ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of May 21, 2012 No. 311

About approval of the Regulations establishing conditions of regulation of preparation, introduction on the market and uses of medicinal forages

Based on 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 the Law No. 119/2018 on medicines of veterinary assignment (The official monitor of the Republic of Moldova, 2018, Art. No. 309-320, 468), and also for the purpose of regulation of production, introductions on the market and uses of medicinal forages DECIDES: the Government

1. Approve the Regulations establishing preparation regulation conditions introduction in the market and uses of medicinal forages 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 May 21, 2012, No. 311

The regulations establishing conditions of regulation of preparation, introduction on the market and uses of medicinal forages

These Regulations shift provisions of the Directive No. 90/167/SEE of Council of the European communities of March 26, 1990 establishing conditions of regulation of preparation, introduction on the market and uses of medicinal forages in community (The official magazine of the European communities No. L 92 of April 7, 1990, p. 42-48).

Chapter I General provisions

1. This regulation regulates conditions of preparation, introduction on the market and uses of medicinal forages.

2. Used in these Regulations the following value knows: intermediate product - the product connected with the production technology of other products of the same group, but which is not relating to the corresponding group.

Chapter II the Obligation on quality check of products

3. The national agency on safety of foodstuff (further - the Agency) resolves introduction on the market of premixes for medicinal forages after their registration in the State register of medicines of veterinary assignment according to provisions of the Law No. 119/2018 on medicines of veterinary assignment. Medicinal forages shall be made only with the registered premixes for medicinal forages.

4. Agency:

1) exercises supervision that production of intermediates was performed only by the farms licensed according to provisions of articles 13 and 18 of the Law No. 221-XVI of October 19, 2007 on veterinary and sanitary activities;

2) watches that medicinal forages were made in case of observance of the following conditions:

a) the producer shall have the rooms which are previously permitted by the Agency, technical equipment, and also rooms for proper storage of products and simplification of conducting checks;

b) the company for production of medicinal forages shall be staffed by personnel with appropriate level of knowledge and qualifications in the field of technology of mixing;

c) the used rooms, personnel and the equipment participating in complete production process shall follow rules and the principles of production hygiene (production process shall correspond to rules of standard work practice);

d) the produced medicinal forages undergo regular testing, including the corresponding laboratory tests for uniformity - from hozyaystvproizvoditel, for the purpose of ensuring compliance of medicinal forages to requirements of these Regulations, especially in that, as for their uniformity, stability, stability and storage periods;

e) producers shall keep daily records of types and amounts of the used premixes and kormoprodukt and also made which are at them or the sent medicinal forages, together with names and addresses of cattle breeders or owners of animals and in case of need with the name and the address of the authorized distributor, surname and the address of the veterinarian who wrote out the recipe.

Records shall be carried out according to this Item, be stored at least within three years from the date of the last record and be represented to the order at any time to the Agency in case of check;

f) premixes for medicinal forages and medicinal forages shall be stored in the certain safe room or in the sealed containers which are specially intended for storage of such products.

5. The producer is responsible for providing:

a) uses only kormoprodukt or their combinations which observe requirements to sterns according to provisions of the Order of the Government No. 1405 of December 10, 2008. "About approval of Veterinary sanitary standard on hygiene of forages and content of undesirable substances in sterns" (The official monitor of the Republic of Moldova, 2008, No. 230-232, of the Art. 1441);

b) from the used kormoprodukt and premix for medicinal forages uniform and steady mix turns out;

c) premix is used during production process according to the established conditions, in case of registration, in particular:

between veterinary medicines, additives and kormoprodukta there is no undesirable interaction;

the medicinal forage is stored during expiration date;

the fodder sterns used for preparation of medicinal forages shall not contain the same antibiotic or the same koktsidiostatik that is used as active agent in premix for medicinal forages;

d) the day dose of medicine contains in the amount of kormoprodukt corresponding to, at least, a half of day fodder diet of the animals who are on treatment or in case of ruminant animals corresponds to at least a half of day need for not mineral additional kormoprodukta.

6. Production of medicinal forages on farms is carried out on condition of accomplishment of provisions of items 4 and 5 these Regulations.

Chapter III Introduction on the market

7. The agency determines that medicinal forages can be placed in the market only in packaging or the container which is sealed up so that when opening packaging the seal was damaged and its use was impossible.

When using automobile tanks or similar containers for placement of medicinal forages in the market they shall be exposed to cleaning before reuse for the purpose of the prevention of further undesirable interaction or infection.

8. The producer takes all necessary measures:

a) for issuance of medicinal forages, only on condition of the corresponding etiketirovka.

The label shall contain the following necessary information without fail:

name of product;

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