Get the free Marketing Authorisation Application Form

EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATEGENERAL Consumer goods Pharmaceuticals Brussels, F2/ (2008) Revision 9 NOTICE TO APPLICANTS Medicinal Products for Human Use VOLUME 2B Module

How to fill out marketing authorisation application form

How to fill out marketing authorisation application form:

1. Begin by carefully reading and understanding the instructions provided with the form. Familiarize yourself with the requirements and any supporting documents that may be needed.
2. Ensure that you have all the necessary information and supporting documentation before starting to fill out the form. This may include details about the drug or product, its composition, indications, dosage, contraindications, and any relevant clinical data or studies.
3. Provide accurate and complete information in each section of the form. Double-check for any errors or missing information. This may include details about the applicant, such as the company name, address, contact information, and relevant licenses or registrations.
4. Clearly specify the intended use of the product and its purpose. This may involve providing information about the therapeutic area, patient population, and any specific claims or indications.
5. Include comprehensive information about the product's safety and efficacy. This may involve submitting results from preclinical and clinical studies, as well as any adverse events or safety concerns associated with the product.
6. Provide detailed information about the manufacturing and quality control processes, including details about the facilities, equipment, and personnel involved in the production and quality assurance of the product.
7. Submit any additional supporting documents, such as labeling or packaging information, patient information leaflets, and summary of product characteristics.
8. Review the filled-out form and supporting documents for accuracy and completeness. Make any necessary corrections or additions before submitting the application.
9. Finally, submit the completed marketing authorisation application form to the relevant regulatory authority along with any required fees.

Who needs marketing authorisation application form:

1. Companies or individuals seeking to market pharmaceutical products or medical devices usually need to submit a marketing authorisation application form.
2. Healthcare professionals or researchers who have developed a new drug or medical device and wish to bring it to the market will need to complete the marketing authorisation application form.
3. Pharmaceutical manufacturers or distributors who want to obtain regulatory approval for the sale of a drug or medical device may require the marketing authorisation application form.

For pdfFiller’s FAQs

How can I manage my marketing authorisation application form directly from Gmail?

In your inbox, you may use pdfFiller's add-on for Gmail to generate, modify, fill out, and eSign your marketing authorisation application form and any other papers you receive, all without leaving the program. Install pdfFiller for Gmail from the Google Workspace Marketplace by visiting this link. Take away the need for time-consuming procedures and handle your papers and eSignatures with ease.

How can I get marketing authorisation application form?

The premium pdfFiller subscription gives you access to over 25M fillable templates that you can download, fill out, print, and sign. The library has state-specific marketing authorisation application form and other forms. Find the template you need and change it using powerful tools.

How can I edit marketing authorisation application form on a smartphone?

You may do so effortlessly with pdfFiller's iOS and Android apps, which are available in the Apple Store and Google Play Store, respectively. You may also obtain the program from our website: https://edit-pdf-ios-android.pdffiller.com/. Open the application, sign in, and begin editing marketing authorisation application form right away.

What is marketing authorisation application form?

Marketing authorisation application form is a document that needs to be submitted to regulatory authorities to request approval for marketing a pharmaceutical product.

Who is required to file marketing authorisation application form?

Pharmaceutical companies and manufacturers are required to file marketing authorisation application forms.

How to fill out marketing authorisation application form?

Marketing authorisation application forms need to be filled out with detailed information about the pharmaceutical product, its efficacy, safety, and quality.

What is the purpose of marketing authorisation application form?

The purpose of the marketing authorisation application form is to obtain approval from regulatory authorities to market a pharmaceutical product.

What information must be reported on marketing authorisation application form?

Information such as the manufacturing process, clinical trial data, product labeling, and pharmacovigilance plans must be reported on the marketing authorisation application form.