Certificate of eligibility for pharmaceutical business is a legal document for drug retail establishments in Vietnam. This document confirms that the facility meets the requirements for facilities, techniques and personnel as prescribed by law. Follow the following article by Long Phan to be provided with detailed information about the conditions, authority to issue and procedures for applying for a Certificate of eligibility for pharmaceutical business for drug retail establishments.

Conditions for issuance of Certificate of eligibility for pharmaceutical business for drug retail establishments

Drug retail establishments need to meet the conditions to be granted a Certificate of eligibility for pharmaceutical business as stipulated in Article 33 of the Law on Pharmacy 2016. Accordingly, physical facilities, techniques and personnel are three factors. important to ensure.

• Regarding facilities, drug retail establishments must have appropriate locations and storage areas. Business locations need to ensure hygiene, safety and convenience for customers. The medicine storage area must meet standards for temperature, humidity and light to maintain medicine quality.
• Regarding technical equipment, the facility needs to have adequate drug storage equipment according to regulations. These devices include refrigerators, thermometers, hygrometers, and other measuring instruments. Technical expertise documents are also a mandatory requirement, including monitoring books, drug use instructions and other specialized documents.
• Regarding personnel, drug retail establishments must have a person responsible for expertise that meets regulations. This person must have a Pharmacy Practice Certificate appropriate to the type of business. In addition, other staff in the facility also need to be trained in pharmacy expertise to ensure service quality.

For establishments specializing in retailing medicinal herbs, herbal medicines and traditional medicines, there are some specific regulations. Point b, Clause 2, Article 69 of the Law on Pharmacy 2016 provides detailed regulations on these requirements. The facility needs to have a separate display and storage area for medicinal herbs and traditional medicines.

Competent authority issues Certificate of eligibility for pharmaceutical business to drug retail establishments

The Director of the Department of Health of a province or centrally run city is the person with authority to issue a Certificate of eligibility for pharmaceutical business to drug retail establishments as prescribed in Clause 2, Article 32 and Clause 2, Article 37 of the Law on Pharmacy 2016.

Procedures for applying for a Certificate of eligibility for pharmaceutical business

Prepared documents

Dossier to apply for a Certificate of eligibility for pharmaceutical business is specified in Article 38 of the 2016 Pharmacy Law and Article 32 of Decree 54/2017/ND-CP. Accordingly, the application for a certificate includes:

1. Application for issuance of Certificate of eligibility for pharmaceutical business. The application form is specified in Appendix II of Decree No. 155/2018/ND-CP;
2. Documents include Certificate of eligibility for pharmaceutical business or Certificate of Good Practice at the business location (if any); Documents on location, storage area, storage equipment, technical documents and personnel according to the principles of Good Pharmacy Practice.
3. A certified copy of the Business Registration Certificate or legal documents proving the establishment of the establishment;
4. Certified copy of Pharmacy Practice Certificate.

Execution order

The process for applying for a Certificate of eligibility for pharmaceutical business is detailed in Article 39 of the Law on Pharmacy 2016 and Article 33 of Decree 54/2017/ND-CP guiding the steps. This process includes the following steps:

Step 1: Submit application

Business establishments need to send documents to the Department of Health of the province or centrally run city where that establishment is headquartered.

Step 2: After receiving the application, the Department of Health shall return to the applicant for the Certificate of eligibility for pharmaceutical business the application receipt according to Form No. 01 Appendix I of Decree No. 54/2017/ND-CP.

1. In case there is no request to amend or supplement records, the Department of Health:

• Issue the Certificate of eligibility for pharmaceutical business within 20 days from the date recorded on the application receipt form in cases where the facilities, techniques and personnel have been inspected and evaluated to meet the Practices. Good and suitable for the scope of business, not an actual assessment organization at the facility applying for a Certificate of eligibility for pharmaceutical business.
• Organize an on-site assessment at the facility requesting the issuance of a Certificate of eligibility for pharmaceutical business within 20 days from the date recorded on the Application Receipt Form.

1. In case there is a request to amend or supplement the dossier, within 10 working days from the date recorded on the dossier receipt slip, the Department of Health will send a document to the facility requesting it, which must specifically state documents and content that need to be revised and supplemented.

Step 3: After assessing the actual facility, the Department of Health is responsible for:

1. Issue the Certificate of eligibility for pharmaceutical business from the date of completion of the actual assessment in cases where there are no requests, remedies or repairs;
2. Issue a written notice of the contents that need to be remedied or repaired within 05 working days from the date of completion of the actual assessment in case of request, remediation or repair.

• Within 20 days from the date of receipt of the written notice and documents proving the completion of remediation and repair of the requesting establishment, the Department of Health shall issue a Certificate of eligibility for pharmaceutical business or pay Reason not given.
• Within 06 months from the date of the Department of Health’s written notification of amendments and supplements, the requesting facility must submit the application for amendments and supplements as requested. After the above deadline, if the establishment does not make amendments or supplements or after 12 months from the date of first submission of the application, if the additional application does not meet the requirements, the submitted application is no longer valid.

Resolution deadline

The time limit for processing applications for a Certificate is specified in Clause 2, Article 39 of the Law on Pharmacy 2016, the maximum time limit is 30 days. This time is calculated from the date of receipt of complete and valid documents.

Consulting services and support for applying for a Certificate of eligibility for pharmaceutical business

In the process of preparing to conduct pharmaceutical business activities, customers can seek professional consulting services to support the process of applying for a Certificate. This service helps customers save time and ensure documents meet requirements. With his experience, Long Phan can support customers most effectively and quickly when carrying out procedures for applying for a Certificate of eligibility for pharmaceutical business. Our consulting services include:

• Consulting on conditions that need to be met to be granted a certificate of eligibility for pharmaceutical business and documents that need to be prepared.
• Support in drafting and completing documents according to regulations;
• Support to supplement necessary documents;
• Representing customers in working with state agencies;
• Track progress and return results to customers.

Applying for a Certificate of eligibility for pharmaceutical business is an important process for drug retailers. Customers need to prepare carefully in terms of facilities, personnel and legal documents. If customers still have questions related to this issue. Please contact Long Phan via hotline 0906735386 for the most detailed advice and support.