WORLD TRADE ORGANIZATION  
ORGANISATION MONDIALE DU COMMERCE  
ORGANIZACIÓN MUNDIAL DEL COMERCIO  IP/N/1/VNM/U/1 
12 February 2008 
 (08-0624) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:   English/ 
 anglais/  inglés 
 
 
MAIN DEDICATED INTELLECTUAL PROPERTY  
LAWS AND REGULATIONS NOTIFIED UNDER  
ARTICLE 63.2 OF THE AGREEMENT 
 
VIET NAM 
 
 
 The present document reproduces the text
1 of Decision No. 30/2006/QD-BYT 
of September 30, 2006, Promulgating the Regulation on  Data Security of Drug Registration Records, 
notified by Viet Nam under Article 63.2 of th e Agreement (see document IP/N/1/VNM/1). 
 
 
Conseil des aspects des droits de propriété intellectuelle qui touchent au commerce 
 
 
PRINCIPALES LOIS ET RÉGLEMENTATIONS CONSACRÉES À LA  
PROPRIÉTÉ INTELLECTUELLE NOTIFIÉES AU TITRE  
DE L'ARTICLE 63:2 DE L'ACCORD 
 
VIET NAM 
 
 
 Le présent document contient le texte
1 de la Décision n° 30/2006/QD-BYT du 
30 septembre 2006 portant promulgation du Règlemen t sur la sécurité des données concernant les 
dossiers d'homologation des médicaments, notifié par le  Viet Nam au titre de l'article 63:2 de l'Accord 
(voir le document IP/N/1/VNM/1). 
 
 
Consejo de los Aspectos de los Derechos de Propiedad 
Intelectual relacionados con el Comercio  
 
 
PRINCIPALES LEYES Y REGLAMENTOS DEDICADOS A LA  
PROPIEDAD INTELECTUAL NOTIFICADOS EN VIRTUD  
DEL PÁRRAFO 2 DEL ARTÍCULO 63 DEL ACUERDO 
 
VIET NAM 
  
 En el presente documento se reproduce el texto
1 de la Decisión Nº 30/2006/QD-BYT, de 
30 de septiembre de 2006, por la que se promulga el Reglamento sobre la seguridad de los datos de 
los expedientes de registro de medicamentos, notific ada por el Viet Nam en virtud de lo dispuesto en 
el párrafo 2 del artículo 63 del Acuer do (véase el documento IP/N/1/VNM/1). 
                                                      
1 In English only./En anglais seulement./En inglés solamente. IP/N/1/VNM/U/1 
Page 2  
 
  DECISION No. 30/2006/QD-BYT OF SEP TEMBER 30, 2006, PROMULGATING THE 
REGULATION ON DATA SECURITY OF DRUG REGISTRATION RECORDS 
 
 
THE MINISTER OF HEALTH 
 
 
Pursuant to the June 14, 2005 Pharmacy Law; Pursuant to the November 29, 2005 Intellectual Property Law;  
Pursuant to the Government’s Decree No. 103/2006/ ND-CP of September 22, 2006, detailing and 
guiding the implementation of a number of articles of the Intellectual Property Law regarding industrial property;  Pursuant to the Government’s Decree No. 49/2003/ND -CP of May 15, 2003, defining the functions, 
tasks, powers and organizational structure of the Ministry of Health; 
 
Pursuant to Official Letter No. 200/UB-VP of Sept ember 22, 2006, of the National Committee for 
International Economic Cooperation, notifying the r esults of negotiations with the United States on 
the protection of test data;  
At the proposal of the Director of the Vietnam Drug Administration,  
DECIDES: 
 
Article 1.-  To promulgate together with this Deci sion the Regulation on data security of drug 
registration records. 
 
Article 2.-  This Decision takes effect 15 days after its publication in “CONG BAO.” 
 
