LAW OF THE REPUBLIC OF MOLDOVA

of June 19, 2025 No. 153

About medicines

The parliament adopts this organic law.

This law:

– partially shifts the Directive of the European parliament and Council 2001/83/EC of November 6, 2001, establishing the Code of Community about medicines for medical application, published in the Official magazine of the European Union by L 311 of November 28, 2001, CELEX: 32001L0083, with the subsequent changes made by the Directive of the European parliament and Council (EU) 2022/642 of April 12, 2022;

– shifts Items (a) and (b) of part (1) Article 2 of Regulations of the European parliament and Council (EU) No. 1394/2007 of November 13, 2007 about high-technology medicines and about modification of the Directive 2001/83/EU and the Regulations (EU) No. 726/2004, of the European Union published in the Official magazine of L 324 of December 10, 2007, CELEX: 32007R1394, with the subsequent changes made by Regulations of the European parliament and Council (EU) 2019/1243 of June 20, 2019;

– shifts Articles 1, 8 and 9 Regulations of the European parliament and Council (EU) No. 141/2000 of the December 16, 1999 about orphan medicines published in the Official magazine of the European Union by L 18 of January 22, 2000, CELEX: 32000R0141, with the subsequent changes made by Regulations of the European parliament and Council (EU) 2019/1243 of June 20, 2019;

– shifts part (2), and also Items (b) and (c) of part (3) Article 3 of Regulations of the Commission (EU) No. 847/2000 of the April 27, 2000 establishing regulations on use of criteria of assignment to medicine of the status orphan and determination of the concepts "similar medicine" and "clinical superiority", published in the Official magazine of the European Union by L 103 of April 28, 2000, CELEX: 32000R0847, with the subsequent changes made by Regulations of the Commission (EU) 2018/781 of May 29, 2018;

– shifts Article 1, part (1) and Items 1-6, 11, 13–17, 19–22, 25, 26 and 29–34 parts (2) articles 2, of article 3 and 4, of part (3) – (6) Articles 5, part (1) Articles 6, part (1) articles 7, of article 9, 10 and 15, of part (1) and (2) articles 25, of article 26, of 28, 47–50, paragraph first of Article 57, of Article 58 and 71, of part (1) and (2) Articles 74, Article 76, of part (1) and (2) Article 77 of Regulations of the European parliament and Council (EU) No. 536/2014 of April 16, 2014 about intervention clinical trials of medicines for medical application and about cancellation of the Directive 2001/20/EU, the European Union published in the Official magazine of L 158 of May 27, 2014, CELEX: 32014R0536, with the subsequent changes made by the Delegated regulations of the Commission (EU) 2022/2239 of September 6, 2022;

– shifts Articles 14, 16a, 16b, 28a and 83 Regulations of the European parliament and Council (EU) No. 726/2004 of March 31, 2004 about establishment for Community of procedures of issue of permissions and supervision of medicines for medical and veterinary application, and also about organization of the European agency on medicines published in the Official magazine of the European Union by L 136 of April 30, 2004, CELEX: 32004R0726, with the subsequent changes made by Regulations of the European parliament and Council (EU) 2019/5 of December 11, 2018;

– partially shifts the Directive of the European parliament and Council 2009/35/EU of April 23, 2009 about dyes which are allowed to be included in composition of medicines (in the new edition), CELEX: 32009L0035, published in the Official magazine of the European Union by L 109 of April 30, 2009.

Chapter I. General provisions

Article 1. Scope of this law

(This law regulates 1):

a) the activities connected with medicines for medical application which are made by industrial method or using industrial process, including the medicines intended only for export, and also the intermediate products operating and excipients;

b) conditions and procedure for carrying out testing, productions, placements in the market, markings, classifications, pharmakonadzor, advertizing, registration of the prices, deliveries, control and supervision in relation to medicines for the purpose of ensuring their quality, safety and efficiency, and also protection of public health.

