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What is a record of cancellation of traditional medicine? Sample record of cancellation of traditional medicine? What is the guideline for drafting a record of destruction of traditional drugs? Regulations of the law on traditional medicine?

Vietnam has a long history of developing traditional medicine. And, it is undeniable that the great contributions of traditional medicine in protecting and improving people’s health as well as preventing and curing diseases. However, the increasingly widespread appearance of traditional medicines without clear origin is a matter of great concern to our Party and State. Therefore, our country has policies and regulations on the destruction of traditional drugs. The following article will help readers learn about the traditional medicine cancellation record form and instructions on how to draft this form in detail.

Lawyer Service legal advice over the phone:

1. What is a record of destruction of traditional drugs?

Vietnam is a country with many precious and rare medicinal herbs and traditional traditional medicine knowledge with many valuable remedies. development of traditional medicine. However, for medicinal products that do not guarantee quality, destruction is extremely necessary to avoid errors and serious consequences for people. Form of minutes of destruction of traditional drugs is a form of minutes issued by competent agencies to organizations and individuals producing traditional drugs that do not meet the standards.

Traditional medicine (including traditional medicine and traditional medicine) means a drug whose ingredients are herbal ingredients that are processed, prepared or mixed according to the theory and methods of traditional medicine or according to the experience of traditional medicine. folk experiment into preparations in traditional or modern dosage forms.

The form of minutes on the destruction of traditional drugs is the form of minutes made to record the destruction of traditional drugs. The form clearly states the content of the minutes, information about the destroyed traditional medicine, the reason for the destruction, etc. The form is issued according to the Circular 13/2018/TT-BYT of the Ministry of Health.

2. Sample minutes of destruction of traditional drugs:

Name of the host unit

Facility name

——-

SOCIALIST REPUBLIC OF VIETNAM

Independence – Freedom – Happiness

—————

……., day month Year…

Minutes of cancellation of traditional medicine

Implementation of decision number: date…month…year….of…. on the destruction of traditional medicines that are not of good quality or have expired.

Today, day ..month ..year at (name of drug destruction place):……

The Drug Cancellation Council was established under Decision No.…. date…. five……. of ………… include:

first ……

2 ……

3 ……

witnessed and destroyed the following drugs:

STT Name of traditional medicine, concentration, content Lot number Name of production unit Quantity of traditional medicine destroyed according to voucher Number of traditional medicines destroyed Deviant

Note

(

If there is a difference between the number of traditional drugs actually destroyed and the quantity of traditional drugs destroyed according to the voucher, the reason must be explained.)

Cancellation method: …….

Minutes of destruction of traditional medicines reported to……. This Minutes is made into… copies, each party keeps 01 copy, sends reports… copies

Participating members cancel

traditional medicine (signature, write full name, title)

Chairman of the Cancellation Council

traditional medicine

(signature, write full name)

3. Instructions for drafting a sample of a written record on destruction of traditional drugs:

– Heading:

+ Name of the managing unit, name of the establishment producing traditional drugs.

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+ Fill in all information including National title, motto.

+ The specific name of the minutes is the record of destruction of traditional drugs.

+ Information related to the time and place of making the minutes.

– Main body of the minutes:

+ Decide to cancel traditional drugs.

Information on the time and place of drug destruction.

+ Basic information about the drug cancellation council.

+ Basic information about traditional medicine.

Methods of destruction of traditional drugs.

+ Agency reporting the destruction of traditional drugs.

– The last part of the minutes:

+ Specify the time to end the meeting.

+ Sign and clearly state the full names and titles of the members participating in the destruction of traditional drugs.

+ Sign and clearly write the name of the chairman of the Council for the destruction of traditional medicines.

4. Legal provisions on traditional drugs:

– Destruction of traditional medicines is specified in Clause 6, Article 19 of Circular 13/2018/TT-BYT regulating the quality of herbal ingredients and traditional drugs issued by the Minister of Health (effective June 30) 2018), whereby:

“a) The head of the establishment whose traditional drugs are destroyed shall issue a decision to establish a drug destruction council. The Council has at least 03 people, of which 01 representative must be the person in charge of the profession;

b) The destruction of traditional drugs must ensure safety for people and animals and avoid environmental pollution in accordance with the provisions of the law on environmental protection;

c) The traditional drug destruction establishment must report together with the record of traditional drug destruction to the provincial Department of Health according to the provisions of Form No. 04, Appendix I issued together with this Circular; d) Pharmaceutical business establishments that have infringing traditional drugs must be responsible for the cost of drug destruction.”– Clause 12, Article 1 of Circular 03/2020/TT-BYT

adding cases where the recalled drug must be destroyed specified in Clause 2, Article 15 of Circular 11/2018/TT-BYT:

“Fake drugs, smuggled drugs, drugs of unknown origin or origin, expired drugs, drugs containing banned substances, drugs manufactured from raw materials that do not meet quality standards, drugs that are destroyed according to the provisions of the Decree on administrative sanctions in the health sector, the stored drug sample has expired as prescribed.”

Thus, from March 16, 2020, in addition to the cases at Points a, b, c, Clause 2, Article 15 of Circular 11, cases of counterfeit, smuggled drugs of unknown origin, origin, etc., will be withdrawn. are all destroyed.
– Circular 03/2020/TT-BYT also amends and supplements Clause 6, Article 15 of Circular 11 on the cancellation of recalled drugs.
“a) The head of the establishment whose drugs are destroyed shall issue a decision to establish a drug destruction council to organize the destruction of the drug, decide on the method of destruction, and supervise the destruction of the drug. The Council has at least 03 people, of which there must be 01 representative who is the person in charge of the facility’s expertise;

b) The destruction of drugs must ensure safety for people and animals and avoid environmental pollution in accordance with the provisions of the law on environmental protection.

