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ORDER OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF MOLDOVA

of July 23, 2012 No. 739

About authorization of medicines for the person and approval of post-registration changes

(as amended on 08-04-2016)

According to provisions of the Law No. 1456-XII of 25.05.1993 on pharmaceutical activities, with subsequent changes and amendments, the Law on drugs No. 1409-XIII for 17.12.1997, with subsequent changes and amendments, article 13 of the Law No. 317-XV of 18.07.2003 on regulations of the Government and other bodies of the central and local public authority, and also proceeding from need of optimization and enhancement of regulatory framework for authorization of medicines for the person according to the European requirements, for the purpose of ensuring efficiency, safety and quality of medicines, for the purpose of coordinating of process of forming of the medicinal assortment permitted for application in medical practice, PRIKAZYVAYU:

1. Approve:

1) Regulations on authorization of medicines (appendix No. 1).

2) Regulations on approval procedure of post-registration changes (appendix No. 2).

3) Analytical, pharmako-toxicological and clinical regulations and protocols of testing of medicines (appendix No. 3).

4) Standard sample of the Registration certificate of medicines (appendix No. 4).

2. To the CEO of the Agency on drugs and medical products:

1) to provide activities of the divisions participating in process of authorization of medicines for the person and approval of post-registration changes according to the provisions and regulations attached to this order;

2) to perform coordinating of activities of the Commission on drugs for the purpose of ensuring efficiency, safety and quality of the medicines permitted to placement in the pharmaceutical market;

3) to provide the advisory and methodical help to applicants;

To bring 4) into accord with this order the departmental regulations.

3. The order becomes effective from the date of publication in the Official monitor of the Republic of Moldova.

4. Cancel:

5. To impose control of execution of this Order on the deputy minister Mr. Octavian Gram.

 

Minister of Health

Andrey Usaty

Appendix No. 1

to the Order of the Minister of Health of the Republic of Moldova of July 23, 2012 No. 739

Regulations on authorization of medicines

The regulations on authorization of medicines (further - the Provision) are developed based on the Law No. 1409-XIII of December 17, 1997 on drugs (The official monitor of the Republic of Moldova, 1998, No. 52-53, of the Art. 368), with further changes and amendments, the Law No. 1456-XII of May 25, 1993 on pharmaceutical activities (pereopublikovano: The official monitor of the Republic of Moldova, 2005, No. 59-61, of the Art. 200), with further changes and amendments, for the purpose of ensuring efficiency, quality and safety of the medicines permitted to delivery in the pharmaceutical market and also for the purpose of ensuring economic and social protection of consumers and pharmakobezopasnost of the country.

Chapter I

Section 1. General provisions

1. The purpose of this Provision is the regulation of powers, requirements and responsibility in case of authorization of medicines.

2. Medicines for the person can be placed in the market of the Republic of Moldova only after issue by the Agency on drugs and medical products of the registration certificate of medicine (RCM).

3. This Provision is mandatory applicants of authorization of medicines in the Republic of Moldova.

4. This Provision extends to the medicines for the person intended for placement in the market of the Republic of Moldova, industrial production or made by other method when using industrial process.

5. This Provision is not applied to:

1) to the drugs made in pharmaceutical conditions of "ex tempore" and also in the form of intra pharmaceutical procurement;

2) to the drugs intended for researches and for clinical testing;

3) to the radionuclides used in the form of the closed sources;

4) to whole blood, plasma or blood cells of the person, except for the plasma produced by industrial method;

5) to the radio pharmaceutical medicines prepared at the time of use by person or organization of the national legal system authorized according to requirements to use these drugs according to instructions of the manufacturer, in the accredited medical center, using only the approved generators of radionuclides, sets or predecessors of radionuclides;

6) the active agents and ingredients used as raw materials, except for made in the Republic of Moldova.

6. The registration certificate of medicine is granted for the drugs meeting quality requirements, efficiency and safety, the provided regulations of the Ministry of Health.

