Circular No. 11/2018/TT-BYT dated May 4, 2018 of the Ministry of Health on drug/drug ingredient quality

THE MINISTRY OF HEALTH 

Circular No. 11/2018/TT-BYT dated May 4, 2018 of the Ministry of Health on drug/drug ingredient quality

Pursuant to the Law No. 34/2005/QH11 dated June 14, 2005 on Pharmacy;

Pursuant to the Government’s Decree No. 54/2017/ND-CP on detailing a number of articles of, and providing measures for implementing, the Law on Pharmacy dated May 8, 2017;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining Functions, Tasks, Powers and Organizational Structure of Ministry of Health;

At the quest of the Director General of the Drug Administration,

The Ministry of Health promulgates the Circular on Drug/Drug Ingredient Quality.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of adjustment

This Circular provides for application of quality standards of drugs (modern drugs, herbal drugs, vaccines and biological) and drug ingredients (except herbal ones); drug/drug ingredient tests and procedures for recall and handling of unconformable drugs.

Article 2. Definitions

For the purpose of this Circular, the terms below shall be construed as follows:

1.Drug/drug ingredient quality standardsare documents regulating technical characteristics of drugs and drug ingredients, including quality criteria, quality levels, test methods and other administrative requirements.

2.GLPstands for Good Laboratory Practice.

3.WHOstands for World Health Organization.

4.ICHstands for International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.

Chapter II

APPLICATION OF DRUG/DRUG INGREDIENT QUALITY STANDARDS

Article 3. General provisions

1. Pharmacy business establishments and drug preparing facilities shall apply drug/drug ingredient quality standards by way of pharmacopeia or internal standards for drugs and drug ingredients produced and prepared by those facilities.

2. Pharmacy business establishments and drug preparing facilities must carry out evaluations of test methods stated in drug/drug ingredient quality standards published and applied by the drug manufacturers. Assessment and evaluation of test methods are carried out in accordance with guidelines for assessment of analytic processes by ASEAN or ICH, specified in the Circular on Registration of Drugs and Drug Ingredients promulgated by the Minister of Health.

3. The Ministry of Health organizes document assessment and approval of drug/drug ingredient quality standards, in accordance with regulations on drug/drug ingredient registration, issuing permits for drugs /drug ingredients which do not have prior registrations for circulation.

Article 4. Application of pharmacopeia

1. Application of Vietnam’s pharmacopeia and reference pharmacopeias:

a) Pharmacy business establishments and drug preparing facilities can apply Vietnam’s pharmacopeia or one of the following reference pharmacopeias: European, British, United States, International, and Japanese;

b) The application of standards of the pharmacopeias specified in Point a of this Clause must include all regulations on quality criteria, quality levels and test methods specified in the respective drug/drug ingredient’s treatise in the chosen pharmacopeia; also including regulations on quality criteria, quality levels and test methods specified in the appendix of that pharmacopeia;

c) If the manufacturer announces its application of one of the pharmacopeias specified in Point a of this Clause, but adopt test methods different from the ones specified in the drug/drug ingredient’s treatise in the chosen pharmacopeia, the manufacturer must prove their chosen methods equivalence to the pharmacopeia’s methods. The test results from the methods stated in the pharmacopeia are the basis for evaluation of drug quality;

d) For herbal drugs, pharmacy business establishments and drug preparing facilities can apply the pharmacopeias specified in Point a of this Clause or the pharmacopeia of the drug’s country of origin.

2. Application of pharmacopeias other than the ones specified in Point a of this Clause:

If the pharmacy business establishment or drug preparing facility decides to apply a pharmacopeia other than ones specified in Point a of this Clause, the applied quality standards must at least:

a) Meet the requirements of quality criteria and levels specified in the respective quality criteria’s treatises in Vietnam’s pharmacopeia or one of the aforementioned reference pharmacopeias;

b) The applied common test methods must be appropriate for the equivalent common test methods stated in Vietnam’s pharmacopeia or one of the reference pharmacopeias specified in Point a of this Clause.

Article 5. Application of internal standards

1. The internal drug/drug ingredient standards must conform to the regulations specified in Point b, Clause 2, Article 102 of the Law on Pharmacy, as follows:

a) Meet the requirements of quality criteria and levels specified in the respective treatises in Vietnam’s pharmacopeia and quality criteria, quality levels and common test methods specified in the appendix of Vietnam’s pharmacopeia;

b) If Vietnam s pharmacopeia or the reference pharmacopeias specified in Point a, Clause 1, Article 4 of this Circular do not have any treatise for the required drug/drug ingredient, the facility shall form the standard using the scientific research results (also including the product development research results) or the regulations in other foreign pharmacopeias as the basis.

2. The internal standards of drugs prepared in medical facilities are formed and evaluated for appropriateness by the facility, and promulgated by the facility s head.

