Circular No. 17/2001/TT-BYT guiding foreign enterprises to register their activities related to drugs and drug ingredients in Vietnam

 

CIRCULAR

OF THE MINISTRY OF HEALTH NUMBER 17/2001/TT-BYT AUGUST 1, 2001 GUIDING FOREIGN ENTERPRISES TO REGISTER FOR ACTIVITIES REGARDING DRUGS AND RAW MATERIALS FOR DRUGS IN VIETNAM

Pursuant to the Law on Protecting People's Health dated July 11, 1989;
Pursuant to Decision No. 113/CT dated May 9, 1989 of the Chairman of the Council of Ministers (now the Prime Minister) on unifying the management of import and export of drugs and raw materials for medicinal purposes;
Pursuant to the Drug Prevention and Treatment Regulations issued together with Decree No. 23/HĐBT dated January 24, 1991 of the Council of Ministers (now the Government);
Pursuant to Decree No. 11/1999/NĐ-CP dated March 3, 1999 of the Government stipulating prohibited goods circulation and services, restricted business goods and services, and conditional business goods and services;
Pursuant to Decree No. 57/1998/NĐ-CP dated July 31, 1998 of the Government detailing the implementation of the Law on Trade regarding export, import, processing, and agency sales of goods with foreign countries;
The Ministry of Health of the Socialist Republic of Vietnam guides specific matters concerning foreign enterprises registering activities regarding drugs and raw materials for drugs in Vietnam as follows:

Chapter 1
GENERAL PROVISIONS

Article 1.

1. As a special type of commodity, drugs in Vietnam are subject to conditional business operations managed by the Ministry of Health of Vietnam. Foreign enterprises must register their activities regarding drugs and raw materials for drugs in Vietnam to ensure that imported drugs are of quality, safe, and effective for users.

2. Foreign enterprises meeting the conditions stipulated in this Circular shall be granted by the Ministry of Health of Vietnam a permit for foreign companies' activities regarding drugs and raw materials for drugs in Vietnam (hereinafter referred to as the permit).

Article 2.

Drugs and raw materials for drugs specified in this Circular include:

- Raw materials for drugs include raw materials, herbal medicines, excipients, drug capsules, and direct contact packaging.

- Drugs include finished chemical products and herbal-based drugs.

Article 3.

Scope of Regulation: This Circular stipulates the conditions, procedures, and registration dossier requirements, rights, and obligations of foreign enterprises registering activities regarding drugs and raw materials for drugs in Vietnam.

Article 4.

Applicability: Foreign enterprises without legal entities in Vietnam (referred to as foreign enterprises) supplying drugs into Vietnam through export-import contracts with domestic enterprises engaged in drug and raw material trade.

Chapter 2

ARTICLE ON CONDITIONS, REGISTRATION PROCEDURES, AND AUTHORITY TO ISSUE PERMITS

Article 5.

Conditions:

1. Conditions for initial registration:

a) It must be an enterprise engaged in the production and sale of drugs and raw materials for drugs established according to the laws of the home country.

b) It must agree to supply drugs and raw materials for drugs into Vietnam under export-import contracts through domestic enterprises engaged in drug trade.

c) The registration dossier must be complete and valid.

d) If it is a manufacturing enterprise, the production facility must meet Good Manufacturing Practice (GMP) standards. If it is a distribution enterprise, it must have permission from the competent authority of the home country to sell, import, and store drugs. In cases where these certificates are unclear or there is doubt about their authenticity, the Ministry of Health of Vietnam will conduct on-site inspections of the production and trading facilities in the home country. (the foreign enterprise must bear all costs associated with the inspection).

e) Business experience in the pharmaceutical sector and financial capability:

- The enterprise must have at least three years of experience in producing and selling drugs and raw materials for drugs;

- The minimum turnover from drug and raw material sales in the most recent year (based on the latest audited financial report):

+ For enterprises solely engaged in the sale of finished chemical drugs: 15 million USD/year

+ For enterprises engaged in the production of finished chemical drugs: 5 million USD/year

+ For enterprises engaged in the production and sale of finished herbal-based drugs, raw materials for drugs, herbal medicines, excipients, and direct contact packaging: 3 million USD/year

g) For enterprises indirectly involved in drug and raw material activities in Vietnam: within two years prior to submitting the registration dossier, they must not have had substandard drugs that were penalized under Article 15 of this Circular.

2. Conditions for re-registration: when the permit expires, the enterprise must submit a new registration dossier and meet the following conditions:

- The registration dossier must be complete and valid

- The average annual turnover from drug sales supplied to Vietnam must be at least 50,000 USD

- There must be no violations of laws or professional regulations that would result in penalties under Article 15 of this Circular.

