Marketing Authorisation Holders – An Overview

Acorn Regulatory’s consultants are experts in the sector.    Members of our pharmaceutical regulatory affairs team have written extensively on this website and in other industry publications about the issues associated with marketing authorisation holders and much more.  Below, we have highlighted just four articles that our team members have written on the subject in recent times.

Marketing Authorisations

1. Applying for a Marketing Authorisation – The Initial Steps

In this blog we look at the initial steps that need to be taken by a marketing authorisations holders when applying for a marketing authorisation for a pharmaceutical product within the EEA.  Read the article here.

2. What Are The Common Variation Validation Issues? Find Out Here

Variations are a critical part of maintaining the lifecycle of all dossiers. A variation is any change to the currently approved content of a marketing authorisation which assists in ensuring continued compliance.  We look at the main types of variations and the critical issues that you need to be aware of when completing a variation. Read more here.

3. How Will Brexit Impact UK Marketing Authorisation Holders?

The European Medicines Agency has had to dedicate considerable resources in dealing with the complex issues related to the UK’s decision to leave the European Union.   In this article, we look at one of the main questions highlighted by the EMA relating to UK Marketing Authorisation Holders.  Find out more here.

4. The Worksharing Procedure for Variations for National Marketing Authorisations in the EU

Did you know that Article 20 of Commission Regulation (EC) N° 1234/2008 (the ‘Variations Regulation’) allows for a Marketing Authorisation Holder to submit the same Type IB or Type II variation, or the same group of variations affecting more than one marketing authorisation from the same Marketing Authorisation, in one application? Read the full article here.

5. Ten Questions To Ask When Moving from A DCP Close Out To Product Launch

When a Decentralised Procedure (DCP) or a Mutually Recognised Product (MRP) process is drawing to a close, much of the emphasis is placed on getting a “positive opinion”. However, it is at a time like this, when submitting the final sequences that the focus on what comes next often gets lost. Frequently, companies close out their regulatory procedures only to be ill-prepared for the national phases and the product launch. What preparatory work should be done upfront to avoid this?  We look at the issue and answer 10 of the most common questions relating to a DCP close-out.  We hope that they will be useful to you in moving to a product launch. Read the full article here.

If you require assistance on an issue related to a Marketing Authorisation, get in touch with us on 00353 52 61 76 706 or simply complete the webform below and we will get back to you.


About the Author
Marie Carroll
Regulatory Affairs Advisor
Marie Carroll is a Regulatory Affairs Advisor with Acorn Regulatory and focuses on issues relating to Chemistry, Manufacturing and Controls. Prior to joining the company she spent over 15 years in senior roles with a large pharmaceutical company. You can read other articles by Marie Carroll by clicking the link below.
Other articles by Marie Carroll