Circular 44/2014/tt-Byt: Drug Registration Regulation

Original Language Title: Thông tư 44/2014/TT-BYT: Quy định việc đăng ký thuốc

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MINISTRY OF HEALTH
Number: 44 /2014/TT-BYT
THE SOCIALIST REPUBLIC OF VIETNAM.
Independence-Freedom-Happiness
Hanoi, November 25, 2014

IT ' S SMART

Prescriptions for drug registration

_____________

The Code of Pharmacy. 34 /2005/QH11 June 14, 2005;

Base of Protocol 63 /2012/NĐ-CP August 31, 2012 of the Government stipulated the function, mandate, jurisdiction and organizational structure of the Ministry of Health;

On the recommendation of the Director of the Department of Pharmacology and the Department of Equipment and Medical Works,

The Minister of Health Department of Health provides for the registration of the drug.

Chapter I

COMMON RULES

What? 1. The adjustment range

It provides the registration of the drug used by the Vietnamese.

What? 2. Explain the word

In this Information, the words below are understood as follows:

1. The medicinal drug is a substance that contains the material that determines the composition, formula, purity.

2. The new activity is active in the composition of the drug first registered in Vietnam.

3. generic drugs are a licensed product that is produced without a licensed company ' s license to be invented and introduced to the market in an attempt to replace an invention drug after patents or monopoles have expired.

4. The franchise drug is the drug of a domestic or foreign manufacturing facility that has been issued by the number of registered regioners in Vietnam or abroad transferred the production rights to another facility in Vietnam that has qualified for the production of drugs.

5. The commercial name of the drug is the drug named differently from the original name or generic name.

6. ASEAN Joint Technical Profile (ACTD) is a document-registration document that meets the general technical requirements of the Association of Southeast Asian Nations (ASEAN) defined at the Appendix I Common ASEAN Technical Profile and the accompanying technical guidelines issued by the ASEAN Association. Come on.

7. The big change is that the changes have a pronounced effect, directly to the quality, safety and effectiveness of the drug, which is regulated at Appendix II major changes, small changes, other changes applicable to the drug that has issued an issued number of issued registration issued by the Information. Hey.

8. Small changes are those that do not affect or affect very little to the effect, quality and safety of the drug, which is regulated at Appendix II major changes, small changes, other changes applicable to the drug that has issued an accompanying issue registration number. This is private.

9. Other changes are the changes that do not vary, small changes specified in Appendix II major changes, minor changes, other changes applicable to the drug-issued issued by this message.

10. The drug registration facility is the name of the filing of the filing license application, filing an updated or changing document of the drug that has been granted the registration number.

11. The drug production facility is the basis of performing at least one production or carrying out the quality test to export the batch.

What? 3. Request, rights and responsibilities for the drug registration facility.

1. The drug registry must meet the following request:

a) There is a qualified certificate of drug business in Vietnam if it is a Vietnamese drug business facility.

b) There is a production permit, a drug business administered by the state governing body of foreign authority and the license to establish a representative office in Vietnam if it is a foreign drug business facility. In the absence of a license to establish a representative office in Vietnam, the foreign drug business facility must authorize Vietnamese drug business to register.

2. The Drug Registry has the following rights:

a) Being instructed on the registration of the drug, which is known for the drug-related information due to the registration of the registration name;

b) It is recommended to withdraw the registration number of the drug due to the registration of the registration name according to Form 01 /TT issued by this message;

c) To be lodged with the administrative decisions of the state governing body having jurisdiction regarding the granting of registration of the drug circulating under the law of the complaint of the complaint.

3. The Drug Registry has the following responsibilities:

a) Secure the quality, safety, effectiveness of the drug and ensure that the drug is correct with the registration profile;

b) Provide full and accurate all of the data, reports, and information related to the drug when applying for registration, during the registration process as well as the process of saving the drug or when required by the state regulator;

c) Update the information related to the quality, safety and efficacy of the drug in case these information is not in the file filed or are in the process of the appraisal of the case; the information, changes of the drug circulated compared to the registration records. In the time the registration number is in effect, even the changes that are not part of the changed items must be registered in Appendix II issued by this message;

d) During a maximum period of 07 (seven) working days, it must be notified to the Department of Pharmacology or the Department of Equipment and Medical Works (for the diagnostic in vitro) and relevant state regulatory agencies in the case of drug-registered drugs. In Vietnam, the force is revoked in any country in the world, stating that the reason is revoked;

