ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of March 6, 2013 No. 169

About approval of the Provision on testing of drugs of veterinary appointment

Based on article 37 of the Law No. 221/2007 on veterinary and sanitary activities (repeated publication: The official monitor of the Republic of Moldova, 2013, Art. No. 125-129, 396) and article 14 of the Law No. 119/2018 on medicines of veterinary appointment (The official monitor of the Republic of Moldova, 2018, Art. No. 309-320, 468) DECIDES: the Government

1. Approve the Provision on testing of drugs of veterinary appointment it (is applied).

2. To impose control of execution of this Resolution on the National agency on safety of foodstuff.

Approved by the Order of the Government of the Republic of Moldova of March 6, 2013 No. 169

Provision on testing of drugs of veterinary appointment

Requirements of the Provision for testing of drugs of veterinary appointment shift appendix No. 1 to the Directive 2001/82/SE of the European Parliament and Council of November 6, 2001 about creation of the Code of community about veterinary medicines (The official magazine of the European community L311 of November 28, 2001, p. 1-66).

Part one. General provisions

1. The provision on testing of drugs of veterinary appointment (further - the Provision) establishes chemical, pharmaceutical and analytical standards, researches on the safety and availability of remaining balance, preclinical and clinical trials concerning testing of drugs of veterinary appointment, and also the requirement to the normative and technical document package of medicine of veterinary appointment (further - packet) provided for registration according to provisions of the Law No. 119/2018 on medicines of veterinary appointment.

2. The packet shall contain all necessary, favorable or adverse information, all relevant data of any incomplete or stopped test on testing of medicine of the veterinary appointment for its assessment specified in this Provision.

3. Process of production of drugs of veterinary appointment is performed according to the Rules of proper practice of production of drugs of veterinary appointment approved by Postanavleny Правителъства № 93 of February 15, 2012.

4. Pharmacological, toxicity tests, researches on availability of remaining balance and safety of drugs of veterinary appointment are carried out according to rules of proper laboratory practice (further - the NLP).

5. Any new information on pharmakobezopasnost, disconnect in packet, is transferred to the National agency on safety of foodstuff (further - the Agency) for the purpose of monitoring of assessment of the report on risk/advantage.

6. Assessment of the environmental risk connected with distribution of the drugs of veterinary appointment containing or consisting of the genetically modified organisms (GMO) is performed by restriction of their contact with people and the environment and ensuring high level of safety of people.

7. Researches on monitoring of remaining balance in the edible fabrics or eggs, milk and honey received from the processed animals shall be conducted for determination under what conditions and in what degree remaining balance can remain in the foodstuff received from animals and also for determination of the period of waiting.

Part two. Requirements to drugs of veterinary appointment, except immunological medicines of veterinary appointment

Section I of the Summary of packet

Chapter I Administrative information. Summary of medicine

8. The medicine of veterinary appointment representing registration subject is identified on:

a) to its name;

b) to the name of active agent and its concentration;

c) to pharmaceutical form;

d) to way and method of application;

e) to the description of the final commercial presentation of product;

f) to packaging;

g) to the label;

h) to the accompanying prospectus.

9. Are enclosed to the registration application of medicine of veterinary appointment:

a) name and applicant's address;

b) the name and the address of the producer and the centers participating in fabrication stages;

c) name and importer's address;

d) the document testimonial of the fact that the producer has the veterinarnosanitarny authorization on implementation of such activities established in the List of allowing documents from appendix to the Law No. 160 of July 22, 2011 on regulation of business activity by permission;

e) copies of the summary of drugs.

10. The applicant shall provide the summary of characteristics of medicine including the label on container for medicine and packaging together with the accompanying prospectus.

Chapter II Detailed summary and summary of critical aspects

11. The applicant shall provide the detailed summary of results:

a) pharmaceutical testing (physical and chemical, biological or microbiological);

b) tests for availability of remaining balance and safety;

c) preclinical and clinical trials;

d) tests according to potential risks for the environment.

12. The summary shall contain assessment of the testing and researches conducted for quality evaluation, safety and efficiency of drugs of veterinary appointment.

13. The detailed summary contains assessment of the different conducted testing and researches which represent packet of administrative technical documentation on medicine of veterinary appointment, and cover all relevant aspects for quality evaluation, safety and efficiency of medicine of veterinary appointment.

14. Qualified person constitutes the detailed summary and the summary of critical aspects which are signed by the expert.

15. The agency publicly gives the chemical, pharmaceutical and biological/macrobiological information concerning final medicine which is included in packet only in format of the general technical document (in further - OTD). The detailed summary and the summary of critical aspects concerning results of pharmaceutical testing are represented in short format concerning quality.

16. In case of the statement concerning type of animal the format of the global summary concerning quality without its preliminary approval of competent authority is used.

Section II Physical and chemical, biological or microbiological pharmaceutical information

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