The dateline for submitting existing veterinary product recently ended on 30-Jun-09.
Many were frustrated at no being able to meet this dateline. There were many documents unavailable and getting them is a real tough job. Documents such as certificate of free sale, and GMP manufacturing license, as well as stability study and materials certificate of analysis..... all these presented problem to the submission process.
However, don't despair... You are still able to submit these products after the dateline. The only difference is you will not be able to enjoy the privilege given to those submitted before the dateline.
Those products will obtain the status as "Existing product" and can continue to be in the market while their submission undergo evaluation.
Non-existing product cannot be in the market until approved by DCA. If found to do so, you may be found guilty and have to pay a penalty for this.
Got it...?
AJ
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