In conjunction with the import facility, the production base recovered on the market of drugs that does not guarantee quality, safety, effectiveness at the request of the state regulator or by the registry itself, the production facility finds; reports the results of the recall and the proposal. It's a homicide.

e) A written report on December 15 annually for the Department of Pharmacology or the Department of Equipment and Medical Works (for the diagnostic in vitro) the registered drug item is circulated; the rationale for the cases of the drug was registered. is not produced (for domestic drugs) or is not imported (for foreign medicines) by Form 02 /TT issued by this message.

g) Save enough records and provide records for the state governing body with jurisdiction when required;

h) Co-operation and facilitation of the implementation of the inspection, evaluation of the production base when informed by the Department of Pharmacology or the Equipment and Medical Works Department (for the diagnostic in vitro);

i) Must change the registration basis for the medicines due to the registration of the registered registration name at the Appendix II issued with this Notice during the maximum period of maximum 1 (a) month, since the date of the suspended registration base or the state governing body is available. the authority to end the operation.

l) Coordinate with the manufacturer to conduct research or provide additional information related to the registered drug when there is suspicion or evidence related to the safety of the drug during circulation at the request of the state regulator.

What? 4. Request, rights and responsibilities for the drug production facility.

1. The basis of the drug production must meet the following requirements:

a) The domestic drug production facility must have a Certificate in Medication Business and Certification Certification Standard "Good Practice Production" (GMP) on the course of a GMP application of the Ministry of Health or a Certificate of Business condition. The drug on the basis of the production facility must be able to judge the production conditions when the certificate level is eligible for the prescribed drug business at Section 8 Article 1 of the Census. 89 /2012/NĐ-CP 24/10/2012 of the Government amended, adding some of the provisions of the Digital Protocol 79 /2006/NĐ-CP August 9, 2006, the government rules out certain provisions of the Law.

b) The foreign drug production facility must achieve the standard "Good practice of producing drugs"-GMP is equivalent or higher than the principle, the "Good Practice of Drug Practice" standard according to the World Health Organization (GMP-WHO) recommendation. The case of the standard recognition certificate "Good practice of drug production-GMP" or pharmaceutical product certificates-CPP does not specify a production base that reaches the principle, the GMP-WHO standard, the registration facility must provide evidence of proof of principle, consumption. The GMP standard that the manufacturing facility has achieved is no lower than the principle, the GMP-WHO standard. For the diagnostic product in vitro, the production base must achieve the standard GMP or ISO standard or other certificate of certification. In the case of suspicion of manufacturing or quality of drugs, the Department of Pharmacy or the Department of Equipment and Medical Works (for the diagnostic product in vitro) will conduct a pre-or-or post-production basis review assessment. Go.

c) The drug must be produced at the correct basis for a production license issued by the state authority, which is not produced in other facilities in the form of the license of the production license (Loan Licence).

2. The basis of the drug production has the following rights:

a) Being instructed on the registration of the drug and is known of the information related to the drug produced by the production facility in Vietnam;

b) It is recommended to withdraw the registration number of the drug produced by the production base in the case of a drug problem with quality, safety, and efficacy affecting the health of the user without necessarily having the consent of the drug registry according to Form 01 /TT issued by this message;

c) Being lodged with the administrative decisions of the state agency with jurisdiction regarding the granting of registration of the drug circulating under the rule of the law of the complaint;

d) Being offered to change the basis of the other subscription to the underlying government drugs in case the registration base does not implement the regulation at the point of paragraph 3 Article 3 This message.

3. The basis of the drug production has the following responsibilities:

a) Secure the quality of quality, safety, effective effectiveness with registered records that have been reviewed by the Ministry of Health;

b) Coordinated with the import facility, the recovery facility on the market of drugs that does not guarantee the quality, safety, effectiveness at the request of the state governing body with jurisdiction or due to the basis of registration, the production facility finds; report results the recovery and the process of processing;

c) Coordinate with the drug registration facility that performs regulatory content at the point, h and k paragraph 3 Article 3 This message.

d) Preparing full media, working conditions for inspection, evaluation of the production facility when required by the Department of Pharmacology or the Department of Equipment and Medical Works (for the diagnostic in vitro);

What? 5. Required for the concession facility and the recipient of the drug production rights, the drug produced in public form.

