Esindaja nimetamine

SoHO COORDINATION BOARD (SCB): DECLARATION OF INTERESTS OF A

MEMBER/ALTERNATE FROM EU MEMBER STATES’ AUTHORITIES

Legal basis:

Article 68(3) of Regulation (EU) 2024/19381

Definitions:

"Conflict of interest" means any situation where an individual has an interest that may

compromise or be reasonably perceived to compromise the individual’s capacity to act

independently and in the public interest in relation to the subject of the work of the SoHO

Coordination Board (SCB).

"Immediate family member" means the individual’s spouse, children and parents.

"Spouse" includes a partner with whom the individual has a registered non marital

regime. "Children" means the child(ren) the individual and the spouse have in common,

the own child(ren) of the individual and the own child(ren) of the spouse.

"Legal entity" means any commercial business, industry association, consultancy,

research institution or other enterprise whose funding is significantly derived from

commercial sources. It also includes independent own commercial businesses, law

offices, consultancies or similar.

"Body" means a governmental, international or non-profit organisation.

"Meeting" includes a series or cycle of meetings.

***

In accordance with Art 68 (3) of the SoHO Regulation, Member States shall submit

the names and affiliation of their nominated members and alternates, together with

the corresponding declaration of interests for any member and alternate, to the

SCB Secratiat.

The nominated members shall represent the views and positions ensdoressed by the

SoHO competent authority.

To the end of determining existence of the conflic of interest, you are invited to

answer each of the questions below. If the answer to any of the questions is "yes",

please briefly describe relevant interests and circumstances, as appropriate.

If you do not describe relevant interests, your DOI form will be considered

incomplete and, therefore, you may not participate in the work of the SCB.

Please note that having a declared interest does not necessarily mean having a

conflict of interest.

1 Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards

of quality and safety for substances of human origin intended for human application and repealing

Directives 2002/98/EC and 2004/23/EC

2

On the basis of this DOI template, Member States shall ensure toassess wether the

conflic of instrest of the candidate exist and ensure that members and alternates

that have no conflict of interest are nominated

Please note that the DOI will be published by the Euopean Commission in

accordance with Article 68(3) of SoHO Regulation.

[Placeholder for a privacy statement]

First name:

Family name:

Name of the Member States’s authority:

Country

Member/alternate of the SCB: [please specify]

Date of first nomination:

1 EMPLOYMENT CONSULTANCY AND LEGAL REPRESENTATION

Within the past 5 years, were you employed or have you had any

other professional relationship with a natural or legal entity, or

held any non-remunerated post in a legal entity or other body with

an interest in the field of SoHO or related fields of biotechnology,

including a role within a tissue or blood establishment?

yes no

1a Employment  

1b Consultancy, including services as an advisor  

1c Non-remunerated post  

1d Legal representation  

Activity Time period

(from… until

month/year)

Name of entity or

body

Description

3

2 MEMBERSHIP OF MANAGING BODY, SCIENTIFIC ADVISORY BODY OR

EQUIVALENT STRUCTURE

Within the past 5 years, have you participated in the internal

decision-making of a legal entity or other body with an interest in

the field of SoHO or related fields of biotechnology, including a role

within a tissue or blood establishment, or have you participated in

the works of a Scientific Advisory Body with voting rights on the

outputs of that entity?

yes no

2a Participation in a decision-making process  

2b Participation in the work of a Scientific Advisory Body  

Activity Time period

(from… until

month/year)

Name of legal entity

or body

Description

3 RESEARCH SUPPORT

Within the past 5 years, have you, or the research entity to which

you belong, received any support from a legal entity or other body

with an interest in the field of SoHO or related fields of

biotechnology?

yes no

3a Research support, including grants, rents, sponsorships,

fellowships, non-monetary support

 

Activity Time period

(from… until

month/year)

Name of legal entity

or body

Description

4

4 FINANCIAL INTERESTS

Do you have current investments in a legal entity with an interest in

the field of SoHO or related fields of biotechnology, including

holding of stocks and shares, and which amounts to more than

10,000 EUR per legal entity or entitling you to a voting right of 5%

or more in such legal entity?

yes no

4a Shares  

4b Other stock  

Investment Name of legal entity Description

5 INTELLECTUAL PROPERTY

Do you have any intellectual property rights that might be affected

by the outcome of the work carried out by the SCB?

yes no

5a Patent, trademarks, or copyrights  

5b Others  

Intellectual property Description

6 PUBLIC STATEMENTS AND POSITIONS

5

Within the past 5 years, have you provided any expert opinion or

testimony in the field of SoHO or related fields of biotechnology, for

a legal entity or other body as part of a regulatory, legislative or

judicial process? Have you held an office or other position, paid or

unpaid, where you represented interests or defended an opinion in

the field of SoHO or related fields of biotechnology?

