Whenever the European Union requires a drug manufacturer to make changes into the product be they minor, substantial or major; there are rules within the European Union about how to report these changes. These changes could be in relation to the quality of the drug, its safety or to its indications. These are what are called filing variations in the European Union, because the manufacturer has to file for these variations.What are the types of variations?
The EU classifies filing variations under the following types:
Type 1A:This represents minor variation, and has to be brought to the notice of the EU authorities on filing variations immediately after it is implemented
Type 1B:This classification of filing variations in the European Union is when the variation is considered neither big nor small, but is of a rather general nature
Type II:This variation is considered major.Who reviews these filing variations?
Reviews for filing variations in the European Union are carried out in this method:
Filing variations in the European Union have the following timeframes:
Filing variation in the European Union should be accompanied by details relating to the background and description as to the particular variation category, such as: