b) The technical documents about the distributor that are prepared in accordance with guidelines for the site master file provided in Form No. 05 in the Appendix IV hereof.

3. The distributor that wishes to apply for issuance of the certificate of GDP compliance together with the certificate of eligibility for pharmacy business shall specify this in the application form for issuance of the certificate of eligibility for pharmacy business.

Article 6. Procedures for inspection of compliance with GDP principles for pharmaceutical products and pharmaceutical starting materials

1. Receipt of application:

The distributor shall submit 01 application prescribed in Article 5 of this Circular and pay assessment fees according to regulations of the Minister of Finance on fees for assessment of GDP for pharmaceutical products and pharmaceutical starting materials to the relevant provincial Department of Health.

2. Procedures for receiving and inspecting an application are specified in:

a) Clauses 2, 3, 4, 5 and 6 Article 50 of the Decree No. 54/2017/ND-CP, applicable to the distributor that trades in combined pharmaceutical products that contain narcotic active ingredients, psychotropic active ingredients or precursors;

a) Clauses 2, 3, 4 and 5 Article 51 of the Decree No. 54/2017/ND-CP, applicable to the distributor that trades in toxic pharmaceutical products, toxic pharmaceutical starting materials, pharmaceutical products and active ingredients on the list of banned substances in certain fields;

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3. Within 05 days from the date of receipt of the satisfactory application, the Provincial Department of Health shall establish an inspectorate, notify the distributor of the inspectorate and expected date on which the on-site inspection is carried out at the premises of the distributor. Within 15 days from the date of notification, the inspectorate shall carry out the on-site inspection at the premises of the distributor.

Article 7. Procedures for inspection and classification of compliance with principles of GDP for pharmaceutical products and pharmaceutical starting materials

1. Inspection procedures:

a) Step 1. The inspectorate shall declare the Decision on establishment of inspectorate, purposes and contents and plan for the site inspection at the premises of the distributor;

b) Step 2. The distributor shall make a brief introduction of organization, personnel, application of GDP principles or specific contents in conformity with the inspected contents;

c) Step 3. The inspectorate shall inspect and assess the application of GDP principles at the premises of the distributor;

d) Step 4. The inspectorate shall hold a meeting with the distributor to inform deficiencies identified during the inspection (if any); assess the degree of each deficiency; discuss with the distributor about its dissenting opinions about the assessment of each deficiency; assess the degree of the distributor's compliance with GDP principles;

dd) Step 5. An inspection record is prepared and signed:

The inspectorate shall prepare a record on inspection of compliance with GDP principles using the Form No. 03 in the Appendix IV hereof. The record shall classify the degree of the distributor’s compliance with GDP principles as prescribed in Clauses 2 and 3 of this Article, list and analyze the deficiencies (if any) that need to be corrected by the distributor, and include assenting and dissenting opinions of the inspectorate and the distributor.

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2. Inspection of the degree of compliance with GDP principles:

The degree of compliance of a distributor with GDP principles shall be assessed as prescribed in the Appendix IV hereof and includes:

a) GDP degree 1 distributor;

b) GDP degree 2 distributor;

c) GDP degree 3 distributor.

Article 8. Processing results of inspection of compliance with principles of GDP for pharmaceutical products and pharmaceutical starting materials

1. In case the GDP inspection record concludes that the distributor is in GDP degree 1 according to Point a Clause 2 Article 7 of this Circular:

Within 10 days from the completion of the on-site inspection at the premises of the distributor and the date of signing the inspection record, the Provincial Department of Health shall issue the certificate of eligibility for pharmacy business or issue the certificate of GDP compliance according to the Form No. 06 in the Appendix IV hereof.

In the case of a distributor of controlled pharmaceutical products, within 20 days from the completion of the on-site inspection at the premises of the distributor and the date of signing the inspection record, the Provincial Department of Health shall issue the certificate of eligibility for pharmacy business or the certificate of GDP compliance according to the Form No. 06 in the Appendix IV hereof.

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a) Within 05 days from the completion of the on-site inspection at the premises of the distributor and the date of signing the inspection record, the Provincial Department of Health shall request the distributor in writing to correct the deficiencies specified in the inspection record.

In the case of a distributor of controlled pharmaceutical products, within 15 days from the completion of the on-site inspection at the premises of the distributor and the date of signing the inspection record, the Provincial Department of Health shall request the distributor in writing to correct the deficiencies specified in the inspection record.

b) After taking corrective actions, the distributor shall send a notification of corrective actions taken, enclosed with evidences (including documents, images, videos or certifications) proving that the deficiencies specified in the inspection record have been corrected;

c) Within 20 days from the date of receipt of the notification of corrective actions, the Provincial Department of Health shall assess the correction result and conclude the GDP compliance status of the distributor.

- In case results of corrective actions make the distributor comply with GDP principles, the Provincial Department of Health shall issue the certificate of eligibility for pharmacy business or the certificate of GDP compliance according to Form No. 06 in the Appendix IV hereof;

- In case results of corrective actions show that the distributor still fails to comply with GDP principles, the Provincial Department of Health shall provide explanation for rejecting the application in writing.

d) Within 06 months from the date on which additional documents are requested in writing by the Provincial Department of Health, the distributor shall submit additional documents as requested. If the distributor fails to satisfy such request by the aforementioned deadline or the application is not satisfactory within 12 months from the first time it is submitted, the application will be rejected.

3. In case the GDP inspection record concludes that the distributor is in GDP degree 3 according to Point c Clause 2 Article 7 of this Circular:

Within 05 days from the completion of the on-site inspection at the premises of the distributor and the date of signing the inspection record, the Provincial Department of Health shall notify the distributor in writing of its failure to comply with GDP principles and refusal to issue the certificate.

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a) Name and address of the distributor;

b) Full name of the chief pharmacist and number of his/her pharmacy practicing certificate;

c) Number of the certificate of eligibility for pharmacy business and certificate of GDP compliance (if any);

d) Expiry date of the inspection of compliance with GDP principles;

dd) Distributor’s scope of operation.

Chapter IV

INSPECTION OF MAINTENANCE OF COMPLIANCE WITH PRINCIPLES OF GDP FOR PHARMACEUTICAL PRODUCTS AND PHARMACEUTICAL STARTING MATERIALS

Article 9. Periodic inspections of maintenance of compliance with principles of GDP for pharmaceutical products and pharmaceutical starting materials

1. A periodic inspection of maintenance of compliance with GDP principles at the premises of a distributor (including non-commercial distributor or distributor of controlled pharmaceutical products) shall be carried out every 03 years from the completion of the previous inspection (excluding unscheduled inspections and audits by the Ministry of Health or the relevant Provincial Department of Health).

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3. According to the periodic inspection plan published by the Provincial Department of Health, the distributor shall submit an application for periodic inspection as prescribed in Clause 7 of this Article to the Provincial Department of Health at least 30 days before the expected date of inspection according to the published plan.

E.g.: The expected date of periodic inspection at the premises of distributor A is on August 18, 2018, such distributor shall submit an application for periodic inspection to the relevant Provincial Department of Health before July 18, 2018.

4. In case the distributor fails to submit the application for periodic inspection by the deadline specified in Clause 3 of this Article, within 10 days from the deadline, the Provincial Department of Health shall request the distributor in writing to provide explanation for its failure to submit the application for the periodic inspection.

5. Within 30 days from the date on which the Provincial Department of Health requests the distributor in writing to provide explanation for its failure to submit the application for periodic inspection, if the distributor still fails to submit the application as prescribed, the Provincial Department of Health shall revoke the distributor’s certificate of eligibility for pharmacy business as prescribed in Clause 2 Article 40 of the Law on Pharmacy or submit a written request for suspension of operation of the non-commercial distributor.

6. After submitting the application within the time limit, the distributor shall continue its distribution activities within the scope specified in the certificate of eligibility for pharmacy business or the certificate of GDP compliance in the case of a non-commercial distributor from the date on which the application is submitted to the date on which the periodic inspection results are obtained.

7. An application for the periodic inspection of maintenance of compliance with GDP principles includes:

a) An application form (Form No. 01 in the Appendix IV hereof);

b) Updated technical documents about infrastructure, technology and personnel of the distributor (in case of change);

c) A brief report on the distribution of pharmaceutical products and pharmaceutical starting materials over the last 03 years from the date of the previous inspection (excluding unscheduled inspections and audits conducted by the Ministry of Health or Provincial Department of Health) to the date on which the periodic inspection is requested.

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Article 10. Processing results of periodic inspection of compliance with principles of GDP for pharmaceutical products and pharmaceutical starting materials

1. In case the GDP inspection record concludes that the distributor is in GDP degree 1 according to Point a Clause 2 Article 7 of this Circular:

Within 10 days from the completion of the on-site inspection at the premises of the distributor and the date of signing the inspection record, the Provincial Department of Health shall issue the certificate of GDP compliance according to Form No. 06 in the Appendix IV hereof.

2. In case the GDP inspection record concludes that the distributor is in GDP degree 2 according to Point b Clause 2 Article 7 of this Circular:

a) Within 05 days from the completion of the on-site inspection at the premises of the distributor and the date of signing the inspection record, the Provincial Department of Health shall request the distributor in writing to correct the deficiencies and submit a notification of corrective actions taken to the Provincial Department of Health;

b) Within 45 days from the date of receipt of the written request from the Provincial Department of Health, the distributor shall take corrective actions and send a notification of corrective actions, enclosed with evidences (including documents, images, videos or certificates) proving that the deficiencies specified in the inspection record have been corrected;

c) Within 20 days from the date of receipt of the notification of corrective actions enclosed with supporting evidences (including documents, images, videos or certificates), the Provincial Department of Health shall assess the correction result and conclude GDP compliance status of the distributor as follows:

- In case results of corrective actions make the distributor comply with GDP principles, the Provincial Department of Health shall issue the certificate of GDP compliance;

- In case results of corrective actions show that the distributor still fails to comply with GDP principles, the Provincial Department of Health shall request the distributor in writing to keep taking corrective actions and provide additional notification of corrective actions. The time limit for keeping taking corrective actions and sending the additional notification is 45 days from the date of receipt of the request.

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3. In case the GDP inspection record concludes that the distributor is in GDP degree 3 according to Point c Clause 2 Article 7 of this Circular:

Within 05 days from the completion of the on-site inspection at the premises of the distributor and the date of signing the inspection record, the Provincial Department of Health shall, upon assessment of risk of deficiencies in pharmaceutical product quality and safety, send a notification of non-compliance with GDP principles and, depending on the nature and severity of the violation, take one or several following actions:

a) Impose penalties against administrative violations in accordance with the Law on penalties for administrative violations;

b) Revoke the issued certificate of eligibility for pharmacy business and certificate of GDP compliance (if any) as prescribed in Article 40 of the Law on Pharmacy.

In case the distributor is ineligible for one or several business activities specified in the issued certificate of eligibility for pharmacy business, the Provincial Department of Health shall revoke the issued certificate of eligibility for pharmacy business in order to remove the business activity for which the distributor is ineligible and revoke the certificate of GDP compliance (if any) as prescribed in Article 40 of the Law on Pharmacy and issue a new certificate of eligibility for pharmacy business covering business activities for which the distributor is eligible.

4. Within 05 days from the date of concluding that the distributor maintains its compliance with GDP principles or from the issue date of the decision to revoke the issued certificate of eligibility for pharmacy business because the distributor fails to maintain its compliance with GDP principles, the Provincial Department of Health shall publish the GDP compliance status according to Clause 4 Article 8 of this Circular, if the distributor complies with GDP principles, or information concerning the revocation of the issued certificate of eligibility for pharmacy or the issued certificate of GDP compliance (if any), if the distributor fails to maintain compliance with GDP principles, on its website.

Article 11. Change control

1. During the interval between periodic inspections, the distributor shall apply for issuance of certificate of eligibility for pharmacy business as prescribed in Point b Clause 1 Article 36 of the Law on Pharmacy or send a notification of change made using the Form No. 06 in the Appendix IV enclosed herewith in one of the following cases:

a) Change of one of the contents specified in Point b Clause 1 Article 36 of the Law on Pharmacy;

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c) Addition of a new storage at the same business location;

c) Expansion of the existing storage facility;

dd) Change in the structure and layout of the storage facility;

e) Change of the auxiliary system or change of principles of design and operation of the utility system which affects the storage conditions.

2. The distributor that makes the change specified in Point a Clause 1 of this Article shall submit an application for issuance of certificate of eligibility for pharmacy business as prescribed in Clauses 2 and 4 Article 38 of the Law on Pharmacy or the documents prescribed in Clause 2 Article 5 of this Circular if it is a non-commercial distributor.

Procedures for inspecting, classifying and processing the result of inspection of compliance with GDP principles are specified in Articles 6, 7 and 8 of this Circular.

3. The distributor that makes the change specified in Points b and c Clause 1 of this Article shall submit a notification of change enclosed with technical documents corresponding to the change to the Provincial Department of Health.

a) The Provincial Department of Health shall carry out an on-site inspection at the premises of the distributor. In case the distributor complies with GDP principles, the Provincial Department of Health shall give a written consent to the change made by the distributor.

b) Procedures for inspecting, classifying and processing the result of inspection of the distributor that makes the change mentioned in Point b Clause 1 of this Article are specified in Articles 6, 7 and 10 of this Circular;

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4. The distributor that makes the change specified in Points d, dd and e Clause 1 of this Article shall submit a notification of change enclosed with technical documents corresponding to the change to the Provincial Department of Health. The Provincial Department of Health shall assess the notification of change submitted by the distributor:

a) Within 10 days from the date of receipt of the distributor’s notification, the Provincial Department of Health shall send a written consent to the change if it complies with GDP principles;

b) Within 10 days from the date of receipt of the distributor’s notification, the Provincial Department of Health shall send a written notification of deficiencies to the distributor if the change fails to comply with GDP principles;

c) Within 45 days from the date of receipt of the notification from the Provincial Department of Health, the distributor shall take corrective actions and send a notification enclosed with evidences (including documents, images, videos, certificates) proving that the deficiencies specified in the notification have been corrected;

d) Within 10 days from the date of receipt of the notification of corrective actions taken enclosed with evidences (documents, images, videos, certificates), the Provincial Department of Health shall assess the results of corrective actions taken and conclude GDP compliance status of the distributor:

- In case results of corrective actions make the distributor comply with GDP principles, the Provincial Department of Health shall send a written consent to the change;

- In case results of corrective actions show that the distributor still fails to comply with GDP principles, the Provincial Department of Health shall carry out an unscheduled inspection and process inspection results as prescribed in Article 12 of this Circular.

Article 12. Unscheduled inspections and audits of maintenance of compliance with principles of GDP for pharmaceutical products and pharmaceutical starting materials

1. Audits and inspections of maintenance of compliance of a distributor with GDP principles shall be carried out as prescribed by law.

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a) Results of corrective actions show that the distributor still fails to comply with GDP principles according to Point d Clause 4 Article 11 of this Circular;

b) The distributor that is in GDP degree 2 shall undergo at least 01 scheduled inspection within 3 years from the completion of the previous inspection;

c) There are reflections, propositions or inspection/audit results about serious violation of GDP principles.

3. The Director of the Provincial Department of Health shall, depending on the scope and purposes of the inspection, decide the members of an inspectorate.

4. Procedures for carrying out and processing unscheduled inspection results are specified in Articles 7 and 10 of this Circular.

Chapter V

INSPECTORATE CARRYING OUT INSPECTIONS OF MAINTENANCE OF COMPLIANCE WITH PRINCIPLES OF GDP FOR PHARMACEUTICAL PRODUCTS AND PHARMACEUTICAL STARTING MATERIALS

Article 13. Members and standards to be satisfied by members of an inspectorate

1. Members of an inspectorate include:

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2. An official that is appointed as a member of the inspectorate must satisfy the following standards:

a) He/she must be a public official or public employee of the Provincial Department of Health or a public official, public employee or official working under an employment contract at an affiliate of the Provincial Department of Health;

b) He/she must possess a bachelor's degree, or higher, or Level 5 of VQF Advanced Diploma or Level 4 of VQF Diploma, or higher, in pharmacy or medicine;

c) He/she has been provided with training in GPP and audit and inspection of compliance with GPP principles and has mastered GPP principles;

d) He/she must be honest and objective, strictly comply with regulations of law during the inspection, and must not create any conflict of interest with the inspected distributor according to Clause 3 of this Article;

dd) The head of the inspectorate must obtain a bachelor’s degree in pharmacy, or higher, and have at least 02 years’ experience in pharmacy management.

3. Principles for assessing conflicts of interest: A member of the inspectorate shall be deemed to involve a conflict of interest with the inspected distributor in one of the following cases:

a) He/she worked at the inspected distributor in the last 05 years;

b) He/she provided counseling for the inspected distributor in the last 05 years;

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d) His/her spouse, parent, child, sibling or parent-in-law is working at the inspected distributor.

Article 14. Responsibilities and rights of an inspectorate

1. Responsibilities of an inspectorate

a) Inspect all operations of a distributor according to corresponding GDP principles prescribed in Article 3 of this Circular, updated GDP principles and relevant applicable regulations; specify inspection contents and discovered deficiencies, prepare GDP inspection records.

b) Inform inspection results or provide explanation for the GDP inspection report in case the distributor expresses its dissenting opinions about any content of the GDP inspection record;

c) Ensure confidentiality of all information about the inspection and distribution activities of the distributor, unless otherwise agreed by the distributor or at the request of a competent authority in order to serve inspections and audits.

2. Rights of an inspectorate:

a) Check the entire premises, storage facility and equipment of the distributor and check other areas in relation to the distribution of pharmaceutical products and pharmaceutical starting materials by the distributor;

b) Request the distributor to provide documents relating to its business activities, quality control and storage of pharmaceutical products and pharmaceutical starting materials;

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d) Take pharmaceutical product and pharmaceutical starting material samples for quality control in accordance with regulations of law;

dd) Make records, request the distributor to partially or totally suspend distribution activities if, during the inspection, the distributor is found to commit violations that seriously affect the quality of one or several pharmaceutical products and pharmaceutical starting materials; report the violation to a competent person for consideration.

Chapter VI

IMPLEMENTATION2

Article 15. Effect

1. This Circular comes into force from March 26, 2018.

2. The Circular No. 48/2011/TT-BYT dated December 21, 2011 of the Minister of Health promulgating GDP for pharmaceutical products is null and void from the effective date of this Circular.

Article 16. Reference clause

If any legislative documents and regulations referred to in this Circular are amended or replaced, the new ones shall apply.

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1. Regarding the wholesaler of pharmaceutical products or pharmaceutical starting materials that has been issued with the certificate of eligibility for pharmacy business or has valid certificate of GDP compliance issued before the effective date of this Circular, the distributor is allowed to distribute pharmaceutical products and starting pharmaceutical products until the expiry of the certificate.

In case the certificate of eligibility for pharmacy business expires, the distributor shall apply for issuance of the certificate of eligibility for pharmacy business as prescribed in the Decree No. 54/2017/ND-CP and inspection of its compliance of GDP principles as prescribed in Chapter III of this Circular.

In case the certificate of GDP compliance expires before the expiry of the certificate of eligibility for pharmacy business, the distributor shall apply for inspection of maintenance of compliance with GDP principles according to Chapter IV of this Circular in order to keep operating until the expiry of the certificate of eligibility for pharmacy business.

2. Regarding the wholesaler of pharmaceutical products or pharmaceutical starting materials that has been issued with the indefinite term certificate of eligibility for pharmacy business, upon the expiry of the certificate of GDP compliance, the distributor shall apply for inspection of maintenance of compliance with GDP principles as prescribed in Chapter IV of this Circular.

3. Regarding the application for issuance of the certificate of eligibility for pharmacy business or application for the periodic inspection of compliance with GDP principles that has been submitted to the Department of Health before the effective date of this Circular, the Department of Health shall keep inspecting the distributor according to the GDP principles issued together with the Decision No. 48/2011/TT-BYT dated December 21, 2011 of the Minister of Health or this Circular.

Article 18. Responsibility for implementation

1. The Drug Administration of Vietnam shall:

a) take charge of and cooperate with relevant units in disseminating this Circular;

b) take charge of and cooperate with relevant units in providing guidelines for implementation of this Circular for the Provincial Departments of Health, health authorities and distributors within their jurisdiction;

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d) publish updated GDP documents on its website and the web portal of the Ministry of Health;

dd) take charge of or cooperate with the Ministry Inspectorate in inspecting and auditing compliance with GDP principles and take actions against violations within its power.

2. The Traditional Medicine Administration of Vietnam shall:

b) take charge of and cooperate with relevant units in providing guidelines for implementation of this Circular for the Provincial Departments of Health, health authorities and distributors of traditional pharmaceutical and herbal starting materials and within its jurisdiction;

b) consolidate and publish the list of nationwide distributors that has been issued with the certificate of eligibility for pharmacy business and certificate of GDP compliance on its website and update the status of the certificate of eligibility for pharmacy business, and GDP compliance and other information specified in Clause 4 Article 8 of this Circular within its jurisdiction;

c) Carry out inspections and audits, and take actions against violations within its power.

3. Provincial Departments of Health shall:

a) cooperate with relevant units in disseminating this Circular and provide guidelines for its implementation for units in their provinces or cities;

b) receive applications for issuance of the certificate of eligibility for pharmacy business or applications for inspection of GDP compliance, inspect GDP compliance, issue the certificate of eligibility for pharmacy business and certificate of GDP compliance to distributors in their provinces or cities;

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d) inspect and audit compliance of distributors their provinces or cities; take actions against violations within their jurisdiction;

dd) 3 periodically submit the list of distributors that have been issued with the certificate of eligibility for pharmacy business and status of GDP compliance according to Clause 4 Article 8 of this Circular to the Drug Administration of Vietnam.

4. Distributors shall:

a) organize the compliance with regulations of the Law on pharmacy and standards specified in this Circular;

b) ensure maintenance of compliance with GDP principles during their operation;

c) distribute pharmaceutical products and pharmaceutical starting materials within the licensed scope of operation in accordance with regulations of law.

Difficulties that arise during the implementation should be reported to the Ministry of Health for consideration.

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PP. MINISTER
DEPUTY MINISTER




Truong Quoc Cuong

1 The Circular No. 29/2020/TT-BYT dated December 31, 2020 providing amendments to and abrogation of some legislative documents promulgated or jointly promulgated by the Minister of Health has been promulgated pursuant to:

“The Law on promulgation of legislative documents dated June 22, 2015 and the Law on amendments to the Law on promulgation of legislative documents dated June 18, 2020;

The Law on pharmacy dated April 06, 2016;

The Law on Prevention and Control of Harmful Effects of Tobacco dated June 18, 2012;

The Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation of the Law on Pharmacy;

The Government’s Decree No. 69/2018/ND-CP dated May 15, 2018 elaborating some articles of the Law on foreign trade management;

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The Government's Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of the Law on Food Safety;

The Government’s Decree No. 34/2016/ND-CP dated May 14, 2016 providing guidelines for implementation of the Law on promulgation of legislative documents;

The Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining functions, tasks, entitlements and organizational structure of the Ministry of Health;

And at the request of Director of the Legal Department,”

2 Article 3, Article 4, Article 5 of the Circular No. 29/2020/TT-BYT stipulate as follows:

“Article 3. Effect

1. This Circular comes into force from February 15, 2021.

2. Regulations of Clauses 5, 6, 7, 8 and 11 Article 1 of this Circular come into force from January 01, 2021.

3. Regulations on online submission and access of documents shall apply during Covid-19 pandemic until revised by the Ministry of Health.

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1. The documents that are submitted before the effective date of this Circular and are still processed will apply relevant regulations of this Circular or the regulations that are effective before the effective date of this Circular, whichever is more convenient for enterprises, organizations and individuals.

2. Regulations of this Circular on online publishing, update, declaration and reporting of information shall be applied as instructed by competent authorities.

“Article 5. Responsibility for implementation