Article 6.

Provisions on Registration Dossier:

The dossier must be either original or certified true copy (certified by a notary or issuing authority). The dossier must be presented in Vietnamese or English (if in another language, a certified translation into Vietnamese must accompany the original document).

The documents include:

1. Application form for foreign enterprises to engage in activities regarding drugs and raw materials for drugs (Form No. 1 in Vietnamese and English).

2. Summary of the enterprise's activities (Form No. 2 in Vietnamese and English).

3. Documents proving the establishment of the enterprise in the home country including its functions of production and/or sale of drugs (registration certificate or business license).

4. For manufacturing enterprises: Certificate of compliance with Good Manufacturing Practice (GMP) standards or product certification (CPP) according to the World Health Organization (WHO) certification system.

For enterprises solely engaged in the sale and import/export of drugs: Permission to sell, import/export, and store drugs in the home country issued by the competent authority of the home country.

These documents must remain valid at the time of application. During operation, if these documents expire, the company must update them.

5. Confirmation of the current bank account number of the enterprise in the home country (confirmed by the bank).

6. Summary audit report of the latest fiscal year (confirmed by an independent auditing firm).

Article 7.

Procedures and authority for issuing licenses:

The Vietnam National Drug Administration guides, receives, and evaluates foreign enterprises' registration files for pharmaceutical activities in Vietnam. Annually, the Vietnam National Drug Administration announces plans and organizes the receipt of files in batches (two batches per year).

Within three months from the date of receiving valid files, the Ministry of Health will consider issuing the license. In cases where the license is not issued, the Ministry of Health (Vietnam National Drug Administration) will notify in writing with clear reasons.

Article 8.

When changing the name or address of the enterprise, a request must be submitted along with relevant legal documents to the Ministry of Health (Vietnam National Drug Administration):

- Notification of change of enterprise name or notification of change of address.

- Relevant legal documents must be original or certified true copies, if not in English, they must have a Vietnamese translation (translated by a legitimate translation agency).

Article 9.

Resubmission procedures:

The file must be original or certified true copy (certified by a notary or issuing authority). The file should be presented in Vietnamese or English (if in another language, it must include a Vietnamese translation attached to a copy of the original document, translated by a legitimate translation agency).

The documents include:

1. Application for resubmission (Form No. 3 including one Vietnamese version and one English version).

2. Summary report on the enterprise's activities in the pharmaceutical field with Vietnamese enterprises (Form No. 4 including one Vietnamese version and one English version).

3. For manufacturing enterprises: Certificate of Good Manufacturing Practice (GMP) for production facilities or Product Certification (CPP) according to the World Health Organization certification system.

For enterprises solely engaged in the sale and import/export of drugs: Permission to sell, import/export, and store drugs in the home country issued by the competent authority of the home country.

These documents must remain valid at the time of application. During operation, if these documents expire, the company must update them.

4. Confirmation of the current bank account number of the enterprise at the local bank (confirmed by the bank).

Article 10.

Regulations on fees and charges

When registering or resubmitting, foreign enterprises must pay evaluation fees and charges as stipulated. Companies must complete all procedures for payment of charges and obtain the license within six months from the date of notification of issuance of the license. Otherwise, the license will automatically become invalid.

Article 11.

GThe license is valid for two years from the date of issuance. If the enterprise wishes to continue operations, it must submit a resubmission application before three months prior to the expiration of the license.

Chapter 3:

RIGHTS AND RESPONSIBILITIES OF FOREIGN ENTERPRISES REGISTERING PHARMACEUTICAL ACTIVITIES IN VIETNAM

Article 12.

Foreign enterprises registering pharmaceutical activities in Vietnam have the right:

1. To be listed as the foreign registrant when registering drugs and drug ingredients with the Vietnamese Ministry of Health.

2. To supply drugs and drug ingredients into Vietnam through export-import contracts signed with Vietnamese pharmaceutical export-import enterprises.

3. To organize scientific seminars, exchange professional experiences, share information, and advertise drugs in accordance with the regulations of the Ministry of Health.

Article 13.

Foreign enterprises registering pharmaceutical activities in Vietnam have the responsibility:

1. To strictly comply with Vietnamese laws, state management regulations of the Ministry of Health, and the Vietnam National Drug Administration.

2. Shall not supply to Vietnam any drugs that are not permitted to circulate in Vietnam, counterfeit drugs, or substandard drugs.

3. Shall not distribute drugs directly in Vietnam in any form.

4. To bear full responsibility before state management agencies and consumers for the quality of drugs supplied into Vietnam. Compensate consumers and Vietnamese partners in cases of damage caused by the supplying enterprise's fault according to the law.

