Circular No. 47/2011/TT-BYT dated December 21, 2011 of the Ministry of Health 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

Summary
Content
Status
Vietnamese
Download

Error message

Font size:

ATTRIBUTE

Issuing body:	Ministry of Health	Effective date:	Known Please log in to a subscriber account to use this function. Don’t have an account? Register here
Official number:	47/2011/TT-BYT	Signer:	Cao Minh Quang
Type:	Circular	Expiry date:	Updating
Issuing date:	21/12/2011	Effect status:	Known Please log in to a subscriber account to use this function. Don’t have an account? Register here
Fields:	Medical - Health

For more details, click here.

Download files here.

LuatVietnam.vn is the SOLE distributor of English translations of Official Gazette published by the Vietnam News Agency

Effect status: Known

MINISTRY OF HEALTH --------	SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness ----------------
No.: 47/2011/TT-BYT	Hanoi, December 21, 2011

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 Vietnamas 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."

2. To amend Clause 1, 2 and 5 of Article 6 as follows:

"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).

2. Summary Report of the enterprise’s activities in the field of operating medicines with Vietnam enterprises (Appendix 1, Form 4). "

"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 Vietnamas 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:

"Registration dossier submitted 01 set in English or Vietnamese with certification for the documents mentioned in point 1.3 of this clause"

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:

" 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 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

Please log in to a subscriber account to see the full text. Don’t have an account? Register here

Processing, please wait...

LuatVietnam.vn is the SOLE distributor of English translations of Official Gazette published by the Vietnam News Agency

VIETNAMESE DOCUMENTS

ENGLISH DOCUMENTS

Others

* Note: To view documents downloaded from LuatVietnam.vn, please install DOC, DOCX and PDF file readers

For further support, please call 19006192

ATTRIBUTE

VIETNAMESE DOCUMENTS

ENGLISH DOCUMENTS

SAME CATEGORY

Circular No. 35/2024/TT-BYT dated November 16, 2024 of the Ministry of Health providing basic quality standards for hospitals

Circular No. 33/2024/TT-BYT dated November 15, 2024 of the Ministry of Health prescribing economic and technical specifications of milk products and functional foods for under-6 children which are subject to price valorization and declaration

Circular No. 83/2011/TT-BNNPTNT dated December 09, 2011 of the Ministry of Agriculture and Rural Development promulgating the list of aquaculture diseases must be announced as epidemics

Circular No. 44/2011/TT-BYT dated December 6, 2011 of the Ministry of Health promulgating the list of products and goods likely to be unsafe subject to the management assigned to the Ministry of Health

Decree No. 108/2011/ND-CP dated November 30, 2011 of the Government amending a number of articles of the government's Decree No. 69/2010/ND-CP of June 21, 2010, on biosafety for genetically modified organisms, genetic specimens and products of genetically modified organisms