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THE MINISTRY OF
HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence– Freedom – Happiness --------------- |
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No: 1545/QD-BYT
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Hanoi, May 08,
2013
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DECISION
ON AMENDING
AND SUPPLEMENTING THE DECISION NO. 2962/QD-BYT DATED AUGUST 22, 2012 OF THE
MINISTRY OF HEALTH, 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 HEALTH
Pursuant to the Pharmacy Law No.
34/2005/QH11 dated June 14, 2005;
Pursuant to the Government’s Decree No.
63/2012/ND-CP dated August 31, 2012 defining the functions, tasks, powers and
organizational structure of the Ministry of Health;
Pursuant to the Joint Circular No.
01/2012/TTLT-BYT-BTC dated January 19, 2012 of the the Ministry of Health - the
Ministry of Finance guiding bidding of drugs procurement in the medical
facilities;
At the proposal of Director of Drug
administration of Vietnam,
DECIDES:
Article 1. To amend and supplement clause 2 section I of
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
promulgated together with the Decision No. 2962/QD-BYT dated August 22, 2012 of
the Ministry of Health as follows:
“2. Patent granted by one of competent
intellectual property agencies (in the List specified in section V of this
Regulation) for:
(i) Active ingredient of medicine
containing an active ingredient; or
(ii) mixture of active ingredients if
medicine contains many active ingredients; or
(iii) Pharmacy or preparations for
injections, infusions, drugs used for eyes, sprays, implants, transdermal
patch, drugs in gel form.
The patent must enclose 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)”.
Article 2. To supplement two below agencies to the list of
intellectual property agencies granting patent approved for consideration of
announce lists of original proprietary medicines at section V of 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
promulgated together with the Decision No. 2962/QD-BYT dated August 22, 2012 of
the Ministry of Health:
“15. German Patent and Trade Mark Office
(national code: DE);
16. United Kingdom Intellectual Property
Office (national code: GB)."
Article 3. Mr. and Mrs: Chief of Ministerial office,
directors of : Pharmacy Administration, Administration of medical
examination and treatment, Department of Science and
training, Department of traditional medicine and pharmacy; and heads of:
Legal Department, Department of Health Insurance, Department of Planning
and Finance and heads of relevant units shall implement this Decision.
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FOR
THE MINISTER OF HEALTH
DEPUTY MINISTER Nguyen Thi Xuyen |
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