(2) Provisions of this law are not applied:

a) to the main dosage forms established by regulations on drugstores;

b) to the ofitsinalny dosage forms established by regulations on drugstores, except as specified, stipulated in Article 6;

c) to the intermediate products intended for the subsequent conversion by the authorized producer;

d) to the radionuclides in the form of the isolated sources regulated by regulations on protection against ionizing radiation and on nuclear safety;

e) to blood, plasma or blood cells of the person, except for the plasma received by the method providing the industrial process applied to production of medicines;

f) to the fabrics and cells of the person intended for medical application, established by regulations on quality and safety of fabrics and cages for therapeutic application.

(3) for the purposes of this law the countries with the similar level of requirements to confirmation of quality, safety and efficiency of medicines are the countries of the European Economic Space (EES), the USA, the United Kingdom of Great Britain and Northern Ireland, Switzerland, Canada, Australia and Japan.

Article 2. Concepts

For the purposes of this law the following concepts are used:

1) abuse of medicines – the permanent or one-time deliberate excessive use of medicines which is followed by harmful physiological or psychological effects;

2) the European agency on medicines (further – EMA) – competent authority of the European Union which bears responsibility for protection of public health and health of animals by means of scientific assessment of medicines and supervision of them;

3) inside package – container or any other type of packaging which directly adjoins to medicine;

4) outside package – packaging in which the inside package is placed;

5) the registration certificate – the allowing document issued by the Agency on drugs and medical products by results of registration of medicine for medical application and its inclusion in the State register of medicines;

6) essential advantage – clinically significant benefit or the significant contribution to treatment of the patient;

7) the brochure of the researcher – summary statement of clinical and preclinical data on medicine or medicines for clinical trial which matter for research of these medicines at the person;

8) proper distributor practice (GDP) – the part of system of the quality assurance which is guaranteeing maintenance of quality of medicines and/or active ingredients at all stages of supply chain against the producer to drugstore or the faces authorized or having the right to provide medicines to the population;

9) proper production practice (GMP) – the part of system of quality assurance guaranteeing that products are made, imported and is under constant control according to the quality standards corresponding to purpose of products;

10) proper laboratory practice (GLP) – the part of system of quality assurance covering procedure for the organization and condition of planning, carrying out, check, registration, archiving and representation of results of preclinical researches of safety for health and the environment according to the practice and managements accepted by the European commission;

11) proper practice of pharmakonadzor (GVP) – complex of the actions developed for assistance to implementation of pharmakonadzor in the Republic of Moldova and based on proper practice of pharmakonadzor of the European Union;

12) proper clinical practice (GCP) – the code of ethical and scientific quality requirements of planning, carrying out, realization, monitoring, audit, registration, the analysis and representation of results of intervention clinical trials which ensure protection of the rights, safety and wellbeing of subjects, and also reliability and the accuracy of the data received within intervention clinical trial;

13) the National price catalog of producers of medicines (NKTs) – the official magazine of registration and accounting of the prices of producers of the medicines approved by the Agency on drugs and medical products;

14) retail trade – purchase and storage of medicine, and also its sale to the population;

15) National committee of ethical examination of clinical trials – the independent body founded in the Republic of Moldova, authorized to issue the conclusions according to provisions of this law, Regulations on clinical trials of medicines for medical application and Regulations on the organization and functioning of National committee of ethical examination of clinical trials taking into account opinion of nonspecialists, in particular patients or the organizations of patients. The national committee of ethical examination of clinical trials (further – NKEEKI) is the public organization acting on the self-government basis as which founder the Ministry of Health acts;

16) medicine dosage – content of active ingredients in quantitative expression on standard unit of dispensing, unit of volume or unit of mass depending on dosage form;

17) quality control – the actions, including sampling, establishment of specifications, carrying out testing, preparation of the analytical conclusions aimed at providing compliance of raw materials, intermediate products, packaging materials and finished pharmaceutical goods to the established specifications concerning authenticity, the concentration, purity and other characteristics performed by producers/importers within proper production practice and also Official laboratory on control of medicines (OLKLS) appointed by the Agency on drugs and medical products;

18) the informed consent – free and voluntary expression by the subject of the consent to participation in certain intervention clinical trial after receipt of information on all related aspects, significant for adoption by the subject of the decision on participation, or – in case of minor or incapacitated subjects – permission or the consent of their legal representatives to participation of such subjects in intervention clinical trial;

