This Decision stipulates a list of 11 active ingredients and dosage forms not accepting new registration and re-registration for foreign drugs. This Decision shall take effect 15 days from the date of publication in the Official Gazette, replacing the previous decision.
适用范围
The Vietnam National Pharmaceutical Administration - Ministry of Health; subordinate units under the Ministry of Health; Provincial and Municipal Health Departments directly under the central government; Heads of health sectors and related units.
要点
- The list specifies 11 active ingredients and dosage forms not accepting new registration and re-registration for foreign drugs.
- This Decision shall take effect 15 days from the date of publication in the Official Gazette, replacing the previous decision.
- Drugs containing active ingredients listed herein may only submit applications for review in the form of new combinations of multiple active ingredients or special dosage forms that have not yet been produced domestically.
- The list does not apply to drugs with active ingredients invented by the manufacturer and supported by relevant documentation confirming the invention.
- This Decision replaces Decision No. 460/200/QD-BYT dated September 17, 2002 of the Minister of Health.
🌐 本文件的社会影响
- Citizens and businesses will not be able to register new or re-register drugs containing active ingredients listed herein.
- Businesses may submit applications for review in the form of new combinations of multiple active ingredients or special dosage forms that have not yet been produced domestically.
❓ 常见问题
Which active ingredients and dosage forms does this Decision apply to?
This Decision stipulates a list of 11 active ingredients and dosage forms not accepting new registration and re-registration for foreign drugs, including amoxycillin, ampicillin, glucose, sodium chloride at various concentrations, cephalexin, chlorpheniramine, metronidazole, paracetamol, sulfamethoxazole + trimethoprim, tetracycline, and the group of vitamins B1, B6, and C.
When does this Decision come into effect?
This Decision shall take effect 15 days from the date of publication in the Official Gazette, replacing the previous decision.
Can drugs containing active ingredients listed herein submit registration applications?
The list specifies active ingredients and dosage forms not accepting new registration and re-registration for foreign drugs. However, in the form of new combinations of multiple active ingredients or special dosage forms that have not yet been produced domestically, applications may be submitted for review.
To which types of drugs does this list apply?
The list specifies 11 active ingredients and dosage forms not accepting new registration and re-registration for foreign drugs, including both single and combination drugs.
Which decision does this Decision replace?
This Decision replaces Decision No. 460/200/QD-BYT dated September 17, 2002 of the Minister of Health.
全文
DECISION OF THE MINISTER OF HEALTH
Regarding the issuance of the List of active ingredients and dosage forms
will not accept new registration and re-registration applications for foreign drugs.
THE MINISTER OF HEALTH
Based on the Law on Health Care for the People dated July 11, 1989;
Pursuant to the Pharmaceutical Regulations for Disease Prevention and Treatment issued pursuant to Decree No. 23/HĐBT dated January 24, 1991 of the Council of Ministers of the Socialist Republic of Vietnam;
Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
At the proposal of the Director of the Vietnam Drug Administration under the Ministry of Health,
DECISION:
Article 1:The list of 11 active ingredients and formulations for which new registration and re-registration applications for foreign drugs will not be accepted (attached list) is hereby promulgated.
Article 2: The list prescribed in Article 1 of this Decision shall not apply to drugs containing active ingredients invented by the manufacturer itself, provided that there are relevant documents recognizing such invention.
Article 3: Drugs containing active ingredients listed in the List prescribed in Article 1 of this Decision:
1. In single or combined form shall not have their registration applications accepted.
2. In a new combination of multiple active ingredients, if there is clinical trial data proving the superiority of the therapeutic effect of the combination form, it shall be considered a new drug and its application may be submitted for review.
3. In special formulations that have not yet been produced domestically: lyophilized powder for injection, effervescent tablets, sustained-release tablets, controlled-release tablets, suppositories, special formulations for children may submit applications for consideration.
Article 4: This Decision shall take effect fifteen days from the date of publication in the Official Gazette and revoke the List of Active Ingredients and Formulations for Which New Registration and Re-registration Applications for Foreign Drugs Will Not Be Accepted issued pursuant to Decision No. 460/200/QĐ-BYT dated September 17, 2002 of the Minister of Health.
Article 5: The Heads of the Office, Inspectorate, Department Heads under the Ministry of Health, Director of the Vietnam Drug Administration, Heads of subordinate units under the Ministry of Health, Directors of Provincial Health Departments, Heads of Health Departments of centrally-administered cities, Heads of health sectors, and Heads of related units are responsible for implementing this Decision./.
LIST of active ingredients and formulations for which new registration and re-registration applications for foreign drugs will not be accepted
|
Serial number |
Active Ingredient Name |
Formulation |
|
1 |
Amoxycillin |
Tablet form |
|
2 |
Ampicillin |
Tablet and injection forms |
|
3 |
Glucose, NaCl solutions at various concentrations |
Injectable and infusion solutions |
|
4 |
Cephalexin |
Tablet form |
|
5 |
Chlorpheniramine |
Tablet form |
|
6 |
Metronidazole |
Tablet form |
|
7 |
Paracetamol |
Tablet form |
|
8 |
Sulfamethoxazole + Trimethoprim |
Tablet form |
|
9 |
Tetracycline |
Tablet form |
|
10 |
Group of vitamins: Vitamin B1, B6, C |
Single-ingredient tablet forms: compressed tablets, capsules, soft capsules |
|
11 |
Various salts of penicillin |
Tablet and injection forms |
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