7. The registration certificate of medicine cannot be granted more than to one owner.

8. Authorization of medicines with identical names, but with different composition of active agents is forbidden.

Section 2. Determinations

9. In this provision the following terms and determinations are used:

primary package - container or any other type of packaging which directly contacts to medicine;

secondary package - packaging in which the primary package is enclosed;

authorization of medicines - process of examination, approval and registration of medicines;

bioavailability - the speed and degree with which active ingredient or its active component is soaked up from dosage form and becomes available in the scene of action;

bioequivalence - two medicines of bioekvivalentna if they are pharmaceutical equivalent, or pharmaceutical alternative and if their bioavailability after introduction in the same molar dose are similar in such degree that effects of these medicines concerning efficiency and safety will be in fact identical;

the validirovanny statement – the statement for which complete picking of the file, i.e. availability of all documents and necessary data for examination implementation was confirmed;

the registration certificate of medicine - the official document which confirms medicine authorization by the Agency on drugs and medical products after its approval;

the certificate of GMP – the certificate confirming compliance of the producer to requirements of the Proper production practice, issued as a result of inspection by authorized body, according to recommendations of the World Health Organization, with PIC/S management about Requirements of proper practice of production of medicines or with the Management of the European Union about Rules of proper practice of production of medicines (issued on the basis of interpretation of the Directive 2003/94/CE of October 8 2003, of the proper practice of production of medicines establishing the principles and reference points of rules for the person and experimental drugs for the person);

The commission of drugs of the Agency on drugs and medical products - consultative body, not being the legal entity, created by the Order of the Ministry of Health, responsible for process of examination, approval and registration of medicines;

concentration of medicine - the content of active agents expressed in quantity on the dosed unit per unit of amount or weight, depending on dosage form;

the name of medicine - the name given medicine which can be fictional, which is not leading to confusion with the international non-proprietary name or with the commonly accepted, or scientific name along with trademark or the name of the owner;

the international non-proprietary name (INPN) – the international unlicensed name recommended by the World Health Organization or in case this name does not exist, the common name;

the owner of the registration certificate of medicine (further - the owner) - the inventor, the producer or any other legal entity authorized by them responsible for efficiency, quality and safety of medicine;

the analitiko-regulating documentation (ARD) - includes the pharmacopeias recognized by the Ministry of Health, Pharmakopeynuyu Article of the company (FS) or the Specification of Regulation of Quality (SRQ);

efficiency of medicine - the amount of positive effects which characterizes degree of useful effect of medicine on sick organism and on life expectancy;

labeling/marking – information provided on primary or on secondary package;

EudraGMDP – the public database managed by the European agency on drugs for the European Union which includes the certificates of proper production practice and proper distributor practice issued by the State Parties;

examination – the process of complex research of medicine and the enclosed documentation for the purpose of the consideration of completeness, authenticity and accuracy of the data and documents included in the file for registration, and also determination of quality of the medicine registered in the Republic of Moldova which is carried out by group of specialists (druggists, pharmacologists, clinical physicians) as a result of which the decision on compliance or discrepancy of medicine of documentation and authenticity of the data included in it is made;

production of medicines - the pharmaceutical activities connected with serial release of medicines which include everything or at least one of stages of engineering procedure, including processes of packing, packaging and marking, quality control in production process and quality control of end product;

registration - development and the publication of the Order of the Ministry of Health, creation and issue of the registration certificate of medicine and its inclusion in the State register of drugs therefore placement of product on the market and its use in medical practice is allowed;

materials for authorization (the file for authorization) – information, documents, samples of end product and reference substances provided to the Agency on drugs and medical products for the purpose of issue of the registration certificate of medicine in the Republic of Moldova;

medicinal raw materials (substance) - any substance, irrespective of its origin which can be:

a) human (for example, blood and medicines of blood);

b) animal (for example, microorganisms, intact animals, parts of bodies, secretion products, toxins, extracts, blood products, etc.);

c) vegetable (for example, microorganisms, plants, parts of plants, products allocated by plants, extracts, etc.);

d) chemical (for example, the chemical elements, natural chemicals and chemical goods received by chemical transformations or as a result of synthesis) and which are used for production/preparation of medicines;

medicine – any substance or combination of the substances having the properties necessary for treatment or prevention of diseases of the person, either any substance or combination of substances which the person can appoint for establishment of the medical diagnosis or to use for recovery, adjustments or changes of physiological functions at the person;

the registered medicine - the medicine included in the State register of drugs with the operating registration term;