Article 6. Update of quality standards and application of updated pharmacopeia

1. When applying for circulation (or circulation extension) of a drug/drug ingredient: The quality standards of that drug/drug ingredient must conform to one of the following pharmacopeias at the time of application:

a) The pharmacopeia’s latest edition;

b) The pharmacopeia’s previous editions which did not come more than two years before the current edition.

2. In the case of drugs or drug ingredients that have already been allowed for circulation: For a maximum of two years from the effective date of the pharmacopeia’s latest edition, the applier or manufacturer have the responsibility to update the standards of drugs/drug ingredients as regulated by that edition.

3. During drug/drug ingredient circulation, if the applier or manufacturer finds any factor that severely affect drug safety, quality or efficacy or is requested by the Ministry of Health (Drug Administration), the manufacturer must the update the drug/drug ingredient standards’ criteria in order to bring that factor under control.

Chapter III

DRUG/DRUG INGREDIENT TESTS

Article 7. Drug/drug ingredient tests

1. The test must be carried out in accordance with the approved and updated drug/drug ingredient quality standards.

If the drug/drug ingredient quality standard is not updated, the testing facility shall use the equivalent pharmacopeia specified in Clauses 1 and 2, Article 6 of this Circular, based on the production date of the drug/drug ingredient being tested.

If the drug is prepared in a medical facility, the test is carried out in accordance with the drug quality standards formed and promulgated by the facility.

2. The collection of drug/drug ingredient samples for testing is carried out in accordance with Appendix I and the sample collection form in Form No. 1 of Appendix III issued together with this Circular.

3. Presenting drug/drug ingredient test/analysis results:

a) The drug/drug ingredient test and analysis results are shown on the test/analysis report based on Samples No. 2 and No. 3 shown in Appendix III issued together with this Circular;

b) The testing facility must present the test/analysis results of the drug sample, which was collected by the quality inspection authority, in no more than 15 days after receiving the drug sample, in the following cases:

- There is information on severely adverse effects of the drug;

- The drug comes from a facility committing serious violations against good practice;

- Additional samples of the drug are collected in the cases mentioned in Point b, Clause 1 and Point b, Clause 2 of this Circular s Article 14.

b) The testing facility must present the test/analysis results of the drug sample in no more than 20 days after receiving it in the following cases:

- The drug requires testing before circulation, as specified in Clause 1, Article 8 of this Circular;

- The drug does not fit any of the cases mentioned in Points b and d of this Clause.

d) The testing facility must present the test/analysis results of the drug/drug ingredient sample in no more than 30 days after receiving it in the following cases:

- The drug/drug ingredient has test methods that require long testing time;

- The drug/drug ingredient requires re-testing or reevaluation of results.

- The drug/drug ingredient has dubious contents or quality, which require test methods other than the ones stated in the registered quality criteria;

- The drug/drug ingredient requires test methods that the testing facility is incapable of conducting (e.g. lack of equipment, chemical, reagents, reference material).

dd) If the deadlines mentioned in Points b, c and d of this Clause are not met, the testing facility has to explain the reason for lateness in a document attached to the test/analysis report;

e) In 24 hours from the time the test/analysis report is issued, the testing facility must send the form to the quality inspection authority, the facilities producing or importing the drug/drug ingredient being tested on and the facility where the sample was taken from.

If the drug/drug ingredient sample does not meet the quality standards, in 24 hours from the time the test/analysis report is issued, the testing facility must notify the Ministry of Health (Drug Administration) of that sample in writing with the test/analysis report attached, both physical and electronic copies (the latter, which is scanned, can be sent to the email address [email protected] or via messaging to the Drug Administration s phone number, with both methods of correspondence using the testing facility s official email address and phone number). A similar notification must also be sent to the Department of Health whose jurisdiction is where the tested drug/drug ingredient comes from.

g) In the case of the drug/drug ingredient sample is sent by a pharmacy business establishment, a facility using it, an organization or an individual for analysis, testing or drug/drug ingredient quality standard assessment, the time of result presentation shall be agreed upon by the parties.

4. Filing and handling of complaints about test results:

a) If there is disagreement with the sample’s test results, in five days from the date the test results are received, the pharmacy business establishment has the right to request the quality inspection authority to assign another testing facility to carry out drug/drug ingredient quality tests/analyses;

b) Re-testing of challenged quality criteria is carried out at the testing facility designated by the Ministry of Health, as specified in Clause 2, Article 105 of the Law on Pharmacy.

5. Retention of samples:

a) The drug/drug ingredient sample must be retained after testing and quality conclusion. The retained sample must be sealed up and preserved as specified in the conditions on the label.

b) Sample retention period:

- In the case of drug/drug ingredient production and importers: the finished product s sample must be retained for a minimum of 12 months after product s expiry date; the active ingredient’s sample must be retained for a minimum of 12 months after the expiry date of the finished product prepared from that ingredient.

- In the case of drug testing facilities: the sample retention period is at least 12 months after the drug’s expiry date, or 24 months after the sample collection date for drug samples collected for quality inspection; or after the date of receipt for additional collected samples specified in Point b, Clause 1 and Point b, Clause 2, Article 14 of this Circular.

6. Archiving records and documents:

a) The records and documents on drug/drug ingredient quality inspection must be archived as specified in the Law on Archives and relevant guiding documents;

b) The records and documents on narcotic, psychiatric, precursor and radioactive drugs/drug ingredients must be archived for a minimum of two years from the expiry dates.

c) After the end of their archive periods, the records and documents shall be handled in accordance with present regulations.

Article 8. Pre-circulation test for drugs specified in Clause 4, Article 103 of the Law on Pharmacy

1. Drugs that belong to one of the following categories must undergo testing carried out by a testing facility designated by the Ministry of Health (Drug Administration) before circulation:

a) The drugs specified in Points a and b, Clause 4, Article 103 of the Law on Pharmacy;

b) Biologicals which are derivatives of human blood and plasma;

c) Imported drugs specified in the Government’s Decree No. 54/2017/ND-CP on detailing a number of articles of, and providing measures for implementing, the Law on Pharmacy dated May 8, 2017;

d) Drugs produced by foreign manufacturers on the list of manufacturers with drugs that do not conform to quality standards, published by the Ministry of Health (Drug Administration).

2. Regulations on drug quality tests:

a) Drug sample collection

- The samples of the drugs specified in Points a, b, c, Clause 1 of this Article shall be collected by manufacturers (in case of domestic drugs) or importers (in case of imported drugs);

- The facilities importing he drugs specified in Point d of this Article shall request the state’s quality inspection or testing authority for to collect samples of those drugs.

b) The importer shall send the drug sample alongside a copy of the producer’s test report to the testing facility specified in Clause 3 of this Article for drug quality inspection in accordance with the approved drug quality standards;

c) Facilities producing or importing vaccines, biologicals which are antisera, derivatives of human blood and plasma mentioned in Points a and b, Clause 1 of this Article shall send the sample as specified in Articles 10 and 11 of this Circular;

d) The testing facility must present the received sample’s test results within the time limit specified in Point c, Clause 3, Article 7 of this Circular.

3. The Ministry of Health (Drug Administration) shall designate a testing facility which is granted certificates of eligibility for pharmacy business including drug testing, or testing facilities specified in Clause 1, Article 35 of the Law of Medicine meeting GLP requirements, to carry out drug tests specified in Clause 1 of this Article.

If the testing facility does not have sufficient capacity for carrying out one or multiple test methods, the testing facility must notify the production/importer and cooperate with the latter in sending samples to other GLP-compliant testing facilities or laboratories compliant to ISO/IEC 17025 which have capacity for carrying out those test methods.

4. The designated testing facility report testing activities to the Ministry of Health (Drug Administration) on a monthly basis, following Form No. 7 of Appendix III issued together with this Circular.

5. The Ministry of Health (Drug Administration) publishes and updates the list of designated testing facilities mentioned in Clause 3 of this Article on the Drug Administration’s website.

6. The production/importer has the responsibility to:

a) Pay its expenses for drug quality tests;

b) Provide reference materials (including those of impurities) to the testing facility if the National Institute of Drug Quality Control, the Institute of Drug Quality Control Ho Chi Minh City, the National Institute for Control of Vaccines and Biologicals or other testing facilities fail to establish;

c) Circulate and distribute the drugs only after their test results show conformity to quality standards.

7. Tests on vaccines, biologicals which are antisera, derivatives of human blood and plasma are carried out in accordance with Articles 10 and 11 of this Circular.

Article 9. The testing periods for facilities on the list of manufacturers with drugs that do not conform to quality standards and withdrawal from that list

1. The testing period starts from the first drug batch s import date after the Ministry of Health (Drug Administration) publishes the list of manufacturers with drugs that do not conform to quality standards and lasts:

a) 6 months for the manufacturer having one drug batch with third-degree violation;

b) 12 months for the manufacturer having one drug batch with second-degree violation or two or more drug batches with third-degree violations;

c) 24 months for the manufacturer having one drug batch with first-degree violation or two or more drug batches with second-degree violations;

d) If the manufacturer continues having uncomformable drugs, the total testing period shall be the sum of individual drugs’ periods.

2. A manufacturer will be withdrawn from the list of manufacturers with drugs that do not conform to quality standards after meeting the following requirements:

a) The manufacturer completes all drug tests before circulation within the time limit specified in Clause 1 of this Article;

The drug manufacturer/registrant files reports which follow Form No. 7 of Appendix III issued together with this Circular, with proof of test on all imported drug batches carried out during the implementation of Clause 1 of this Article;

c) The manufacturer has no drug quality violation (including voluntary drug recall due to quality) during the implementation of Clause 1 of this Article.

3. On a monthly basis, the Ministry of Health (Drug Administration) publishes and updates the list of manufacturers with drugs that do not conform to quality standards, drops the names of facilities complying with the regulations this Article s Clause 2 from the list based on reports from testing facilities that participate in testing activities, drug manufacturers and registrants.

Article 10. Test on vaccines, biologicals which are antisera, derivatives of human blood and plasma

1. The production/importer must send the samples and production records of vaccines, biologicals which are antisera, derivatives of human blood and plasma to the National Institute for Control of Vaccines and Biologicals for testing and evaluation before circulation. The sample sending documents are specified in Article 11 of this Circular.

The production/importer must only circulate vaccines, biologicals which are antisera, derivatives of human blood and plasma after the National Institute for Control of Vaccines and Biologicals confirms the vaccine/biological batches quality, safety and efficacy and issues quality certificates.

2. Within the time limit specified in Clause 3, Article 7 of this Circular, from the date all samples and documents specified in Article 11 of this Circular are received, National Institute for Control of Vaccines and Biologicals shall:

a) Review the records and conduct tests on the vaccine/biological samples received;

b) Issue quality certificates which follow Form No. 8 of Appendix III issued under this Circular, in which the requirements that are met and which requirements are not, alongside conclusions on the vaccine/biological batch s quality, safety and efficacy;

c) Notify the Ministry of Health (Drug Administration) of the test results.

Article 11. Test samples and records for evaluation of quality, safety and efficacy of vaccines, biologicals which are antisera, derivatives of human blood and plasma

1. For local vaccines, biologicals which are antisera, derivatives of human blood and plasma: The manufacturer shall send the production records and samples from the product batches (either finished semi-finished products) to the National Institute for Control of Vaccines and Biologicals, including:

a) The sample sending form;

b) The vaccine/biological samples to be test on (the number of samples for each kind of vaccine/biological is specified in the Guidelines for testing finished vaccines, biologicals which are antisera, derivatives of human blood and plasma);

c) The records summarizing the vaccine/biological batch’s production and quality tests (copies certified by the manufacturer);

d) The manufacturer’s batch test report.

2. For imported vaccines, biologicals which are antisera, derivatives of human blood and plasma: The importer shall send the production records and samples from the product batches to the National Institute for Control of Vaccines and Biologicals, including:

a) The sample sending form;

b) The vaccine/biological samples to be test on (the number of samples for each kind of vaccine/biological is specified in the Guidelines for testing finished vaccines, biologicals which are antisera, derivatives of human blood and plasma);

c) The records summarizing the imported vaccine/biological batch’s production and quality tests (copies certified by the manufacturer or importer)

d) The quality certificate issued by the country of origin’s authorities for each batch of imported vaccine/biological (copies certified by the importer);

dd) The table of data on preservation conditions (cold storage) during the imported batch’s transport (certified by the importer) from automatic temperature recorders, freeze indicators (if any).

3. The manufacturer and importer must be responsible for their documents legality.

Chapter IV

REGULATIONS ON RECALL AND HANDLING OF NONCONFORMABLE DRUGS

Article 12. Compulsory drug recall procedure

1. Receiving information on unconformable drugs:

The Ministry of Health (Drug Administration) receives information on unconformable drugs as follows:

a) Information on drugs that do not guarantee effective treatment or is unsafe from the drug registration advisory board or post-vaccination complication handling advisory board;

b) Information on drug quality criteria that are not met from drug testing facilities;

c) Information on discovered unconformable drugs from the Drug Administration, Health/Pharmaceutical inspection authority;

d) Unconformable foreign drug notices from manufacturers, pharmaceutical and drug quality inspection authorities;

dd) Information on unconformable drugs from public security, customs and market surveillance;

e) Drug information from pharmacy business establishments requesting voluntary drug recall.

2. Identification of the violation’s seriousness:

a) In 24 hours from the time the information on unconformable drugs mentioned in Points a, c, d, dd and e, Clause 1 of this Article, the Ministry of Health (Drug Administration) shall identify the violation’s seriousness and draw conclusions on drug recall, based on evaluation of consumer health s risks.

If the drug registration advisory board s opinion is requested for identification of the violation’s seriousness, as specified in Section IV, Appendix II issued together with this Circular, the time limit of identification of violation s seriousness will be 7 days.

b) The seriousness of a drug’s violation is specified in Appendix II issued together with this Circular;

c) For information on unconformable drugs mentioned in Point b, Clause 1 of this Article, the handling shall be carried out in accordance with Article 14 of this Circular.

3. Issuance of drug recall decision:

a) In 24 hours from the time the conclusion on drug recall is drawn, the Ministry of Health (Drug Administration) shall issue the drug recall decision in accordance with Clause 1, Article 65 of the Law on Pharmacy;

b) The drug recall decision must include the following information: drug name, circulation registration number or import permit number, name of active ingredient, concentration, content, form of preparation, batch number, expiry date, manufacturer, importer, recall level, the facility responsible for drug recall.

4. Notification of drug recall decision:

a) The drug recall decision of the Ministry of Health (Drug Administration) is announced by post, fax, email, telephone or the mass media. The scope of drug recall announcement is specified in Clause 3, Article 63 of the Law on Pharmacy;

b) Immediately after making the recall decision, the Ministry of Health (Drug Administration) announces the drug recall decision on websites of the Ministry of Health and the Drug Administration, and the Ministry of Health’s national pharmaceutical database;

Departments of Health announce drug recall decisions on their websites immediately after receiving those decisions.

Domestic drug manufacturers and importers must notify the information about recalled drugs to drug traders/users which purchased those drugs.

c) For recalling drugs with first-degree violations, besides carrying out the actions specified in Point b of this Clause, the Ministry of Health must announce the drug recall decision on Vietnam Television and Voice of Vietnam.

5. Recalling drugs:

a) The drug trader/user must discontinue provision and use of the recalled drugs; place inventory drugs in quarantine; make a list of drug traders/users and individuals (if any) that purchased those drugs, contact them and receive the returned drugs; return the drugs to the providers;

b) The manufacturer (of domestic drugs) and importer cooperate with the import entrustor or distribution hub (of imported drugs) in recalling unconformable drugs. The recall form follows Form No. 4 of Appendix III issued together with this Circular.

The drug trader/provider that fails to recall drugs or receiving returned drugs shall be notified by facilities and individuals purchasing those drugs to the local Department of Health and face actions.

c) Drug recall has to be completed within one of the time limits specified in Clause 3, Article 63 of the Law on Pharmacy.

6. Drug recall report, evaluation and additional measures:

a) In one day (for first-degree recalls) or three days (for second- and third-degree recalls) from the recall’s date of completion, the facility in charge of recalling must report the results to the Ministry of Health (Drug Administration) and the local Department of Health in writing. The report consists of the following documents:

- Summary drug recall report, which follows Form No. 5 of Appendix III issued together with this Circular.

- List of drug traders/users (including those receiving drugs from the facility in charge of recalling unconformable drugs, or from distributors) with their addresses, phone numbers, email addresses (if any), amount of drugs received, amount of drugs recalled;

- Delivery reports, receipts of return or other evidence of drug recall;

- Drug recall self-evaluation form;

- Investigation results, evaluation of causes, evaluation of risks in the unconformable drug s other batches and/or other drugs coming from the same production line.

b) The Ministry of Health (Drug Administration) consider the report mentioned in Point a of this Clause, evaluate it or send it to the Department of Health for evaluation. If the drug recall is evaluated to be insufficient and the product can still be circulated and used, posing a risk to the consumers health, the Drug Administration cooperates with the Department of Health and other related authorities in coercive drug recall.

Article 13. Voluntary drug recall procedure

1. The pharmacy business establishment that carries out voluntary drug recall shall evaluate and identify the seriousness of the drug s violation and report on the unconformable drug, seriousness of violation, reason for recall and handling measure proposal to the Ministry of Health (Drug Administration) in writing, as specified in Clauses 3 and 4, Article 15 of this Circular.

2. In three days from the date the pharmacy business establishments’ report is received, the Ministry of Health (Drug Administration) consider the report and identify the seriousness of the drug s violation as specified in Appendix II issued together with this Circular.

a) If an agreement with the pharmacy business establishment’s proposal concerning the drug with third-degree violation is reached, the Ministry of Health (Drug Administration) shall send an document allowing the facility to voluntarily recall the drug.

b) In the case of drugs with first- or second-degree violations, the Ministry of Health (Drug Administration) shall follow the drug recall procedures mentioned in Clauses 3, 4, 5 and 6, Article 12 of this Circular;

c) If additional information or clarification of information in the pharmacy business establishment’s report is needed, the Ministry of Health (Drug Administration) shall request the establishment to provide additional information and explanations in writing. In five days from the day the Ministry of Health’s request is received, the establishment must provide additional information and explanations in writing.

3. In 24 hours from the time the Ministry of Health (Drug Administration ) issues the document allowing voluntary drug recall, the establishment can issue the drug recall decision, notify it to traders/users and carry out drug recall as specified in Clauses 5 and 6, Article 12 of this Circular.

Article 14. Handling of drugs not meeting quality standards by place of collection

1. In the case of unconformable drug samples collected from retailers, level-III and level-IV medical facilities:

a) In 24 hours from the time the testing facility’s test/analysis report is received, the Department of Health shall seal the unconformable drug at the sample’s facility of origin.

b) In 48 hours from the time the testing facility’s test/analysis report is received, the Ministry of Health (Drug Administration) shall request the responsible drug registrant/manufacturer/importer to:

- Report its drug distribution to the Ministry of Health (Drug Administration);

- Request the quality inspection authorities to collect additional samples from domestic drug manufacturers or importers, and from at least two wholesalers, with one of them already supplied drugs to the facility where the samples are collected from;

- Send samples to central testing facilities in order to have the unfulfilled criteria tested.

c) If at least one of the additional sample does not meet the quality standards, the Ministry of Health (Drug Administration) shall identify the violation’s seriousness and draw the conclusion on recalling the unconformable drug as specified in Appendix II issued together with this Circular, and issue the drug recall decision as specified in Clause 3, Article 12 of this Circular. The recall s scope and time limit is specified in Clause 3, Article 63 of the Law on Pharmacy;

d) If all of the additional samples meet the quality standards, the Ministry of Health (Drug Administration) shall only carry out the steps of identifying the violation’s seriousness, drawing the conclusion on recalling the unconformable drug, issuing the drug recall decision and drug handling to the drugs of the facility providing the initial samples.

2. In the case of unconformable drug samples collected from wholesalers, level-II or above medical facilities:

a) In 24 hours from the time the testing facility’s test/analysis report is received, the Department of Health shall seal the unconformable drug at the facility of origin.

b) In 48 hours from the time the testing facility’s test/analysis report is received, the Ministry of Health (Drug Administration) shall issue the drug recall decision applying to the province the facility of origin is based on and traders/users receiving the drug from that facility, as specified in Clause 3, Article 12 of this Article, and request the responsible trader/user/importer to:

- Report its drug distribution to the Ministry of Health (Drug Administration);

- Request the quality inspection authorities to collect at least two additional samples from other wholesale establishments, with one of them already supplied drugs to the facility where the samples are collected from;

- Send samples to central testing facilities in order to have the unfulfilled criteria tested.

c) If at least one of the additional sample does not meet the quality standards, the Ministry of Health (Drug Administration) shall identify the violation’s seriousness and draw the conclusion on recalling the unconformable drug as specified in Appendix II issued together with this Circular, and issue the drug recall decision as specified in Clause 3, Article 12 of this Circular. The recall s scope and time limit is specified in Clause 3, Article 63 of the Law on Pharmacy;

d) If all of the additional samples meet the quality standards, the Ministry of Health (Drug Administration) shall only carry out the process specified in Point b of this Clause.

3. If the sample is collected from manufacturers, importers and preservation service providers, or the sample s quality violation is identified to be caused by the production process, the Ministry of Health (Drug Administration) shall identify the violation’s seriousness and draw the conclusion on recalling the unconformable drug as specified in Appendix II issued together with this Circular, and issue the drug recall decision as specified in Clause 3, Article 12 of this Circular. The recall s scope and time limit is specified in Clause 3, Article 63 of the Law on Pharmacy.

Article 15. Handling of recalled drugs

1. The recalled drug can either be rectified or re-exported if it has third-degree violation and does not fall into the type of drug mentioned in Point b, Clause 2 of this Article.

2. The recalled drug must be destroyed if it has:

First- or second-degree violation;

b) Third-degree violation, considered by the Ministry of Health (Drug Administration) to be neither rectifiable nor re-exportable, as specified by Clauses 3 and 4 of this Article;

c) Third-degree violation, considered by the Ministry of Health (Drug Administration) to be rectifiable or re-exportable, but the facility fails to rectify or re-export that drug.

3. Procedure for proposing rectification of recalled drugs:

a) The facility that has recalled drugs shall send the Ministry of Health (Drug Administration) a document stating the rectification process, drug quality and stability risk assessment, the program for monitoring and surveillance of the drug’s quality, safety and efficacy during circulation.

b) In 60 days from the date the facility’s rectification proposal is received, the Ministry of Health (Drug Administration) must consider the proposal and reply their agreement or disagreement in writing the reason for disagreement must be specified;

c) If additional information or clarification of the rectification s information is required, in 60 days from the date the Ministry of Health’s (Drug Administration) document is received, the facility must provide documents additional information and explanations. Failure to do so within the aforementioned time limit will result in invalidation of the rectification proposal.

4. Procedure for proposing re-export of recalled drugs:

a) The facility that has recalled drugs shall send the Ministry of Health (Drug Administration) a document with the re-export plan, stating the time and re-export country;

b) In 15 days from the date the facility’s proposal is received, the Ministry of Health (Drug Administration) shall reply their agreement or disagreement on the re-export in writing; the reason for disagreement must be specified.

5. The rectification and re-export of recalled drug shall only be carried out after the written agreement of the Ministry of Health (Drug Administration) is issued.

6. Drug destruction:

a) The head of the facility that has drugs to be destroyed shall decide to form the drug destruction council. The council shall have at least three persons, with one representative having professional responsibility;

b) Drug destruction must be safe for both humans and animals, does not pollute the environment in accordance with the rules of law in environmental protection;

c) Drug destruction that requires special control must be carried out as specified in Article 48 of Decree No. 54/2017/ND-CP;

d) The facility carrying out drug destruction must notify the Department of Health, and send the Department a drug destruction form that follows Form No. 6 in Appendix III issued together with this Circular.

7. The recalled drug handling period shall not exceed 12 months from the recall’s date of completion, as specified in Points a, b and c, Clause 3, Article 63 of the Law on Pharmacy.

Article 16. Responsibilities for drug recall

1. Responsibilities of pharmacy business establishments, medical facilities and drug users:

a) Comply with the regulations in Clauses 1, 2 and 3, Article 64 of the Law on Pharmacy;

b) Regularly review and update information on drug recall from websites of the Ministry of Health, the Drug Administration, and Departments of Health.

2. Responsibilities of the Drug Administration:

a) Receive information, identify seriousness of drug’s violations and issue drug recall decisions;

b) Announce drug recall decisions as specified in Point a, Clause 4, Article 12 of this Circular, publish information about recalled drugs on websites of the Ministry of Health and the Drug Administration after those decisions are issued. Cooperate with Vietnam Television and Voice of Vietnam in announcing recall of drugs with first-degree violations;

c) Consider the evaluation reports and reply to the pharmacy business establishments’ proposals for voluntary drug recall, rectification or re-export of recalled drugs;

d) Cooperate with related units (Ministerial Inspector, Department of Health, health divisions of other agencies) in inspection of organization and execution of drug recall; take actions against violating facilities in accordance with the regulations of law;

dd) Produce documents providing detailed guidelines for the processes of drug recall and handling, evaluation of drug recall in drug manufacturers and pharmacy business establishments.

3. Responsibilities of Departments of Health:

a) Publish drug recall decisions on websites of the Departments of Health;

b) Organize announcement and dissemination of drug recall information to local drug manufacturers, pharmacy business establishments and medical facilities;

c) Cooperate with facilities having drugs with quality violations in collecting additional drug samples as specified in Point b, Clause 1 or Point b, Clause 2, Article 14 of this Circular, or direct the testing facilities to do so;

d) Organize surveillance of drug recall in the Departments’ jurisdictions; take actions against and penalize facilities violating drug recall regulations within their competence;

dd) Participate in or carry out evaluations of pharmacy business establishments’ drug recall in the Departments’ jurisdictions, under the Ministry of Health’s (Drug Administration’s) direction. Report any drug manufacturer, importer, wholesalers which are distribution hubs that fail to, or insufficiently, recall drugs to the Ministry of Health (Drug Administration)

e) Organize and participate in coercive drug recall.

Chapter V

IMPLEMENTATION PROVISIONS

Article 17. Effect

1. This Circular takes effect on June 20, 2018.

2. To annul the following documents at the effective date of this Circular:

a) The Minister of Health’s Circular No. 09/2010/TT-BYT dated April 28, 2010 providing guidance on drug quality management;

b) The Minister of Health’s Circular No. 04/2010/TT-BYT dated February 12, 2010 providing guidance on sample collection for quality identification.

Article 18. Implementation organization

1. The Drug Administration has the responsibility to:

a) Preside over and cooperate with related units in organizing propagation, dissemination and implementation of this Circular;

b) Preside over and cooperate with the National Institute of Drug Quality Control, the Institute of Drug Quality Control Ho Chi Minh City, the National Institute for Control of Vaccines and Biologicals in formulating plans to collect drug samples for quality inspection and present those plans to the Ministry of Health for consideration, approval and allocate budget for plan implementation within the Ministry’s competence.

Collect drug samples for quality inspection and update the Ministry of Health’s drug quality inspection database with information on collected drug/drug ingredient samples (including: name of drug/drug ingredient, concentration, content, type of preparation, batch number, expiry date, circulation registration number or import permit number, manufacturer, importer, sample collector) and the drug/drug ingredient’s quality inspection results;

c) Provide scientific and technical information on ensuring drug/drug ingredient quality.

Provide the National Institute of Drug Quality Control and the Institute of Drug Quality Control Ho Chi Minh City with label Forms and the quality standard of the drug/drug ingredient that is issued circulation registration certificate or import permit (the updated standard if any changes occur). In the case of vaccines and biological, the label Form and quality standard shall be sent to the National Institute for Control of Vaccines and Biologicals;

d) Organize quality inspections on drug/drug ingredients manufactured, prepared, circulated and used nationwide. Direct and survey the drug testing system nationwide. Draw conclusions on drug quality, based on the test results from state-owned drug testing facilities’ and relevant records;

dd) Preside over or participate in carrying out state inspections, inspect and take action against violations against the law in drug quality within the Administration s competence.

