The DECISION issued the "regulation on drug prevention and cure work for people," health MINISTER pursuant to article 38 of the law on protection of people's health;
At the suggestion of Mr. Director of the Pharmacy and the equipment, the decision: article 1: Now attached to this decision, "the regulation of processing drugs prevention and cure for the" prescribed specific conditions put work and get to work.
Article 2: this decision is effective from the date of signing.
Article 3: Mr. Chief, Director of Service: medicine-TTB, QLSK, environmental hygiene, General Director of the Vietnam Pharmaceutical companies Association, Director of the Health Department of the province, city and district level is responsible for the implementation of this decision.
 
REGULATION of PROCESSING DRUGS PREVENTION and CURE for the i. GENERAL PROVISIONS article 1: medication is the machining units are made of raw materials contracts with pharmaceutical companies to manufacture finished products or out each stage of the product.
Unit of raw material and finished product receipt called brought machining.
The unit manufactures finished product out called the receiving party.
Article 2: this regulation aims at contributing to ensure the quality, make use of the capacity of machinery and equipment, experience in the conditional basis of drug production.
Article 3: the party bringing the work must be: 1. The unit had sales of business functions, production of medicines of Central and provincial, city, district of Columbia.
2. Pharmaceutical companies, districts have pharmaceutical-chemical raw materials by exporting as medicinal herbs, essential oils through import-export agencies of the medical industry.
Article 4: the units not specified in article 3 such as: hospitals, nursing Institute, Institute or medical specialty stations when there are specialty materials needed tools to serve the Mission of the unit itself, to make the text of permission management.
The central unit please allow the Ministry of health (Pharmaceutical Services-TTB) The local unit please allow article 5 Department of health: party: The Central pharmaceutical enterprise, the combined pharmaceutical companies or the pharmaceutical factory, the city, the District of Columbia are eligible and only receive work items that his unit had registered.
Article 6: the units not specified in article 5 would like to get permission to work: get work items by the Ministry, the registration level; Please allow the Ministry of health (Pharmaceutical Services-TTB) get to work items by the comment, the registration level; Please allow the Department of health.
 
II. Content 1. The material included article 7: machining of raw materials brought outsourcing to intact original labeled packaging, furniture clear, standard quality assurance records on the label at the time of the original offer; The case takes the seal must have a valid quality assessment.
Article 8: do not respond or change of raw material and finished products in the State plan for the work. Do not use this unit's raw materials finished goods for other units that have not been approved by the party bringing the work 2. Machining procedure article 9: when giving the drug to ensure that the processing of documents and the following procedures: with the right processing letter dispatch allows the Ministry of health or the Department of health (for objects inscribed in article 4).
If the pharmaceutical companies of the district must be the local Committee (county or district) and the Department of health had confirmed the export (medicinal herbs or essential oils) with vouchers, invoices of drug import and export agencies in the health sector.
Election officials have pharmaceutical expertise, knows enough about certain drugs work items with a referral, record category, product yield, product quality standards to make the contract.
Article 10: each time, and the receiving party brought outsourcing to contract stipulates the technical economic conditions, detailed quality accompanied by limitation of liability on each side.
3. outsourcing products article 11: Both sides receive processing and fabrication brought to bear responsibility for the quality of finished products standard machining has registered.
Article 12: the products Label: on the basis of product label work (already registered) and must have a separate symbol. This badge must be reported to the governing body.
4. Governing the manufacture, testing, report of drug processing article 13: production management, quality management, inspection regimes, drugs work to be done in full as the primary products in the State party's plans and regulations of the State.
5. by article 14 processing: material here may be the initial raw materials semi-finished products, finished products not yet packaged. Machined from stages also apply as in the case of processing raw material receiving the finished product delivery spoke above.
Article 15: the case of raw materials as semi-finished products, finished products not yet packed, when giving machining must be sealed and the minutes confirmed the quality according to the production process.
Article 16: right of each machining stages only get the machining stages in those items of his unit has been registered and is responsible for product quality in the receiving phase.
 
III. The TERMS of article 17 ENFORCEMENT: 1. This regulation applies only to work the drug by pharmaceutical chemical raw materials.
2. Do not apply due to the sudden drug needs for epidemic, war, natural disasters.
3. The regulations contrary to this regulation are repealed.
Service-Pharmacy-responsible equipment Guide and check the implementation of this regulation within the country. The Department of health is responsible for the instructions check local regulations.
Article 18: the units violate these rules will be dealt with according to law.