This decree stipulates that pharmacists must affix labels to medicines prepared according to Western pharmaceutical methods before selling them on the market. The label must clearly indicate information about the brand name or pharmacist's name, address (if necessary), drug name, and dosage form. Violating pharmacies will be fined and may be closed down.
适用范围
Pharmacists, medicine production and trading establishments
要点
- Pharmacists must affix labels to medicines prepared according to Western pharmaceutical methods before selling them on the market (Article 1).
- The label of injectable drugs must indicate the brand name or pharmacist's name, drug name, and dosage form (Article 1).
- The label of non-injectable drugs must additionally indicate the address of the production establishment (Article 1).
- Pharmacies that have been operating for one month from the date of publication in the Official Gazette must affix labels according to regulations (Article 2).
- Non-compliance will result in a fine up to $10,000 and may lead to closure of the pharmacy; repeat offenses can result in imprisonment for three to ten days (Article 3).
🌐 本文件的社会影响
- Strengthening management of quality and origin of medicines prepared according to Western pharmaceutical methods.
- Facilitating consumers' easy access to information about drugs, ensuring health safety.
- Pharmacists and medicine production and trading establishments may face difficulties in complying with the new regulations.
❓ 常见问题
What information must pharmacists record on drug labels?
Brand name or pharmacist's name, address (if necessary), drug name, and dosage form of ingredients contained in the drug.
What is the deadline for pharmacies to comply with labeling requirements?
Within one month from the date of publication in the Official Gazette.
How will non-compliance be penalized?
Non-compliance will result in a fine up to $10,000 and may lead to closure of the pharmacy; repeat offenses can result in imprisonment for three to ten days.
全文
DECREE
On the Mandatory Labeling of Medicines Prepared According to Western Pharmacy Methods
CHAIRMAN OF THE COUNCIL OF MINISTERS OF THE DEMOCRATIC REPUBLIC OF VIETNAM
Pursuant to the Declaration dated August 28, 1945 on the establishment of the Democratic Republic of Vietnam;
In accordance with existing regulations governing Western pharmacy practices;
Upon the recommendation of the Minister of Social Affairs;
After deliberation by the Council of Ministers,
ISSUES THE DECREE:
Article 1
Pharmacists are required to affix a label before selling any medicine they prepare themselves.
Labels for injectable medicines shall include:
- Name or trade name of the pharmacist:
- Name of the drug;
- Dosage amount.
Labels for other types of medicines (excluding those prepared in individual bottles according to a physician's prescription, which continue to follow existing regulations) shall include:
- Name or trade name of the pharmacist;
- Address;
- Name of the drug;
- Dosage amounts of ingredients in the medicine.
Article 2
Medicines sold at pharmacies must be labeled according to this Decree within one month from the date of publication in the Official Gazette.
Article 3
Those who fail to comply with this Decree shall be fined up to ten thousand dollars (10,000$) and may have their pharmacy closed down.
Repeat offenders may be imprisoned for three to ten days.
Article 4
The Ministers of Interior Affairs, Social Affairs, and Justice are responsible for implementing this Decree.
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Huynh Thuc Khang (Signed)
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