biological medicine - medicine which active agent is made from live organism or is to its derivatives;

bioanalogical medicine (biosimilyar) - the reproduced biological medicine similar to the authorized biological medicine ("reference biological medicine");

biotechnological medicine - the medicine received by means of methods of genetic engineering, technology of hybridization, fabric or cellular engineering, engineering enzimologiya, engineering immunology and other modern technologies;

medicine with well studied medical application - medicine which contains one or more active agents, with well studied medical application, with the acknowledged efficiency and acceptable safety proved by scientific literature, the registered and present at the pharmaceutical market of the European Union (EU) or domestic at least 10 years;

phytogenesis medicine - any medicine with content of active agents, one or more of which are phytogenesis;

reference medicine – the medicine registered according to this Provision which is comparison medicine for generic medicine. Medicine with well studied medical application, medicine with the fixed combination of two or more active agents or the medicine registered based on the statement based on the informed consent provided that these medicines were registered based on own documentation, complete documentation - original medicine can be reference medicine;

the medicines received from blood or plasma of blood of the person - the medicines on the basis of blood components made in the industrial way at the state and private enterprises; such medicines include, in particular, albumine, factors of fibrillation and immunoglobulins of human origin.

medicine from herbs for traditional use - any medicine from plants to which the simplified procedure of authorization can be applied, in case of obligatory observance of the following conditions:

a) medicine which according to the structure is intended for the medical purposes without appointment of the doctor is released without recipe and does not require observation of treatment process;

b) medicine is applied in certain concentration and dose;

c) medicine is intended for internal, local or inhalation application;

d) it is proved documentary that medicine is used in world medical practice - at least 30 years, including at least 15 years in the territory of the European Union, and in the Republic of Moldova - at least 10 years;

e) availability of enough data of rather traditional use of medicine (the proved safety of use in usual conditions and efficiency);

generic medicine - the medicine satisfying criteria of the same quantitative and high-quality composition of active ingredients, the same dosage form, as reference medicine which bioequivalence was proved to rather reference medicine in the corresponding researches of bioavailability;

homeopathic medicine – any medicine received from the products, substances or compositions called homeopathic raw materials according to the procedure of homeopathic production described in the European Pharmacopoeia or in case of its absence in the pharmacopeia used at the moment in official type, member states of the European Union, and also other pharmacopeias recognized in the Republic of Moldova. One homeopathic medicine may contain several active agents;

immunological medicine - any medicine which contains vaccines, toxins, serums or allergenic products, such as:

a) vaccines, toxins or serums, in particular:

- the agents used for creation of active immunity such as anticholera vaccine, BTsZh, poliomiyelitny vaccine, smallpox vaccine;

- the agents used for diagnostics of the immunological status, including first of all tuberkulin and tuberkulin PPD, toxins used for reaction of the slowed-down hypersensitivity of Chic Is also wild, diphtherias and scarlet fevers, brutsellin;

- the agents used for creation of passive immunity such as diphtheritic anti-toxin, antiospenny globulin, anti-lymphocytic globulin;

b) allergenic medicines - the products intended for detection or induction of the specific and acquired change of the immune answer to some allergen;

innovative (original) medicine - the medicine for the first time registered based on own preclinical and clinical trials;

orphan medicine (orphan medicine) - the medicine used for diagnostics, prevention and treatment of rare disease: not more often than 5 cases on 10000 populations, at the time of filing of application for authorization and to which the separate procedure of authorization is applied;

The state register of drugs - the register of the drugs permitted as appropriate to production, import and application in medical practice which is kept by the Agency on drugs and medical products;

approval - the procedure of official recognition including creation of the report of experts and official confirmation of results of examination of medicine, method of commission expert evaluation of results owing to what its registration is allowed or deviates;