2. Departments of Health have the responsibility to:

a) Organize drug quality inspections within their jurisdictions and take actions against violations in accordance with the law;

b) Formulate plans to collect drug samples for quality inspection and present those plans to the provincial People’s Committees for consideration, approval and allocate budget for plan implementation within the Committees’ competence;

c) Update the Ministry of Health’s drug quality inspection database with information on collected drug/drug ingredient samples (including: name of drug/drug ingredient, concentration, content, type of preparation, batch number, expiry date, circulation registration number or import permit number, manufacturer, importer, sample collector) and the drug/drug ingredient’s quality inspection results.

3. Responsibilities of the drug testing system:

a) Central drug testing facilities (National Institute of Drug Quality Control, Institute of Drug Quality Control Ho Chi Minh City, National Institute for Control of Vaccines and Biologicals):

- Analyze and test samples to identify the quality of manufactured, circulated and used drugs/drug ingredients; report the test results to the Ministry of Health (Drug Administration) and the local Department of Health;

- Research, establish and publish on websites of the institute and the Drug Administration the list of reference materials (including those of impurities) for analyses and tests on manufactured, imported, circulated and used in Vietnam;

- The National Institute of Drug Quality Control and the Institute of Drug Quality Control Ho Chi Minh City have the responsibility to provide drug testing centers in assigned provinces with physical and electronic copies of drug/drug ingredient quality standards;

- The National Institute for Control of Vaccines and Biologicals, on an annual basis, review and evaluate vaccine/biological quality trends and present the evaluation to the Ministry of Health for consideration, and formation of guidelines for testing finished vaccines, biologicals which are antisera, derivatives of human blood and plasma (including reviewing vaccine/biological batch quality certificate’s test criteria).

Update information about quality certificate issuance for vaccines, biologicals which are antisera, derivatives of human blood and plasma on websites of the institute and the Drug Administration.

b) Provincial testing facilities:

- Analyze and test samples to identify the quality of manufactured, circulated and used drugs/drug ingredients;

- Report the test results to the Department of Health and the Ministry of Health (Drug Administration).

4. Traders have the responsibility to:

a) Organize researches and carry out implementation of the regulations of law on drug/drug ingredient quality promulgated by this Circular;

b) Implement regulations on inspection, control of drugs/drug ingredients’ source and quality. Carry out quality control in order to ensure drug/drug ingredient quality throughout the facility s operation;

c) Establish a system of records and documents in order to monitor circulation of drugs/drug ingredients. Carry out monitoring and surveillance of the quality of drugs/drug ingredients produced by the facility; timely discover and handle unconformable drugs, report those drugs to the pharmaceutical and drug quality inspection authorities.

5. When the drug quality inspection force has not yet been established at all levels, the Ministry of Health shall assign:

a) The National Institute of Drug Quality Control, the Institute of Drug Quality Control Ho Chi Minh City, the National Institute for Control of Vaccines and Biologicals, by their functions, tasks and jurisdictions, to:

- Formulate plans to collect drug samples for testing and surveillance of drug/drug ingredient quality; reserve, receive and use the annual budget for sample collection and tests on drug/drug ingredient samples;

- Collect drug/drug ingredient samples in accordance with the approved plans at establishments doing pharmacy business and using drugs;

- Update the Ministry of Health’s drug quality inspection database with information on drug/drug ingredient samples collected for quality inspection and those samples’ test results;

- Report the test results to the Ministry of Health (Drug Administration) and the local Department of Health if the drug/drug ingredient samples do not meet the quality standards as specified in Clause 3, Article 7 of this Circular.

- The National Institute of Drug Quality Control shall the drug quality inspection database for the Ministry of Health;

b) Provincial testing facilities:

- Formulate plans to collect drug samples for testing and surveillance of drug/drug ingredient quality; reserve, receive and use the annual budget for sample collection and tests on drug/drug ingredient samples;

- Collect drug/drug ingredient samples for quality inspection in accordance with the approved plans at establishments doing pharmacy business and using drugs;

- Update the Ministry of Health’s drug quality inspection database with information on drug/drug ingredient samples collected for quality inspection and those samples’ test results;

- Report the test results to the Ministry of Health (Drug Administration) and the Department of Health if the drug/drug ingredient samples do not meet the quality standards as specified in Clause 3, Article 7 of this Circular.

Article 19. Implementation responsibilities

The Director General of the Drug Administration, Chief of the Ministry Office, Chief Ministerial Inspector, heads of units affiliated with the Ministry of Health, provincial Departments of Health, pharmacy business establishments, other related authorities, organizations and individuals have the responsibility to implement this Circular.

If any complication arises during implementation, the authorities, organizations and individuals are advised to notify the Ministry of Health (Drug Administration) for consideration and solution.

For the Minister

The Deputy Minister

Truong Quoc Giang