1. Certificate of good practice for drug retail establishments
Pursuant to Clauses 1 and 5, Article 2 of Circular 02/2018/TT-BYT, Good practice at drug retailers (GPP) is a set of principles and standards in practice at drug retailers to ensure the supply of drug retailing directly to drug users and promoting the safe and effective use of drugs for drug users.
A certificate of good practice for a drug retailer (GPP) is a certificate that a retailer has met GPP standards.

2. Standards of Good Practice for Drug Retailers
Appendix I-1a promulgated under Circular 02/2018/TT-BYT stipulates the standards of Good Practice for drug retailers as follows:
2.1. About personnel
– The person in charge of expertise must have a university degree in pharmacy, must have a pharmacy practice certificate according to current regulations.
– Pharmacies have appropriate human resources (number, qualifications, professional experience) to meet the scale of operation.
– Employees directly involved in drug sales, delivery, receipt, preservation, drug quality control, drug preparation must have professional qualifications and have practice time suitable to their assigned jobs.
– All employees who are not in the period of being disciplined in the form of warnings or higher related to medical and pharmaceutical professions.
– Staff must receive initial and up-to-date training in drug retail good practice standards.
2.2. In terms of material and technical facilities
a. About construction and design
– Fixed location, arranged in a high, cool, safe place, far away from pollution sources.
– The operating area of ​​the pharmacy must be separate from other activities.
– Solid construction, with dustproof ceiling, easy-to-clean walls and floors, enough light. And to avoid confusion, do not expose the medicine to direct sunlight.
b. About the area
– An area suitable for business scale but at least 10m2, must have an area for displaying and storing drugs and an area for drug buyers to contact and exchange information on drug use with retailers. .
– An additional area must be arranged for other activities such as: Prescription dispensing room if there is an organization to dispense prescriptions, retailing area for drugs without packaging in direct contact with drugs for direct retailing to consumers. patient, separate drug storage warehouse (if necessary), separate consulting room or area for drug buyers/patients.
– In case of additional business of cosmetics, dietary supplements and medical instruments, there must be a separate area, which is not displayed and sold together with drugs and does not affect the drug; There must be a sign in the area stating “This product is not a medicine”.
– In case the pharmacy has a room for preparing prescriptions or a room for retailing drugs, there is no packaging in direct contact with the drug.
c. About drug storage equipment at the pharmacy
– Having enough equipment to store drugs. Avoid adverse effects of light, temperature, humidity, pollution, insect penetration.
– Drug storage equipment conforms to the requirements stated on the drug label. Storage conditions at room temperature: temperature does not exceed 30°C, humidity does not exceed 75%.
– There are tools for retailing and retail packaging suitable for drug preservation requirements.
– Drug labeling.
d. About dossiers, books and professional documents of drug retailers
– Having documents or means of looking up updated drug user manuals, current pharmacy regulations, and relevant notices of drug regulatory agencies.
– There must be books or computers to manage the import, export, storage, tracking of batch numbers, expiry dates, origin of drugs and other relevant information.
– Pharmacies must have information technology equipment and applications, connect to the network, ensure control of origin, price and origin of purchased and sold drugs. There is a mechanism to transfer information on drug purchase and sale, drug quality between suppliers and customers as well as the transfer of information to relevant regulatory agencies when required.
– Records or books must be kept for at least 1 year from the expiry date of the drug. Records or books store data related to patients with prescriptions or special cases in a secure place for timely retrieval when needed.
– In case the establishment has a drug business subject to special management, it must comply with the provisions of Article 43 of Decree 54/2017/ND-CP dated May 8, 2017 and other relevant documents.
– Develop and follow documented standard operating procedures for all professional activities for all employees to apply
2.3. About pharmacy activities
Pharmacies must ensure compliance with the provisions of law and standards on Good Practice of drug retail establishments for the following activities:
– Buy medicine.
– Selling medicine.
– Preservation of drugs.
– Requirements for retailers in professional practice
3. Dossier, order and procedures for applying for the Certificate of Good Practice at a drug retailer
3.1. About profile
Pursuant to Clause 1, Article 5 of Circular 02/2018/TT-BYT, amended and supplemented by Clause 1, Article 1 of Circular 12/2020/TT-BYT, the dossier serves as a basis for assessing GPP satisfaction for establishments. drug retailing means an application for a Certificate of eligibility for pharmacy business.
3.2. About the order of assessing the response to Good Practice of drug retailers
– Receipt of dossiers: Drug retail establishments shall submit 01 set of dossiers with appraisal fee to the Departments of Health of the provinces and centrally-run cities.
