Tuesday, December 6 2016

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Conditions for starting a Drugs Business in VN

Update: September, 14/2016 - 10:23

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.

Conditions for Drug Businesses

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.

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

Conditions for Materia Medica business

Materia Medica business exporters, importers, wholesalers, retailers or preservation service providers must obtain a certificate of eligibility for drug business, including that for a Materia Medica business. The owner or manager of the Materia Medica business must obtain a pharmacy practice certificate. Besides that the enterprises must have qualified personnel and required facilities and equipment corresponding with the type of business.

Good Practice Requirements

The drug business entities must additionally obtain WHO good practice requirements, particularly for:

(1) Drug Manufacturers: Good Manufacturing Practice (GMP)

(2) Drug Wholesalers: Good Distribution Practice (GDP)

(3) Drug Retailers: Good Pharmacy Practice (GPP)

(4) Drug Preservation Service Providers and Drug Importers: Good Storage Practice (GSP)

(5) Drug Testing Service Providers: Good Laboratory Practice (GLP)

(6) Clinical Trial Service Providers: Good Clinical Practice (GCP)

(7) Materia Medica Preservation Service Providers and Importers: GSP requirements applied to materia medica

(8) Materia medica Wholesalers: GDP requirements applied to materia medica

The Decree will become effective July 1, 2016 and will replace Articles 20 to 26 and 27 of the Government Decree 79/2006/ND-CP (August 09, 2016).

MAI COUNSEL

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