Yes no

6a For a legal entity or other body as part of a regulatory,

legislative or judicial process

 

6b Represented interests or defended an opinion  

Activity Time period

(from… until

month/year)

Name of legal entity

or body

Description

7 INTERESTS OF IMMEDIATE FAMILY MEMBERS yes no

7a To your knowledge, are there any interests of your immediate

family members which could be seen as undermining your

independence when participating in the works of the SCB?

 

Interests Time period

(from… until

month/year)

Name of legal entity

or body

Description

7b If interests of your immediate family members are declared, it is your

responsibility to inform them about the collection and publication of information

on their interests included in the DOI and to provide them with the privacy

statement attached to the guidance for filling in this DOI, and this at the

latest when you file the DOI form with the Commission.

6

8 OTHER RELEVANT INFORMATION yes no

8a Are there any other elements that could be seen as undermining

your independence when participating in the works of the SCB?

 

Description:

I declare on my honour that the information disclosed in this form is true and

complete to the best of my knowledge.

Should there be any change to the above information, including as regards

upcoming activities, I will update this DOI and describe the changes in question.

I am informed that my personal data are stored, processed and published by the

Commission in accordance with Regulation (EU) 2018/17252 and Regulation (EU)

2024/1938.

I have been provided with the corresponding privacy statement which provides

further information on how the Commission processes my personal data.

Date: ________________ Signature: ________________________________

*****

In accordance with Article 68(3) of Regulation (EU) 2024/1938, your DOI form shall be

made publicly available on the EU SoHO Platform, as long as you are appointed to the

SCB. Technical measures will be taken to indicate to search engines that your DOI form

should not appear in search results.

2 Regulation (EU) 2018/1725 on the protection of natural persons with regard to the processing of

personal data by the Union institutions, bodies, offices and agencies and on the free movement of such

data.

To all Deputy Permanent Representatives of the EU Member States Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË

EUROPEAN COMMISSION DIRECTORATE GENERAL FOR HEALTH AND FOOD SAFETY The Director-General

Brussels,

SANTE D2/KB/eb/(2024)9962963

Your Excellency,

Subject: Request for the nomination of members of the SoHO Coordination

Board (SCB)

I am writing to you regarding the nomination of members and alternates to the newly

established SoHO Coordination Board (SCB) following the adoption of Regulation (EU)

2024/1938 on standards of quality and safety for substances of human origin (SoHO)

intended for human application.

The role of the SCB is to promote and support coordination between Member States

concerning the implementation of the SoHO Regulation, as well as to facilitate

cooperation with stakeholders in that regard. The tasks of the SCB include documenting

best practices on the implementation of SoHO supervisory activities and conditions for

compensation, providing advice on whether the SoHO Regulation applies and providing

opinions on the regulatory status for inclusion in the SoHO Compendium, setting

indicative criteria for ‘critical SoHO’ and for ‘critical SoHO entities’, providing support

for joint oversight activities related to inspections and to the assessment of SoHO

preparation processes, supporting the Commission on the specifications for the SoHO

platform and supporting the coordination during emergencies.

Art 68(2) of the SoHO Regulation specifies that each Member State shall appoint two

permanent members and two alternates representing the SoHO national authority and,

where the Member State chooses so, the Ministry of Health or other relevant authorities.

The SoHO national authority may nominate members from other SoHO competent

authorities. Appointed members shall nevertheless ensure that the views and suggestions

they express are endorsed by the SoHO national authority.

I herewith invite your Member State to submit, in accordance with Art 68(3) of the

SoHO Regulation, the names and affiliation of your nominated members and alternates,

together with their corresponding declaration of interests. To this end, a form for the

declaration of interests is Annexed to this letter. Member States shall nominate only

members and alternates who do not have such conflicts. Please note that the Commission

will make publicly available, on the EU SoHO Platform, the membership list, including

the name, the institution of origin and the declaration of interests.

