Circular No. 19/2001/TT-BYT guiding conditions for directly importing medicines for disease prevention and treatment in humans

CIRCULAR

Guidelines for Direct Import Conditions of Medicines for Disease Prevention and Treatment

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- Pursuant to the Law on Health Care for the People dated June 30, 1989;

- Pursuant to the Law on Trade dated May 10, 1997;

- 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;

- Pursuant to Decree No. 11/1999/NĐ-CP dated March 3, 1999 of the Government on prohibited goods circulation and services, restricted business goods and services, and goods and services subject to conditions for business operations;

The Ministry of Health guides enterprises to register and meet the conditions for direct import of medicines for disease prevention and treatment as follows:

I. Scope of Regulation and Applicability

1) Scope of Regulation:

This Circular stipulates the conditions for direct import of medicines for disease prevention and treatment.

2) Applicability:

Enterprises established in accordance with Vietnamese law that engage in pharmaceutical trade and meet the conditions specified in this Circular may directly import medicines for disease prevention and treatment.

Limited liability companies and private enterprises meeting the conditions specified in this Circular may import medicines that have been registered by the Ministry of Health, but they are not allowed to import finished products that have not been registered by the Ministry of Health.

Enterprises with production functions may import raw materials for their own production purposes.

This Circular does not apply to foreign-invested enterprises without the function of producing medicines.

II. Conditions for Enterprises Engaged in Export and Import of Medicines for Disease Prevention and Treatment

1) Production, Storage, and Transportation Conditions:

For enterprises solely engaged in medicine trading, storage and transportation conditions must comply with the "Good Storage Practices" (GSP) standards issued by the Ministry of Health.

For enterprises engaged in production, production facilities must meet the "Good Manufacturing Practices" (GMP) standards issued by the Ministry of Health.

2) Financial Capacity and Business Experience:

a) The enterprise must be established and operating for at least three years.

b) The entrusted import turnover of the most recent year must reach at least one million US dollars, with foreign partners being companies licensed by the Ministry of Health.

3) Management Capacity and Quality Assurance:

The enterprise must have a quality monitoring system and ensure quality control, with at least one university-level pharmacist responsible for the quality control department (section) and follow-up on quality assurance, and plans to establish a quality control laboratory meeting the "Good Laboratory Practices" (GLP) standards issued by the Ministry of Health.

The enterprise must have all drug regulations and related documents concerning production, circulation, and import-export of medicines.

The enterprise must not violate drug regulations in the last three years of operation.

4) Personnel:

a) The team directly involved in importing medicine business must include personnel with full expertise in pharmacy (university-level pharmacists) or traditional Chinese medicine (if dealing with herbal medicines or traditional medical products).

b) There must be dedicated staff for export and import activities. The person directly responsible for importing medicine business must hold a bachelor's degree in international trade or other economic degrees, or possess a certificate in international trade training and language proficiency (level B or higher).

III. Documents and Procedures for Recognizing Enterprises Meeting Conditions for Importing Medicines for Disease Prevention and Treatment

1) The application for recognition of enterprises meeting the conditions for direct import of medicines should be submitted to the Ministry of Health (National Drug Administration) and include the following documents:

1- Enterprise registration form meeting the conditions for direct import of medicines for disease prevention and treatment (Form 1)

2- Decision on establishment of the enterprise with pharmaceutical business functions or certificate confirming compliance with pharmaceutical business conditions (original or certified copy)

3- Registration certificate for business code for exporting and importing medicines for disease prevention and treatment (or herbal medicines, traditional medical products) issued by customs authorities of provinces and cities.

4- Opinion of the Provincial Department of Health where the enterprise is headquartered.

5- Financial report of the most recent fiscal year confirmed by the competent authority.

6- Documents proving compliance with the conditions set forth in this document (certified copies of certificates and diplomas of assigned staff for export-import activities, confirmation of land use rights or warehouse lease contracts with terms exceeding five years, certificates of compliance with GSP and GMP standards)

2) Procedure for Issuing Recognition Certificate for Enterprises Meeting Conditions for Direct Import:

Enterprises meeting the conditions for direct import of medicines for disease prevention and treatment as stipulated in this Circular shall submit the required documents to the Ministry of Health (National Drug Administration) for review and recognition of compliance with the conditions for direct import of medicines for disease prevention and treatment.

The National Drug Administration will organize relevant work for reviewing, assessing the documents, and recognizing compliance with the conditions for direct import of medicines for disease prevention and treatment.

Within thirty days from the date of receipt of valid documents, the Ministry of Health (National Drug Administration) will recognize the enterprise's eligibility for importing medicines and, in cases of non-recognition, will provide a written response stating the reasons.

Enterprises already recognized by the Ministry of Health for the function of exporting and importing medicines continue to be eligible for direct imports while also addressing deficiencies according to this Circular. Upon meeting the conditions specified in this Circular, the enterprise must report to the Ministry of Health (National Drug Administration) for assessment and formal recognition.

This Circular takes effect fifteen days after its issuance date. All previous provisions contrary to this Circular are hereby repealed.