THE MINISTRY OF PUBLIC HEALTH
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THE SOCIALIST REPUBLIC OF VIETNAM
Independence– Freedom – Happiness
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No: 2962/QD-BYT
Hanoi, August 22, 2012
 
DECISION
ON PROMULAGTING TEMPORARY REGULATION ON DOCUMENTS NEED SUPPLY IN ORDER TO ANNOUNCE LISTS OF ORIGINAL PROPRIETARY MEDICINES, MEDICINES USED FOR TREATMENT SIMILAR WITH ORIGINAL PROPRIETARY MEDICINES, MEDICINES WITH DOCUMENTS PROVING BIOEQUIVALENCE
THE MINISTER OF PUBLIC HEALTH
 
Pursuant to the Pharmacy law No.34/2005/QH11, of June 14, 2005;
Pursuant to the Goverment's Decree No. 188/2007/ND-CP, of December 27, 2007 defining the functions, tasks, powers and organizational structure of the Ministry of Public Health;
Pursuant to the Joint Circular No. 01/2012/TTLT- BYT- BTC, of January 19, 2012 of the Ministry of Public Health and the Ministry of Finance guiding the medicine purchasing bid in medical facilities;
At the proposal of Director of Drug administration of Vietnam,
DECIDES:
Article 1. To promulgate together with this Decision “Temporary regulation on documents need supply in order to announce lists of original proprietary medicines, medicines used for treatment similar with original proprietary medicines, medicines with documents proving bioequivalence".
Article 2. Facilities having medicines circulating in Vietnam and satisfying documents specified in the temporary regulation enclosed with this Decision shall send a request dossier to the Ministry of Public Health (Drug administration of Vietnam) to be considered and announce medicines under the corresponding list.
Article 3. This Decision takes effect from the day of signing.
Article 4. Mr./Mrs.: Chief of Ministerial office, directors of  Pharmacy Administration, Administration of medical examination and treatment;  Legal Department, Health Insurance, Department of traditional medicine and pharmacy, Department of Planning and Finance, Department  of Science and training and heads of relevant units shall implement this Decision.
 
FOR MINISTER OF PUBLIC HEALTH
DEPUTY MINISTER




Nguyen Thi Xuyen
 
TEMPORARY REGULATION
ON DOCUMENTS NEED SUPPLY IN ORDER TO ANNOUNCE LISTS OF ORIGINAL PROPRIETARY MEDICINES, MEDICINES USED FOR TREATMENT SIMILAR WITH ORIGINAL PROPRIETARY MEDICINES, MEDICINES WITH DOCUMENTS PROVING BIOEQUIVALENCE".
I. Documents need supply in order to announce medicines under lists of original proprietary medicines:
1. A written request to the Ministry of Public Health for announcement of original proprietary medicines (made in according to the Form in Annex 1 enclosed with this Decision).
2. Paten granted by one of competent intellectual property agencies (in the List specified in section V of this Regulation) for active ingredient of medicine containing an active ingredient or mixture of active ingredients if medicine contains many active ingredients, enclosing part referencing point requiring protection, determining scope of protection for corresponding medicine (original has consular legalized as prescribed; or a valid notarized copy as prescribed; or a copy certified by the seal of facility if the patent may search, define at websites supplying database of  intellectual property agencies – in this case, it should indicate clearly address for search, name of intellectual property agency  and search code).
3. Documents certifying on being transfer of patent use right  (license transfer) or transferring ownership of patent from the owner of patent specified in clause 2, section I above in case the facility is not owner of patent of active ingredient, enclosed with the facility's commitment for exactness of this documents.