Regulations on the Administration of Veterinary Drug Production Enterprises

兽药生产企业管理规定

ຂໍ້ຕົກລົງວ່າດ້ວຍ ການຄຸ້ມຄອງໂຮງງານຜະລິດຢາສັດຕະວະແພດ

Summary

This regulation governs the establishment, operation, and supervision of veterinary drug production enterprises, with core content specifying enterprise qualifications, personnel conditions, approval procedures, and production standards.

Articles

Article ມາດຕາ 1

Article 2 Management of Veterinary Drug Manufacturing Plants
Management of veterinary drug manufacturing plants is the process of controlling the organization, establishment, operation, inspection, and monitoring of veterinary drug production with efficiency and effectiveness by operators, both public and private. Such management includes the construction of buildings, assembly of equipment, and complete personnel in veterinary or medical fields to carry out processing, filling, packaging, storage, and distribution of veterinary drugs.

Article ມາດຕາ 2

Article 2
Interpretation of Terms
The terms used in this agreement have the following meanings:

Veterinary drugs: means drugs for prevention, treatment and health care of animals and aquatic animals, including vaccines, antibiotics, antiparasitics, vitamins, as well as feed processed into drugs, chemicals or biological substances that are semi-finished veterinary drugs, and also pharmaceutical raw materials used for veterinary purposes;

Raw materials: means active ingredients or inactive ingredients, whether stable or not, all of which are used in the production of veterinary drugs;

Production: means the processes and operational steps related to the production of veterinary drugs, including formulation, processing, filling, packaging, labeling, instructions for use, cleaning, storage and quality inspection;

Batch: means a code identifying the product that has undergone a complete production cycle, where the key factors of that batch have the same characteristics;

Good manufacturing practice: means a part of the quality control system that the producer must adopt and strictly implement;

Batch code: means numbers or letters representing and certifying that batch for tracking and inspection.

Article ມາດຕາ 3

Article 6
Application for Establishment of Veterinary Drug Manufacturing Plant
Individuals, legal entities, and organizations intending to establish a veterinary drug manufacturing plant must prepare documents and submit an application to the Ministry of Agriculture and Forestry for consideration in accordance with the regulations.

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