Application for issuance of GPP certificate in Vietnam: Required documents and validity period
What is the GPP certificate form in Vietnam?
According to Clause 5 Article 2 of Circular 02/2018/TT-BYT, GPP is the abbreviation of the English phrase "Good Pharmacy Practices" which translates to Vietnamese as "Thực hành tốt cơ sở bán lẻ thuốc".
Thus, the GPP certificate or legally referred to as the Good Pharmacy Practices retail pharmacy certificate is a recognition for retail pharmacies that ensures adherence to principles, standards, and effective and safe operation in retail pharmacy practice.
The GPP certificate template is specified in Form No. 03 in the appendix issued along with Circular 02/2018/TT-BYT as follows:
Download the GPP certificate template here.
What documents does an application for issuance of GPP certificate include? What is the validity period of a GPP certificate in Vietnam? (Image from the internet)
How long is the GPP certificate valid in Vietnam?
Based on Clause 1 Article 9 of Circular 02/2018/TT-BTC, the validity period of the GPP certificate is recorded as follows:
Periodic assessment of the maintenance of Good Pharmacy Practices at retail pharmacies
1. The periodic assessment period for maintaining compliance with GPP at retail pharmacies is 03 years, from the date of the previous assessment (excluding unscheduled assessments, inspections, and checks by the Ministry of Health, Department of Health).
According to the above regulation, it can be understood that from the date of completion of the previous assessment, the periodic assessment interval for maintaining GPP compliance at retail pharmacies is 03 years.
Thus, the GPP certificate will be valid for 03 years. Because after 03 years, the retail pharmacy must undergo reassessment to maintain GPP compliance.
What documents are required to apply for a GPP certificate in Vietnam?
Based on Article 5 of Circular 02/2018/TT-BYT (amended and supplemented by Clause 1 Article 1 of Circular 12/2020/TT-BYT), the documents for evaluating GPP compliance are the documents requesting the issuance of the certificate of eligibility to do business in pharmaceuticals, including:
- Application for the Certificate of eligibility to do business.
- Certificate of eligibility to do business in pharmaceuticals or good practices certificate at the business location (if any).
- Documents according to the principles of good pharmacy practices for retail pharmacies: location, storage area, technical expertise documents, personnel, storage equipment. In which includes:
- Declaration of facilities, equipment: layout drawing of areas; list of equipment; documents, materials, standard operating procedures.
- Personnel list, organization chart and names, titles, professional qualifications of the personnel.
- Self-inspection report for good pharmacy practices at retail pharmacies
- Business registration certificate or legal documents proving the establishment of the facility (certified copy).
- Pharmaceutical practice certificate (certified copy).
What is the procedure for issuing a GPP certificate in Vietnam?
Based on Article 6 of Circular 02/2018/TT-BYT (amended by Clause 2 Article 1 of Circular 12/2020/TT-BYT) and Article 7 of Circular 02/2018/TT-BYT (amended by Clause 3 Article 1 of Circular 12/2020/TT-BYT), the steps for issuing the GPP certificate are regulated as follows:
Step 1: Prepare the documents for requesting the GPP certificate.
Step 2: Receive the documents and form the assessment team, inform the retail pharmacy about the assessment team as well as the expected time for on-site assessment within 05 days from the receipt of valid documents.
Step 3: The assessment team will conduct on-site assessment within 15 days with the following steps:
- Announce the decision to establish the team as well as the purpose, content, and expected plan of the assessment at the retail pharmacy.
- The retail pharmacy provides a brief presentation on its organization, personnel, activities, and other contents of the assessment.
- Conduct an on-site assessment of the implementation of the GPP principles.
- The assessment team meets to inform and discuss the assessment results as well as existing issues during the assessment; evaluate and categorize the GPP compliance of the retail pharmacy.
- Form and sign the assessment record.
Step 4: Issue the GPP certificate within 10 days from the date of the conclusion and signing of the assessment record.
What fee is required to issue a GPP certificate in Vietnam?
The fee for issuing a GPP certificate is regulated in the Fee rate table in the field of pharmaceuticals and cosmetics issued along with Circular 277/2016/TT-BTC as follows:
- For assessing the conditions, standards of retail pharmacy (GPP): 1 million VND.
- For assessing the conditions, standards of retail pharmacy (GPP) in areas of difficulty, mountains, islands: 500,000 VND.
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