1. For pharmaceutical drugs, vaccines, blood serum containing antibodies, medical students: franchised basis and delivery of the right to produce the standard GMP-WHO standard; for students diagnosed in vitro: must achieve the standard GMP, ISO or other standards. It ' s different.

2. For the drug in medicine, medicine from pharmaceuticals, raw materials:

a) The overseas franchisor must reach the GMP-WHO standard. The domestic franchise facility carried out the implementation of the Ministry of Health ' s GMP application;

b) The franchisor execution facility pursues the deployment of the Ministry of Health ' s GMP.

3. For the production drug in the form of macho macho, executed by regulation at Digital Notice 23 /2013/TT-BYT August 13, 2013, the Minister of Health's Guide to the Department of Public Health.

What? 6. Request for drug testing in registration records.

1. For medicinal drugs, medical delivery, medical medicine, medicine from pharmaceuticals.

a) The basis of the drug production that achieves the standard self-appraisal, testing, and testing of the manufacturing base itself to file registration;

b) The case of a drug-producing facility in the country has not yet reached the standard GMP, the drug registry must conduct a standard appraisal and test the testing of one of the state ' s drug testing facilities in the Central or Enterprise as a service. Drug testing is issued with a Certificate in Certificate of Drug Business.

2. For the vaccine, serum containing antibodies, the diagnostic product in vitro.

a) The vaccine registry, the serum containing antibodies to conduct the standard appraisal and examination of the testing of the National Institute of Vaccine Control, medical care;

b) The diagnostic product registration facility in vitro is used by the government's own test base to file registration records if the production base reaches the GMP standard or other standards equivalent. Where the manufacturing base has not yet reached the standard of GMP or ISO standard or other standards equivalent, the registry must conduct a standard appraisal and test of the testing of the National Institute of Vaccine Control, medical delivery.

3. During the appraisal of the drug registration filing, the drug registration facility must redefine the standard and test method at the test facilities specified by the Ministry of Health for regulation cases at Annex III issued by this Information.

What? 7. Request for safety, effectiveness of medication

1. The new drug when registration is filed in Vietnam must perform a prescribed clinical trial at No. 1. 03 /2012/TT-BYT 02/02/2012 of the Minister of Health guidance on clinical trials on clinical trials.

2. The drug was issued for the first time in circulation but requires a tracking, safe assessment, efficacy in the process of circulation, registration base, and examination facility, the cure for the use of the drug to carry out the safety report, the effectiveness of the drug when filing a case. registration is again following the following regulation:

a) The registry base in coordination with the production facility (the case of the registration facility that is not the basis of production) is responsible for reporting safety, effectiveness of medications according to Section 03A/TT issued by this message and sent to the Ministry of Health (Bureau of Pharmacy or Pages of Pages). appliances and medical works (for biodiagnostic in vitro) and perform the storage of records, documents related to safety reports, effectiveness of the drug.

b) The disease examination facility, cure for the use of prescription drugs, assess safety, efficacy assessment, efficacy reporting the situation using the number 03B/TT issued by this message and sent to the Department of Health (Bureau of Pharmacy or Equipment) Medical works (for the diagnostic in vitro); carry out the storage of records, documents related to the report of the use of the drug to serve the test, effective evaluation, safety of the drug.

What? 8. Request for fertility and the biological equivalent of medicine

The filing of the feasibility study metrics and the biological equivalent of the circulating registered drug is carried out as prescribed by the filing of the application of the available research data, the equivalent of the regulation biology at the Digital Information. 08 /2010/TT-BYT April 26, 2010, of the Minister of Health, the guidelines report the number of available biomedical research, equivalent to biology in the drug registry.

What? 9. Drug registration forms

Pharmaceuticals, medical students, vaccines, blood serum containing antibodies, biotherapy in vitro, medical medicine, medicine from pharmaceuticals, raw materials that are registered in the following forms:

1. First registration applies to the drug belonging to one of the following cases:

a) The drug has not yet been registered in circulation in Vietnam;

b) The drug has been registered by the number of regioners in Vietnam and in the period the registration number is valid but there is another change under the regulation at Appendix II issued by this message or when the registration number expires must require a first registration;

c) The drug has been registered in Vietnam but does not submit the case in the correct time filing a reregistration or accession term by regulation at paragraph 2 Article 12 of this time when the registration number expires.

