Decision No. 4819/2004/QD-BYT on issuing the List of active substances and formulations not accepting new registration and re-registration applications for foreign drugs

DECISION OF THE MINISTER OF HEALTH

Regarding the issuance of the List of active ingredients and dosage forms

not accepting new registration and re-registration applications for foreign drugs

THE MINISTER OF HEALTH

Pursuant to the Law on Health Care for the People dated July 11, 1989;

Pursuant to the Pharmaceutical Regulations for 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 Drug Administration of Vietnam under the Ministry of Health,

DECISION:

Article 1. Issuing the List of seven active ingredients and dosage forms for which new registration and re-registration applications for foreign drugs will not be accepted (the List is attached).

Article 2. The List prescribed in Article 1 of this Decision shall not apply to drugs containing active ingredients invented by the manufacturer, 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 dosage forms that have not yet been produced domestically: freeze-dried powder for injection, effervescent tablets, sustained-release tablets, controlled-release tablets, suppositories, and special dosage forms for children may submit applications for review.

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 dosage forms for which new registration and re-registration applications for foreign drugs were not accepted, as issued by Decision No. 6075/2003/QĐ-BYT dated November 24, 2003 of the Minister of Health.

Article 5. You are hereby notified: Heads of the Office, Director of the Drug Administration of Vietnam, Heads of Departments under the Ministry of Health, Inspector General; Heads of units directly under the Ministry of Health, Directors of Provincial Health Services, Municipalities directly under the Central Government, Health Sector Heads, and Heads of related units are responsible for implementing this Decision./.