Chương III Thông tư 11/2018/TT-BYT: Kiểm nghiệm thuốc, nguyên liệu làm thuốc

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 Template 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 Template 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 Template 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 Template 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.