This volume covers the different United States Food & Drug Administration (FDA) filing types of marketing authorizations for European Union countries through the European Medicines Agency (EMA), sometimes referred to as the European Medicines Evaluation Agency (EMEA). Given that EMA is the regulatory body for multiple countries, it can provide authorizations for all countries, a group of countries, or single countries. This distinction determines the type of filing. Read on below to find out more!
European Union (EU) Regulatory Filing Types
EU Regulatory Filings
What is the European Commission?
Did you know that under EU law the EMA has no authority to permit marketing of the medicines in the different EU countries?
In the EU, the European Commission is the authorizing body for all centrally authorized products. They are the legal entity that makes a legally binding decision to market a product based on EMA's recommendation.
EU Filing Types: Centralized versus National Procedures
Centralized Authorization Procedure
In general, new, innovative medications are filed using the centralized authorization process. (This includes both small molecules and biologics.)
Under the centralized authorization procedure, pharmaceutical companies submit a single marketing-authorization application to EMA.
Once granted by the European Commission, the authorization is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.
National Authorization Procedure
While the majority of new medications are evaluated under the centralized procedure, most generic medicines and over-the-counter medications are assessed and authorized at national level in the EU. Each EU Member State has its own national authorization procedures.
National authorizations fall into one of two categories:
- Mutual-recognition procedure: When authorization granted in one Member state can be recognized in other EU countries.
- Decentralized procedure: When a medicine that has not yet been authorized in the EU can be simultaneously authorized in several EU Member States.
Variations on an Approved EU Market Authorization
Once a centralized or national Market Authorization is approved, the product can be manufactured and marketed in the applicable EU and EEA countries based on the information specified in the authorization. However, any variations from the approved Market Authorization may require notification to and/or approval from the agency before implementation. Read below to learn more about the different types of variations.
Reporting Categories for Variations to an Approved Marketing Authorization
Major Change
Type II Variation
The change requires EMA approval before implementation. They typically follow a 60 day approval timeline.
Examples:
- Widening of an approved specification limit
- Additional indications (90 day review timeline)
Moderate Change
Type IB Variation
The change requires EMA approval before implementation. It typically follows a 30 day approval timeline.
These are sometimes called "tell, wait, and do" variations.
Examples:
- Addition of a new drug product manufacturing site
- Large increase in standard drug product batch size
Minor Change
Type IAIN Variation
These changes allow for distribution of the updated product to occur after Immediate Notification (IN) of the change to the authority.
Examples:
- Change in address of market authorization holder (pharmaceutical company)
Type IA Variation
The authorization holder needs to describe any minor changes in the next Annual report submitted to the authority.
These are sometimes called "tell and do" variations.
Examples:
- Removal of a manufacturing site
- Tightening of an approved specification limit
