Joint Circular No. 13-TT/LB-YT-TN guiding the implementation of Decision No. 113-CT dated May 9, 1989 on unified management of export and import of medicines and raw materials for medicinal treatment for patients and Directive No. 131-CT dated May 3, 1990 regarding continued reform and mechanism management of export and import activities.

CIRCULAR JOINT

GUIDELINES FOR IMPLEMENTING DECISION 113-CT OF THE COUNCIL OF MINISTERS ON MAY 9, 1989 REGARDING UNIFIED MANAGEMENT OF EXPORT AND IMPORT OF MEDICINE AND RAW MATERIALS FOR MEDICATION AND DIRECTIVE NO. 131-CT OF THE COUNCIL OF MINISTERS ON MAY 3, 1990 REGARDING CONTINUOUS REFORM OF POLICY AND MANAGEMENT MECHANISMS FOR EXPORT AND IMPORT ACTIVITIES

Medicine and raw materials for medication (hereinafter referred to as Medicine - raw materials) are special goods; if not strictly managed in all aspects, they can cause significant harm to health and lives of people. Implementing the Law on Protecting the Health of the People (Chapter VI, Article 38), which was adopted by the National Assembly of the Socialist Republic of Vietnam on June 30, 1989.

Pursuant to Decision 113/CT dated May 9, 1989 of the Chairman of the Council of Ministers regarding unified management of export and import of Medicine - raw materials and Directive No. 131-CT dated May 3, 1990 of the Chairman of the Council of Ministers regarding continuous reform of policy and management mechanisms for export and import activities.

The Ministry of Health and the Ministry of Trade hereby provide specific guidelines for implementation as follows:

1- Combating counterfeit goods is the responsibility of all ministries, sectors, People's Committees at all levels, political and social organizations, enterprises, business households, and the entire population.

1. All types of Medicine - raw materials (new drugs, decoctions, pills, powders, etc.) imported into Vietnam must be subject to unified management by the Ministry of Health to ensure quality, safety for users, and implement a national drug policy (protect domestic production, drug usage policies, etc.) through the issuance of a list and review of all import orders for Medicine - raw materials.

2. Only units specializing in the export and import of Medicine - raw materials approved by the Ministry of Health may regularly engage in the export and import of Medicine - raw materials.

3. Encourage units to establish joint ventures with foreign entities at any scale to produce medicine (especially from domestic medicinal herbs) after obtaining approval from the Ministry of Health in terms of expertise to meet domestic demand and for export.

4. Export and import of Medicine - raw materials shall be carried out in accordance with current laws and regulations governing export and import management.

II. LIST OF IMPORTED MEDICINE - RAW MATERIALS.

1. Imported Medicine - raw materials into the Socialist Republic of Vietnam shall be implemented according to the following three categories of lists:

a) Category 1: Medicine - raw materials prohibited from being imported into the Socialist Republic of Vietnam.

In exceptional cases where imports are necessary for state needs, the Ministry of Health will decide on the type, quantity, specifications, and designate the specialized unit for export and import of Medicine - raw materials to carry out the import. Procedures and formalities for import shall comply with current regulations.

b) Category 2: Priority Medicine - raw materials for import into Vietnam. Specifically:

- Essential medicines.

- Necessary medicines.

Issued pursuant to Decision No. 548-BYT/QD of the Ministry of Health dated September 16, 1989.

c) Category 3: Other general Medicine - raw materials allowed to be imported into the Socialist Republic of Vietnam.

The Ministry of Health will periodically review and supplement the list of Medicine - raw materials belonging to the above categories.

2. The Department of Pharmacy and Medical Equipment of the Ministry of Health is responsible for reviewing all import orders for Medicine - raw materials (purchase, sale, aid) submitted by domestic units.

3. All foreign Medicine - raw materials imported into Vietnam must be reviewed and registered by the Ministry of Health (Department of Pharmacy and Medical Equipment) in accordance with the registration regulations for foreign Medicine - raw materials imported into Vietnam issued by the Ministry of Health under Decision No. 249-BYT-QD dated May 15, 1989.

4. After importation into the Socialist Republic of Vietnam, production, processing, trading, storage, quality control, and use of all types of Medicine - raw materials must comply with current regulations of the Ministry of Health.