The establishment whose drug is destroyed must bear all responsibility related to the drug destruction and must report together with the drug destruction minutes to the local Department of Health as prescribed in form No. this fourth.”

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The head of the establishment whose drugs are destroyed shall issue a decision to establish a drug destruction council to organize the destruction of drugs, decide on methods of destruction, and supervise the destruction of drugs. The destruction of drugs must ensure the safety of people and animals and avoid environmental pollution in accordance with the provisions of the law on environmental protection. The establishment whose drug is destroyed must bear all responsibility related to the drug destruction and must report together with the drug destruction minutes to the local Department of Health as prescribed in form No. (In this case, the establishment does not have to send a written request to cancel the drug to the Department of Health and proceed to destroy it like a regular drug).

Article 18

Circular 11/2018/TT-BYT regulating the handling of traditional drugs that do not meet quality standards:

“first. In case the infringing traditional drug sample is taken by the quality inspection agency at a drug retailer, class III or class IV medical examination and treatment establishment:a) Within 24 hours from the time of receiving the test report or analysis sheet sent by the testing establishment, the Department of Health shall seal up the inferior quality traditional medicine at the sampling establishment;b) Within 48 hours from the time of receiving the test report or analysis sheet issued by the testing establishmentehi to, the Ministry of Health (Department ofher Traditional Medicine and Pharmacy Administration) requests in writing to the registration establishment, manufacturing facility orliveimport

n

You are responsible for:– Report on the distribution of traditional drugs to the Ministry of Health (the Administration of Traditional Medicine and Pharmacy);– Request the quality inspection agency to take additional samples at domestic traditional drug manufacturers or importers.n u for drugs

drive

transmission abroad and at the wholesale establishment;– Send the sample taken to the central level testing facility to check the quality for the unsatisfactory criteria. c) In case at least 01 (one) additional sample of traditional medicine is taken and fails to meet quality standards, the Ministry of Health (the Department of Management of Traditional Medicine and Pharmacy) shall determine the extent of the violation and conclude on the collection. recovery medicine

drive

Communicating violations as prescribed in Appendix II issued together with this Circular, issuing a decision on recall of traditional drugs according to the provisions of Clause 3, Article 16 of this Circular;d) If the additional samples of traditional drugs meet quality standards, the Ministry of Health (the Department of Traditional Medicine and Pharmacy) will only determine the extent of the violation and conclude on the recall of traditional drugs. and issue a decision on drug recall for the establishment that took the initial sample. 2. In case the sample is taken by the quality inspection agency at the wholesaler, the

liveMedical examination and treatment class II or higher:a) Within 24 hours from the time of receiving the test report or analysis sheet sent by the testing establishment, the Department of Health shall seal the collectionohtraditional c does not meet the quality at the facility

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intook samples;b) Within 48 hours from the time of receipt of the ballot eh? Test results or analysis sheets sent by testing establishments, the Ministry of Health (the Department of Traditional Medicine and Pharmacy) issues a decision to recall traditional drugs in the province.

central cities

the place of sampling as prescribed in Clause 3, Article 16 of this Circular and request in writing the registrar, manufacturer or importer to:

– Report on drug distribution to the Ministry of Health (the Administration of Traditional Medicine and Pharmacy);– Request the quality inspection agency to take additional samples of at least 02 samples of traditional drugs at other wholesalers; – Send the sample taken to the central testing facility to check the quality of the samples

depend on

target is not met.

c) In case at least 01 (one) additional sample of traditional medicine is taken and fails to meet quality standards, the Ministry of Health (the Department of Management of Traditional Medicine and Pharmacy) shall determine the extent of the violation and conclude on the collection. recalling infringing traditional drugs according to the provisions of Appendix II issued together with this Circular, and issuing a decision on recalling infringing traditional drugs nationwide according to the provisions of Clause 3, Article 16 of this Circular;d) If the additional samples of traditional drugs meet quality standards, the Ministry of Health (the Department of Traditional Medicine and Pharmacy) will only determine the extent of the violation and conclude on the recall of traditional drugs. and issue a decision on recall of traditional drugs to the establishment that took the initial sample in the province or centrally run city where the sample was taken.3. If the sample of traditional medicine is taken by the quality inspection agency at the manufacturer, importer or service provider b.

hero If a sample of traditional drugs is stored or samples are determined to be in violation of quality due to causes during the production process, the Ministry of Health (the Administration of Traditional Medicine and Pharmacy) determines the extent of the violation and concludes on the recall of the drug. traditional medicine in violation according to the provisions in Appendix II issued together with this Circular, issue a decision on recalling the infringing traditional medicine according to the provisions of Clause 3, Article 16 of this Circular.4. In case the infringing traditional drug is a traditional medicine manufactured by a medical examination and treatment establishment as prescribed in Clauses 1 and 2, Article 70 of the Law on Pharmacy, the Ministry of Health (the Department of Traditional Medicine and Pharmacy Management) ) assess and determine the extent of violations and issue a decision on recall of traditional drugs in accordance with Clauses 2 and 3, Article 16 of this Circular. The decision to withdraweh i go to the hospital and WILL

liveThe health department of the province where the medical examination and treatment establishment operates to recall traditional drugs.”

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