2

The SCB will start its activities in early 2025 and will gradually take over the activities

related to blood, cells and tissues currently performed by the Competent Authorities on

Substances of Human Origin Expert Group (BTCO), including the activities performed

by its sub-groups on vigilance (VES), inspections in blood, cells and tissues (IES), and

coding of tissues and cells (CES). Therefore, the SCB could be composed, for example,

of members with a profile similar to the members of the Expert Group BTCO.

The members of the SCB will actively contribute to the above-mentioned tasks and

should therefore be selected for their competence and experience in the field of SoHO.

The composition of the SCB should be balanced to allow discussions of technical, policy

and legal nature, in order to contribute to the work of the SCB and its sub-groups. It

should be noted that members of the SCB will have the responsibility to disseminate

information and documentation shared with the SCB members to other relevant

competent authorities within their Member State.

The Commission will also set-up sub-groups of the SCB on inspections (replacing IES),

vigilance and traceability (replacing VES and CES), authorisation and assessment of

SoHO preparations, regulatory questions, supply of critical SoHO; and registration of

entities and authorisation of establishments. Member States will be invited to nominate

members for these sub-groups once these have been established (expected later in the

course of 2025). Nominees for the sub-groups can be the same or different from the SCB

nominees.

Please note that the existing Expert Group BTCO will be maintained but will be

convened for meetings on organs only. Regarding the adoption of implementing acts

under the SoHO Regulation, a dedicated (regulatory) Committee will need to be set up,

in accordance with Art 79 of the SoHO Regulation.

The first meeting of the SCB will take place virtually via Webex on Friday 24 January

2025. During this meeting, the rules of procedure, as specified in Art 68 (8) of the SoHO

Regulation, will be presented for approval. Candidates for co-chairing the SCB are

invited to express their interest by Friday 31 January 2025. The second meeting of the

SCB will take place physically at the Commission premises in Brussels in the week of 10

February 2025. At this meeting, the co-chair of the SCB will be elected.

In order to keep the above-mentioned timeframe, the European Commission would be

very grateful if you could provide the requested information, i.e. the names and

affiliation of your nominated members and alternates together with the corresponding

declaration of interests for any member and alternate, by 8 January 2025 at the latest.

Should you need any additional information, you may contact Stefaan Van Der Spiegel,

Team Leader SoHO/ SANTE D2 (email: [email protected],

office number: +32 229 55406) and Katleen Baert, Policy Officer SoHO/ SANTE D2,

(email: [email protected], office number +32 229 55981).

Yours sincerely,

Sandra GALLINA

3

Annex: Form to declare interests

Privacy statement

Copy: Health attachés,

L. BOIX ALONSO, R. BECKER, R. MCGEEHAN, L. BATTISTINI, M.

MOYA DIAZ, B. GAUTRAIS, M. CICCARELLO, S. VAN DER

SPIEGEL, M. AMBROSIO, K. BAERT, E. MARCHAND, R. PITEIRA

(SANTE)

SoHO COORDINATION BOARD (SCB): DECLARATION OF INTERESTS OF A

MEMBER/ALTERNATE FROM EU MEMBER STATES’ AUTHORITIES

Legal basis:

Article 68(3) of Regulation (EU) 2024/19381

Definitions:

"Conflict of interest" means any situation where an individual has an interest that may

compromise or be reasonably perceived to compromise the individual’s capacity to act

independently and in the public interest in relation to the subject of the work of the SoHO

Coordination Board (SCB).

"Immediate family member" means the individual’s spouse, children and parents.

"Spouse" includes a partner with whom the individual has a registered non marital

regime. "Children" means the child(ren) the individual and the spouse have in common,

the own child(ren) of the individual and the own child(ren) of the spouse.

"Legal entity" means any commercial business, industry association, consultancy,

research institution or other enterprise whose funding is significantly derived from

commercial sources. It also includes independent own commercial businesses, law

offices, consultancies or similar.

"Body" means a governmental, international or non-profit organisation.

"Meeting" includes a series or cycle of meetings.