19) joint promotion – marketing strategy within which two or more parties perform mutual promotion of goods or services;

20) the name of medicine – the name which can be as the fictional name which shall not lead to mixture with the commonly accepted name, and the commonly accepted or scientific name accompanied with the trademark or the name of the owner of the registration certificate;

21) the international commonly accepted name (ICAN) – the international non-proprietary name recommended by the World Health Organization (further – WHO), or – in the absence of such name – the common name;

22) wholesale trade by medicines – all types of activity on purchase, storage, delivery or export of medicines, except for activities for their leave to the population. The specified types of activity are performed by the producers or the warehouse organizations, importers, other wholesale distributors or druggists and persons authorized or having the right to provide medicines to the population of the Republic of Moldova;

23) the main file of system of pharmakonadzor – the detailed description of the system of pharmakonadzor used by the owner of the registration certificate concerning one or several registered medicines;

24) the main file of intervention clinical trial – the file which is constantly containing the main documents relating to the corresponding intervention clinical trial, allowing to check the course of performing intervention clinical trial and quality of the obtained data taking into account all characteristics of intervention clinical trial;

25) error of use of medicine – inadvertent omission in the course of drug treatment which conducts or can potentially lead to causing to the patient of harm;

26) marking – information provided on inside or outside package;

27) the undesirable phenomenon – any event, adverse from the medical point of view, which is arising at the subject in case of use of medicine and not necessarily having cause and effect relationship with the corresponding treatment;

28) the serious undesirable phenomenon – any event, adverse from the medical point of view, which irrespective of dose of medicine requires hospitalization or its prolongation leads to permanent or considerable restriction of opportunities or incapacity, causes congenital anomaly or malformation, poses threat for life or leads to death;

29) excipient – any component of medicine which is not active ingredient or packaging material;

30) the European pharmacopeia – the official normative management used in pharmaceutical practice, guaranteeing quality of medicines due to development of the general and obligatory rules intended for practical application. This pharmacopeia is provided by the Convention of the Council of Europe on development of the European pharmacopeia (1964) published by the European management on quality of medicines and health care (EDQM);

31) pharmakonadzor – knowledge domain about undesirable consequences of use of medicines and the activities performed for identification, assessment, understanding and prevention of such consequences;

32) the main dosage form – any medicine made in drugstore according to the recipe for the specific patient;

33) ofitsinalny dosage form (galenovy medicine) – any medicine made in drugstore according to pharmakopeyny requirements and intended for direct leave to the patients served by this drugstore;

34) the radio nuclide generator – any system containing the fixed primary radionuclide of which the secondary radionuclide extracted by eluating or any other method and used for receipt of radio pharmaceutical medicine is formed;

35) parallel import of medicines – import of the registered medicines to the Republic of Moldova with use of alternative channels, excellent from established by the producer/owner of the registration certificate or suppliers of medicines, according to the procedure, provided by this law;

36) the parallel importer – the importer performing activities for parallel import;

37) pharmaceutical inspection – set of actions for check of observance by persons who are subject to the state control, provisions of regulations according to the Law on the state control No. 131/2012 and this law;

38) inspection of clinical trial – the activities performed by competent authority consisting in official studying of documents, venues of clinical trials, records, systems of quality assurance and any other elements which according to the decision of competent authority are related to clinical trial and which can be in the venue of clinical trial, in rooms of the sponsor and/or the contractual research organization or in any other organization which, according to competent authority, requires inspection;

39) mediation in the field of medicines – any activities connected with sale or purchase of medicines except wholesale trade which does not provide their physical movement and consists in negotiation from own name and on behalf of other legal entity or physical person;

40) the researcher – the physical person who is responsible for performing intervention clinical trial in the venue of intervention clinical trial;

41) the chief researcher – the researcher who is the responsible head of group of the researchers conducting intervention clinical trial in the venue of intervention clinical trial;

42) the beginning of intervention clinical trial – the first action for involvement of the potential subject for participation in certain intervention clinical trial if other is not provided by the protocol;

