Thông tư 47/2011/TT-BYT sửa đổi Thông tư 17/2001/TT-BYT hướng dẫn doanh nghiệp nước ngoài đăng ký hoạt động về thuốc và nguyên liệu làm thuốc tại Việt Nam và Thông tư 10/2003/TT-BYT hướng dẫn công ty nước ngoài đăng ký hoạt động về vắc xin, sinh phẩm y tế với Việt Nam do Bộ Y tế ban hành

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 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:

"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./.

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