Dear Ben,

On behalf of Dr. Tamar Gabunia, I would like to clarify that application and distribution timetable will be provided by the LEPL Social Service Agency.

Hereby, kindly ask you to send a letter (preferably by e-mail for quick response) with indication of the amount and series of the medications.

In addition, please, be informed that the list of documents should include a document confirming the registration issued by the producer country (that means that registration by DCGI in India (their FDA) will be sufficient).

Please, kindly let me know if any clarification is required.

Sincerely,

Ekaterine Adamia

Ministry of IDPs from the Occupied Territories,

Labour, Health and Social Affairs of Georgia

Address: 144, Ak. Tsereteli Ave. Tbilisi 0119

Phone: (032) 5100381110

Mob: (+995) 577282825

Hi Tamar,

Thanks!  To clarify:

1. Application. What is this?  Is this a form?  A letter?
2. Accompany:
1. Request letter: This is from you? Will you supply this?
2. Confirmation assessment: Would registration by DCGI in India (their FDA) be sufficient?
3. Distribution timetable and legal basis: Will you provide this?
4. Patient leaflet.  Done.
5. Quality certificate:  Would registration by DCGI in India be sufficient?

The product is ready to ship right now so only pending the import permit and Mylan can ship.

Ben

-----Original Message-----
From: Tamar Gabunia <tgabunia@moh.gov.ge>
Sent: Thursday, January 9, 2020 1:11 AM
To: Ben Kamarck <Ben.Kamarck@gilead.com>
Cc: Graeme Robertson <Graeme.Robertson@gilead.com>; Ekaterine Adamia <eadamia@moh.gov.ge>
Subject: [EXTERNAL] RE: SOF/VEL

Dear Ben,

Please find the list of documents needed for granting the registration waiver.

According to the Georgian legislation unregistered medicinal products may be imported, for non-commercial purposes in the following case:

Under particular circumstances (a natural disaster, mass injury of the population, epidemic, rare disease) for humanitarian purposes, as well as in the case of a special state interest, with the consent of the Ministry. In such cases, the purpose of the import should be clearly stated in the shipping documents.

In order to obtain the consent of the Ministry the following documents should be submitted to the Department of health and LEPL Regulatory Agency:

1. Application.

2. The application should be accompanied with:

a) A request from the donor's representative organization (if the donor organization is importer) and the electronic version of the list of medicines (on CD)

b) A preliminary confirmation assessment document of medicines issued by World Health Organization and/or a document confirming the registration of medicines issued by the country or interstate pharmaceutical product state regulatory authority, which are recognized by the Georgian Government and/or a document confirming the registration of medicines in the country of manufacture;

c) Distribution timetable of medicines and legal basis of importation of medicines for humanitarian purposes (an agreement, a contract or an official letter, etc.);

d) Patient leaflet of medicine;

e) A copy of the certificate of quality of medicines and/or a document certifying the medicines were manufactured in accordance with international standards, issued by the competent authority (relevant governmental body, recognized international organizations, special regulatory bodies).

On the bases of intermediate decisions by the Regulatory Agency and Department of Health policy the consent or refusal for importing unregistered medicines into Georgia will be issued by the Minister.  

Please kindly let me know if any clarification is required.

პატივისცემით,

თამარ გაბუნია

მინისტრის მოადგილე

Sincerely,

Tamar Gabunia, MD, MPH

Deputy Minister

-----Original Message-----

From: Ben Kamarck <Ben.Kamarck@gilead.com>

Sent: Monday, January 6, 2020 4:35 AM

To: Tamar Gabunia <tgabunia@moh.gov.ge>

Cc: Graeme Robertson <Graeme.Robertson@gilead.com>

Subject: SOF/VEL

Hi Tamar,

We have decided to source from Mylan, at least initially, as they can deliver fastest and because they have a pending application for WHO prequalification and expect it in Q2.  They have the first 4,003 units ready to go and are planning for 20k March as discussed.

What do they need to submit for the registration waiver / import permit for this first shipment?  We can coordinate any documents they may need.

Of course, they will also begin the registration process but they will likely take longer than this order and the March order.

Thanks!

Ben