of products that fall under the regulatory scope of the EU Directives and Regulations are required to complete EU Module 1.
2. Importers and distributors may also need access to Module 1 documentation to verify the compliance of the products they handle.
3. Notified Bodies or competent authorities responsible for product conformity assessment may request EU Module 1 documentation for verification purposes.
4. End users or customers may also request access to EU Module 1 documents to ensure the products they are purchasing meet the necessary safety and quality requirements.

Note: It is important to consult the specific EU Directives and Regulations relevant to your product to ensure a comprehensive understanding of the requirements for filling out Module 1.

For pdfFiller’s FAQs

What is eu module 1?

Eu module 1 is a regulatory submission required by the European Medicines Agency (EMA) for marketing authorization applications.

Who is required to file eu module 1?

Marketing authorization applicants are required to file eu module 1.

How to fill out eu module 1?

Eu module 1 can be filled out electronically using the eSubmission Gateway or Web Client.

What is the purpose of eu module 1?

The purpose of eu module 1 is to provide regulatory authorities with detailed information about the medicinal product.

What information must be reported on eu module 1?

Eu module 1 must include information on the applicant, the product, the manufacturing process, and the quality control.

How can I modify eu module 1 without leaving Google Drive?

Using pdfFiller with Google Docs allows you to create, amend, and sign documents straight from your Google Drive. The add-on turns your eu module 1 into a dynamic fillable form that you can manage and eSign from anywhere.

How do I fill out the eu module 1 form on my smartphone?

You can quickly make and fill out legal forms with the help of the pdfFiller app on your phone. Complete and sign eu module 1 and other documents on your mobile device using the application. If you want to learn more about how the PDF editor works, go to pdfFiller.com.

How do I complete eu module 1 on an iOS device?

Get and install the pdfFiller application for iOS. Next, open the app and log in or create an account to get access to all of the solution’s editing features. To open your eu module 1, upload it from your device or cloud storage, or enter the document URL. After you complete all of the required fields within the document and eSign it (if that is needed), you can save it or share it with others.