43) early termination of intervention clinical trial – premature completion of intervention clinical trial for any reason before accomplishment of the conditions specified in the protocol;

44) completion of intervention clinical trial – the last visit of the last subject or other later timepoint determined in the protocol;

45) temporary stop of intervention clinical trial – the suspension by the sponsor of performing intervention clinical trial which is not provided by the protocol with intention to renew it further;

46) medicine – any substance or combination of substances, which:

a) are represented as having medicinal or preventive properties concerning diseases of the person; or

b) corrections or changes of physiological functions by means of rendering pharmacological, immunological or metabolic action or for the purpose of establishment of the medical diagnosis can be applied or be appointed to the person for the purpose of recovery;

47) the medicine allowed for use for children (medicine for children), – medicine which use is authorized in all children's population or its part (aged from the birth up to 18 years) and data on the allowed indication for to which use are provided in general characteristic of medicine;

48) bioanalog medicine – the biological medicine similar to already registered reference biological medicine;

49) reference medicine – the medicine registered according to provisions of Articles 48 and 49;

50) herbal remedy – any medicine containing in quality of active ingredients only one or several types of vegetable raw materials, either one or several vegetable medicines, or one or several types of vegetable raw materials in combination with one or several vegetable medicines;

51) counterfeited medicine – any medicine concerning which are in a false manner provided:

a) its identification data, including packaging and marking, the name or structure of any its components, including excipients, and dosage of the corresponding components;

b) its source, including the producer, the country of origin, country of source, the owner of the registration certificate; or

c) history of its address, including the records and documents concerning the used distribution channels.

This determination does not extend to inadvertent defects of quality and does not affect violation of intellectual property rights;

52) the reproduced medicine – medicine which has the same high-quality and quantitative composition of active ingredients and the same dosage form, as reference medicine and which bioequivalence to reference medicine is confirmed by the corresponding researches of bioavailability. Various salts, simple and the esters, isomers and mixes of isomers, complexes or derivatives received from one active ingredient are recognized the same active ingredient if their properties significantly do not differ on indicators of safety and/or efficiency. In such cases the applicant shall provide the additional data intended for confirmation of safety and/or efficiency of salts, air or derivatives of the registered active ingredient. Various dosage forms for intake with immediate release are recognized the same dosage form. The applicant shall not conduct bioavailability researches if he can prove that the reproduced medicine answers the corresponding criteria determined in the operating detailed managements;

53) homeopathic medicine – any medicine made of the substances which are referred to as with homeopathic substances according to the procedure of homeopathic production described in the European pharmacopeia or – in the absence of the description of such procedure – in the operating pharmacopeias officially used in member states of the European Union. Homeopathic medicine may contain several active components;

54) immunological medicine – any medicine incorporating vaccines, toxins, serums or allergens:

a) vaccines, toxins and serums, in particular, represent:

(i) the components applied to forming of active immunity such as cholera vaccine, vaccine BTsZh (Kalmet's bacillus – Gerena), poliomiyelitny vaccine, ospenny vaccine;

(ii) the components applied to diagnostics of the immune status, including, in particular, tuberkulin and tuberkulin PPD (cleared tuberkuloprotein), the toxins used for tests of Chic It is also wild, brutsellin;

(iii) the components applied to forming of passive immunity such, as diphtheritic anatoksin, protivoospenny globulin, anti-lymphocytic globulin;

b) allergen represents any medicine intended for identification or development of the acquired specific change of the immune answer to allergiziruyushchy component;

55) orphan medicine – medicine which is given the status of orphan medicine based on the following criteria:

a) medicine is intended:

(i) for diagnosis, prevention and treatment of the life-endangering, chronically exhausting or serious chronic illness which occurs no more than at five people on 10 000 populations in the European Union and the Republic of Moldova at the time of application; or

