To amend and supplement a number of regulations related to investment and business conditions in the medical field

Published on 14 - 12 - 2023
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On 11/12/2023, the Government has just issued Decree No. 88/2023/ND-CP dated December 11, 2023 amending and supplementing a number of articles of Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government detailing a number of articles and measures to implement the Pharmacy Law and Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government amending and supplementing a number of regulations related to business investment conditions under the state management of the Ministry of Health.

Accordingly, Decree No. 88/2023/ND-CP amends and supplements Article 132 of Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government detailing a number of articles and measures to implement the Pharmacy Law as follows:

The state management agency on drug prices has the following rights: Issue a document requesting pharmaceutical business establishments to declare prices, report on declared prices, and re-declare them in accordance with the declared price level of similar products on the market, in accordance with the fluctuations in price formation factors to serve price stabilization, state management of prices, inspection and testing according to the provisions of law. To carry out inspections of pharmaceutical businesses on drug prices according to the provisions of law. To refer to a competent authority to handle violations according to the provisions of law if a drug trading establishment is discovered to violate regulations on drug price management in the following cases: fail to declare or re-declare; incompletely declare drug prices according to regulations or not adjust prices but not report according to the written request of the state management agency on drug prices for the enterprise's declaration and re-declaration dossiers; untruthfully report price-forming factors or sell drugs higher than the declared or re-declared prices in effect. To consider applying measures in case a pharmaceutical business establishment has committed violations 02 times or more within 01 year: temporarily stop receiving dossiers requesting confirmation of drug information and advertising content; temporarily stop receiving applications for importing drugs that do not have a drug circulation registration certificate in Vietnam; temporarily stop receiving applications for issuance and extension of registration certificates for circulation of drugs and medicinal ingredients.

The period of temporary suspension of receiving dossiers specified in this Point is from 03 months to 12 months from the date of issuance of the written notice of violation by the competent authority.

The state management agency on drug prices has the following responsibilities: Strictly comply with regulations on receiving dossiers for declaration and re-declaration of drug prices specified in Article 131 of this Decree. To review dossiers of declaration and re-declaration of drug prices declared by pharmaceutical business establishments according to the Forms specified in Clause 1, Clause 2, Clause 4, Article 130 of this Decree. To keep in secret the declared and re-declared prices of organizations and individuals during the time the declared and re-declared prices are not yet effective according to the provisions of law.

The Decree No. 88/2023/ND-CP amends and supplements Article 133 of Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government detailing a number of articles and measures to implement the Law Medicines as follows:

Pharmaceutical business establishments have the following rights: Have the rights to buy and sell drugs at the declared and re-declared prices from the date the manufacturing facility, processing facility, or drug importer submits complete declaration documents and re-declare drug prices according to regulations and received by competent state management agencies. In case an importing facility, manufacturing facility or drug processing facility adjusts to reduce the declared price compared to the adjacent declaration, the facility has the rights to immediately buy and sell at the adjusted price and at the same time the declaration of price reductions is in accordance with reduced fluctuations in price-forming factors.

Pharmaceutical business establishments have the following responsibilities: Fully implement the regulations on declaring and re-declaring drug prices and notifying prices according to the provisions of law and the provisions of this Decree; take full responsibility before the law for the accuracy and truthfulness of drug price declaration and re-declaration documents; comply with reports on declared and re-declared prices at the request of state management of drug prices to serve the work of price stabilization, state management of prices, testing and inspection; comply with inspection and examination by competent state agencies (if any). Do not wholesale or retail drugs at a price higher than the declared or re-declared price made by the manufacturing facility, the processing facility, or the drug importer. In case the competent state management agency issues a document requesting a pharmaceutical business establishment to report on the price of the drug item declared or re-declared by the establishment, within 30 days from the date of receipt of document from the competent state management agency, the establishment must have a written response to the report on the declared price in accordance with the declared price level of similar items on the market or in accordance with fluctuations of factors forming prices or adjusting declared or re-declared prices in accordance with the opinion of the state management agency on drug prices. After the above deadline, if the pharmaceutical business establishment does not have a written response, the submitted declaration and re-declaration documents are no longer valid. To comply with the forms of handling drug price declaration according to the provisions of law on the sanctions for administrative violations in the field of prices, fees, charges and invoices.

The Decree takes effect from December 11, 2023.

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