***

In accordance with Art 68 (3) of the SoHO Regulation, Member States shall submit

the names and affiliation of their nominated members and alternates, together with

the corresponding declaration of interests for any member and alternate, to the

SCB Secratiat.

The nominated members shall represent the views and positions ensdoressed by the

SoHO competent authority.

To the end of determining existence of the conflic of interest, you are invited to

answer each of the questions below. If the answer to any of the questions is "yes",

please briefly describe relevant interests and circumstances, as appropriate.

If you do not describe relevant interests, your DOI form will be considered

incomplete and, therefore, you may not participate in the work of the SCB.

Please note that having a declared interest does not necessarily mean having a

conflict of interest.

1 Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards

of quality and safety for substances of human origin intended for human application and repealing

Directives 2002/98/EC and 2004/23/EC

2

On the basis of this DOI template, Member States shall ensure toassess wether the

conflic of instrest of the candidate exist and ensure that members and alternates

that have no conflict of interest are nominated

Please note that the DOI will be published by the Euopean Commission in

accordance with Article 68(3) of SoHO Regulation.

[Placeholder for a privacy statement]

First name:

Family name:

Name of the Member States’s authority:

Country

Member/alternate of the SCB: [please specify]

Date of first nomination:

1 EMPLOYMENT CONSULTANCY AND LEGAL REPRESENTATION

Within the past 5 years, were you employed or have you had any

other professional relationship with a natural or legal entity, or

held any non-remunerated post in a legal entity or other body with

an interest in the field of SoHO or related fields of biotechnology,

including a role within a tissue or blood establishment?

yes no

1a Employment  

1b Consultancy, including services as an advisor  

1c Non-remunerated post  

1d Legal representation  

Activity Time period

(from… until

month/year)

Name of entity or

body

Description

3

2 MEMBERSHIP OF MANAGING BODY, SCIENTIFIC ADVISORY BODY OR

EQUIVALENT STRUCTURE

Within the past 5 years, have you participated in the internal

decision-making of a legal entity or other body with an interest in

the field of SoHO or related fields of biotechnology, including a role

within a tissue or blood establishment, or have you participated in

the works of a Scientific Advisory Body with voting rights on the

outputs of that entity?

yes no

2a Participation in a decision-making process  

2b Participation in the work of a Scientific Advisory Body  

Activity Time period

(from… until

month/year)

Name of legal entity

or body

Description

3 RESEARCH SUPPORT

Within the past 5 years, have you, or the research entity to which

you belong, received any support from a legal entity or other body

with an interest in the field of SoHO or related fields of

biotechnology?

yes no

3a Research support, including grants, rents, sponsorships,

fellowships, non-monetary support

 

Activity Time period

(from… until

month/year)

Name of legal entity

or body

Description

4

4 FINANCIAL INTERESTS

Do you have current investments in a legal entity with an interest in

the field of SoHO or related fields of biotechnology, including

holding of stocks and shares, and which amounts to more than

10,000 EUR per legal entity or entitling you to a voting right of 5%

or more in such legal entity?

yes no

4a Shares  

4b Other stock  

Investment Name of legal entity Description

5 INTELLECTUAL PROPERTY

Do you have any intellectual property rights that might be affected

by the outcome of the work carried out by the SCB?

yes no

5a Patent, trademarks, or copyrights  

5b Others  

Intellectual property Description

6 PUBLIC STATEMENTS AND POSITIONS

5

Within the past 5 years, have you provided any expert opinion or

testimony in the field of SoHO or related fields of biotechnology, for

a legal entity or other body as part of a regulatory, legislative or

judicial process? Have you held an office or other position, paid or

unpaid, where you represented interests or defended an opinion in

the field of SoHO or related fields of biotechnology?

Yes no

6a For a legal entity or other body as part of a regulatory,

legislative or judicial process

 

6b Represented interests or defended an opinion  

Activity Time period

(from… until

month/year)

Name of legal entity

or body

Description

7 INTERESTS OF IMMEDIATE FAMILY MEMBERS yes no

7a To your knowledge, are there any interests of your immediate

family members which could be seen as undermining your

independence when participating in the works of the SCB?

