Joint Circular No. 08/2003/TTLT-BYT-BTC guides the declaration and public display of prices for disease prevention and treatment drugs for people.

CONSOLIDATED DOCUMENT JOINT CIRCULAR

Guidelines for price declaration and public display of prices for medicines to prevent and treat diseases in humans

publish prices for disease prevention and treatment drugs for humans

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Based on the Price Ordinance dated April 26, 2002;

Implementing the guidance of the Prime Minister on managing the prices of medicines to prevent and treat diseases in humans as stated in the Government Office's Notification No. 41/TB-VPCP dated 28/3/2003 of the Government Office;

To protect the rights and legitimate interests of consumers, the Ministry of Health and the Ministry of Finance jointly issue these guidelines for the declaration and public display of prices for medicines to prevent and treat diseases in humans as follows:

I GENERAL PROVISIONS

1. SCOPE OF REGULATION AND APPLICABLE SUBJECTS.

a) This joint circular guides the declaration and public display of prices and state management over the declaration and public display of prices for medicines to prevent and treat diseases in humans (hereinafter referred to as "medicines").

b) This joint circular applies to organizations and individuals within Vietnam and from foreign countries (hereinafter referred to as "entities") engaged in the production, importation, and trade (wholesale and retail) of medicines in Vietnam.

2. Explanation of terms

In this Circular, the following terms shall be understood as follows:

a) Medicines to prevent and treat diseases in humans are finished products that have been registered for circulation by the Ministry of Health or permitted for importation.

b) Price declaration for medicines involves declaring several types of prices (retail price of foreign medicines, import price of medicines into Vietnam, wholesale price, and retail price of those medicines in Vietnam) which entities registering medicines or importing medicines must perform according to point 1, Section II of this joint circular.

c) Public display of medicine prices involves:

Announcing the retail price of medicines publicly by printing or affixing or writing the retail price of medicines onto

the packaging containing the medicines or outer packaging of the medicines or announcing it publicly on a board or paper at the place where medicines are sold.

Announcing the wholesale price of medicines publicly on a board or paper at the place where wholesale medicines are conducted.

d) Packaging containing medicines is direct packaging containing medicines, forming a shape or form for the medicines or completely enclosing them according to their shape.

e) Outer packaging of medicines is packaging containing one or more packages containing medicines.

II SPECIFIC PROVISIONS

1 Declaration of medicine prices.

a) Domestic medicine manufacturing entities when submitting registration application documents for circulating medicines must declare the wholesale price and retail price of those medicines in Vietnam.

b) Medicine trading entities (Vietnamese or foreign) when submitting registration application documents for circulating foreign medicines in Vietnam must declare the retail price of those medicines in their home country, and the import price of those medicines into Vietnam (the declared price is converted into Vietnamese Dong based on the cross-exchange rate published by the State Bank of Vietnam at the time of submission).

c) Import entities of medicines without registration numbers in Vietnam when submitting import application documents must declare the retail price of those medicines in their home country, the import price of those medicines into Vietnam, and the retail price of those medicines in Vietnam (the declared price is converted into Vietnamese Dong based on the cross-exchange rate published by the State Bank of Vietnam at the time of submission).

2 Public display of medicine prices.

a) Public display of wholesale prices:

The public display of wholesale prices must meet the following requirements:

Convenience for entities while also meeting the inspection and supervision requirements of customers and competent state management agencies.

Wholesale medicine prices must be recorded on a board or printed on paper and placed at the place where medicines are sold.

b) Public display of retail prices:

The public display of retail prices must meet the following requirements:

All medicines must be publicly displayed with their retail prices;

The displayed price must fully reflect the price level and pricing unit (Example: Price: 100,000 VND/1 box Price: 2,000 VND/1 bottle; Price: 2,500 VND/1 tablet or Price: 15,700 VND/1 strip);

Information on the packaging containing the medicines or outer packaging of the medicines must not be obscured;

Retail medicine prices must be publicly displayed on the packaging containing the medicines or outer packaging of the medicines or recorded on a board or printed on paper and placed at the place where medicines are sold.

3 Rights and responsibilities of manufacturing entities, import entities, and wholesale medicine selling entities.

a) Manufacturing entities and import entities of medicines must publicly display the wholesale price at the place of wholesale sales and may not sell above the displayed price, and must also publicly display the retail price of medicines by printing or affixing or writing the retail price of medicines onto the packaging containing the medicines or outer packaging of the medicines before wholesaling the medicines to other wholesale entities, treatment facilities, or retail entities. In case of adjustment of the retail price already publicly displayed on the packaging, the manufacturing entity or import entity has the right to adjust the price and must notify in writing to customers (other wholesale entities, treatment facilities, or retail entities). Other wholesale entities within their scope of responsibility must notify in writing the adjusted price of medicines by the manufacturing or import entity to their customers. Adjusted price notification documents must be retained and presented to competent state agencies responsible for medicine prices upon request.

b) Wholesale medicine selling entities must publicly display the wholesale price of all medicines they sell at the place of wholesale sales and may not sell above the displayed price.

