Type II variations

Note for Guidance on Stability Testing for Type II Variation to a Marketing Authorization — CPMP/QWP/576/96. 

Type II variations affecting active ingredients, extension or a new indication and changes of pharmaceutical form or way of administration are defined cis major. 

Standard application forms must be completed by applicants for MAs and for variations, and provided usually separately for each product for each proposed change, with supporting documentation, including an updated expert report for Type II variations, and accompanied by the appropriate fee. 

License variations are divided into three main categories termed Type I variation , Type II variation and extensions . The main changes introduced by the new legislation are... 

Complex Type II variations require a higher fee, as the review involved is more extensive the timeline is also longer. The following changes are usually regarded as complex ... 

A me-too application, for a product, which has analogous products with the classification applied for already in the market, is handled as standard Type II variation, and the corresponding fee is charged. 

Type II variation 60,000 30,000 for type II variations not requiring detailed scientific evaluation, as specified in the implementing rules adopted by the EMEA Management Board... 

For products approved globally, API retest period and finished product shelf-life can be extended through a type IB (major) variation. One of the conditions for shelf-life changes is that the change not be due to stability concerns therefore, shortening and then re-extending product shelf-life would need to be filed via a Type II variation. 

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