 

Interests Time period

(from… until

month/year)

Name of legal entity

or body

Description

7b If interests of your immediate family members are declared, it is your

responsibility to inform them about the collection and publication of information

on their interests included in the DOI and to provide them with the privacy

statement attached to the guidance for filling in this DOI, and this at the

latest when you file the DOI form with the Commission.

6

8 OTHER RELEVANT INFORMATION yes no

8a Are there any other elements that could be seen as undermining

your independence when participating in the works of the SCB?

 

Description:

I declare on my honour that the information disclosed in this form is true and

complete to the best of my knowledge.

Should there be any change to the above information, including as regards

upcoming activities, I will update this DOI and describe the changes in question.

I am informed that my personal data are stored, processed and published by the

Commission in accordance with Regulation (EU) 2018/17252 and Regulation (EU)

2024/1938.

I have been provided with the corresponding privacy statement which provides

further information on how the Commission processes my personal data.

Date: ________________ Signature: ________________________________

*****

In accordance with Article 68(3) of Regulation (EU) 2024/1938, your DOI form shall be

made publicly available on the EU SoHO Platform, as long as you are appointed to the

SCB. Technical measures will be taken to indicate to search engines that your DOI form

should not appear in search results.

2 Regulation (EU) 2018/1725 on the protection of natural persons with regard to the processing of

personal data by the Union institutions, bodies, offices and agencies and on the free movement of such

data.

EUROPEAN COMMISSION

PROTECTION OF YOUR PERSONAL DATA

Processing operation: Management of the SoHO (Substances of Human Origin) Coordination Board

Data Controller: European Commission, Directorate-General for Health and Food Safe, Unit D2

Record reference: DPR-EC-29748

Table of Contents

1. Introduction

2. Why and how do we process your personal data?

3. On what legal ground(s) do we process your personal data?

4. Which personal data do we collect and further process?

5. How long do we keep your personal data?

6. How do we protect and safeguard your personal data?

7. Who has access to your personal data and to whom is it disclosed?

8. What are your rights and how can you exercise them?

9. Contact information

10. Where to find more detailed information?

2

1. Introduction

The European Commission (hereafter ‘the Commission’) is committed to protect your personal data and to respect your privacy. The Commission collects and further processes personal data pursuant to Regulation (EU) 2018/1725 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data.

This privacy statement explains the reason for the processing of your personal data in the context of a (type of a) meeting or event, organised by the European Commission. It explains the way we collect, handle and ensure protection of all personal data provided, how that information is used and what rights you have in relation to your personal data. It also specifies the contact details of the responsible Data Controller with whom you may exercise your rights, the Data Protection Officer and the European Data Protection Supervisor.

The information in relation to the processing operation “Management of the SoHO (Substances of Human Origin) Coordination Board”, is presented below.

2. Why and how do we process your personal data?

Purpose of the processing operation: the Commission collects and further processes your personal data to set-up and manage the SoHO Coordination Board (SCB) and its working groups within the framework of Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC SoHO Regulation (hereafter ‘SoHO Regulation’), to organise the meetings of the SCB and its working groups and to process your application for participation in its meetings. The SCB aims at promoting coordination between Member States concerning the implementation of the SoHO Regulation and of the delegated and implementing acts adopted pursuant thereto, and to support them in that coordination, as well as to facilitate cooperation with stakeholders in that regard. In addition, the Commission shall make publicly available on the EU SoHO Platform the membership list indicating the name, the institution of origin and the declaration of interests of each nominated member and alternate. Regarding the observers, their DOIs are collected by Commission but they will not be published on the EU SoHO Platform.

Your personal data will not be used for any automated decision-making including profiling.

3. On what legal ground(s) do we process your personal data?

The processing operations on personal data, for the abovementioned purposes, are based on Article 11 of the Treaty on European Union, Article 15 of the Treaty on the Functioning of the European Union and the Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (hereafter called the substances of human origin (SoHO) Regulation) and in particular, on the provisions of Article 68.

Consequently, those processing operations are lawful under Articles 5(1)(a) and (b) of Regulation (EU) 2018/1725 (processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the Union institution or body and for compliance with a legal obligation to which the controller is subject).

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4. Which personal data do we collect and further process?

