Circular No. 47/2011/TT-BYT amends and supplements certain provisions of Circular No. 17/2001/TT-BYT and Circular No. 10/2003/TT-BYT to guide foreign enterprises to register their activities related to drugs, raw materials for drug production, and vaccines and medical products in Vietnam. The main contents include experience requirements, registration files, licensing procedures, license validity periods, and re-registration procedures.
Scope of application
Foreign enterprises wishing to register their activities related to drugs, raw materials for drug production, and vaccines and medical products in Vietnam.
Key points
- Foreign enterprises must have at least three years of experience in producing and trading drugs and raw materials for drug production (Article 1.1).
- Registration file includes application form, summary activity report, and confirmation document from tax authority (Articles 6 and 9).
- Licensing procedure is guided, received, and reviewed by the Drug Administration Department within thirty working days (Article 7).
- License has a validity period of five years; if continuing operations, re-registration must be completed three months before expiration (Article 11).
- Foreign enterprises must submit registration files in English or Vietnamese with certification (Article 2.4).
🌐 Social impact of this document
- Positive impact: Strengthening management and supervision of foreign enterprises' activities, protecting consumer rights.
- Negative impact: Increased costs for enterprises due to the need to certify registration files in English or Vietnamese.
- Foreign enterprises benefit from clear regulations on registration procedures and license validity periods.
❓ Frequently asked questions
What are the experience requirements for foreign enterprises to register their activities related to drugs?
Enterprises must have at least three years of experience in producing and trading drugs and raw materials for drug production (Article 1.1).
What are the deadlines for submitting registration files and completing the licensing process?
The licensing process is completed within thirty working days from the date of receipt of complete and valid files (Article 7).
How long is the license valid, and what must enterprises do to continue operations?
The license is valid for five years; if continuing operations, re-registration must be completed three months before expiration (Article 11).
What should be included in the registration file?
The registration file should include the application form, summary activity report, and confirmation document from the tax authority (Articles 6 and 9).
In which language must foreign enterprises submit their registration files?
Registration files must be submitted in English or Vietnamese with certification (Article 2.4).
Full text
| MINISTRY OF HEALTH -------- |
SOCIALIST REPUBLIC OF VIET NAM Independence - Freedom - Happiness ---------------- |
| Number: 47/2011/TT-BYT | Hanoi, December 21, 2011 |
CIRCULAR
AMENDING AND SUPPLEMENTING CERTAIN PROVISIONS OF THE CIRCULAR NO. 17/2001/TT-BYT OF AUGUST 1, 2001 GUIDING FOREIGN ENTERPRISES TO REGISTER FOR ACTIVITIES ON MEDICINES AND MEDICINE RAW MATERIALS IN VIETNAM AND CIRCULAR NO. 10/2003/TT-BYT OF DECEMBER 16, 2003 GUIDING FOREIGN COMPANIES TO REGISTER FOR ACTIVITIES ON VACCINES AND MEDICAL BIOPRODUCTS WITH VIETNAM
Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
The Ministry of Health guides foreign enterprises to register for activities on medicines and medicine raw materials in Vietnam as follows:
Article 1. Amending and supplementing certain provisions of Circular No. 17/2001/TT-BYT dated August 1, 2001 guiding foreign enterprises to register for activities on medicines and medicine raw materials in Vietnam as follows:
1. Amending Point e Clause 1 Article 5 as follows:
“e) Experience in pharmaceutical business:
The enterprise must have at least three years of experience in producing and trading in medicines and medicine raw materials.”
2. Amending Clause 1, Clause 2, and Clause 5 Article 6 as follows:
“1. Application form for foreign enterprises to register for activities on medicines in Vietnam. (Annex 1, Form 1).
2. Summary report on the activities of the enterprise. (Annex 1, Form 2).
5. Confirmation letter from the tax authority (where the enterprise registers its activities) regarding the activities or tax level implemented with the local state for twelve months prior to the month of submitting the application for registration of activities.”
3. Repealing Clause 6 Article 6.
3. In cases where the Cam Ranh International Port performs tasks according to the State’s and other ministries' programs and plans, the financial assurance for operations shall be implemented in accordance with relevant laws."