Article 3.-  The director of the Office and the director of  the Inspectorate of the Health Ministry, the 
directors of the Vietnam Drug Administration and the Preventive Medicine Department, heads of 
units under the Health Ministry, directors of provi ncial/municipal Health Services, and heads of 
concerned drug-trading establishments, testing estab lishments and medical treatment establishments 
shall implement this Decision.  Minister of Health TRAN THI TRUNG CHIEN  
  IP/N/1/VNM/U/1 
 Page 3 
 
 
  REGULATION ON DATA SECURITY OF DRUG REGISTRATION RECORDS 
(Promulgated together with the Health  Minister’s Decision No. 30/2006/QD-BYT 
of September 30, 2006) 
 
Chapter I 
 
GENERAL PROVISIONS 
 
Article 1.-  Scope of regulation and subjects of application 
 
1. Scope of regulation: This Regulation provides th e order and procedures related to the security of 
data of drug registration records.  2. Subjects of application: This Regulation ap plies to domestic and foreign organizations and 
individuals that carry out drug registration procedures in Vietnam and to concerned agencies in charge 
of state management of pharmacy. 
 
Article 2.-  Interpretation of terms 
 In this Regulation, the terms below are construed as follows: 
 
1. Drug means a substance or a mixture of substances for human use for the purposes of disease prevention, treatment or diagnosis or rehabilitati on of human physical functions, including finished 
drugs, drug materials, vaccines and medical  biologicals, except functional foodstuff. 
 
2. Pharmaceutical substance (also referred to as ac tive ingredient) means a substance or a mixture of 
substances having treatment active-ingredients which are used in drug manufacture.  3. New drug means a drug containing a new pha rmaceutical substance or drug with a new 
combination of circulated pharmaceutical substances.  
4. Clinical drug test means a scientific research in to drugs on humans in a systematic manner with a 
view to verifying clinical efficiency, identifying and discovering harmful effects of the researched 
products; the ability of such products to absorb , distribute, transform or discharge, aiming to 
determine the safety and effectiveness of drugs.  
5. Additional indication, formula or preparation form means a new indication, new formula or new 
preparation form of a new drug which has been granted a circulation registration number.  6. Business secret means information received from financial investment or intellectual activities 
which has not been revealed and can be used in business activities. 
 
7. Data security means the application of necessary me asures to ensure that data are neither used for 
unhealthy commercial purposes nor revealed, unl ess when the revelation is necessary for the 
protection of people. 
 
Article 3.-  Types of data to be secured 
 
1. Test results related to toxicity and clinical drug test data of new drugs  which have never been 
publicized or revealed.  IP/N/1/VNM/U/1 
Page 4  
 
  2. Other data (except additional indications, fo rmulas and preparation forms) which meet the 
conditions specified in Article 4 of this Regulation. 
 
Article 4.-  Conditions for data to be secured 
 
Data to be secured must fully meet the following conditions: 
 1. Being business secrets.  2. Being results of investment of significant efforts. 
 
3. Being supplied by drug-registering establishments  under current regulations on drug registration. 
 4. Being requested to be secured by drug-register ing establishments under the provisions of Article 5 
of this Regulation.  
Article 5.-  Required documents for data security consideration  
 1. Required documents include:  a/ An application for enforcement of data  security (made according to a set form); 
 
b/ A document proving that data which need be  secured fully meet the conditions specified in 
Clause 1, Article 4 of this Regulation.  c/ A document proving that data which need be  secured are under lawful ownership of the drug-
registering establishment which request s the enforcement of data security. 
 2. The application for enforcement of data security and proof documents specified in Clause 1 of this 
Article constitute part of a drug registration dossier  and must be submitted together with the dossier. 
Applications and documents subm itted after drug registration dossiers shall not be considered. 
 
Article 6.-  Forms of applications and documents rela ted to data security enforcement request 
 1. An application for enforcement of data secur ity and enclosed documents must be made in 
Vietnamese or English, signed and stamped for cer tification by the drug-registering establishment on 
every page of those documents. 
 
