IP/N/1/VNM/O/15  
 
16 October 2013  
(13-5677)  Page: 1/7  
Council for Trade-Related Aspects 
of Intellectual Property Rights  Original: English/anglais/inglés  
 
NOTIFICATION OF OTHER INTELLECTUAL PROPERTY LAWS AND REGULATIONS  
UNDER ARTICLE 63.2 OF THE TRIPS AGREEMENT 
VIET NAM 
This document reproduces the text1 of the unofficial translation of Circular No. 05/2010/TT-BYT on 
guiding the confidential protection of trial data in  drug registration, as notified by Viet Nam on 
14 August 2013 under Article 63.2 of the Agreement (see document IP/N/1/VNM/5). 
 
Conseil des aspects des droits de propriété 
intellectuelle qui touchent au commerce 
AUTRES 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 texte1 d e  l a  t r a d u c t i o n  n o n  o f f i c i e l l e  d e  l a  C i r c u l a i r e  
n° 05/2010/TT-BYT contenant des orientations pour la protection du caractère confidentiel des 
données d'essais relatives à l'homologation des médicaments, notifié par le Viet Nam le 14 août 2013 au titre de l'article 63:2 de l'Accord (voir le document IP/N/1/VNM/5). 
 
Consejo de los Aspectos de los Derechos de Propiedad 
Intelectual relacionados con el Comercio 
OTRAS 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 texto1 de la traducción no oficial de la Circular 
Nº 05/2010/TT-BYT que establece directrices para la  protección del carácter confidencial de los 
datos de ensayos clínicos en el proceso de registro de medicamentos, notificado por Viet Nam el 
14 de agosto de 2013 en virtud de lo dispuesto en el párrafo 2 del artículo 63 del Acuerdo 
(véase el documento IP/N/1/VNM/5).  
                                               
1 In English only./En anglais seulement./En inglés solamente. IP/N/1/VNM/O/15 
 
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THE MINISTRY OF HEALTH  
No.: 05/2010/TT-BYT SOCIALIST REPUBLIC OF VIETNAM  
Independence – Freedom - Happiness  
  
 
Hanoi, March 01, 2010 
 
 
CIRCULAR 
 
ON GUIDING THE CONFIDENTIAL PROTECTION  OF TRIAL DATA IN  DRUG REGISTRATION  
 
 THE MINISTRY OF HEALTH 
 
Pursuant to Law No. 34/2005/QH11 on pharmacy dated June 14, 2005; 
 
Pursuant to Law No. 50/ 2005/QH11, on Inte llectual Property dated November 29, 2005, 
which was amended and supplemented by Law No . 36/2009/QH12 dated June 19, 2009 Amending 
and Supplementing a Number of Articles of the Law on Intellectual Property; 
 Pursuant to the Government's Decree No. 188/2007/ND-CP dated December 27, 2007, 
defining the functions, tasks, mandate and organizational structure of the Ministry of Health; 
 Pursuant to the Government's Decree No. 103/2006/ND-CP dated September 22, 2006, 
detailing and guiding the implementation of a nu mber of articles of the Law on Intellectual 
Property on industrial property; 
 
The Ministry of Health guides the protection  of confidentiality of trial data in drug 
registration as follows:   
Chapter I 
 
GENERAL PROVISIONS 
 
  Article 1.  Scope of regulation 
 
1. This Circular guides the request and procedures for protecting confidentiality of trial 
data in drug registration. 
 2. This Circular applies only to finished drug products containing new active ingredients 
and does not apply to medicine materials. 
 Article 2.  Subjects of application 
 
This Circular is applicable to Vietnamese and foreign organizations and individuals who 
conduct activities related to medicine registration in Vietnam. 
 
Article 3.  Interpretation of terms 
 In this Circular, the following terms and expressions are construed as follows: 
 
1. Drug means a substance or mixture of substances for human use for disease 
prevention, treatment or diagnosis or adjustment of physiological functions of human body, 
including finished drug products, drug materials, vaccines and medical biological other than 
functional foods. 
 
2. Active ingredient  (also pharmaceutical active ingredient  or pharmakon ) means in 
substance or mixture of substances having a therapeutic treatment and used in drug manufacture. 
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  3. New active ingredient  means an active ingredient that has never been permitted for 
market in Vietnam and not yet permitted for market in anywhere else in the world for 12 months counting back from the date of filing the application for registration of a drug containing such ingredient in Vietnam. 
 
4. Data confidentiality protection and trial data  (herein collectively referred to as " data 
confidentiality protection ") means protection the confidentiality of pharmaceutical trial data in drug 
registration as specified in Article 128 of the Law on Intellectual Property and Article 20 of the 
Government's Decree No. 103/2006/ND-CP of Se ptember 22, 2006, detailing and guiding the 
implementation of a number of articles of the Law on Intellectual Property on industrial property. 
 
5. Circular on Drug Registration means the Minister of Health's Circular No. 22/2009/TT-
BYT of November 24, 2009, on drug registration. 
 
