Legal Document Updates in English (26/2017)

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NUMBER

TITLE

 

In This Updates:

FINANCE – BANKING

 

FINANCE – BANKING

1

45/2017/TT-BTC


Circular No. 45/2017/TT-BTC dated May 12, 2017 of the Ministry of Finance on bracket of property auction fees in accordance with the law on property auction

 

* Maximum fee bracket does not exceed VND 300 millions

Page 2

2

42/2017/QH14

Resolution No. 42/2017/QH14 dated June 21, 2017 of the National Assembly on the pilot settlement of bad debts of credit institutions

 

* Pilot settlement of bad debts of credit institutions

Page 2

MEDICAL - HEALTH

 

MEDICAL – HEALTH

3

54/2017/ND-CP


Decree No. 54/2017/ND-CP dated May 08, 2017 of the Government on detailing a number of articles of and providing measures for implementing the Pharmacy Law

 

* Not allow to the price of a drug higher than the highest declared price

Page 2

4

07/2017/TT-BYT

Circular No. 07/2017/TT-BYT dated May 03, 2017 of the Ministry of Health on the Promulgation of List of OTC drugs

 

* Promulgation of List of OTC drugs

Page 3

5

06/2017/TT-BYT

Circular No. 06/2017/TT-BYT dated May 03, 2017 of the Ministry of Health on the List of toxic drugs and toxic medicinal ingredients

 

* List of toxic drugs and toxic medicinal ingredients

Page 3

 

SUMMARY:

 

Ü  FINANCE - BANKING         


MAXIMUM FEE BRACKET DOES NOT EXCEED VND 300 MILLIONS
 

On May 12, 2017, the Ministry of Finance issued the Circular No. 45/2017/TT-BTC on bracket of property auction fees in accordance with the Law on property auction.

In particular, fee bracket applicable to a property auction contract in case of successful auction is as minimum fee: VND 1,000,000 per contract; maximum fee equivalent to each bracket of property value by starting prices , but not exceeding VND 300,000,000 per contract. The auction fees prescribed in Clause 1 of this Article excludes VAT but includes reasonable and valid expenses charged by auction companies for the property which have been put up for auction as prescribed.

 

In case of unsuccessful auction, the seller must pay to the auction company for reasonable and valid expenses as specified in the auction contract, but not exceeding the amount of auction fee in case of successful auction.

Within 20 working days from the date on which the closing day of auction, regardless of successful or unsuccessful case, the seller must pay to the auction company for fee or expenses associated with public notices on bulletin board, and other reasonable expenses; unless otherwise agreed upon by the parties or prescribed by law.

This Circular takes effect on July 1, 2017 and replaces Circular No. 335/2016/TT-BTC dated December 27, 2016.


PILOT SETTLEMENT OF BAD DEBTS OF CREDIT INSTITUTIONS
 

On June 21, 2017, the National Assembly passed the Resolution No. 42/2017/QH14 on the pilot settlement of bad debts of credit institutions, a bad debt prescribed in the Resolution refers to a debt that has arisen and has been considered as a bad debt before August 15, 2017; a debt that has arisen before August 15, 2017 and has been considered as a bad debt during the effective period of the Resolution.

In accordance with the Resolution, credit institutions and the bad debt purchaser/manager sell bad debts or collateral transparently and in accordance with regulations of law; the selling price is consistent with market price, probably greater or smaller than principal balance of the debt.

The purchaser of a debt derived from bad debt of credit institution secured by collateral being land use right, property on land or off-the-plan property on land is entitled

 

to receive pledge or register pledge of land use right, property on land or off-the-plan property on land as the security of the purchased debt.

A credit institution or bad debt purchaser/manager is entitled to assign collateral being a real property project if the project has been approved by competent authorities as per the law; a decision on land allocation or land lease has been issued by competent authority; the project is not in dispute over land use right in a case that has been accepted but remained unsolved or has been resolving at an authorized court; and no decision on revocation of project or land expropriation has been issued by competent authorities.

This Resolution takes effect on August 15, 2017 and remains in force for 5 years from the effective date.

Ü   MEDICAL - HEALTH 


NOT ALLOW TO THE PRICE OF A DRUG HIGHER
THAN THE HIGHEST DECLARED PRICE
 

The Decree No. 54/2017/ND-CP detailing a number of articles of and providing measures for implementing the Pharmacy Law issued on May 08, 2017 with many important contents.

Firstly, this Decree requires that Pharmaceutical business establishments may not sell drugs which have no prices declared or re-declared by establishments manufacturing, ordering the processing of, or importing these drugs and announced on the Ministry of Health’s portal.   Pharmaceutical business establishments may not wholesale or retail drugs at prices higher than their prices announced on the Ministry of Health’s portal which are declared or re-declared by establishments manufacturing, ordering the processing of, or importing these drugs.