– The order of receipt and appraisal of dossiers shall comply with the provisions of Clauses 2 and 5, Article 33, Article 49 of Decree No. 54/2017/ND-CP and Clause 12, Article 5 of Decree No. 155/2018/ND. -CP, which is similar to the order of receipt and appraisal of dossiers of eligibility for pharmacy business.
– Within 05 days from the date of receiving the valid dossier, the Department of Health shall set up an assessment team, notify the drug retailer about the assessment team and the estimated time of actual assessment at the establishment. . Within 15 days from the date of the written notice, the assessment team conducts the actual assessment at the drug retailing establishment.
3.3. Response assessment process and response classification
Pursuant to Article 7 of Circular 02/2018/TT-BYT, as amended by Clause 3, Article 1 of Circular 12/2020/TT-BYT, the process of assessing the compliance and classifying the Good Practice of retail establishments belonging is done as follows:
a. Evaluation process
Step 1: The audit team announces the decision to establish the audit team and the expected audit plan.
Step 2: The drug retailer presents a summary of the organization, personnel and activities of implementing and applying Good Pharmacy Practice or specific content according to the content of the assessment.
Step 3: The evaluation team conducts a practical assessment of the application of Good Pharmacy Practice at drug retail establishments according to each specific content.
Step 4: The assessment team meets with the drug retailer to report the existence of findings during the assessment process (if any); evaluate the extent of each existence; discuss with the drug retailer in case the drug retailer does not agree with the assessment team’s assessment for each problem; Evaluation of the response to Good Pharmacy Practice of drug retailers.
Step 5: Make and sign the minutes
Classification meets GPP
– Drug retailers that meet GPP. The drug retailer does not make any errors in the unacceptable score and achieves 90% of the total score or more.
– Drug retailers must report remedial measures. The drug retail establishment does not make any errors in the unacceptable score and achieves from 80% to less than 90% of the total score.
– Drug retailers do not respond. A drug retailer has made at least one error in the unacceptable score or less than 80% of the total score.
3.4. Processing the results of the response assessment of Good practice in drug retail establishments
Article 8 Circular 02/2018/TT-BYT, amended and supplemented by Clauses 4 and 5, Article 1 of Circular 12/2020/TT-BYT providing for the handling of results that meet Good Practice in drug retail as follows:
a. In case the assessment report concludes that the facility meets GPP
Within 10 days after finishing the actual assessment at the drug retailer and signing the assessment record, the Department of Health shall issue a Certificate of Good Practice at the drug retailer.
b. In case the assessment report concludes, the basis must be reported for remedial measures
– Within 05 days from the date of completing the actual assessment at the establishment and signing the assessment record, the Department of Health shall send a written request to the drug retailer to remedy and repair the shortcomings stated in the report. assessment record.
– After completing the remedy or repair, the drug retailer must send a written notice enclosed with evidences (documents, photos, videos, certificates) proving that the remedy has been completed. Restoration and repair of existing problems are recorded in the assessment report.
– Within 20 days from the date of receipt of the written remedial report, the Department of Health evaluates the remedial results of the drug retailer and concludes on the GPP compliance status of the drug retailer: In case the remedial work has been satisfactory, the Department of Health shall issue a Certificate of GPP satisfaction. And in case the remedial work is not satisfactory, the Department of Health will issue a written refusal to accept the GPP Satisfaction Certificate.
– Within 06 months from the date the Department of Health issues a written request for amendment or supplementation, the drug retail establishment must submit the amended and supplemented dossier as required. After the above time limit, if the drug retailer does not amend or supplement, or after 12 months from the date of submitting the application for the first time, if the additional dossier fails to satisfy the requirements, the submitted dossier is no longer valid.
c. In case the assessment report concludes that the facility does not meet GPP
Within 5 days after completing the physical assessment at the drug retailer and signing the assessment record, the Department of Health shall issue a written notice to the drug retailer of its failure to meet GPP. and not yet certified.

4. Implementing agency
Pursuant to Clause 1, Article 6 of Circular 02/2018/TT-BYT, the Department of Health of the province or centrally run city where the drug retailer is located has the authority to evaluate and issue the Certificate of Good Practice. drug retailer.

5. Notes
Periodic time to evaluate the maintenance of GPP compliance at drug retail establishments is 03 years from the end of the previous assessment (excluding unexpected evaluations, inspections and inspections by the Ministry of Health). Health, Department of Health).
Above is the advice of Khoa Tin Law on: “Sequence and procedures for applying for the Certificate of Good Pharmacy Practice”
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