Conditions for starting a Drugs Business in Vietnam

Decree No 102/2016/ND-CP issued by Vietnamese Government on July 01, 2016 governs a drug business's conditions. The Decree provides conditions for all business types related to drugs. Below are highlights of the conditions one must follow in the drug business.

A certificate of drug business eligibility will be granted to the drug business entity satisfying all conditions for its type of drug business required under law. The drug business entities must operate in the registered location and within the registered business scope. The owner or manager in charge must have a pharmacy practice certificate required for related drug businesses.

• Drug Manufacturer: The drug manufacturer must satisfy the conditions of personnel and facilities, such as factory, auxiliary systems, equipment, quality inspection area and storage that are sufficient and appropriate for its production scale, and the availability of a system for quality control and document management.
• Drug Wholesaler: The drug wholesaler must satisfy conditions of personnel and facilities: (1) Its warehouse and auxiliary systems appropriate for use and storage; (2) Its storage and transport equipment also appropriate for use and storage, and there must be a backup generation system serving the cold storage; (3) Drug transporting vehicles satisfying requirements of storage, security and safety; (4) Availability of the system for quality control and document management.
• Drug Retailer. The drug retailer, except materia medica retailer, must satisfy these conditions: (1) The business place is fixed and safe, and drugs are protected from direct sunlight; (2) Area for the business scale, area for drug display and storage, area for buyers to exchange drug use information and separate areas for other activities must be sufficient; (3) Drugs are stored on shelves satisfying requirements of storage conditions, security and safety.
• Drug Exporter-Importer. The drug importer-exporter must satisfy the conditions of personnel and facilities comprising of (1) The warehouse and auxiliary systems appropriate for use and its business scale; (2) Storage and transport equipment appropriate for use and storage; (3) Availability of system for quality control and document management. Additionally, the enterprise must obtain a certificate of drug wholesale eligibility.
• Drug Preservation Service Provider. The above conditions specified for the drug importer- exporter are applicable to the drug preservation service provider as well. The drug preservation service provider must ensure responsibilities for quality, quantity and value of drugs.
• Drug Testing Service Provider. The drug testing service provider must satisfy the conditions of personnel and facilities comprising of requirements for design and size of the testing laboratory, its equipment appropriate for the testing methods and testing purposes, sampling, analysis, calibration, and data processing; sufficiency of qualified chemicals and technical documents for testing purposes. The drug testing service provider must also have a system for quality control and document management, instructions and procedures for its activities.
• Clinical Trial Service Provider. The clinical trial service provider must satisfy the conditions of personnel and facilities comprising of (1) Its location, testing laboratory, testing equipment and area appropriate for clinical trial services; (2) Availability of system for quality control and document management meeting requirements applicable to clinical trial activities.

Source: Vietnam Investment Review (http://www.vir.com.vn/conditions-for-starting-a-drugs-business-in-vn.html)