“Article 7. Procedures and authority for issuing licenses
The Drug Administration will guide, receive, and review applications for foreign enterprises to register for activities on medicines and medicine raw materials in Vietnam.
Within thirty working days from the date of receiving complete and valid applications, the Ministry of Health shall examine and issue licenses. In case of non-issuance, the Ministry of Health (Drug Administration) shall notify in writing with specific reasons.”
5. Amending Clause 1, Clause 2, and Clause 4 Article 9 as follows:
“1. Application for re-registration. (Annex 1, Form 3).
2. Summary report on the enterprise's activities in the pharmaceutical field with Vietnamese enterprises (Annex 1, Form 4).”
“4. Confirmation letter from the tax authority (where the enterprise registers its activities) regarding the activities or tax level implemented with the local state for twelve months prior to the month of submitting the application for registration of activities.”
6. Amend Article 11 as follows:
“Article 11. The license is valid for five years from the date of issuance, if the enterprise wishes to continue operations, it must re-register before the license expires by three months.”
Article 2. Amending and supplementing certain provisions of Circular No. 10/2003/TT-BYT dated December 16, 2003 guiding foreign companies to register for activities on vaccines and medical bioproducts with Vietnam as follows:
1. Amending Clause 1.1, Clause 1.2, and Clause 1.4 Section 1 Part II as follows:
“1.1. Application form for activities in the fields of vaccines, finished medical bioproducts, semi-finished products, raw materials for vaccine production, and medical bioproducts (Annex 2, Form 1).
1.2. Company history (Annex 2, Form 2).”
“1.4. Confirmation letter from the tax authority (where the enterprise registers its activities) regarding the activities or tax level implemented with the local state for twelve months prior to the month of submitting the application for registration of activities.”
2. Amending the last paragraph of Section 1 Part II as follows:
“The application shall be submitted in one copy in English or Vietnamese with certified copies for the documents mentioned in Point 1.3 of this clause.”
3. Amending Clause 2.1, Clause 2.3, and Clause 2.4 Section 2 Part I as follows:
“2.1 Application for re-registration (Annex 2, Form 3).”
“2.3 Confirmation letter from the tax authority (where the enterprise registers its activities) regarding the activities or tax level implemented with the local state for twelve consecutive months prior to the month of submitting the application for registration of activities, accompanied by a notarized translation.”
“2.4. Activity report (Annex 2, Form 4).”
4. Amending the last paragraph of Clause 2.4 Section 2 Part II as follows:
“The application shall be submitted in one copy in English or Vietnamese with certified copies for the documents mentioned in Section 2.2 of this clause.”
5. Amending Clause 3 Section II Part II as follows:
“Within thirty days from the receipt of complete and valid applications, the Ministry of Health shall examine and issue licenses. In case of non-issuance, a written notification with specific reasons must be provided.”
6. Amending Clause 4 Section II Part II as follows:
“The license is valid for five years from the date of issuance, if the enterprise wishes to continue operations, it must re-register before the license expires by three months.”
Article 3. Effectiveness
This circular takes effect from February 5, 2012.
Repealing Point e Clause 1 Article 5, Clause 1, Clause 2, and Clause 5 Article 6, Clause 6 Article 6, Article 7, Clause 1, Clause 2, and Clause 4 Article 9, Article 11 of Circular No. 17/2001/TT-BYT dated August 1, 2001 guiding foreign enterprises to register for activities on medicines and medicine raw materials in Vietnam; Clause 1.1, Clause 1.2, and Clause 1.4 Section 1 Part II, the last paragraph of Section 1 Part II, Clause 2.1, Clause 2.3, and Clause 2.4 Section 2 Part I, the last paragraph of Clause 2.4 Section 2 Part II, Clause 3 Section II Part II, and Clause 4 Section II Part II of Circular No. 10/2003/TT-BYT dated December 16, 2003 guiding foreign companies to register for activities on vaccines and medical bioproducts with Vietnam.
During implementation, if there are difficulties or obstacles, please promptly reflect them to the Drug Administration - Ministry of Health for study and appropriate amendments and supplements.
DEPUTY MINISTER
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