Focus on Variations
Acorn Regulatory’s 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.
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.
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.
In this article, we look at the issue of Repeat Use Procedure. We give an overview and consider some of the issues that need to be addressed during the process. Read more here.
Over the years, we have worked with a significant number of US innovator companies and supported them 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.
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 and MRP 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.
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.