Document from CIS Legislation database © 2003-2024 SojuzPravoInform LLC

LAW OF THE REPUBLIC OF MOLDOVA

of February 29, 2024 No. 42

About biological bank of the person

The parliament adopts this organic law.

This law shifts:

a) Items (a), (c), (g), (j) and (k) of Article 3, parts (1) and (2) Articles 4, Article 7, parts (2) and (4) Articles 8, Article 17, Article 18, Article 22-24 and part (1) Article 25 of the Directive 2004/23/EC of the Commission of October 24, 2006 about enforcement of the Directive 2004/23/EC of the European parliament and Council on requirements to traceability, the notification on serious undesirable reactions and the phenomena, and also about certain technical requirements to coding, processing, preservation, storage and distribution of fabrics and cells of the person (the text concerning EEP), with the last changes made by Regulations (EU) No. 596/2009 of the European parliament and Council of June 18, 2009;

b) Items (a) and (g) of Article 2 and appendix I to the Directive 2006/86/EC of the Commission of October 24, 2006 about enforcement of the Directive 2004/23/EC of the European parliament and Council regarding requirements to traceability, the notification on serious undesirable reactions and the phenomena, and also about certain technical requirements to coding, processing, preservation, storage and distribution of fabrics and cells of the person (the text concerning EEP), with the last changes made by the Directive (EU) 2015/565 Commissions of April 8, 2015.

Chapter I. General provisions

Article 1. Regulation subject

(1) This law establishes the legal base of regulation of creation and maintenance of activities of biological bank of the person (further – biobank) provided by organized collections of biosamples/selections of biosamples of the person and the related data and is applied to their donorship, withdrawal, control, processing, preservation, storage, distribution and destruction.

(2) This law is applied also to fabrics and cages, including stem haemo poetic cells from peripheral blood, from umbilical blood and from marrow, to reproductive cages (ova, spermatozoa), to adult and embryonic fabrics and stem cells, to liquids of the person, such as whole blood, plasma, serum, urine, phlegm, saliva, cerebrospinal fluid and others, to hair follicles, to cellular components and subcomponents, such as cytoplasm, kernels, mitochondrions, fragments of cellular membranes, and also to biochemical/molecular fractions – to DNA, RNA, proteins and their derivatives.

(3) If listed in part (2) biosamples fall under operation of other laws, this law is applied to area of biomedical researches.

(4) This law observes the basic rights and the principles stated in the European convention on human rights protection and human dignity in connection with application of achievements of biology and medicine of April 4, 1997, the Convention on human rights and biomedicine.

(5) This law corresponds to provisions of the Law on assessment and accreditation in health care system No. 552/2001, of the Code of the Republic of Moldova about science and innovations No. 259/2004, of the Law on organ transplantation, fabrics and cells of the person No. 42/2008, of the Marine life protection act of personal data No. 133/2011, of the Law about reproductive health No. 138/2012, of the Law on judicial examination and the status of the court expert No. 68/2016, of the Recommendation of CM/RÑß (2016)6 of the Council of Europe.

Article 2. Basic concepts

For the purposes of this law the following concepts mean:

the administrator – the physical person authorized by the founder for the organization and monitoring of activities for biobankirovaniye of biosamples/selections of biosamples and the related data;

biobankirovaniye – the activities consisting in donorship, withdrawal, acceptance, coding/decoding, testing, processing, storage, preservation, freezing, defrosting, distribution and/or destruction of biosamples and the related data;

the receiver – person or group of persons to which services of biobankirovaniye are provided;

biobank – the organization uniting organized collections of biosamples/selections of biosamples and the related data, created and served by the founder;

biosample – the biological sample consisting of selection of fabric, cages, intracellular components or the liquid of organism withdrawn from the person for the diagnostic, therapeutic and/or research purposes;

cages – the separate cells of human body or set of cells of human body which are not connected by any type of fabric;

reproductive cages – cages, held for use for the purpose of reproduction of the person;

coding – assignment of unique code / identifier to the donor for the purpose of protection of its personal data;

cellular components and subcomponents – structural and functional elements of cage;

preservation – process of preserving or maintenance during the long period of time of characteristics and integrity of cages or fabrics by use on processing stage of chemical and/or physical agents or other methods;

consent – the voluntary, conscious and directly expressed in the written application confirmation by the donor/receiver (the legal representative or the guardian depending on circumstances) consent to rendering any offered medical care (diagnostic, therapeutic or research);

quality control – the practician based on the principles proper process of supervision of quality according to the certain technical requirements adapted for quality indicators;

the connected data – the relevant medical and not medical information concerning the donor/receiver;

decoding – process, the return to coding which allows to identify accessory of biosample and the connected data, using unique code / identifier;

distribution – transportation and delivery of biosamples for the purpose of use by the person and/or for carrying out researches;

donorship – voluntary provision of biosamples/selections of biosamples, held for use the person and/or for carrying out researches;

the donor – body of the living person or corpse of the person (after confirmation of death) as source of biosamples/selections of the biosamples used in the diagnostic, therapeutic and/or research purposes;

the founder – delivering medical services public or private legal entity which creates also serves biobank;

liquids of the person – any liquid substance withdrawn from internal or external environment of body of the donor;

withdrawal – selection process of biosamples/selections of biosamples;

processing – set of the transactions connected with preparation, manipulations, preservation and conversion of biosamples/selections of biosamples held for use the person and/or carrying out researches;

storage – content of biosample in proper and controlled conditions before distribution or destruction;

the user having permission – physical person or legal entity which based on the agreement acquires from the administrator of biobank the right to implementation of activities for biobankirovaniye, except for coding and decoding;

Warning!!!

This is not a full text of document! Document shown in Demo mode!

If you have active License, please Login, or get License for Full Access.

With Full access you can get: full text of document, original text of document in Russian, attachments (if exist) and see History and Statistics of your work.

Get License for Full Access Now

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info

Effectively work with search system

Database include more 50000 documents. You can find needed documents using search system. For effective work you can mix any on documents parameters: country, documents type, date range, teams or tags.
More about search system

Get help

If you cannot find the required document, or you do not know where to begin, go to Help section.

In this section, we’ve tried to describe in detail the features and capabilities of the system, as well as the most effective techniques for working with the database.

You also may open the section Frequently asked questions. This section provides answers to questions set by users.

Search engine created by SoyuzPravoInform LLC.