Business Medicine Counter Announcement Guide

The business medicine counter announcement is a mandatory legal requirement. Organizations and individuals must complete this step before operation. Compliance ensures legal status. It also affirms professionalism in pharmaceutical supply. This Long Phan Consulting Company analysis details the regulations, dossiers, and procedures for this administrative process.

Conditions for Business Medicine Counter Announcement

Under Sub-item 1, Part II, Decision No. 2257/QD-BYT 2025, the business establishment must satisfy two primary conditions:

• The establishment possesses business registration.
• The establishment maintains medicine storage conditions suitable for the drug label requirements. It must appoint a professionally responsible person holding a primary pharmaceutical degree (sơ cấp dược) or higher. The establishment may only sell medicines specified in the List in Appendix II of Circular No. 31/2025/TT-BYT (July 1, 2025). This circular details parts of the Law on Pharmacy and Decree No. 163/2025/ND-CP (June 29, 2025).

>>> See more at: Pharmaceutical Manufacturing Licensing Service

Competent Authority

The competent authority for the business medicine counter announcement procedure is the specialized health agency under the provincial-level People’s Committee where the counter is located. This is regulated in Sub-item 1, Part II, Decision No. 2257/QD-BYT 2025.

In practice, this unit is the provincial Department of Health (Sở Y tế). The Department of Health is responsible for receiving dossiers, checking the validity and completeness of documents, and assessing the operational conditions of the establishment.

Procedure for Business Medicine Counter Announcement

The procedure is standardized to ensure transparency, efficiency, and uniformity nationwide. This process includes dossier preparation, submission methods, and state agency processing stages.

Dossier Components

Preparing a complete and accurate dossier is a critical factor for a successful business medicine counter announcement. As required by Clause 1, Article 6, Circular No. 31/2025/TT-BYT, a full dossier includes:

• The business medicine counter announcement form (Form No. 05, Appendix I, Circular No. 31/2025/TT-BYT).
• A copy, signed and stamped by the establishment, of the legal document proving establishment. This applies to establishments lacking an Investment Registration Certificate or Enterprise Registration Certificate.
• A certified copy of the diploma or certificate (primary pharmaceutical level or higher) of the professionally responsible person. This requirement is waived if the national database on qualifications has been connected and shared.
• A list of medicines intended for sale. This list must strictly adhere to Appendix II of Circular No. 31/2025/TT-BYT.
• A photograph of the actual cabinet, counter, or shelf used for medicine storage and display at the establishment.
• The required number of dossiers is 01 (one) set.

>>> See more at: Form No. 05, Appendix I of Circular No. 31/2025/TT-BYT.

Submission Methods

According to Sub-item 1, Part II, Decision No. 2257/QD-BYT 2025, the establishment can choose one of three methods to submit the dossier for the business medicine counter announcement.

• First, direct submission at the One-Stop-Shop (Bộ phận Một cửa) of the Department of Health. This is the traditional method.
• Second, submission via postal service. The establishment must package the dossier carefully and send it to the Department of Health’s address.
• Third, online submission through the National Public Service Portal or the provincial-level Public Service Portal.

Clients should consider the most suitable method for their conditions.

Processing Steps

The procedural sequence is clearly defined in law. Adhering to these steps ensures the dossier is processed sequentially and on time. The process is specified in Sub-item 1, Part II, Decision No. 2257/QD-BYT 2025.

The business medicine counter announcement procedure follows three steps.

• Step 1: Before operating, the establishment submits 01 dossier set for the business medicine counter announcement to the specialized health agency under the provincial-level People’s Committee where the counter is located. Dossier submission complies with Article 15 of Decree No. 118/2025/ND-CP (June 9, 2025) regarding administrative procedures at the One-Stop-Shop and the National Public Service Portal. If submitting online, the establishment follows Decree No. 45/2020/ND-CP (April 8, 2020), as amended and supplemented by Decree No. 59/2022/ND-CP (September 5, 2022), Decree No. 68/2024/ND-CP (June 25, 2024), and Decree No. 69/2024/ND-CP (June 25, 2024).
• Step 2: Upon receiving the dossier, the specialized health agency issues the establishment a Dossier Receipt Note (Form No. 01, Appendix I, Circular No. 31/2025/TT-BYT).
• Step 3: Within 05 (five) working days from the date on the Receipt Note, the specialized health agency is responsible for issuing a Decision announcing the establishment is eligible to organize a medicine counter. The agency must also publish the list of eligible establishments on its website. If the announcement is not made, a written response stating the reasons must be provided.

Procedural Costs

According to Sub-item 1, Part II, Decision No. 2257/QD-BYT 2025, current Vietnamese law does not stipulate state fees for the business medicine counter announcement procedure. This means the business establishment will not pay any fees to the state agency for processing and issuing the decision.

Consulting Service for Business Medicine Counter Announcement

Self-executing the procedure can present difficulties due to complex legal requirements. Professional consulting services from Long Phan Consulting Company are an optimal solution to ensure the process is quick, accurate, and legally compliant. We provide a comprehensive service package, partnering with clients from the first step.

At Long Phan Consulting Company, we provide comprehensive and professional support for the business medicine counter announcement procedure. This includes:

• Analyzing current legal regulations related to medicine counter operating conditions.
• Assessing the client’s compliance regarding business licenses, personnel qualifications, and medicine storage conditions.
• Providing optimal legal solutions for the establishment to meet all requirements before dossier submission.
• Drafting the business medicine counter announcement form (Form No. 05) and other related documents.
• Guiding clients in preparing necessary legal documents, ensuring accuracy and validity.
• Finalizing the complete dossier according to state agency requirements to minimize the risk of revision requests.
• Representing the client in submitting the dossier directly to the Department of Health and working with competent authorities.
• Closely monitoring the dossier processing progress, proactively providing explanations and supplementary information as required.
• Receiving the final Decision announcing the establishment is eligible to organize a medicine counter and delivering it to the client.

Frequently Asked Questions (FAQ)

Below are common questions regarding the business medicine counter announcement procedure.

Competent agency for dossier reception?

The competent authority is the specialized health agency under the provincial-level People’s Committee (in practice, the Department of Health) where the medicine counter is located. Legal basis: Sub-item 1, Part II, Decision No. 2257/QD-BYT 2025.

Resolution timeline for the procedure?

The resolution timeline is 05 working days, starting from the date on the Dossier Receipt Note. During this time, the Department of Health will issue the Decision or a written response if not approved. Legal basis: Sub-item 1, Part II, Decision No. 2257/QD-BYT 2025.

Minimum qualification for the professionally responsible person?

The professionally responsible person must hold a diploma or certificate of primary (sơ cấp) pharmaceutical level or higher. Legal basis: Clause 1, Article 6, Circular No. 31/2025/TT-BYT.

State fees for the procedure?

According to current regulations, the establishment does not have to pay any state fees for this procedure. Legal basis: Sub-item 1, Part II, Decision No. 2257/QD-BYT 2025.

Number of dossier sets required?

The business establishment must prepare 01 (one) complete dossier set for submission. Legal basis: Clause 1, Article 6, Circular No. 31/2025/TT-BYT.

Conclusion

The business medicine counter announcement involves detailed legal requirements for conditions, dossiers, and procedures. To ensure the procedure is smooth, prompt, and compliant with the law, engaging a professional consulting firm is an effective solution. Clients who require support or need clarification, please contact Long Phan Consulting Company via hotline 1900636389 for timely and specialized assistance.