Decision No. 6075/2003/QD-BYT on issuing the list of active ingredients and dosage forms not accepting new registration and re-registration for foreign drugs.

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