2. Legal documents (diplomas, certificates, etc.) must  be originals or copies notarized in Vietnam. 
Diplomas and certificates which are issued, notar ized or authenticated by foreign agencies or 
organizations must be legalized by consular offices and translated into Vietnamese. The translations must be notarized in accordance with Vietnamese law.  
3. Parts of a dossier which contain data to be secured must be sealed and appended with a 
confidentiality stamp of the drug-registering establishment.   IP/N/1/VNM/U/1 
 Page 5 
 
 
  Chapter II 
 
PROCEDURES FOR SUBMISSION AND RECEIPT OF DRUG REGISTRATION DOSSIERS 
CONTAINING DATA TO BE SECURED 
 
Article 7.- Submission of dossiers 
 1. A drug registration dossier containing data whic h need be secured and relevant proof documents 
shall be submitted directly at the drug circulati on-licensing agency or at the place of receipt of 
dossiers designated by the drug circulation-licensing agency, or shall be sent by registered mail. 
 
2. If, at the time the drug registration dossier is  being submitted (or arriving at the drug circulation-
licensing agency), the parts of data which need be secured no longer have confidentiality signs or 
intact seals, the drug circulation-licensing agency  shall not be responsible for data security. 
 
Article 8.-  Receipt of dossiers 
 Upon receiving a drug registration dossier containi ng data which need be secured, the drug 
circulation-licensing agency shall:  1. Inspect the intactness of the dossier and its confidentiality seal. 
 
2. Check documents in the dossier against those li sted in the application for enforcement of data 
security.  3. Append a stamp on the application and all enclosed  documents, certifying the date of receipt of the 
dossier; and write down necessary information in the dossier receipt book. 
 4. Temporarily keep data which need be secured a ccording to current regulations until it officially 
accepts or rejects the application for enforcement of data security.  
Chapter III 
 
RESPONSIBILITIES OF THE DRUG CIRCULATION-LICENSING AGENCY 
 
Article 9.-  Consideration of and reply to a data security enforcement request 
 
1. Within six months after receiving a drug regist ration dossier containing data which need be 
secured, the drug circulation-licensing agency shall ev aluate the application for enforcement of data 
security and relevant documents required in Articles 3, 4, 5 and 6 of this Regulation and notify in 
writing the drug-registering establishment of its acceptance or rejection of the data security 
enforcement request.  
2. If rejecting a data security enforcement request , the drug circulation-licensing agency shall clearly 
state the reasons therefor. 
 
Article 10.-  Security enforcement and duration 
 
1. For data to be secured, the drug circulation-li censing agency shall take necessary security measures 
as stipulated in Clause 1, Article 128 of the Intell ectual Property Law until those data no longer meet 
the conditions specified in Article 4 of this Regulation.  IP/N/1/VNM/U/1 
Page 6  
 
  2. Except the case defined at Point d, Clause 2, Article 125 of the Intellectual Property Law, within 5 
years after the drugs for which the drug registration do ssier containing confidential is submitted to the 
drug circulation-licensing agency are granted ci rculation permits, the drug circulation-licensing 
agency may not license any drug-registering establishm ents which submit later dossiers with the same 
confidential data without consent of the person who has submitted those data. 
 
Article 11.-  Processing of data after security duration 
 At the end of the security duration stipulated in Ar ticle 10 of this Regulation, the submitted data shall 
be archived by the drug circulation-licensing agency like data which need not be secured. 
 
Chapter IV 
 
HANDLING OF VIOLATIONS 
 
Article 12.-  Handling of violations 
 Organizations or individuals that violate the provi sions of this Regulation shall, depending on the 
severity of their violations, be disciplined, admini stratively sanctioned or examined for penal liability 
in accordance with law.  
Minister of Health 
TRAN THI TRUNG CHIEN  
 
__________