(ii) for diagnostics, prevention and treatment of the life-endangering, chronically exhausting or serious chronic illness in the European Union and the Republic of Moldova, and without acceptance of the stimulating measures it is improbable that realization of medicine will allow to gain income sufficient for reasons for necessary investments; and

b) in the European Union or the Republic of Moldova there is no permitted satisfactory method of diagnostics, prevention or treatment of the corresponding disease, or – in the presence of such method – medicine will bring essential benefit to persons having this disease;

56) similar orphan medicine – the medicine containing the active ingredient or active ingredients similar containing in the orphan medicine registered for the corresponding moment with the similar indication to application;

57) the medicine received from blood or plasma of blood of the person – the medicine on the basis of blood components made by industrial method at the state or private enterprises, including, in particular, albumine, factors of fibrillation and immunoglobulins of human origin;

58) medicine for clinical trial – medicine which is subjected to test or is applied as reference medicine, including as placebo, within intervention clinical trial;

59) high-technology medicine – any of the following medicines for medical application:

a) genoterapevtichesky medicine – the biological medicine having the following characteristics:

(i) contains the active ingredient including recombinant nucleinic acid or consisting of recombinant nucleinic acid which is used or entered to the person for the purpose of regulation, recovery, replacement, addition or removal of the genetic sequence;

(ii) therapeutic, preventive or diagnostic effects of medicine are directly caused by the sequence of recombinant nucleinic acid containing in it or product of genetic expression of this sequence;

b) medicine on the basis of somatic cages – the biological medicine having the following characteristics:

(i) contains cages or fabrics or consists of cages or fabrics which underwent to essential impact, and as a result the biological characteristics, physiological functions or structural properties concerning specific clinical use were changed in comparison with cages or fabrics which are not held for use for the purpose of accomplishment of the same main function / the same main functions at the recipient and the donor;

(ii) it is provided as having necessary properties or it is applied at the person to treatment, prevention or diagnosis of disease by means of pharmacological, immunological or metabolic action of cages and fabrics;

c) tkaneinzhenerny medicine – medicine, which:

(i) contains cages or fabrics or consists of cages or fabrics which are received by means of cellular or fabric engineering;

(ii) it is provided as having properties of regeneration, recovery or replacement of tissue of the person or it is used or entered to the person for this purpose;

60) traditional herbal remedy – the herbal remedy answering to the conditions provided by part (2) Article 59;

61) the minor – the subject who according to the legislation of the Republic of Moldova did not reach capable age for making the informed consent;

62) essential change – any change concerning any aspect of intervention clinical trial which is brought after approval of intervention clinical trial in the Republic of Moldova and which can have significant effect on safety or the rights of subjects or to reliability and stability of the data obtained within intervention clinical trial;

63) the obligation on rendering public service – the obligation assigned to wholesale dealers on providing on permanent basis of sufficient range of the medicines meeting needs of the Republic of Moldova and on delivery in all territory of the country of required amount of medicines in the shortest possible time after receipt of the order;

64) the risk management plan – the detailed description of risk management system;

65) the plan of research at children – the research and development programme aimed at providing receipt of necessary data for determination of conditions under which medicine can be authorized for treatment of children's population;

66) children's population – part of the population aged from the birth up to 18 years;

67) the commonly accepted clinical practice – the treatment mode which is usually applied to treatment, prevention or diagnosis of disease or condition;

68) radio nuclide predecessor – any radionuclide intended for introduction of radioactive tag in other substance before its application;

69) vegetable medicines – the medicines received by conversion of vegetable raw materials, for example by extraction, distillation, extraction, separation into fractions, cleanings, concentration or fermentations. Vegetable medicines also include the crushed or powdered vegetable raw materials, tinctures, extracts, essential oils, the wrung-out juice and substances emitted in the course of conversion;

70) the recipe – any recipe issued by person having the corresponding qualification;

71) ready medicine – medicine which passed all production stages, including packaging in final container;

72) intermediate products – partially processed raw materials which shall pass the subsequent production stages before it becomes bulk products;

73) radio pharmaceutical medicine – any medicine which contains in form, ready for use, entered into it in the medical purposes one or several radionuclides (radioactive isotopes);

74) leaf insert – the document attached to medicine containing information for the user;