III. REGARDING DOMESTIC SPECIALIZED UNITS FOR EXPORT AND IMPORT OF MEDICINE - RAW MATERIALS.

1. Specialized units for export and import of Medicine - raw materials, in addition to the general conditions stipulated by the Ministry of Trade for business units engaged in export and import (Decision No. 725-TN/XNK dated September 28, 1990), must also meet the following conditions:

a) Currently permitted by the Ministry of Health to produce or trade in Medicine - raw materials, regardless of whether the unit is directly managed by central or local authorities.

The Ministry of Health particularly prioritizes units producing specialty drugs from medicinal herbs, processing high-value medicinal herbs for export, and units in joint ventures with foreign entities to produce medicine for domestic use and export.

b) Possess a team of pharmacists with university-level qualifications, experienced, deeply knowledgeable in their field, and well-versed in laws related to the export and import of Medicine - raw materials.

c) Have sufficient technical documentation and facilities to receive and store imported Medicine - raw materials.

d) Fully comply with the Ministry of Health's regulations on drug management.

Specialized units for export and import of Medicine - raw materials must submit their application forms and articles of association to the Ministry of Health. After review, the Ministry of Health (Department of Pharmacy and Medical Equipment) will issue a written opinion for the Ministry of Trade to consider issuing a direct and regular business license for export and import of Medicine - raw materials.

2. Specialized units for export and import of Medicine - raw materials may engage in other product lines (if deemed necessary to support their export and import activities of Medicine - raw materials). In such cases, the specialized unit for export and import of Medicine - raw materials must submit a written request to the Ministry of Health. Upon approval by the Ministry of Health, the unit must register for business and pay the industry registration fee as prescribed by the Ministry of Trade.

3. Units permitted to export and import Medicine - raw materials (regularly) in their business operations must not adversely affect the operations of other units currently engaged in the production and trade of medicine, contributing to the stability of the domestic medicine market and serving the health care of the people effectively.

4. The Ministry of Health has the right to inspect units authorized to export and import Medicine - raw materials and handle them according to industry regulations. If serious violations or non-compliance with stipulated conditions are found, the Ministry of Health will recommend the Ministry of Trade to revoke the business license for export and import of Medicine - raw materials of that unit.

IV. ON THE APPROVAL OF ORDERS, REGISTRATION OF EXPORT AND IMPORT PLANS FOR MEDICINES - RAW MATERIALS, AND ISSUANCE OF PERMITS FOR GOODS TRANSFER.

1. The Ministry of Health shall approve the annual and quarterly export and import plans for medicines - raw materials of specialized units engaged in such activities before transferring them to the Ministry of Trade for confirmation as "Registered." The deadline for approving the annual plan at the Ministry of Health is no later than October 15, and the confirmation as "registered" at the Ministry of Trade is no later than October 31.

2. The Ministry of Health shall review all import orders outside the registered plans of authorized units for regular export and import of medicines - raw materials, as well as import orders for aid. The Ministry of Trade will only process the issuance of import permits after the specific orders have been approved by the Ministry of Health.

3. For certain rare medicines - raw materials that require special storage conditions, the Ministry of Health shall coordinate with the General Customs Department to handle the receipt of goods directly from the transport means upon arrival at the storage facility under customs escort and sealing, and will complete the customs procedures at the Ministry of Health's warehouse.

4. In cases of urgent medical needs (to control epidemics, emergency care, medicines - raw materials requiring special storage conditions...), the Ministry of Health shall issue an urgent notification to the Ministry of Trade regarding the import of medicines - raw materials belonging to any category, including those not listed in the registered plans at the Ministry of Trade, and designate specialized units for their export and import. Upon receiving this notification from the Ministry of Health, the Ministry of Trade will issue an urgent permit to ensure timely and safe importation of these shipments.

5. The Drug and Medical Equipment Department of the Ministry of Health is responsible for centrally reviewing all import orders for medicines submitted by domestic organizations.

6. Reporting and handling violations:

a) Reporting system:

Units shall report monthly on the implementation of export and import plans according to the form specified in Circular No. 1819-TN/XNK dated July 25, 1990, of the Ministry of Trade. (This report shall be sent to the Import-Export Department of the Ministry of Trade and the Drug and Medical Equipment Department of the Ministry of Health each one copy). (In addition, to monitor the drug supply, the Ministry of Health requests separate reports from the units).

b) Handling of violations:

All violations of regulations governing the export and import of medicines - raw materials shall be handled in accordance with current laws.

This Circular takes effect from the date of signature and replaces Circular No. 17-TT/LB-YT-KTĐN issued jointly by the Ministry of Health and the Ministry of Foreign Economic Relations on August 10, 1989.