Focus on Marketing Authorisations

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

1. Applying for a Marketing Authorisation – The Initial Steps

In this blog we look at the initial steps that need to be taken 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.

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.