2. Subscription applied to the drug has been registered with the registration number but the registration number expires and does not meet the condition to register the specified extension at paragraph 3 This.

3. The application extension applied to the drug has been given the first registration number or the drug has been re-registered but expires and meets the following requirements:

a) Pharmacochemistry, medical medicine, medication from pharmaceuticals and raw materials:

-Has been granted a registration number valid for five years when registering for the first time or re-registering and having a circulation in the market after being granted a registration number.

-First registration records, registered rescriptions made in accordance with the ACTD or ICH-CTD template and the ASEAN Technical Guide to Pharmaceuticals or by Regulation at No. 1. 22 /2009/TT-BYT September 24, 2009, of the Secretary of Health on September 24, 2009, the Secretary of Health provides for drug registration for drug-based drugs, drugs from pharmaceuticals and medicine (registration records for the first time filed after 24 May 2010 or registration records filed after 1 January 2012).

-Not one of the specified cases at Article 32, Article 33 of this.

-There is not any recommendation by the World Health Organization or of the Vietnam or Vietnam Pharmacy management agency or abroad on the therapeutic effectiveness during the period of accession registration.

-Do not have any changes, additions at the time of filing a renewal register and during the appointment of the renewal registration case.

b) Vats, medical students, blood serum containing antibodies, bio-diagnos in vitro:

-Has been granted a registration number valid for five years when registering for the first time or reregistering and having a circulation in the market after being granted a registration number;

-The first registration record or registration has taken as specified by the specified Number of Information. 22 /2009/TT-BYT November 24, 2009, of the Secretary of Health for the United States Secretary of Health for the registration of the drug (registration records for the first time filed after 24 May 2010 or the registration records filed after 1 January 2012).

-Do not belong to one of the specified cases at Article 32, Article 33 This Information;

-There is not any recommendation by the World Health Organization or of the Vietnamese or foreign or foreign medicine governing body either in terms of treatment effectiveness or use during the period of accession registration;

-Do not have any changes, additions at the time of filing a renewal register and during the appointment of the renewal registration case.

c) A drug may be considered to be renewed several times if the full response of the regulation requirements at this point a or b.

4. Register for change, the addition applicable to a drug has had the number of registration but changes, additions in the time the registration number is in effect as specified in Annex II issued this message.

When there are changes or additions at the request of the Registration Level Advisory Council, the registration facility in coordination with the production base makes an update, supplemally in the right direction of the competent state governing body and is responsible for its internal affairs. It changed without having to file a change registry.

What? 10. Place the drug

1. The Ministry of Health encourages registered facilities to use the drug name in the common name International (INN).

2. The case does not name the drug after the INN name, the drug registry may name a trade name for the drug. The commercial name of the drug must ensure the following principle:

a) Not to override the therapeutic effect of the drug;

b) Not to miswrite the therapeutic effect and the pharmacological effect of the drug;

c) Do not violate the customs, customs, traditions of Vietnam;

d) Not to cause conflict with individual intellectual property subjects, other organizations being protected;

No match or similar to the drug name has been given the registration number of another facility.

e) Not to be named the same drug if the drug has a different active ingredient.

g) No different drug names in the case of the drug have the same cellular formula, the same production process of the same manufacturer.

What? 11. Language, profile form, drug sample and waste fee

1. The language used in the registration profile:

a) A registered drug registry in the country must be written in Vietnamese;

b) Foreign drug registration records must be written in Vietnamese or English. In English writing, the information in the Guide to the Use of the Drug and the Summary of the Product must be translated into the Vietnamese language.

2. The drug registration filing must be prepared on the A4 gauge, closing certain. The profile must be arranged in accordance with the order of the index, which has a split between the sections. The sections must be evaluated in order to be easy to reference and have the confirmation of the registry or the basis of the drug production at the first page of each part of the entire profile.

3. Each pill must have its own registration record, unless the drug case contains all the following factors that can be registered in the same profile:

a)

b) The form of a cell;

c) The formula for a dose unit (for single-dose form) or the same concentration of content (for multi-dose medication);

d) Producer.

