Hi Tamar,

Here are the attachments.

Ben

Dear Ben,

With this I am sending the response from the Drug agency on required documents. It seems that the production permit will not be sufficient. Should you have additional questions please let me know.

The Regulatory Agency wrote:

Thank you for your e-mail. Based on the requirements of the Agency for Medical and Pharmaceutical Activities, we kindly ask you to provide us with the following documents:

A Certificate of Pharmaceutical Product (CPP) could be provided as a registration document in the producing country. This document should be fully completed. Also, there should be indicated that the medical product has market access in producing country and undergoes periodic inspection by the regulatory authority (see Annex 1 as an example).

As for the quality certificate of pharmaceutical product, microbiological purity research data (for N3105979 and N3105355 series) should be provided in addition (see Annex 2 as an example).

With kind regards

პატივისცემით,

თამარ გაბუნია

მინისტრის პირველი მოადგილე

Sincerely,

Tamar Gabunia, MD, MPH

First Deputy Minister