Regulatory News


Changes in Use of Confidential Commercial Information

The APVMA have relaxed the requirements for registration of generic products around use of Confidential Commercial Information. 

This has important implications for the use of items (categories) 6 and 7.

To have the best chance of success with item 6 and 7 applications it is important that the applicant is confident that their product is either similar or closely similar to the reference product.

De Groot Technical Services can assist you with your item 6 & 7 applications.

Take advantage of this opportunity ………………………..  Talk with us today!  

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