4. General requests for documents to be filed in the first registration records, reregistration, renew registration, other change registration is as follows:

a) 01 (one) the original full of the prescribed profile at paragraph 1 and 2 Article 16 This is for pharmaceuticals, vaccines, blood cells containing antibodies, medical students (except for the diagnostic in vitro), paragraph 1 and 2 Article 21 This information for the organism. diagnostive in vitro and paragraph 1 and 2 Article 25 This information on drugs from pharmaceuticals, ointment, raw materials;

b) 02 (two) copies of documents include drug registration and product standards; separately for vaccine, antibody serum, medical delivery (except for a diagnostic biopsy), additional 1 (a) full copy of the original profile;

c) drug labels: 02 (two) design label sets. These labels are mounted on the A4 paper which stamped the hybrid of the registry or the production facility. When you proceed to register again, do not request to submit the label if there is no change compared to the first registration;

d) Product information: The guide used in accordance with each of the prescribed drugs at the Digital Information. 04 /2008/TT-BYT December 12, 2008, of the Minister of Health, the Minister of Health, instructs the receipt to seal the receipt of the registry or the production facility. When you proceed to register again, do not require to submit the product information if there is no change compared to the first registration;

Sample of drugs, raw materials:

-01 (a) the packaging unit for a registered registration process;

-Volume enough for 3 (three) test times for raw materials;

-For the vaccine, the serum contains antibodies, the registration base sent the sample to the National Review of Vaccine and Medical Biocare.

5. For the change register profile, additional: required to submit 1 (a) the original full of documents depending on the major changes, the minor changes prescribed at paragraph 5, paragraph 6 Article 16 This information for pharmaceuticals, vaccines, serum contained. Antibody, medical delivery, paragraph 3 and 5 Article 21 This is for the diagnosis of printing in vitro and paragraph 3, paragraph 4 Article 25 This is for the drug, medicine, medicine, and medicine.

6. Regulation for legal filing:

a) Pharmaceutical product certification (known as CPP), Production license, drug business administered by the state governing body of foreign authority, certificates to obtain a good practice of producing drugs (known as GMP), the license to establish the Office of the Republic of China. The representative room in Vietnam or the certification of the equivalent standard for the diagnostic in vitro may be submitted to itself or the copy or translation of the Vietnamese language from foreign language but must meet specific regulations on each category. the certificate of regulation at the point b, c or this id and the general regulations are as follows:

-The main filing case: The correct one must have full signatures directly, the surname, the signor of the signor and the confirmation mark of the state governing body with the authority of the state at the certificate level; must be legally legalised at the diplomatic representative body. Vietnam follows the provisions of the legal legalization law, except for the case of legal papers provided by the state governing body of those countries to sign the Judicial Assistance Agreement with Vietnam.

-The case of filing a copy: A copy provided by the state governing body of Vietnam is valid in accordance with the provisions of the Vietnamese law on the actual evidence from the main copy or copy issued from the original book. In case of the original presentation to be shown.

-The case filed for Vietnamese translation from foreign language: the Vietnamese translation must have a prescribed sense (the evidence here is understood to have to be taken by the local or diplomatic agency, the Consulate or other agency). The authority of the foreign country recognizes the signature of the translator (the translator must commit to the correct translation according to the rules of the law) and must submit to the correct version or copy of the certificate.

-The validity of the validity of the license or certificate: The validity deadline must be written specifically on the certificates and must remain valid at the time of the appraisal; do not accept the publication of this certificate. The case of this certificate does not specify a valid deadline, only accepting certificates issued in the 24-month period, since the date of the grant.

b) The Certificate of CPP, in addition to meeting the regulations at the point of a paragraph, must also meet the following regulations:

-Due to the competent drug administration (according to the WHO list on the website) http://www.who.int ) issued; the model of the World Health Organization (WHO) applies to the quality certification system of pharmaceutical products circulated in international trade.

-There are confirmed drugs are allowed to circulate in the production water. The drug case is not licensed to circulate in the produced or licensed country but the practice of non-circulating drugs in the production country, the registration facility must provide a certified CPP certificate of medication stored in one of the reference countries: UK, France, Germany, Australia, Canada or the countries in the international agreement area on the ICH harmony.

c) A production permit, a drug business administered by the state governing body of foreign authority in addition to meeting the regulations at the first line, second and third points a paragraph to the full amount of content:

-The name and address of the state governing body with authority.

-The name and address of the drug business.

-Range of activity.