PIC/S (Pharmaceutical Inspection Co-operation Scheme) – the scheme of interaction in the field of pharmaceutical inspections established between competent national authorities for the purpose of assistance to cooperation and exchange of information concerning rules of proper practice of production of medicines;

the procedure of validation of the statement – the procedure of consideration of the given materials for the purpose of confirmation of availability of the documents and data necessary for accomplishment of examination of the file of the medicine offered for registration;

producer of medicines - the legal entity performing at least one of medicine production phases including packaging;

phytotherapeutic medicine - the vegetable medicine or medicine containing the plant extracts used for the purpose of prevention or treatment;

product of "in bulk" - any medicine which passed all stages of engineering procedure, except for stages of packing and/or final packaging and marking;

radio pharmaceutical medicine - any medicine which contains one or several radionuclides (radioactive isotopes) entered into it with the medical purpose in condition, ready for application;

leaf insert: information for the patient - the document accompanying medicine, containing information for the consumer;

periodically updated reports of safety (POB) - the updated reports submitted after authorization of medicine containing information on safety of the registered medicine in the Republic of Moldova or in any other country. POB are represented with the frequency established by the Agency on drugs and medical products;

ratio risk advantage - assessment of positive therapeutic effects of medicine in comparison with possible risks for health of the patient or for public health, connected with its quality, safety and efficiency

collateral reaction - any reaction, inadvertent and harmful to human body, in case of use of medicine in regular doses for the purpose of prevention, treatment and diagnostics or for the purpose of rehabilitation or correction of some physiological functions of organism;

serious collateral reaction - collateral reaction, can lead to death; to the condition posing threat for life; to the condition requiring urgent hospitalization or its prolongation; disability or considerable and resistant disability; to development of congenital anomalies / malformation;

unforeseen collateral reaction - collateral reaction, nature, weight or outcome of which do not correspond to data in the short characteristic of medicine;

the short characteristic of medicine - the document in the form of analytical synthesis containing results of preclinical, pharmaceutical and clinical trials, the complete information characterizing medicine, being obligatory component of the file for authorization; the risks connected using medicine:

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

b) any risk of undesirable effects on the environment;

safety of medicine - the characteristic of medicine based on comparison of ratio of the expected advantage and potential harm (risk) for the patient in case of acceptance of this medicine;

the applicant - the person designated and authorized by the owner as his representative during procedure of authorization of medicines in the Republic of Moldova;

clinical trial - any research conducted on the person, for the purpose of opening or confirmation of clinical, pharmacological effects and/or other phracodynamic of effects of one or several medicines for clinical trial and/or for the purpose of identification of any collateral reactions of one or several medicines for clinical trial and/or for studying of absorption, distribution, metabolism and removal of one or several medicines for clinical studying, for the purpose of assessment of their safety and/or efficiency, carried out in one or in several centers, in one or in several countries;

safety research after authorization - pharmako-epidemiological research or clinical testing which are conducted in accordance with the terms of issue of the registration certificate of medicine for the purpose of identification or quantitative risk assessment concerning safety of the registered medicine;

medicinal (active) substance - biologically active agent, natural origin synthesized or received by means of biotechnologies, used for production or production of medicines;

vegetable raw materials - plants, parts of plants, seaweed, mushrooms, lichens, fresh or dried up, integral or crushed, in the raw form, and also the certain exudates which are not processed in unusual way, are considered as vegetable raw materials; vegetable raw materials are determined by part of the used plants and by botanical names in binomial system (sort, type, version and the author);

preclinical researches - chemical, physical, biological, microbiological, pharmacological, toxicological and other pilot scientific research or series of researches on studying of the tested substance, or physical action, methods and technologies of prevention, diagnostics and treatment of diseases for the purpose of identification of specific action and/or safety for health of the person.

Chapter II the Statement and documentation for authorization

Section 1. Submission of requests for authorization

10. For implementation of the procedure of authorization of medicine the applicant fills and represents to the Agency on drugs and medical products the form of the statement which is component of this provision (appendix No. 1).

11. To the application for authorization it is enclosed:

1) the file for authorization, according to the specified requirements, in appendix No. 2 to this Provision, on paper (only the Module 1) and on the electronic medium (in one copy);

2) medicine samples, in enough for carrying out the complete laboratory analysis, according to the quality parameters provided in the specification of end product according to the methods provided in the analitiko-regulating documentation (ARD);

3) standard substances, impurity and products of disintegration, according to AND.

12. Depending on contents of the submitted documentation for the authorization enclosed to the application there are following types of requests:

1) the statement for authorization based on own complete documentation with availability of administrative data and information concerning quality, safety and efficiency of the medicine provided to authorization (the "independent" statement = the "independent" statement);

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