In order to carry out the processing operations, the following personal data may be collected and processed :

• identification data: o name; o job title in the organisation; o affiliation o country representing (in case of members and alternates); o role in the SCB and/or in one of its working groups: member/ alternate/

observer/ invited expert;

• contact data (for example e-mail address, telephone number, mobile phone number, fax number, postal address);

• data required to access the premises where the meeting is held (e.g. nationality, passport or identify card number and its data of issue and expiry data);

• financial data (such as a payment card number or bank account) may be collected for the payment of fees of the meeting or for possible reimbursements;

• data collected during meetings held virtually via a webconferencing service: recording of the meeting, information exchanged in the chat function of meetings held virtually, as well as technical and connection data that make it possible to use the webconferencing service;

• data collected during physical meetings: data necessary for establishing the attendance list and the minutes: e.g. name and signature;

• data included in the declarations of interest: o employment, consultancy and legal representation; o membership of managing body, scientific advisory body or an equivalent

structure; o research support; o financial interests; o intellectual property; o public statement and positions; o interests of immediate family members; o other relevant information that could be seen as undermining members'

independence.

5. How long do we keep your personal data?

The Data Controller only keeps your personal data for the time necessary to fulfil the purpose of collection or further processing.

For each of the categories of personal data that may be processed, please find below the retention details and the reference to the relevant record of processing:

 Personal data related to the organisation and management of meetings or events (this includes the information given during the registration, before, during or after the event) will be kept for five years after the meeting or event.

 Personal data shared with the Directorate-General for Human Resources and Security of the European Commission for the participants to gain access to Commission buildings is kept for 6 months after the termination of the link between the data subject and the

4

Commission. More information is available in the Record of Processing DPR-EC-00655 (Commission Physical Access Control System (PACS)).

 In case of audio-visual recording of meetings or events, the recordings will be kept for 5 years after the meeting or event before being deleted.

 Data related to the membership (i.e. the name, the institution of origin and the declaration of interests of each nominated member and alternate) will be kept for fifteen years after the date on which the members and alternates no longer participate in

the SCB or in one of its working groups. The data will be published on the EU SoHO Platform for the duration of the participation in the SCB. After that, the data will be kept by the European Commission without making it publicly available.

 Data included in the declarations of interest of observers and invited experts will be kept for fifteen years after the date on which the observers and invited experts no longer

participate in the SCB or in one of its working groups. The data will not be published on the EU SoHO Platform but will be kept by the European Commission.

6. How do we protect and safeguard your personal data?

All personal data in electronic format (e-mails, documents, databases, uploaded batches of data, etc.) are stored on the servers of the European Commission (or of its contractors, if contractors are engaged to assist the controller in the organisation and management of a specific meeting or event). All processing operations are carried out pursuant to Commission Decision (EU, Euratom) 2017/46 of 10 January 2017 on the security of communication and information systems in the European Commission.

In order to protect your personal data, the Commission has put in place a number of technical and organisational measures. Technical measures include appropriate actions to address online security, risk of data loss, alteration of data or unauthorised access, taking into consideration the risk presented by the processing and the nature of the personal data being processed. Organisational measures include restricting access to the personal data solely to authorised persons with a legitimate need to know for the purposes of this processing operation.

7. Who has access to your personal data and to whom is it disclosed?

Access to your personal data is provided to the Commission staff responsible for carrying out this processing operation and to other authorised Commission staff according to the “need to know” principle. Such staff abide by statutory, and when required, additional confidentiality agreements.

Cookies

Cookies are short text files stored on a user’s device (such as a computer, tablet or phone) by a website. Cookies are used for the technical functioning of a website (functional cookies) or for gathering statistics (analytical cookies).

If registration for the meeting/event takes place via a Commission website, the cookies employed by the Commission on the registrant’s device for that purpose will be covered by the cookie policy of the Commission, which is available here: https://ec.europa.eu/info/cookies_en.

When you visit the website(s) of the meeting/event and when you register, we will indicate in the specific privacy statement how long we will keep the browser history of your visit. This

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information will then be deleted. The collection, aggregation and anonymising operations are performed in the data centre of the European Commission under adequate security measures.

Cookies are stored by Europa Analytics, the corporate service which measures the effectiveness and efficiency of the European Commission's websites on EUROPA. More information is available in the Record of Processing DPR-EC-00685 (Europa Analytics).

Enabling these cookies is not strictly necessary for the website to work but it will provide you with a better browsing experience. You can delete or block these cookies, but if you do that, some features of the meeting/event website may not work as intended.