-The validity term of the License and the deadline must remain at least 24 months at the time of the appraisal. The case does not specify the statute of limitations, the foreign drug business facility must provide the certificate of the authority to grant a permit to confirm the facility is still active in the pharmaceutical sector and only accept the certificate issued in the case. Twenty-four months from the date.

d) The certificate of receiving a good practice of drug production (GMP-WHO) (not applicable to domestic drug production facilities), ISO or certificates of equivalent standard must be attributed to the competent authority in the country of production, which has confirmation of the name. and producer addresses.

A certificate of qualifying the drug business of the registry may be a copy of a certificate or a copy of the self-confirmed business (case of another registration facility).

e) Certificate certification, protonation, contract transfer contract ownership of the relevant industrial property in the case of the drug registration (if any) provided by the competent authorities on the possession of a business or confirmation must be a copy of a certificate or a certificate. The copy of the drug registry.

7. Other administrative records:

a) The application must be issued by the director of the drug registration facility or the authorized representative of the registration facility directly on the application and stamped (if any) of the registry, do not accept the signature signature.

b) The authorization certificate pursues to Form 05 /TT issued with this message and is required to submit in the following cases:

-The authorized authority is named after the number 5A issued by this message;

-The commission signed the name of the drug registry when the basis for the registration of the jurisdiction for the representative office of the agency registration facility in Vietnam by Type 5B issued with this message;

-The authority to use that name registers the goods label when the owner of the brand name is not a drug registry according to the number 5C issued by this message.

Each case must submit a major copyright or copy of the correct copy of the registration basis or of the representative office in Vietnam.

c) The copy of the contract has a concession contract for the production drug in the form of franchisor.

8. Drug labels and product information:

The contents of the label and the product information are in accordance with the regulation at the Digital Information 04 /2008/TT-BYT December 12, 2008, of the Minister of Health, instructs the label.

9. Drug registration fee:

The basis of the drug registration must be paid in connection with the registration and circulation of the drug, examination, GMP monitoring of the drug-producing facility under the law of the current law on fees and fees.

What? 12. The effect of the drug registration number and the deadline for filing the registration case, the registration profile renewed.

1. The validity period of the registration number of the maximum drug circulation is 05 (year) year, since the date of the issue of the decision to issue the registration number or to renew the registration number. The School of Health Consultative Advisory Council of the Ministry of Health requires further evaluation of the safety and effectiveness of the drug, the validity deadline of the maximum registration number of 3 (three) years, since the date of the issue of the decision to issue the registration number.

2. The deadline for the filing of the registration file again, the registration file extension:

a) During the time of 06 (six) months before the number of registered registration expires, the registration base may submit a limited registration profile. The Bureau of Pharmacology has a written notice and states that the reason for the records does not meet the conditional registration conditions under the regulation at paragraph 3 This Article 9, the drug registration facility may submit the prescribed registration file as specified and immediately after the application. filing.

b) In the previous 12 months and 06 (six) months after the number of registered registration expires, the facility may file a reregistration file. The base case that filed the registration case is not allowed to file a limited subscription.

Chapter II

INTELLECTUAL PROPERTY FOR REGISTERED MEDICINE

What? 13. Common Principles

1. The drug registry is responsible for intellectual property ownership of the registered registered drug.

2. Drug registration facilities that identify intellectual property rights or conduct an investigation of relevant intellectual property holders prior to registration of the drug circulation in Vietnam.

3. The case with a dispute over intellectual property while reviewing the registration level, the opposition to the granting of the registration number to the intellectual property dispute must provide the conclusion of the state governing body for intellectual property or the functional body of the intellectual property. Exercise intellectual property rights to intellectual property rights. The Ministry of Health does not have the registration number circulating for that drug if there is sufficient basis to claim the drug when issued a circulation registration number that will violate the individual's protected intellectual property rights, other organizations.

4. The case with intellectual property disputes after the issue of the registration number, on the basis of consideration of the subject of intellectual property rights or the third party has the relevant interest and the base on the judgment of the Court or the final conclusion of the agency. State management of intellectual property or intellectual property rights enforcement authority on the conduct of intellectual property rights, the Ministry of Health will decide to withdraw the registration number or suspend circulation by regulation at paragraph 6 Article 32 or paragraph 2 Article 33 News Hey.