75) the protocol – the document containing the description of the purposes, design, methodology, statistical aspects and procedure for the organization of intervention clinical trial. This concept includes the subsequent versions of the protocol and change to it;

76) ratio of advantage and risk – assessment of positive therapeutic effects of medicine in relation to any risk for health of patients or public health connected with quality, safety or efficiency of medicine;

77) undesirable reaction – inadvertent adverse reaction to medicine;

78) serious undesirable reaction – undesirable reaction which can lead to death poses threat for life, requires hospitalization of the patient or its prolongation, leads to permanent or considerable restriction of opportunities or incapacity or causes congenital anomalies / malformations;

79) unforeseen serious undesirable reaction – serious undesirable reaction, nature, weight or outcome of which do not correspond to reference information on safety;

80) unforeseen undesirable reaction – undesirable reaction, nature, weight or current of which do not correspond to information containing in general characteristic of medicine;

81) the representative of the owner of the registration certificate – the person who is usually acting as the local representative, appointed the owner of the registration certificate for representation of its interests in the Republic of Moldova;

82) the legal representative – physical person or legal entity, body or organization which according to the legislation of the Republic of Moldova are authorized to give the informed consent on behalf of the incapacitated subject or the minor;

83) the risks connected using medicine:

a) any risk for health of patients or public health connected with quality, safety or efficiency of medicine;

b) any risk of undesirable impact on the environment;

84) safety signal – information on the new or known undesirable phenomenon which can be caused by medicine and requires additional research;

85) system of pharmakonadzor – the system used by the owner of the registration certificate and the Republic of Moldova for accomplishment of the tasks and obligations intended for monitoring of safety of the registered medicines and identification of any changes in the ratio of advantage and risk listed in Chapter XII;

86) risk management system – complex of the actions for pharmakonadzor and intervention intended for identification, determinations of characteristics, prevention or risk minimizations connected with medicine including efficiency evaluation of such intervention;

87) the sponsor – the physical person, society, organization or the organization which are responsible for initiation of intervention clinical trial, management of such research and the organization of its financing;

88) suspension of the procedure of registration – the period during which assessment of the registration file stops and during which the applicant prepares answers to the provided notes; the procedure of registration is resumed after submission of the corresponding answers by the applicant;

89) clinical trial – any research with participation of people conducted for the purpose of assessment of safety and/or efficiency of medicines directed:

a) on identification or check of clinical, pharmacological or other pharmakodinamichesky effect of one or several medicines;

b) on identification of any undesirable reactions to one or several medicines; or

c) on studying of absorption, distribution, metabolism and removal of one or several medicines;

90) intervention clinical trial – the clinical trial answering to any of the following conditions:

a) to the subject the certain therapeutic strategy which is not falling under the commonly accepted clinical practice applied in the Republic of Moldova is beforehand appointed;

b) the decision on prescription of medicines for clinical trial is made along with the decision on inclusion of the subject in clinical trial; or

c) supplementary procedures of diagnostics or monitoring are applied to subjects, in addition to the commonly accepted procedures in clinical practice;

91) low-intervention clinical trial – the intervention clinical trial answering to all following conditions:

a) medicines for clinical trial, except for placebo, are registered;

b) according to the protocol of intervention clinical trial:

(i) medicines are applied to clinical trial in accordance with the terms, established by the registration certificate; or

(ii) use of medicines is based on proofs and is supported with the published scientific data on safety and efficiency of such medicines for clinical trial in any of the following states: member states of the European Union, USA, United Kingdom of Great Britain and Northern Ireland; and

c) supplementary procedures of diagnostics or monitoring bear for safety of subjects no more than minimum additional risk or the minimum additional burden in comparison with the commonly accepted clinical practice applied in the Republic of Moldova;

92) not intervention research – the clinical trial which is not intervention clinical trial;

93) post-registration research of safety – any research concerning in the registered medicine, conducted for the purpose of identification, determination of characteristics or quantitative risks assessment for safety, confirmation of profile of safety of medicine or efficiency evaluation of measures for risk management;

94) the subject – the physical person who is taking part in intervention clinical trial which or receives medicine for clinical trial or is part of control group;

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