c) When adjusting the retail price already publicly displayed on the packaging, the manufacturing entity or import entity has the right to adjust the price and must notify in writing to customers (other wholesale entities, treatment facilities, or retail entities). Other wholesale entities within their scope of responsibility must notify in writing the adjusted price of medicines by the manufacturing or import entity to their customers. Adjusted price notification documents must be retained and presented to competent state agencies responsible for medicine prices upon request.

d) When selling medicines, invoices must be issued to buyers in accordance with regulations, including full details about the medicines such as: name of the medicine, dosage, specifications, unit of measurement, quantity, wholesale price, name of the manufacturing entity, name of the import entity, import permit number (for medicines without registration numbers); batch number and expiration date of the medicine. Purchase or sale invoices of medicines must be retained in accordance with current national regulations.

e) There must be a record of medicine receipts and dispatches noting the following details: name of the medicine, dosage, specifications, unit of measurement, quantity, wholesale price, name of the manufacturing entity, name of the import entity, import permit number (for medicines without registration numbers), batch number, and expiration date of the medicine, and these records must be retained together with purchase and sale invoices in accordance with regulations.

4 Rights and responsibilities of retail medicine selling entities.

a) They can only buy and sell medicines whose retail prices have been publicly displayed by manufacturing or import entities in accordance with this joint circular and may not sell above the publicly displayed retail price.

b) For medicines whose retail prices are regulated by the State and medicines for which manufacturing or import entities set uniform retail prices nationwide, retail entities must sell at the publicly displayed price on the packaging.

c) For types of drugs (excluding point 4b mentioned above) that retail establishments sell at a lower price than the price listed by the production or import entity, they shall base their pricing on the purchase price recorded on the invoice (wholesale price), retailing costs, market conditions, and current regulations to independently set and list the retail price of their establishment by printing or affixing or writing the retail drug price on the packaging containing the drug or the outer packaging of the drug, or publicly announcing it on a board or paper at the place where the drug is sold. This price must not be higher than the retail price listed by the production or import entity on the packaging and must not be sold at a price higher than the retail price independently set and listed by the retail establishment.

d) Upon receiving notice of drug price adjustments from the production or import entities,

they must re-list the retail drug prices according to the notice, the retail price independently set by the establishment as stipulated in point c of this Section (if applicable), and the provisions regarding listing retail prices in this Circular.

At the location where drugs are handed over to customers, there must be placed in a visible location the phrase "We request customers to check the expiration date and the listed retail price of the drug."

They must retain drug purchase invoices in accordance with state regulations and keep price adjustment notices sent by wholesale drug units.

5. Responsibilities of treatment facilities.

a) Must list the selling price of drugs for patients according to the price level prescribed by the competent authority.

b) Form of listing: Written on a board or printed on individual pages placed or affixed at the location where patients pay hospital fees or drug charges.

c) Content of listing: Drug name, dosage, place of production, country of production, unit of measurement, and selling price.

III IMPLEMENTATION

1. The Ministry of Health will coordinate with the Ministry of Finance to organize the implementation, guide, and instruct production and import entities, and drug trading entities to comply with the provisions of this Circular to ensure reasonable stability in drug prices.

2. The Ministry of Health will coordinate with the Ministry of Finance to inspect, audit, and handle violations of the provisions of this Circular nationwide. Provincial People's Committees and municipal people's committees directly under the central government are responsible for guiding the implementation, inspection, auditing, and handling of violations of the provisions of this Circular within their respective jurisdictions. Departments of Health and Departments of Price Management are responsible for assisting provincial people's committees and municipal people's committees in performing these functions.

3. Ministries and sectors with production or trading entities for drugs shall periodically or randomly inspect, audit, and handle violations according to their functional and assigned tasks.

4. Production, import, and trading entities for drugs shall immediately implement necessary measures to comply with the provisions of this Circular. As of October 1, 2003, all types of drugs circulating in the market must be listed with prices in accordance with the provisions of this Circular.

5. For existing stocks of drugs at retail establishments, if they have not listed the retail price on the packaging containing the drug or the outer packaging of the drug by the time this Circular takes effect, these establishments must directly list the retail drug price in accordance with the provisions of this Circular before selling the drugs to consumers.

6. Associations, professional associations, and trade unions within their scope of responsibility shall publicize, disseminate, and supervise the implementation of drug pricing regulations by their members. They shall promptly reflect changes in drug prices, provide opinions, and propose measures to stabilize drug prices to relevant state management agencies responsible for drug pricing.

IV. IMPLEMENTATION PROVISIONS

1. This Circular shall take effect fifteen days after its publication in the Official Gazette.

2. Organizations and individuals producing, importing, and trading drugs in Vietnam, and state management agencies authorized to manage drug prices shall be responsible for implementing the provisions of this Circular.

3. Organizations and individuals who violate the provisions of this Circular or other laws related to pricing shall be subject to administrative penalties or criminal liability, depending on the nature and severity of the violation, and shall be required to compensate for losses in accordance with the law if damage is caused.

4. In the course of implementation, if difficulties arise, units and localities must promptly report to the Ministry of Health and the Ministry of Finance for research and resolution.