Dear Marijan,

I have forwarded your email to NRA to receive list of candidates, but regarding some issues, we have to wait a little beat.

In point of your previous email (06.02.18):

,,Immediate technical assistance/mission to Georgia

We propose one week mission which will be divided into two parts.

2 days of interactive presentations on main regulatory issues with a focus on GMP/GDP implementation, import licensing, WHO certification scheme, etc.

This should be a dialogue with NRA (National regulatory Authority) and main actors (manufacturers and distributors).

Max 25 participants – 8 inspectors and 17 distributors/manufacturers.

3 days to work with the NRA (mainly inspectors which by that time will be already selected and focal person for communication appointed) on the development of internal guidelines, QMS, SOPs, etc.

It is really vital that future inspectors will be selected and  their motivational issues resolved by that time."

So, on these stage, as the selection of future  GMP/GDP inspectors is on-going process, we can't send you list of these (8) people.

 In the next week we will be able send you only list of our, NRA and manufacturer's representatives and clarify some details about workshop.

With best,

Marina

Dear Marina, dear colleagues

As agreed the mission on GMP will come to Tbilisi on 19-23 March 2018.

Provisionally we plan meetings at the ministry to take place on Monday, 19 March, to discuss actions and expectations of the mission and to fine tune workshop for 20 – 21 March and follow-up activities on 22 – 23 March.

We expect that by the 23 March afternoon the team from the ministry / National regulatory Authority lead by the international/WHO experts will draft  GMP strategy implementation plan with timelines, milestones, resources, etc.

The plan should be made ready for MoH for endorsement.

Attached is the programme of the workshop planned for 20 – 21 March. In total there could be 20 to max 25 participants. The workshop is intended for the staff from the ministry, the National Regulatory Authority and the representatives from the pharma industry.

The meetings on 19 March 2018 and the follow-up work on the GMP strategy provisionally scheduled for 22 – 23 March is intended only for the staff from the ministry incl. the National Regulatory Authority. For details see the attached draft Terms of reference.

We kindly ask you to provide the list of participants for the meetings and the workshop.

WHO will secure international consultants, as discussed before. WHO shall also take care of the venue for the workshop incl. services during the workshop.

Please, let us know, if the minister would also like to meet the team and discuss the work with them.

The experts are fluent in Russian language. Please, let us know, if this is acceptable or if interpretation is needed.

Please, keep in mind, that the mission on GMP coincides with the mission on UHC/SSA.

Thank you and best regards,

Marijan Ivanusa

WHO Representative

Head of WHO Country Office Georgia

Office location: 81 Vasil Barnov Street, 0179 Tbilisi, Georgia

Mailing address: UN House, 9 Rapiel Eristavi Street, 0179 Tbilisi, Georgia

Mobile 1: +995 599 305 207

Mobile 2/EU/private: +386 40 528 639

Email: ivanusam@who.int

Skype: who-ivanusam

GPN: 74211

Web: www.euro.who.int