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MINISTRY
OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.: 47/2011/TT-BYT
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Hanoi, December 21, 2011
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CIRCULAR
ON
AMENDMENT AND SUPPLEMENT OF A NUMBER OF ARTICLES OF CIRCULAR NO.17/2001/TT-BYT
DATED AUGUST 01, 2001 OF THE MINISTRY OF HEALTH GUIDING FOREIGN COMPANIES IN REGISTRATION FOR TRADING MEDICINES AND MEDICINE
MATERIALS IN VIETNAM AND CIRCULAR NO.10/2003/TT-BYT ON DECEMBER 16, 2003
GUIDING THE FOREIGN COMPANIES FOR REGISTRATION ON THE OPERATION OF TRADING
VACCINES, MEDICAL BIOLOGICAL PRODUCTS WITH VIETNAM
Pursuant to Decree
No.188/2007/ND-CP dated 27/12/2007 of the Government regulating functions,
duties, powers and organizational structure of the Ministry of Health;
Ministry of Health guides foreign companies in registration for trading medicines and
medicine materials in Vietnam as follows:
Article 1. To amend and
supplement some Articles of Circular No.17/2001/TT-BYT dated 01/08/2001 guiding
foreign companies in registration for trading
medicines and medicine materials in Vietnam as follows:
1. To amend point e clause 1
of Article 5 as follows:
"e) Experience in medicinal business:
The enterprise must have at
least 3 years experience in manufacturing and trading medicines and medicinal
materials."
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"1. Application for
registration of foreign companies to trade in medicines in Vietnam. (Appendix 1, Form 1).
2. The brief profile of the
enterprise’s operations. (Appendix 1, Form 2).
5. Written certification by the
tax authorities (where the enterprise registers its operation) on the
operations or tax rate performed with home State 12 months preceding the month
of filing registration for operation.".
3. To annul Clause 6, Article
6.
4. To amend Article 7 as
follows:
"Article 7.
Procedures, competence to license
Vietnam Drug Administration
guides, receives, and evaluates dossiers of registration for foreign companies
trading in medicines and medicine materials in Vietnam.
Within 30 working days from date of receipt of valid dossiers, the Ministry of
Health reviews and license. In case of refusal, the Ministry of Health (Vietnam
Drug Administration) sends notice in writing stating clearly the reason."
5. To amend Clause 1, Clause
2 and Clause 4 of Article 9 as follows:
"1. Application for
re-registration. (Appendix 1, Form 3).
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"4. Written certification
by the tax authorities (where the enterprise registers its operation) on the
operations or tax rate performed with home State 12 months preceding the month
of filing registration for operation."
6. To amend Article 11 as
follows:
"Article 11. The licenses take effect within 05 years from the date of
signing. If the enterprises wish to continue its operation, they shall carry
out the re-registration procedures 3 months before the licenses expired ".
Article 2. To amend and
supplement some Articles of Circular No.10/2003/TT BYT dated 16/12/2003 guiding
the foreign company for registration on the operation of trading vaccines,
medical biological products with Vietnam as
follows:
1. To amend Clause 1.1,
Clause 1.2 and Clause 1.4, Section 1, Part II as follows:
"1.1. Application for
operation in the field of vaccines and finished and semi-finished medical
biological products and raw materials for producing vaccines and medical
biological products (Appendix 2, Form 1).
1.2. Company Profile (Appendix
2, Form 2). "
"1.4. Written certification
by the tax authorities (where the enterprise registers its operation) on the
operations or tax rate performed with home State 12 months preceding the month
of filing registration for operation."
2. To amend the end paragraph
of Section 1 of Part II as follows:
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3. To amend Clause 2.1, 2.3
and 2.4, Section 2, Part I as follows:
"2.1 Application for
re-registration (Appendix 2 Form 3)."
"2.3 Written certification
by the tax authorities (where the enterprise registers its operation) on the
operations or tax rate performed with home State 12 months preceding the month
of filing registration for operation attached to the notarized
translation."
"2.4. Operation Report
(Appendix 2, Form 4)."
4. To amend the last
paragraph of Clause 2.4 Section 2, Part II as follows:
"Registration dossier
submitted 01 set in English or Vietnamese with certification for the documents
mentioned in section 2.2 of this clause."
5. To amend Clause 3 of
Section II of Part II as follows:
"Within 30 days after
receiving the valid dossiers, the Ministry of Health considers to license. In
case of refusal, shall notify in writing, stating clearly the reason. "
6. To amend clause 4 of
Section II of Part II as follows:
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Article 3. Effect
This Circular takes effect from
February 05, 2012.
To annul Point e, Clause 1,
Article 5, clause 1, 2 and 5, Article 6, clause 6 of Article 6, Article 7,
Clause 1, Clause 2 and Clause 4, Article 9, Article 11 of Circular
No.17/2001/TT- BYT dated 01/08/2001 guiding foreign companies to register the
operation in medicines and medicine materials in Vietnam; Clause 1.1, Clause
1.2 and Clause 1.4, Section 1, Part II, last paragraph of Section 1, Part II,
clause 2.1 , 2.3 and 2.4, Section 2, Part I, last paragraph Clause 2.4 Section
2 of Part II, Clause 3 of Section II, Part II, clause 4, Section II Section II
of Circular No.10/2003/TT BYT dated 16/12/2003 guiding the foreign companies to
register activities on vaccines, medical bio-products with Vietnam.
During the implementation, if
any difficulties, problems arise, the units should promptly reflect to Vietnam
Drug Administration - Ministry of Health for study to amend and supplement
properly./.
FOR
MINISTER
DEPUTY MINISTER
Cao Minh Quang