5. To report annually to the Ministry of Health (Vietnam National Drug Administration) on pharmaceutical trading activities with Vietnam (Form No. 4).

6. To report to the Ministry of Health (Vietnam National Drug Administration) and submit related legal documents in the following cases:

a) Change of director or person responsible for pharmaceutical activities.

b) Termination of business operations in the field of pharmaceutical trading with Vietnam.

c) Merger or division of the enterprise.

7. Foreign enterprises shall have the responsibility to report promptly in the following cases:

a) When requested by competent authorities.

b) Report to the Ministry of Health (Vietnam National Drug Administration) upon discovering that drugs supplied by the enterprise into Vietnam do not meet quality standards or violate other professional regulations.

c) Report to the Ministry of Health (Vietnam National Drug Administration) upon discovering serious adverse events caused by the use of drugs supplied by the enterprise into Vietnam. Report to the ADR Center about adverse drug reactions.

Chapter 4

INSPECTION, AUDIT AND VIOLATION HANDLING

Article 14.

Inspection and Audit:

Foreign enterprises granted licenses for pharmaceutical activities in Vietnam are subject to inspection by the Ministry of Health (Vietnam National Drug Administration), provincial health departments, and national health audit (pharmaceutical audit) by the Ministry of Health and provincial health department audits.

Article 15.

Handling Violations:

During their operation in Vietnam, foreign enterprises violating laws and professional regulations will be handled according to the following provisions depending on the severity:

1. Regarding the license:

1.1. Six-month probation period (enterprises violating professional regulations still allowed to operate but must submit reports for six months, the Ministry of Health will evaluate and consider, if no further violations occur, the license will be renewed):

- Quality violation level 2 (as stipulated in Article 25 of the drug quality management regulation), twice within twelve months and penalized administratively by the Health Inspectorate according to Decree 46/CP of the Government will be warned and placed under six-month probation.

- Quality violation level 3 (as stipulated in Article 25 of the drug quality management regulation), three times within twelve months will be warned and placed under six-month probation.

1.2. Revocation of license:

- Quality violation level 1 (as stipulated in Article 25 of the drug quality management regulation) and penalized by the Health Inspectorate (according to points a, b Clause 3; points a, b Clauses 4, 7 Article 17 Decree 46/CP dated August 6, 1996 of the Government) will result in revocation of the license.

- During the six-month probation period (as stipulated in Section 1.1 of this article), if the enterprise continues to produce substandard products at level 2, the license will be revoked.

- Quality violation level 2 three or more times within twelve months will result in revocation of the license.

In cases where the enterprise has had its license revoked or not renewed due to violations, it may reapply after at least two years (application procedures as for first-time applicants).

1.3. In case of violation of pharmaceutical regulations and other provisions, the Ministry of Health (the Drug Administration Department, the Ministry of Health Inspectorate) will consider and decide based on the severity of the violation.

2. For other violations, enterprises shall be subject to handling in accordance with current laws.

Article 16.

The Drug Administration Department and the Ministry of Health Inspectorate regularly exchange information regarding the issuance of permits and cases of violations, handling, and administrative penalties. Provincial Health Departments' Inspectors report the results of handling and penalizing violations within their jurisdiction to the Ministry of Health Inspectorate for coordination, consolidation, and nationwide notification.

Chapter 5

IMPLEMENTING PROVISIONS

Article 17.

This Circular takes effect fifteen days from the date of issuance. It replaces Circular No. 07/BYTT dated March 30, 1991, issued by the Ministry of Health on guiding the registration of foreign companies permitted to export and import drugs and drug raw materials with organizations and companies of the Socialist Republic of Vietnam.

Permits granted before this Circular becomes effective remain valid until their expiration date as specified in the permit, but must be renewed three months prior to expiration in accordance with the registration procedures set forth in this Circular.

During implementation, if there are difficulties or obstacles, local units are requested to promptly reflect them to the Ministry of Health (Vietnam Drug Administration Department) for review and appropriate amendments.

Model No. 1

APPLICATION FOR FOREIGN ENTERPRISES TO OPERATE IN THE FIELD OF DRUGS AND DRUG RAW MATERIALS IN VIETNAM

(New Registration)

To: Ministry of Health of the Socialist Republic of Vietnam

Drug Administration Department of Vietnam

Name of the enterprise:

Fax:

Email/Website:

2. Intellectual Property Rights Owner:

Fax:

Email/Website:

We hereby submit this application to register our enterprise with the Ministry of Health of the Socialist Republic of Vietnam to operate in the field of drugs and drug raw materials in Vietnam. If approved, we commit to strictly comply with Vietnamese laws, pharmaceutical regulations, and the Ministry of Health's provisions, and accept supervision and inspection by competent authorities in Vietnam.

