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Chapter 4 Centralised Procedure EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATEGENERAL Consumer goods Pharmaceuticals Brussels, ENTR/F2/BL D(2006) Revision April 2006 NOTICE TO APPLICANTS.

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Obtaining an EU marketing authorisation, step-by-step Steps prior to submitting an application. Submission of the application. Assessment of the application. European Commission decision on the marketing authorisation. Voluntary sharing of market launch intentions: pilot project.

The EMA is a decentralised body of the European Union situated in Amsterdam. Under the centralised procedure, companies submit a single marketing authorisation application to the European Medicines Agency.

The EMA serves the EU and three countries from the EEA—Iceland, Norway, and Liechtenstein. The EMA practices pharmacovigilance to ensure the safety and efficacy of medicines. The EMA is not involved in clinical trials or R&D.

Centralization and Decentralization are two modes of working in any organization. In centralization, there is a hierarchy of formal authority for making all the important decision for the organization. And in decentralization decision making is left for the lower level of organization.

Article 83 of Regulation (EC) No 726/2004 on compassionate use is complementary to national legislations and provides an option to MS who wish to receive a CHMP opinion regarding the conditions for compassionate use of a specific medicinal product which falls within the scope of Article 83(1) and 83(2).

The centralised procedure is a European authorisation route resulting in a centrally authorised product with a single Marketing Authorisation. If a product has been authorised using the centralised procedure it has been assessed on an EU wide basis and approved by the European Commission.

The European Union-wide procedure for the authorisation of medicines, where there is a single application, a single evaluation and a single authorisation throughout the European Union. Only certain medicines are eligible for the centralised procedure.

Following a CHMP opinion the European Commission takes usually its decision, a legally binding authorisation, after 67 days.

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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232