What? 14. Patent-related Patent

1. For drugs containing the activity that is in the protective period of intellectual property, the registry may provide legal documents related to the state of protection and intellectual property rights (patent monopoles) for registered drugs (if any).

2. In the 02 (two) years before a pre-patent medication expired, the drug registration facility may conduct a generic filing of the generic drug circulation registry with the proof of the protective drug that is about to expire in effect and must specify the offer in the application. registration in the 6A/TT template issued with this message.

What? 15. Data security for registration records

The drug registry has a need for data security for new drug registration records according to the regulation of data security for the prescribed drug registration records at Digital Information. 05 /2010/TT-BYT On March 1, 2010, the Minister of Health's Office of the Ministry of Health guidelines for the security of the test data in the drug register must specify a proposal in the 6A/TT subscriptions issued by this message.

Chapter III

DRUG REGISTRY PROFILE

Item 1

DRUG REGISTRY RECORDS, VACCINES,

THE SERUM CONTAINS ANTIBODIES, MEDICAL DELIVERY.

What? 16. The records must file

1. First registration records for new pharmaceutical drugs, vaccines, blood serum containing antibodies, medical students, including:

a) Part I. Administrative records and product information;

b) Part II. Quality profile;

c) Part III. Preclinical record;

d) Part IV. Clinical record.

2. First registration records for generic drugs (applicable only to pharmaceutical drugs), including:

a) Part I. Administrative records and product information;

b) Part II. Quality profile;

3. re-registration records, including:

a) Part I. Administrative records and product information;

b) Part II. Quality Profile: The case of registered records for the first time is prepared according to the ASEAN joint technical record (ACTD) or by the sample of the International Agreement Zone (ICH-CTD) and meet the joint technical requirements of ASEAN, when the registration is only required to submit. That ' s what we ' re going to do.

4. renew registration records include:

a) Part I. Administrative records and product information;

b) Part II. Other files include:

-Copy of the offices of the Department of Pharmacology or the Department of Equipment and Medical Works that allow for change, additions in the process of circulation, record copies, documents that have made changes, added in the form of only notification requirements;

-The standard copy and product test method for medicines not according to the standard of pharmacology;

-Records, medical records imported to Vietnam for foreign medicine. The record, the proof that the drug has produced and distributed in Vietnam to the drug in the country.

5. Sign up for major changes:

a) Part I. Administrative records and product information;

b) Part II. Quality profile;

c) Part IV. Clinical records;

The content changes are large and the corresponding records must be submitted in accordance with the instructions on Appendix II of this message.

6. Registration profile minor changes:

a) Part I. Administrative records and product information;

b) Part II. Quality profile;

The content changes are small and the corresponding records must be submitted in accordance with the instructions on Appendix II issued by this message.

7. The profile registers other changes: The file must submit as specified at 1 Article.

8. Regulation records at 1, 2, 3, 4 and paragraph 5 This must be done in accordance with the following regulations:

a) Apply in accordance with the regulations at Annex I issued with this message, including:

-ASEAN Joint Technical Profile (ACTD);

- Guidance for the study of stability;

- Production Process Appraisal Guidelines;

- Instructions for the analysis of the analysis method;

- Guidelines for the study of bioavailability and bioequipability;

b) The layout of ACTD. In the case of new pharmaceutical drugs, vaccines, antibody serum antibodies, medical students are unable to arrange according to ACTD, which may be arranged according to the Joint Technical Profile of the International Agreement on Pharmaceutical Agreement (ICH-CTD).

9. For the macho-producing medicine, the requirement for the records must be filed by regulation at the Digital Notice. 23 /2013/TT-BYT August 13, 2013, the Minister of Health's Guide to the Department of Public Health.

What? 17. Administrative records and product information

Administrative records and product information include:

1. Table of entry;

2. The report on safety, effectiveness after the release of the 3 /TT license issued with this message to the drug requires a safety evaluation, effectiveness of the drug when the initial registration level is issued.

3. Summary of product by Form No. 04 /TT issued with this message;

4. authorization paper (if available) by Form 05 /TT issued with this message. ()

5. The registered application number 06 /TT issued with this message;

6. Cover by Form 07 /TT issued with this message;

7. Report the process of circulating the drug on the registration file again according to Form 08 /TT issued with this message;

8. Summary of the history of registration of the drug on the accession register according to Form 09 /TT issued with this message;

9. The certificate is eligible for a drug business if it is a Vietnamese drug business facility and only submit once to all the drugs filed under the license deadline.

