Author

Marco Theobold

Director of Medical Device and Drug Services

Submitting Master Files to European Union (EU) Medicine Agencies

Oct 17, 2023

If you plan to submit Master Files to most European countries, you will likely need to work with one or more European Union (EU) agencies. The Europe Medicines Agency (EMA) and Heads of Medicines Agency (HMA) both serve the 27 member states of the EU and accept Master File submissions.   

Unlike the U.S. Food and Drug Administration (FDA), EMA and HMA only accept one type of Master File: Active Substance Master Files (ASMFs). The objective of an ASMF is to protect the confidential intellectual property of active substance manufacturers (ASMs). It also allows Applicants or Marketing Authorization (MA) holders to take full responsibility of the medicine or medicinal product and the quality control of any active substances.  

Once an ASMF has been submitted, National Competent Authorities (NCA) like the EMA and HMA have access to all of the information they need to accurately evaluate the suitable use of the product’s active substance(s). 

Procedures for Submitting an Active Substance Master File in the EU 

The four different marketing pathways that an ASMF may be submitted by are: 

  • Centralized Procedure (CP): A European authorization route resulting in a centrally authorized product with a single Marketing Authorization. Submissions to EMA are considered centralized procedures. 
  • Nationally Authorized Product: A product that has been assessed and approved on a national basis only, i.e. there has been no interaction with other Member States. Submission to only one authority such as the State Agency of Medicines of Latvia would be a nationally authorized product. 
  • Mutual Recognition Procedure (MRP): A European authorization route resulting in a mutually recognized product. Mutual recognition must be used when a product is already authorized in at least one Member State on a national basis and the Marketing Authorization Holder wishes to obtain a Marketing Authorization (MA) for the same product in at least one other Member State. 
  • Decentralized Procedure (DCP): A European authorization route resulting in a mutually recognized product (MRP). The difference between MRP and DCP is that a product must already be authorized in at least one Member State on a national basis for MRP to be used. DCP may be used if the product is not already authorized in any Member State, CP is not a viable option, or the product is not eligible for CP.  

 

Master File Requirements for the EMA and HMA 

Like FDA Master Files, ASMFs must be submitted in eCTD format. However, ASMFs include Applicant and Restricted Parts.  

The Applicant Part (AP) contains any information that the ASMF holder regards as non-confidential to the Applicant or Marketing Authorization holder, while the Restricted Part (RP) contains the information that the ASMF holder sees as confidential. FDA treats the entire Master File as confidential, but the EMA and HMA only treat the RP of an ASMF as such.  

Annual reports are required for ASMFs submitted to EMA or agencies under HMA. Instead, the Master File is expected to be kept up to date with amendments as needed.  

Submissions to EMA are submitted through the Axway Syncplicity portal. Submissions to HMA must be submitted through the Common European Submission Portal.  The Common European Submission Portal may be used to submit to multiple National Competent Authorities in a European Union Member State. 

The Challenge of Submitting ASMFs Yourself

Submitting ASMFs accurately and completely to EMA and HMA can be a complicated process. But working with Master File Specialists like those at Registrar Corp assures that your ASMF will be filed properly while your confidential information remains secure. Learn more about how Registrar Corp can help you submit your Active Substance Master Files to EMA and HMA today. 

Author


Marco Theobold

Director of Medical Device and Drug Services

A highly regarded expert in medical device and drug regulations by the U.S. Food & Drug Administration (FDA), Marco brings a unique perspective for medical device and drug companies seeking to distribute products in the United States. He proudly provides guidance on FDA regulations for pharmaceutical, medical device, and radiation emitting device (RED) companies.

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