Dear Brigita,

Thank you for your letter.

I would like to inform that we agree your suggestions regarding preparation of table of concordance.

As for rest of the issues:

1) Convenient time for us would be either 15-19 of July or after 30 of July.

2) Please find the new agenda attached.

3) We do not have an appropriate expert. It is very important that the expert has adequate experience in working with Organ, Tissue and Cell transplantation directives and developing of National Legislations in this field.

In addition, we will provide the translated version of the Laws in English language.

Best Regards,

Natia

Dear Natia,

Thank you for your clarifications.

Yes, we can engage an expert for the final mission to assist in providing guidance on revising the table. An expert could be engaged for up to 5 days long mission to sit together with you and your colleagues and go through the list of legislation and the latest version of the table of concordance. It is important that you have all the concerned pieces of legislations available in English as TAIEX is not covering the costs of the translations in writing. Also, it would like to underline that the engaged expert is not expected to prepare the revised table, but to advise you and your colleagues on the gaps and missing links to the latest EU legislation. This means that drafting of the table will be under your responsibility.

Another important note to underline – the revision of the table of concordance with the support from the EU MS expert does not automatically mean the confirmation of the correct and ultimate approximation; it will be up to SANTE colleagues to give such a confirmation upon the assessment of the revised table.

If you agree to proceed as indicated above, then I would be happy to continue working with you.

For proceeding you would need to:

·         indicate an estimated period, when you would like the mission to take place

·         prepare the agenda (in the same template as previously)

·         do you have already a MS in mind or could I proceed with contacting different experts?

It would be great if you are able to provide the feedback to the above questions at the earliest possibility. We have many activities planned for this autumn already in cooperation with different beneficiaries in the region, so planning ahead would be essential in case you wish to have this assessment mission organized still this year.

Many thanks

Brigita

Dear Brigita,

Thank you in advance for your assistance.

Currently, the EU association agreement includes following directives: “EU Directive 2004/23/EC, EU directive 2006/17/EC, EU Directive 2006/86/EC, EU Directive 2010/53/EC”, three out of mentioned directives (EU Directive 2004/23/EC, EU directive 2006/17/EC, EU Directive 2006/86/EC) touch the issue on tissues and cells (including reproductive cells), and EU Directive 2010/53/EC covers the organ transplantation matter. On account of this fact, our Ministry on the basis of the EU expert - Ms. Mirela Busic’s first recommendation is drafting three laws. Two draft law on “tissues and cells” and on “organ transplantation” are already elaborated and regarding the draft law on reproductive technologies is in the process of elaboration. In order to harmonize aforementioned draft laws (on “tissues and cells” and “organ transplantation”) with The Eu Directives it is necessary to create the table of concordance.

Here we must inform you that, in September, 2018 we did send the prepared table of concordance about national legislation full compliance with the directives, however considering the fact that legislation is going to be amended we need the new table of concordance.

We ask you for your support in this direction and sending you the agenda.

Kind regards,

Natia

Dear Brigita,

First of all we would like to take this chance and thank you very much for your priceless efforts on the drafting process of the law. We also do appreciate Ms Mirela Busic for her taken steps towards our ministry, that will definitely help us to fulfill properly the obligations of the association agreement.

Moreover, in order to achieve the desired results, we think that there is a need to involve the professional legal expert in the elaboration process the table of concordance.

We will send you this agenda by the end of this week.

Kind regards,

Natia

Dear Natia,

Thank you for your email. In case you would like to have the mission to take place in the first half of July, then we need to receive the agenda from you basically now in order to have enough time to proceed with planning and contacting the expert. Are you able to provide already the agenda? Do you know which expert you would prefer or shall I contact EU Member States?

Kind regards

Brigita

Dear Brigita.

Thank you for your email.

I would like to inform you, that for us it is important to prepare the table of concordance( of the two Laws: “Organ Transplantation”, "Cell and Tissue Transplantation") within final planned mission.

Also, for the purpose of fulfilling planned activities, it would be good, if the mission will be held in first half of July.

Thank you in advance for your help.

Kind regard,

Natia Nogaideli

Dear Natia,

This is a kind reminder to my email below.

Kind regards

Brigita

Dear Natia,

Do we have any news about the final planned mission?

Since we are receiving many requests, we need to know the dates in order to be able to plan our workload.

Kind regards

Brigita

Dear Brigita,

Thank you for your email.

I will inform you about the planned date of next event(Expert Mission) in the next week.

Kind regards,

Natia

Dear Natia,

Thank you for your email.

Your request to have the workshop replaced by an expert mission is accepted. Please kindly prepare the agenda based on the templates sent to you previously. I would also like to kindly ask you to inform us about the planned dates.

Kind regards

Brigita

Dear Brigita.

Today we had a meeting with the EU delegation regarding future activities.

As you know, there is only one event left within the framework of TAIEX - Workshop.

However, due to the need, we have a request to replace the Workshop with the Expert Mission which will be used for preparation of table of concordance of the two Laws (“Organ Transplantation”, "Cell and Tissue Transplantation").

Please let us know your opinion regarding the above-mentioned issue.

Thank you in advance for your help.

Kind regard,

Natia Nogaideli

Dear Natia,

Thanks for your email, will be then looking forward to receiving the list.

As regards the interpretation, dear Mirela, I assume we will do as the last time – English – Georgian?

Kind regards

Brigita

Dear Brigita,

Thank you for email.

I will send you information about participants on the next week.

Also, I want to inform you that we need interpretation for the meetings.

Kind regards,

Natia

Dear Natia,

Thank you for your email. The agenda looks good, thanks for your efforts. It would be great to know if Mirela has any suggestions or comments to it.

I am sending you the excel sheet for the participants. Could you please fill it in and send it to me by 23 April the latest? Will you need interpretation for the meetings during the mission?

Looking forward to hearing from you

Brigita

Dear Mirela, Good Morning,

How are you, how does the matter stand?

I hope, everything is fine.

I also want to discuss with you about our Expert Mission.

Please, Find enclosed document….

Thank you in advance for your help.

We look forward to meet with you in Tbilisi.

Kind regards,

Natia

Dear Mirela and Natia,

Great to hear that we have a date.

Could you note discuss bilaterally the agenda for the mission and send it back in the template attached by 11 April?

Many thanks

Brigita

Dear Brigita,

Thank you very much for assistance.

May 13th -17^th is acceptable for us.

Kind regards,

Natia

Dear Brigita and Natia,

May 13^th -17^th is convenient for me. I’m also available from 6^th till 10^th of May, for your consideration.

Regards

Mirela

----------------------------

Mirela Bušić, dr. med.

nacionalna transplantacijska koordinatorica

Ministarstvo zdravstva

Zavod za transplantaciju i biomedicinu

Ksaver 200a

HR - 10000 Zagreb

www.zdravstvo.hr

Tel. + 385 1 4556 105

Fax. + 385 1 4596 161

E-mail Mirela.Busic@miz.hr

----------------------------

Dear Mirela,

Thanks for your email. Yes, sure, let us know in the end of this week.

Kind regards

Brigita

----------------------------

Mirela Bušić, dr. med.

nacionalna transplantacijska koordinatorica

Ministarstvo zdravstva

Zavod za transplantaciju i biomedicinu

Ksaver 200a

HR - 10000 Zagreb

www.zdravstvo.hr

Tel. + 385 1 4556 105

Fax. + 385 1 4596 161

E-mail Mirela.Busic@miz.hr

----------------------------