Date...
Director...
(signature, full name, stamp)

Form No. 2a

COMPANY HISTORY

1. Enterprise name:

2. Nationality of the company:

3. Address:

Email/Website:

Fax: E-mail:

4. Type of company:

- Trading company

- Manufacturing company

5. Fields authorized to produce and trade in the home country:

 

Production Trading

 

Pharmaceuticals: - Raw materials

 

- Finished products

 

- Finished herbal medicine products

a/ Maintaining and culturing aquatic animal breeds in laboratories or ponds according to standards to determine their effectiveness, potential harm, differences, uniformity, and stability;

Other fields of production and business: (if applicable)

6. Year of establishment:

7. Place of establishment:

8. Registered capital:

9. Operating capital:

10. Bank account number:

11. Permit number:... Expiry date of permit:

12. Name and address of the authority issuing the permit in the home country:

13. Pharmaceutical revenue of the last three years:

14. Total number of employees:

15. Total number of pharmaceutical employees:

16. Company director:

- Full name:

- Professional qualifications:

17. Legal representative responsible for the company's activities in Vietnam: (if applicable)

Full name, position:

Professional qualifications:

Signature:

Duration of authorization:

I hereby guarantee that the above contents are true. If not, I will bear full responsibility.

Date... Month... Year…
(General) Director of the company
(Signature, full name, stamp)

Form No. 2b

REPORT ON ACTIVITIES WITH VIETNAMESE PARTNERS IN THE FIELD OF DRUGS AND DRUG RAW MATERIALS

(For new registrations)

1. Vietnamese enterprises with which there are business relations (if any)

2. Sales volume sold into Vietnam (including sales through other foreign companies)

* Note: Sales figures are based on executed contracts, not on unexecuted or pending contracts

3. List of drugs and drug raw materials sold into Vietnam (specify drug name, form, packaging specifications, concentration)

4. List of drugs and drug raw materials registered for circulation in Vietnam.

5. Report on other activities in the pharmaceutical field with Vietnam.

Date... Month... Year…
(General) Director of the company
* Individuals need confirmation from local authorities

Model No. 3

APPLICATION FOR FOREIGN ENTERPRISES TO OPERATE IN THE FIELD OF DRUGS AND DRUG RAW MATERIALS IN VIETNAM

(Renewal)

To: Ministry of Health of the Socialist Republic of Vietnam

(Attached to the letter No. of the Department of Information and Communications [province/city])

Fax:

Email/Website:

2. Intellectual Property Rights Owner:

E-Mail:

Has been granted permission by the Ministry of Health of the Socialist Republic of Vietnam to operate in the field of drugs and drug raw materials in Vietnam.

First permit number issued: Date of issue:

Valid permit number: Expiry date:

We hereby apply to the Ministry of Health of Vietnam for renewal of the permit for our foreign enterprise to operate in the field of drugs and drug raw materials in Vietnam. We commit to strictly adhere to professional regulations and Vietnamese laws.

Thank you very much!

Date... Month... Year…
DIRECTOR
(Sign and write full name)

Model No. 4

ACTIVITY REPORT
(For two years)

To: Ministry of Health of the Socialist Republic of Vietnam

Name of the enterprise:

Fax:

Telephone: Fax: Email:

Content of the report:

1. Representative office:

- Representative office permit number: Date of issue:

- Address:

- Responsible person for the representative office:

2. Business relations with Vietnamese companies as follows:

3. Sales report:

Analysis:

a. Raw materials

b. Finished products:

4. Report on violations of regulations, batches of substandard drugs sold into Vietnam, and the results of handling.

We guarantee that the above reports are accurate. If incorrect, we will bear full responsibility.

Date... Month... Year…
DIRECTOR
(Sign and write full name)

Model No. 5

ACTIVITY REPORT

Year...

To: Ministry of Health of the Socialist Republic of Vietnam

Name of the enterprise:

Fax:

Telephone: Fax: Email:

Content of the report:

1. Representative office:

- Representative office permit number: Date of issue:

- Address:

- Responsible person for the representative office:

2. Business relations with the following Vietnamese companies:

3. Sales report:

Total sales revenue from drugs sold into Vietnam:

(based on contracts - converted to USD)

4. Report on violations of regulations, batches of substandard drugs sold into Vietnam, and the results of handling.

We guarantee that the above reports are accurate. If incorrect, we will bear full responsibility.

Date... Month... Year…
DIRECTOR
(Sign and write full name)