Decision No. 30/2006/QD-BYT of the Ministry of Health issues data protection regulations for drug registration files, applicable to drug business establishments and testing facilities. The Decision takes effect fifteen days from the date of publication in the Official Gazette.
适用范围
Drug business establishments, testing facilities, and related treatment facilities.
要点
- Drug business and testing facilities → must protect data in drug registration files → may not disclose information without the consent of the rights holder.
🌐 本文件的社会影响
- Positive impact: Protects the privacy and legitimate interests of pharmaceutical manufacturers.
- Negative impact: May cause difficulties in information exchange between healthcare facilities and businesses.
❓ 常见问题
Who does this Decision apply to?
The Decision applies to drug business establishments, testing facilities, and related treatment facilities.
When does the Decision take effect?
The Decision takes effect fifteen days from the date of publication in the Official Gazette.
What must drug business establishments do under this Decision?
Drug business establishments must protect data in drug registration files and may not disclose information without the consent of the rights holder.
On which legal documents is this Decision based?
The Decision is based on the Medicine Law 2005, the Intellectual Property Law 2005, Decree No. 103/2006/NĐ-CP, and Decree No. 49/2003/NĐ-CP.
Will drug business establishments be fined if they violate this regulation?
Information about penalties is not mentioned in the Decision, so it is unclear whether drug business establishments will be fined or not.
全文
Pursuant to …;
REGARDING THE ADOPTION OF DATA PROTECTION REGULATIONS FOR DRUG REGISTRATION FILES
_________________________
THE MINISTER OF HEALTH
Pursuant to the Drug Law dated June 14, 2005;
BASED ON THE INTELLECTUAL PROPERTY LAW dated November 29, 2005;
BASED ON THE DECREE NO. 103/2006/NĐ-CP dated September 22, 2006 of the Government detailing and guiding the implementation of certain provisions of the Intellectual Property Law concerning industrial property rights;
BASED ON THE 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;
BASED ON THE LETTER NO. 200/UB-VP dated September 22, 2006 of the National Committee for International Economic Cooperation regarding the notification of negotiation results with the United States on data protection issues;
PURSUANT TO THE PROPOSAL OF THE DIRECTOR OF THE VIETNAM MEDICINE ADMINISTRATION CIRCULAR,
DECISION:
Article 1. ATTACHED HERETO WITH THIS DECISION IS THE "REGULATION ON DATA PROTECTION FOR DRUG REGISTRATION FILES".
Article 2. The Standard Measurement Quality Control Department shall be responsible for organizing and guiding the implementation of the Regulations adopted herein.
Article 3. MR./MS. HEADS OF THE MINISTRY OF HEALTH'S OFFICE, INSPECTOR GENERAL, DIRECTOR OF THE VIETNAM MEDICINE ADMINISTRATION, DIRECTOR OF THE PREVENTIVE MEDICINE CIRCULAR, HEADS OF MINISTRY OF HEALTH'S SUBORDINATE UNITS, DIRECTORS OF PROVINCE AND CITY LEVEL HEALTH DEPARTMENTS, DIRECTORS OF PHARMACEUTICAL BUSINESS ESTABLISHMENTS, TESTING FACILITIES, TREATMENT FACILITIES RELATED TO THIS DECISION SHALL BE RESPONSIBLE FOR ITS IMPLEMENTATION.
关系图
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