Focus on Variations

Acorn Regulatory’s pharmaceutical regulatory affairs consultants are experts in the sector.  Every day our team members are working on behalf of clients to ensure that their variations are completed in as timely a manner as possible.  Members of our team have written extensively on this website and in other industry publications about the issues associated with variations and much more.  Below we have highlighted just five articles that our team members have written on the subject in recent times.

1. 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 more 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. What Are The Steps To Consider In a Repeat Use Procedure?

In this article, we look at the issue of the Repeat Use Procedure. We give an overview and consider some of the issues that need to be addressed during the process. Read more here.

4. Using a US Dossier for a European MA Application? Here Is What You Need To Know

Over the years, we have worked with a significant number of US innovator companies and supported them in getting their ‘US developed medicinal product’ registered as a medicinal product in Europe. In this article, we look at some of the issues we have encountered in taking a US developed dossier for a new marketing authorisation.  Read more here.

5. Type I Variation: Apparently Not So Simple

Regulatory professionals would generally perceive the Type I variation as a fairly simple regulatory procedure. New figures released by the EMA suggest differently. Statistical data released by the EMA has revealed that 44% of all Type I variation applications received for assessment by the EMA contain errors. It is reasonable to assume that these figures are mirrored for National Procedures and Mutually Recognised Procedure variations. The figure of 44% is quite high when you consider that the variations classification guideline for Type I variations is quite detailed. The pharmaceutical industry is always pursuing initiatives to achieve “perfection” in our processes. This lean approach increases efficiency, improves quality, and achieves what the Pharmaceutical industry is primarily focused on, providing safe and effective medicinal products to the public. The function of Regulatory Affairs is no different. Identifying areas of improvement and increasing “Right First Time” is a goal of all regulatory personnel. This article details the common deficiency areas with the idea of promoting awareness. Read more here.

6. 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

Talk To Us About Variations

If you would like us to help you with variations or any other regulatory issue then please feel free to contact us on 00353 52 61 76706 or submit you details 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