Article 4.  Responsibility to protect confidential data 
 The Vietnam Drug Administration is the compet ent agency responsible for protecting data 
confidentiality in drug registration under this Circular. 
   
Chapter II 
 
REQUIREMENTS FOR DATA CO NFIDENTIALITY PROTECTION 
 
  Article 5.  Data eligible for confidential protection 
 
A data that is eligible for being confidentially protected shall include the data of clinical 
trials of drugs containing new active ingredients provided by drug-registration establishments in 
drug registration dossiers (to use for proving the sa fety and efficiency of drugs in accordance with 
the Circular on Drug Registration) and meet requirem ents as specified in Article 6 of this Circular. 
 
Article 6.  Requirements for the data to be confidently protected 
 A data shall be protected confidentially if it fully satisfies the following requirements: 
 
1. Being a business secret, which meet requirements for protection as specified in 
Paragraph 23 in Article 4 and Article 84 of the Law on Intellectual Property; 
 
2. Being the outcome of a considerable investment of effort;  3. Having the request for confidentiality protection as specified in Para 1, Article 7 of this 
Circular. 
   
Chapter III 
 
REQUIREMENTS FOR AND ORDER OF RECEIPT OF DRUG REGISTRATION DOSSIERS 
CONTAINING REQUESTS FOR DATA  CONFIDENTIALITY PROTECTION 
   Article 7.  Requirements for the receipt of drug registration dossiers having requests for 
data confidentiality protection 
 
1. Apart from general requirements on dossiers as specified in the Circular on drug 
registration, a drug registration dossier having the request for protection data confidentiality must 
also contain at least following documents: 
 a. The application shall be made in the form attached to the Circular on Drug Registration, 
in which the drug-registration establishments shall express their request for protecting data 
confidently ticking in an appropriate box for su ch request and list documents containing data 
requested for confidential protection; 
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  b. Documents containing data to be confidently protection must be presented in a form of 
clinical reports as prescribed in the Circular on Drug Registration. 
 2. All the above documents must be sealed by a "confidential" stamp, enveloped in a 
separate package, which is also sealed an d appended with a "confidential" stamp. 
 Article 8.  Order of receipt of drug registration dossiers having requests for data 
confidentiality protection 
 A drug registration dossier having the request for data confidentiality protection shall be 
filed to the Vietnam Drug Administ ration in the following order: 
 
1. Identifying contents requested for data confidentiality protection as indicated in drug 
registration dossiers according to Para 1, Article 7 of this Circular. 
 
2. Checking the appearance of the confidential document package before breaking the 
seal, and checking formality of documents contained therein in accordance with Point b, Para 1, 
Article 7 of this Circular. 
 3. Matching up documents contained in the confidential document package to documents 
listed in the request for data confidentiality protection. 
 
4. Recording the request for data confidentiality protection in the register of receiving 
dossiers and dossier receipts, and at the same time re-sealing the confidential document package 
for dossiers satisfying requirements specified in Ar ticle 7 of this Circular. If drug registration 
dossiers having requests for data confidentiality protection fail to meet requirements specified in Article 7 of this Circular, the Vietnam Drug Admi nistration shall only receive drug registration 
dossiers of drug-registration establishments who withdraw their request for data confidentiality 
protection.    
Chapter IV 
 
PROTECTION OF DATA CONFIDENTIALITY 
 
Article 9.  Acceptance of the request for data confidentiality protection 
 
1. With respect to received drug registration dossiers having requests for data 
confidentiality protection (except those referred to in Article 10 of this Circular), the Vietnam Drug 
Administration shall accept such requests and take measures to protect it confidentially as specified in Article 12 of this Circular. 
 
2. Decisions on acceptance of requests for data confidentiality protection shall be notified 
by the Vietnam Drug Administration to drug registration establishments and published on the 
Vietnam Drug Administration's website, together with notices of decisions on grant of market 
approval numbers. 
 
Article 10.  Refusal of data confidentiality protection 
 1. In the following cases, the Vietnam Drug Administration shall to protect data 
confidentiality: 
 
a. The data requested for being protected confidentially is not fallen into those listed in 
Article 5 of this Circular; 
 
b. The drug in the registration dossier having the request for data confidentiality protection 
is not permitted for marketing in Vietnam; 
 
d. There is a firm ground to determine that  the requested data fails to satisfy one of 
requirements specified in Article 6 of this Circular; 
 
dd. The confidential protection of data mi ght cause serious impacts on human health. IP/N/1/VNM/O/15 
 
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2. Notices of refusal to protect data confidentiality shall be sent by the Vietnam Drug 
Administration to drug-registration establishments together with notices of decisions on granting 
or refusal of drug registration numbers, clearly stating reasons for refusal. 
 
Article 11.  Opinions of third parties on data confidentiality protection 
 
1. From the date of accepting the request for data confidentiality protection is published, 
all organizations and individuals may request the Vietnam Drug Administration to terminate such protection in accordance with Article 14 of this Circular. 
 
2. The request for termination must be made in writing by the form provided in this 
Circular, and accompanied by documents or indications of sources to support the request. 
 
