Chương VI Thông tư 22/2009/TT-BYT: Tổ chức thực hiện

Chapter VI

ORGANIZATION OF IMPLEMENTATION

Article 38. Effect

1. This Circular takes effect 6 months from the date of its signing.

2. To annul the Health Minister's Decision No. 3121/2001/QD-BYT of July 18, 2001, promulgating the Regulation on registration of drugs; Decision No. 4012/2003/QD-BYT of July 30, 2003, promulgating the Regulation on registration of vaccines and biologicals; and Decision No. 3947/2004/QD-BYT of November 8, 2004, amending and supplementing the Regulation on registration of vaccines and biologicals.

Article 39. Transitional provisions

Drug registration dossiers submitted prior to the effective date of this Circular shall be examined and drugs shall be granted registration numbers under the Regulation on registration of drugs promulgated together with the Health Minister's Decision No. 3121/2001/QD-BYT of July 18, 2001, and the Regulation on registration of vaccines and biologicals promulgated together with Decision No. 4012/2003/QD-BYT of July 30, 2003.

Article 40. Roadmap for application of this Circular

1. From the effective date of this Circular, drug registration establishments shall submit registration dossiers in accordance with this Circular.

2. Before January 1, 2012, if quality dossiers of drugs to be re-registered cannot be prepared according to the ACTD form and ASEAN technical guidelines attached to this Circular (not printed herein), registration establishments may re-submit dossiers containing testing standards and methods like those upon the grant of first-time registration numbers under the Regulation on registration of drugs promulgated together with the Health Minister's Decision No. 3121/ 2001/QD-BYT of July 18, 2001, and the Regulation on registration of vaccines and biologicals promulgated together with Decision No. 4012/2003/QD-BYT of July 30, 2003.

3. Requirements on dossiers of research into drug stability under practical conditions (for new drugs and drugs to be registered for the first time) under ASEAN guidelines are uniformly applicable from January 1, 2011.

4. The Ministry of Health encourages drug registration establishments to submit dossiers in accordance with this Circular before its effective date.

Article 41. Implementation responsibility

1. The Drug Administration of Vietnam shall:

a/ Guide and implement this Circular;

b/ Edit and keep updated ACTDs and enclosed technical guidelines for concerned entities' compliance;

c/ Regularly keeping updated on its website the lists of drugs granted circulation registration numbers by the Ministry of Health (in each drive);

d/ Develop and promulgate Standard Operating Procedures (SOPs) and quality manuals (QMs) and apply them;

e/ Step by step publish on its website the following information relating to drug registration:

- General data of drugs with valid registration numbers;

- Lists of active ingredients still in the period of invention protection;

- Approved drug labels and use instructions;

- Lists of registration establishments and manufacturers violating the provisions of this Circular;

f/ Annually propose, based on the practical grant of circulation registration numbers, appropriate management measures to regulate the drug circulation registration under Vietnamese law and international practice.

2. Provincial-level Health Departments, the Vietnam Pharmacy Corporation, medicinal materials manufacturers and traders, and licensed foreign pharmacy companies shall implement this Circular.

3. Any problems arising in the course of implementation should be promptly reported to the Ministry of Health (the Drug Administration of Vietnam) for consideration and settlement.-