 Drug wholesaling establishments shall display wholesale prices of drugs at their transaction places or drug sale places; Drug retailing establishments shall display retail prices of drugs at their establishments;  Drug wholesaling and retailing establishments may not sell drugs at prices higher than displayed ones. The display of drug prices must satisfy the requirements such as wholesale prices shall be displayed on boards or paper or in other appropriate forms easy to be seen by customers and competent state agencies; retail prices shall be printed or written on or affixed to direct or external packages of drugs or displayed on boards, paper or in other appropriate forms easy to be seen by customers and competent state agencies, without hiding compulsory drug labels;

 

Besides, this Decree shall have guidance on requirements on drug advertisement contents. Drug advertisement contents must include the compulsory information such as Drug name; Pharmaceutical ingredients or medicinal materials written in the approved use instruction sheet of the drug; Indications; Usage; Dosage; Contraindications or warnings for special users; Cautions and recommendations when using the drug; Side effects and adverse reactions; Name and address of drug manufacturer; The phrase “Read instructions carefully before use”… Information and images banned from use in drug advertisements such as words and phrases: “điu trị tận gốc” (treat to the root), “tiệt trừ” (eliminate), “chuyên trị” (exclusively treat), “hàng đầu” (leading), “đầu bảng” (top), “đầu tay” (first), “lựa chọn” (selected), “chất lượng cao” (high quality), “đảm bảo 100%” (100% guaranteed), “an toàn” (safe), “dứt” (thoroughly), “cắt đứt” (thoroughly end), “chặn đứng” (stop), “giảm ngay”(promptly reduce), “giảm liền”, “giảm tức thì” (reduce at once), “khỏi ngay” (immediately relieve or recover), “khỏi hẳn” (completely relieve or recover), “yên tâm”(feel at ease), “không lo”(do not worry), “khỏi lo” (no longer worry), “khuyên dùng” (advise), “hotline”, “đin thoại tư vấn” (call for counseling) and those with similar meanings….

This Decree takes effect on July 01, 2017.


PROMULGATION OF LIST OF OTC DRUGS
 

On May 03, 2017, the Ministry of Health issued the Circular No. 07/2017/TT-BYT on Promulgation of List of OTC drugs, takes effect on July 01, 2017.

Accordingly, Drugs that satisfy all criteria below shall be put on the List of OTC drugs such as any drug with low toxicity, does not create toxic degradation products, does not have serious adverse reactions that are known or warned against by the World Health Organization, regulatory authorities of Vietnam or foreign countries, and may cause any of the following adverse effects; The dosage range is wide and safe for various age groups, does not significantly affect the diagnosis and treatment of diseases that need clinical monitoring;

Drugs of which the administration routes and dosage forms are simple (oral, topical administration), and
 

the concentration are appropriate for self-treatment by patients; drugs that rarely interact with other drugs or common foods and drinks; drugs that do not cause dependence; drugs that do not pose risks of overdose or misuse affecting the safety of drug users; drugs that have been selling in Vietnam for at least 05 years.

The List includes 243 OTC modern drugs and biological, within that Vitamin A and provitamin A (Betacarotene) as a single substance or combined with vitamins, Panthenol; Paracetamol as a single substance; Enzymes as a single substance or combined with other substances…

This Circular replaces the Circular No. 23/2014/TT-BYT dated June 30, 2014.


LIST OF TOXIC DRUGS AND TOXIC MEDICINAL INGREDIENTS
 

On May 03, 2017, the Ministry of Health issued the Circular No. 06/2017/TT-BYT on the List of toxic drugs and toxic medicinal ingredients.

Accordingly, Drugs and medicinal ingredients that threaten to cause one or several of the following effects on human body shall be selected for inclusion in the List of toxic drugs and toxic medicinal ingredients such as  Carcinogenicity; Teratogenicity or Developmental toxicity; Reproductive toxicity; Organ toxicity at low doses; Genotoxicity. The List includes 111 toxic drugs and toxic medicinal ingredients, within that includes: Abiraterone; Azacitidine; Colistin; Docetaxel; Oxytocin; Paclitaxel; Pazopanib; Topotecan; Triptorelin; Vincristine…

In accordance with the regulations, with regard to drugs and medicinal ingredients that have registration number of import permit before July 01, 2017, holders of certificate of

 

free sales and importers of drugs and medicinal ingredients must classify, update and provide additional information concerning classifications of drugs and medicinal ingredients in accordance with regulations herein on drug labels and package inserts according to the roadmap prescribed in Minister of Health’s Circulars on labeling of drugs and medicinal ingredients before selling such of drugs and medicinal ingredients on the market.

Drugs and active ingredients of which applications for sale registration in Vietnam or applications for permit to import drugs without certificate of free sale in Vietnam have been submitted to the Drug Administration of Vietnam before July 01, 2017 but are not yet processed must be classified in accordance with regulations herein.

This Circular takes effect on July 01, 2017.

 

 

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