3. Within 15 working days as of receiving the request for termination, the Vietnam Drug 
Administration shall notify in writing such request to the drug-registration establishment whose data are kept confidential. Within 03 working months as of the signing date of the notice by 
Vietnam Drug Administration, the drug-registration establishment shall respond in writing to the 
Vietnam Drug Administration, and provide with necessary documents and evidences as requested in the notice. 
 
4. Based on results of consideration of the request for termination and opinions by 
interested parties, the Vietnam Drug Administration , if finding such request is well-grounded, shall 
issue a decision to terminate the data confidentia lity protection and publish such decision on its 
website; or issue a decision on refusal to terminate the data confidentiality protection and notify 
such to organizations/individuals who request for termination of such decision if finding the such request is invalid. 
 
Article 12.  Measures of data confidentiality protection 
 In case of the request for data confidential ity protection is accepted, the Vietnam Drug 
Administration shall take the following measures to: 
 1. Archive and manage documents containing da ta requested for confidential protection in 
accordance with legal provisions on management of secret documents. 
 2. Prevent any third party from accessing to confidential data unless the access by a 
competent agency to assess clinical trial results, sa fety and efficiency of a drug or to protect the 
public health. 
 3. Prevent the disclosure of data unless the di sclosure is necessary to protect the public 
health. 
 4. Temporarily refuse to consider and grant market approval to drug-registration 
establishments who file their registration dossiers later than accepted dossier if the later dossiers 
refer to data currently confidentially protected wi thout the consent of the earlier drug-registration 
establishment and without evidence of their inde pendent creation from the confidential data. 
 
Article 13.  Term of data confidentiality protection 
 1. The measures of data confidentiality protection as specified in Paras 1, 2 and 3 of 
Article 12 shall be applied from the filing date of the data to the disclosure date of the data. 
However, the term of the data confidentiality protection shall not exceed the term of the management of secret documents as prescribed by applicable laws and regulations. 
 
2. The measures of data confidentiality protection as specified in Para 4, Article 12 shall be 
applied from the filing date of the request to th e expiration of the 5-year counting from the date 
on that drug-registration establishment is granted the market approval for that drug. 
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  Article 14.  Termination of the data confidentiality protection 
 The data confidentiality protection shall be terminated partially or wholly in the following 
cases: 
 
1. The data no longer meets the requirements as specified in Article 6 of this Circular. 
 
2. A competent agency has firm grounds to determine that the drug-registration 
establishment owning the confidential data has no lawful right to use the data. 
 3. The decision on granting the market approval for the drug having confidential data is no 
longer valid or the drug registration number is revoked or the drug-registration establishment 
voluntarily revocate th e registration number. 
 
4. A competent agency issues a compulsory license of a patent relating to the drug 
containing the confidential data. 
 
5. A competent agency on settlement-disputes invalidates the decision on acceptance of 
the request for data confidentiality protection. 
 6. The termination of the data confidentiality protection is necessary to protect the public 
health and to meet urgent needs of the society. 
   
Chapter V 
 
RIGHTS AND OBLIGATIONS OF ESTABLISHM ENTS HAVING THE CO NFIDENTIAL DATA 
 
Article 15 . Rights of establishments having the confidential data 
 Drug-registration establishments having the confidential data have following rights: 
 
1. To prevent other drug-registration establis hments from using the confidential data for 
unfair commercial purposes, including illegal use of data to apply for drug registration. 
 
2. To appeal with the Vietnam Drug Administration if they are suspected on illegal 
disclosure or use of the confidential data to apply for drug registration. 
 
Article 16 . Obligations of drug registration establishments having the confidential data 
 Drug-registration establishments having the confidential data have following obligations: 
 
1. To prove their ownership of the data, and satisfies the requirements for confidential 
protection of the data at the request of the Vietnam Drug Administration in cases specified Para 3, 
Article 11 of this Circular. 
 2. To evidence illegal disclosures and/or uses  of the confidential data for unfair commercial 
purposes in case they exercises their rights as provided in Article 15 of this Circular. 
  
Chapter VI 
 
IMPLEMENTATION ARRANGEMENTS 
 
Article 17.  Come into effect 
 1. This Circular shall come into effect after 45 days as of the signing date. 
 
2. This Circular shall replace the Minister of Health's Decision No. 30/2006/QD-BYT dated 
September 30, 2006, promulgating the Regulation on data confidentiality protection in drug 
registration dossiers. Dossiers having requests for data confidentiality protection filed with the IP/N/1/VNM/O/15 
 
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  Vietnam Drug Administration before the effect date of this Circular shall be examined and 
communicated in accordance with this Regulation. 
 3. Any matter arising during implementation of this Circular should be promptly informed 
and reported to the Ministry of Health (the Vietnam Drug Administration) for consideration and 
settlement. 
 
 
  FOR THE MINISTER OF HEALTH  
 
DEPUTY MINISTER  
  
  
(signed and sealed) 
  
 
 
CAO MINH QUANG  
 
__________