LAW OF THE REPUBLIC OF MOLDOVA

of July 5, 2018 No. 119

About medicines of veterinary assignment

The parliament adopts this organic law.

This law partially shifts the Directive 2001/82/EC of the European parliament and Council of November 6, 2001 about creation of the Code of Community about veterinary medicines published in the Official magazine of the European community L 311 of November 28, 2001 and shifts the Directive 2006/130/EC of the Commission of December 11, 2006 about application of the Directive 2001/82/EC of the European parliament and Council concerning establishment of criteria for exception of the veterinary code of some veterinary medicines intended for animals from whom foodstuff is made (the document extends to the EEA) published in the Official magazine of the European Union by L 349 of December 12, 2006, Regulations (EU) No. 540/95 of the Commission of March 10, 1995 determining procedures of the notification about the unexpected collateral reactions which do not have the serious effects arising in Community or in the third country on medical supplies intended for people or animals, permitted to use according to Regulations (EEC) No. 2309/93 of Council, published in the Official magazine of the European community L 55 of March 11, 1995, and Regulations (EU) the No. 1662/95 of the Commission of July 7, 1995 establishing some rules of application of procedures of decision making in Community concerning permissions to placement in retail chain stores of medicines for the use in the veterinary purposes or for people, published in the Official magazine of the European Union by L 158 of July 8, 1995.

Chapter I General provisions

Article 1. Field of regulation and purpose of this law

This law establishes conditions and the procedure of registration, production, import, export, storage, distribution and issue of medicines of veterinary assignment for the purpose of introduction on the market of the Republic of Moldova.

Article 2. Basic concepts

In this law the following concepts are used:

medicine of veterinary assignment:

a) any substance or combination of substances intended for treatment or prevention of diseases of animals; or

b) any substance or combination of substances which can be used or applied to animals for the purpose of recovery, adjustment or change of physiological functions by pharmacological, immunological or metabolic impact or for the purpose of establishment of the medical diagnosis;

substance - any matter, irrespective of its origin which can be:

a) human origin, for example: human blood or medicines of human blood;

b) animal origin, for example: microorganisms, intact animals, parts of offal, secretion products, toxins, extracts, medicines of blood of animals;

c) plant origin, for example: microorganisms, plants, parts of plants, products allocated by plants, extracts;

d) chemical origin, for example: the natural chemical elements or substances and their combinations received by chemical transformations or as a result of synthesis;

active agent - biologically active agent of natural, synthetic or biotechnology origin used for production or preparation of medicines of veterinary assignment;

premix for medicinal forages - any medicine of veterinary assignment prepared for the subsequent production of medicinal forages;

medicinal forages - any mix from one or several medicines of veterinary assignment and one or several forages prepared for introduction on the market and intended for forage of animals without further processing because of its medicinal, preventive or other properties characteristic of medicine of veterinary assignment;

immunological medicine of veterinary assignment - any medicine of veterinary assignment entered by animal for increase in active or passive immunity or for diagnostics of the immunological status of one animal or livestock of animals;

homeopathic medicine of veterinary assignment - any medicine of veterinary assignment prepared from the medicines, substances or compositions called homeopathic inventories according to the procedure of homeopathic production described in the European Pharmacopoeia;

reference medicine of veterinary assignment - the medicine registered according to provisions of Articles 4, 5 and 8-11;

generic medicine of veterinary assignment - medicine of the same pharmaceutical form, with the same high-quality and quantitative composition of active agents, as reference medicine of veterinary assignment which bioequivalence to reference medicines of veterinary assignment is proved by the corresponding researches of bioavailability;

the expectation period - time interval between the last introduction animal medicine of veterinary assignment in usual conditions of use according to provisions of this law, until product receipt of power supply, occurring from these animals. This period is necessary for protection of public health and guaranteeing that these food do not contain remaining balance in the quantity exceeding the maximum limit of remaining balance;

the maximum limit of remaining balance - the maximum content of the remaining balance formed as a result of use of medicine of veterinary assignment (expressed in mg/kg or mkg/kg of fresh product), permitted and legally acknowledged for foodstuff. This limit is based on type and quantity of remaining balance which are considered not constituting toxicological health hazard of the person. The maximum limit considers also other risks for public health, including technology aspects of food;

collateral reaction - the undesirable and inadvertent reaction of organism arising at one or several animals owing to introduction of medicine of veterinary assignment in the doses which are usually ordered to animals for the purpose of prevention, diagnostics or treatment of certain diseases or for the purpose of recovery, adjustment or change of physiological function;

collateral reaction of the person - undesirable and inadvertent reaction of the person to impact of medicine of veterinary assignment;

heavy collateral reaction - collateral reaction which can lead to deterioration in the state of health or even by death or can lead to permanent or long symptoms at the animals who underwent treatment or can cause anomaly or inborn defect;

unexpected collateral reaction - collateral reaction, nature, weight or outcome of which do not correspond to the data provided in the short characteristic of the corresponding medicine of veterinary assignment;

the applicant - the physical person or legal entity designated and authorized by the certificate holder about registration of medicine of veterinary assignment to represent it in the procedure of registration of medicines of veterinary assignment;

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

supervising research after introduction on the market - the pharmako-epidemiological or clinical trial conducted in accordance with the terms, specified in the registration certificate provided in the List of the allowing documents issued by bodies issuers to physical persons and legal entities for implementation of business activity, the approved Law on regulation of business activity by permission No. 160/2011, for the purpose of establishment and studying of possible risks for safety of the registered medicine of veterinary assignment;

application out of the indications specified on the label - use of medicine of veterinary assignment without observance of the short characteristic of medicine of veterinary assignment, including its wrong application or abuse of it;

wholesale trade by medicines of veterinary assignment - any business activity, including purchase, sale, import, export or any other trading activity with medicines of veterinary assignment, irrespective of whether profit earning or not, except for is its purpose:

a) supply of medicines of self-produced veterinary assignment by the producer;

b) retail trade by medicines of veterinary assignment by persons, representatives to perform similar trading activities according to Article 24 provisions;

ratio risk advantage - assessment of positive effects of medicine of veterinary assignment in comparison with the following risks connected with its application:

a) any risk connected with quality, safety and efficiency of medicines of veterinary assignment concerning health of animals or people;

b) any risk of adverse environmental impact;

c) any risk connected with development of stability to antimicrobic substances;

the commonly accepted name - the international unlicensed name recommended by the World Health Organization, or if this name does not exist, the common name;

primary package - any form of packaging which directly adjoins to medicine of veterinary assignment;

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

the label - any written, printed, lithographed, engraved or illustrations which are applied on primary or secondary package and on which information on medicine of veterinary assignment is specified;

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