European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure. General-EMA/339324/2007-2025

Get Form
european medicines agency pre authorisation procedural advice for users of the centralised procedure Preview on Page 1

Here's how it works

01. Edit your european medicines agency pre authorisation procedural advice for users of the centralised procedure online
Type text, add images, blackout confidential details, add comments, highlights and more.
02. Sign it in a few clicks
Draw your signature, type it, upload its image, or use your mobile device as a signature pad.
03. Share your form with others
Send it via email, link, or fax. You can also download it, export it or print it out.

The easiest way to edit European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure. General-EMA/339324/2007 in PDF format online

Form edit decoration
9.5
Ease of Setup
DocHub User Ratings on G2
9.0
Ease of Use
DocHub User Ratings on G2

Adjusting documents with our feature-rich and user-friendly PDF editor is simple. Adhere to the instructions below to complete European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure. General-EMA/339324/2007 online easily and quickly:

  1. Log in to your account. Log in with your credentials or register a free account to test the product before upgrading the subscription.
  2. Import a document. Drag and drop the file from your device or import it from other services, like Google Drive, OneDrive, Dropbox, or an external link.
  3. Edit European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure. General-EMA/339324/2007. Easily add and underline text, insert pictures, checkmarks, and symbols, drop new fillable areas, and rearrange or delete pages from your document.
  4. Get the European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure. General-EMA/339324/2007 completed. Download your adjusted document, export it to the cloud, print it from the editor, or share it with other people through a Shareable link or as an email attachment.

Take advantage of DocHub, one of the most easy-to-use editors to rapidly manage your paperwork online!

be ready to get more

Complete this form in 5 minutes or less

Get form

Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.
Contact us
The FDA is responsible for regulating a wide range of products for human and animal use in the US, including medicines, medical devices, tobacco products, cosmetics and most foods. In contrast, the EMA governs only human and veterinary medicines and participates in the process of medical devices evaluation.
Eligibility request and letter of intent to submit an MAA You must use the EMA Pre-submission request form, which also provides an overview of the type of MAA the EMA should expect to receive from you. You can submit your eligibility request up to 18 months and at least 7 months before you plan to submit your MAA.
Centralised authorisation procedure This allows the marketing-authorisation holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorisation.
It is responsible for the scientific evaluation, supervision and safety monitoring of medicines. EMA protects public and animal health in EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.
Submission of the application Applicants should use the electronic common technical document (eCTD) format and submit the application through the eSubmission gateway or web client . If EMA needs additional information to complete its validation of the application, it will ask the applicant to supply this by a deadline.
be ready to get more

Complete this form in 5 minutes or less

Get form

People also ask

Additional detail on the EMA procedure for checking proposed invented names is also provided. A name review request should be submitted once CHMP has confirmed the product is eligible for evaluation under the Centralised Procedure (this can happen 18 to 7 months prior to planned MAA submission date).
The eligibility request should be submitted 18 to 7 months before the planned MAA submission date and submitted to EMA 10 calendar days before the planned and published CHMP meeting date. Decision of eligibility is received in the week following CHMP meeting where the discussion took place.
The accelerated assessment is a procedural tool to reduce the centralised procedure review period of a marketing authorisation applicant from 210 to a maximum of 150 days, excluding clock stops.

Related links