The cookie-related information is not used to identify data subjects personally and the pattern data is fully under the Commission’s control. These cookies are not used for any purpose other than those described here.

Should you wish to opt your personal data out of our anonymised, aggregated statistics, you can do so on our cookies page. In particular, you can control and/or delete those cookies as you wish.

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8. What are your rights and how can you exercise them?

You have specific rights as a ‘data subject’ under Chapter III (Articles 14-25) of Regulation (EU) 2018/1725, in particular the right to access, your personal data and to rectify them in case your personal data are inaccurate or incomplete. Where applicable, you have the right to erase your personal data, to restrict the processing of your personal data, to object to the processing, and the right to data portability. You have the right to object to the processing of your personal data, which is lawfully carried out pursuant to Article 5(1)(a) of Regulation (EU) 2018/1725 on grounds relating to your particular situation. The European Commission will ensure that the data subjects can exercise their right to object to processing whenever possible by the organisers of the meeting/event (for example, on the spot by indicating a non-web streamed seat if requested; or ex-post, by deleting a specific sequence from the online video/voice recording). You can exercise your rights by contacting the data controller, or in case of conflict the Data Protection Officer. If necessary, you can also address the European Data Protection Supervisor. Their contact information is given under Heading 9 below.

Where you wish to exercise your rights in the context of one or several specific processing operations, please provide their description (i.e. their Record reference(s) as specified under Heading 10 below) in your request.

9. Contact information

- The Data Controller

If you would like to exercise your rights under Regulation (EU) 2018/1725, or if you have comments, questions or concerns, or if you would like to submit a complaint regarding the collection and use of your personal data, please feel free to contact the secretariat of the SCB (SANTE D2 Unit) at [email protected].

- The Data Protection Officer (DPO) of the Commission

You may contact the Data Protection Officer ([email protected]) with regard to issues related to the processing of your personal data under Regulation (EU) 2018/1725.

- The European Data Protection Supervisor (EDPS) You have the right to have recourse (i.e. you can lodge a complaint) to the European Data Protection Supervisor ([email protected]) if you consider that your rights under Regulation (EU) 2018/1725 have been infringed as a result of the processing of your personal data by the data controller.

10. Where to find more detailed information?

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The Commission Data Protection Officer (DPO) publishes the register of all processing operations on personal data by the European Commission, which have been documented and notified to him. You may access the register via the following link: http://ec.europa.eu/dpo- register.

This specific processing operation has been included in the DPO’s public register with the following Record reference:DPR-EC-29748.

To all Deputy Permanent Representatives of the EU Member States Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË

EUROPEAN COMMISSION DIRECTORATE GENERAL FOR HEALTH AND FOOD SAFETY The Director-General

Brussels,

SANTE D2/KB/eb/(2024)9962963

Your Excellency,

Subject: Request for the nomination of members of the SoHO Coordination

Board (SCB)

I am writing to you regarding the nomination of members and alternates to the newly

established SoHO Coordination Board (SCB) following the adoption of Regulation (EU)

2024/1938 on standards of quality and safety for substances of human origin (SoHO)

intended for human application.

The role of the SCB is to promote and support coordination between Member States

concerning the implementation of the SoHO Regulation, as well as to facilitate

cooperation with stakeholders in that regard. The tasks of the SCB include documenting

best practices on the implementation of SoHO supervisory activities and conditions for

compensation, providing advice on whether the SoHO Regulation applies and providing

opinions on the regulatory status for inclusion in the SoHO Compendium, setting

indicative criteria for ‘critical SoHO’ and for ‘critical SoHO entities’, providing support

for joint oversight activities related to inspections and to the assessment of SoHO

preparation processes, supporting the Commission on the specifications for the SoHO

platform and supporting the coordination during emergencies.

Art 68(2) of the SoHO Regulation specifies that each Member State shall appoint two

permanent members and two alternates representing the SoHO national authority and,

where the Member State chooses so, the Ministry of Health or other relevant authorities.

The SoHO national authority may nominate members from other SoHO competent

authorities. Appointed members shall nevertheless ensure that the views and suggestions

they express are endorsed by the SoHO national authority.

