EU: New Variation System in force as of Jan 1, 2010.
Everyone knows that things are changing – We know how to change things!
The regulatory framework for filing variations to the European Authorities is changing. As of January 2010 new regulations are coming into force defining new categories and procedures for filing variations. This will change your processes. With the new system applicable for EU you can implement changes much faster, as certain categories are now allowed to be implemented without prior notification to Authorities.
This way you can implement your changes easier, faster and you have more flexibility.
The new procedures can be described as follows:
- Do and Tell
- Tell and Do
- Tell, Wait and Do
Have you already realised that the process of filing variations will become easier for you with this new system? You may implement certain changes within your company immediately, as long as you file the corresponding variation with the Authorities later on in form of an annual report. Is this not something that you always wanted to do? However, please bear in mind that you need to have a close look into the new categories. Check, if you fulfil the appropriate conditions.
There are a few things which are important in dealing with changes in the future:
- Annual reporting system for minor changes
- Grouping of variations
- Work-sharing of Authorities
We know the details of these new regulatory requirements. We help you to speed up your change processes and to adapt your change control system accordingly. You can benefit from our long term-experience in dealing with worldwide changes. We guide you through the process of implementing changes and filing your variations according to these new regulations.
You can find further details on the new procedures in the "Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products", published in the Official Journal of the European Union on 31.12.2009:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2009:323:0009:0022:en:PDF
Details on the categorisation of variations are laid down in the "Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products", published in the Official Journal of the European Union on 22.01.2010:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2010:017:0001:0044:en:PDF
Update your change control system now, implement your changes fast and stay compliant within the new regulatory environment. We can show you how to do this efficiently. Benefit from the new regulations.