I herewith invite your Member State to submit, in accordance with Art 68(3) of the

SoHO Regulation, the names and affiliation of your nominated members and alternates,

together with their corresponding declaration of interests. To this end, a form for the

declaration of interests is Annexed to this letter. Member States shall nominate only

members and alternates who do not have such conflicts. Please note that the Commission

will make publicly available, on the EU SoHO Platform, the membership list, including

the name, the institution of origin and the declaration of interests.

2

The SCB will start its activities in early 2025 and will gradually take over the activities

related to blood, cells and tissues currently performed by the Competent Authorities on

Substances of Human Origin Expert Group (BTCO), including the activities performed

by its sub-groups on vigilance (VES), inspections in blood, cells and tissues (IES), and

coding of tissues and cells (CES). Therefore, the SCB could be composed, for example,

of members with a profile similar to the members of the Expert Group BTCO.

The members of the SCB will actively contribute to the above-mentioned tasks and

should therefore be selected for their competence and experience in the field of SoHO.

The composition of the SCB should be balanced to allow discussions of technical, policy

and legal nature, in order to contribute to the work of the SCB and its sub-groups. It

should be noted that members of the SCB will have the responsibility to disseminate

information and documentation shared with the SCB members to other relevant

competent authorities within their Member State.

The Commission will also set-up sub-groups of the SCB on inspections (replacing IES),

vigilance and traceability (replacing VES and CES), authorisation and assessment of

SoHO preparations, regulatory questions, supply of critical SoHO; and registration of

entities and authorisation of establishments. Member States will be invited to nominate

members for these sub-groups once these have been established (expected later in the

course of 2025). Nominees for the sub-groups can be the same or different from the SCB

nominees.

Please note that the existing Expert Group BTCO will be maintained but will be

convened for meetings on organs only. Regarding the adoption of implementing acts

under the SoHO Regulation, a dedicated (regulatory) Committee will need to be set up,

in accordance with Art 79 of the SoHO Regulation.

The first meeting of the SCB will take place virtually via Webex on Friday 24 January

2025. During this meeting, the rules of procedure, as specified in Art 68 (8) of the SoHO

Regulation, will be presented for approval. Candidates for co-chairing the SCB are

invited to express their interest by Friday 31 January 2025. The second meeting of the

SCB will take place physically at the Commission premises in Brussels in the week of 10

February 2025. At this meeting, the co-chair of the SCB will be elected.

In order to keep the above-mentioned timeframe, the European Commission would be

very grateful if you could provide the requested information, i.e. the names and

affiliation of your nominated members and alternates together with the corresponding

declaration of interests for any member and alternate, by 8 January 2025 at the latest.

Should you need any additional information, you may contact Stefaan Van Der Spiegel,

Team Leader SoHO/ SANTE D2 (email: [email protected],

office number: +32 229 55406) and Katleen Baert, Policy Officer SoHO/ SANTE D2,

(email: [email protected], office number +32 229 55981).

Yours sincerely,

Sandra GALLINA

3

Annex: Form to declare interests

Privacy statement

Copy: Health attachés,

L. BOIX ALONSO, R. BECKER, R. MCGEEHAN, L. BATTISTINI, M.

MOYA DIAZ, B. GAUTRAIS, M. CICCARELLO, S. VAN DER

SPIEGEL, M. AMBROSIO, K. BAERT, E. MARCHAND, R. PITEIRA

(SANTE)

Saatja: Webdesktop <[email protected]>

Saadetud: 13.12.2024 15:15

Adressaat: <[email protected]>; <"Maret Voore">

Koopia: <"[email protected]">; <"Tiina Rootamm">

Teema: Webdesktop: Esindaja nimetamine SoHO koordinatsiooni komiteesse

Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga.Tundmatu saatja

korral palume linke ja faile mitte avada.Tere!Edatsan Komisjoni kirja.EV

AEEL juures reg. number: 10.2-11/1288Reg. kuupäev: 13.12.2024Sisu:

Esindaja nimetamine SoHO koordinatsiooni komiteesse. Coordination Board

(SCB) as stipulated in the recently adopted Regulation (EU) 2024/1938 on

safety and quality of substances of human origin.-- Heade soovidegaTiiu

Noobelsekretär, EV alaline esindus EL juures&#43;32 2227 4337