10. A production license, a drug business administered by the state governing body with foreign jurisdiction over the foreign drug registry and only filed once for all of the drug registration records during the license deadline.

11. The Certificate of CPP by Form 01 /ACTD issued this same message for foreign medicines.

12. The GMP certificate of a foreign drug production facility if the CPP does not have confirmation of the production base to the GMP standard. In case there are many facilities involved in the production of the drug, the basis for the registration of the GMP certificate of all production facilities involved in the production of the product.

13. The drug label, which only requires a copy of the drug label that has been approved for a limited registration profile;

14. Product information: The guide to the prescribed drug at the Medication Manual Labeling, only requires a copy of the extension registry;

15. Summary of product properties for new pharmaceutical drugs, vaccines, blood serum containing antibodies and medical products by Form 02 /ACTD issued this message (not required for extended registration records);

16. Agreement or contract for the franchise. Public contract for public production drugs.

17. Certificate of certification, protection deed, contract transfer of relevant industrial property rights (if any).

18. Other legal papers (if any).

19. GMP certification of the basis of the packaging of the packaging of direct contact with prescribed drugs at the Digital Information 14 /2012/TT-BYT August 31, 2012, the Minister of Health rules the principles, standards, "Good practices of the production of pharmaceuticals" or equipated certification of the production conditions of the packaging facility directly exposed to the drug.

What? 18. Quality Profile

1. The quality profile performs pursuant to Section II-ACTD and includes the following documents:

a) Table,

b) Summary of the quality;

c) Content and data;

d) references;

e) The overall profile of the production facility by Type 10 /TT issued with this message. Where a product is produced through multiple segments, the overall record must be a record of all manufacturers participating in the product production prior to the introduction of the market.

2. Quality profile in the registration of the drug-produced drug in the form of the concession must include full of regulatory content at paragraph 1 of this. The content and data part of the quality profile is done as follows:

a) Content and data related to the drug produced prior to the concession to the right of the franchisor and provided include:

-Drug Section (S): Common Information (S1); Special; (S3) and Drug Testing (S4), except for the results of the quality test of the pharmaceutical shipments used in the production of finished drug shipments at the franchisor for the purpose of registering a concession production drug. power;

-Section Section (P): Description and composition (P1); Development of Pharmacology (P2); Production (P3), minus section P3.4. Appraisal and/or process evaluation; Audit of the drug (P4); Control of the finished product (P5), except for the portion of the batch analysis (P5.4); the packaging packaging system (P7).

b) Content and data related to the drug produced in the form of the concession to the recipient of the implementation and supply include:

-Medicinal Purposes (S): Manufacturing (S2); Standard Quality or Passport Material (S5); Packaging Packaging System (S6) and stability (S7);

-Section Section (P): Appraisor and/or evaluation of the process (P3.4); batch analysis (P5.4); Standard Material or Passport Material (P6); Stability (P8) And The Interchangeability Of The Product (P9).

c) The case of the drug produced in the form of the concession is changed compared to the pre-production medication before the concession is associated with the content and the data provided in the prescribed profile at the point of paragraph 2 This: The recipient of the concession must manifest. full of content changes in the Registration Form by Form 6E issued by this message and provide relevant documents specified in Appendix II for each corresponding change content.

What? 19. pre-clinical record

Preclinical records perform in the direction in Part III-ACTD and include the following documents:

1. Table of entry;

2. The concept of preclinical research;

3. Summary of pre-clinical research;

4. Clinical preclinical research report;

5. references.

What? 20. Clinical records

Clinical records perform in the section IV-ACTD and include the following documents:

1. Table of entry;

2. Clinical Consul;

3. Clinical Summary;

4. List of clinical studies;

5. Clinical Research Report;

6. references.

Item 2

BIO-DIAGNOS IN VITRO

What? 21. The files must submit

1. First registration records for the diagnostic in vitro, including semi-finished products, including:

a) Part I. Administrative records;

b) Part II. Quality profile;

c) Part III. Diagnostic effectiveness records, do not apply this regulation to semi-finished products;

2. re-registration records, including:

a) Part I. Administrative records;

b) Part II. Quality profile.

3. The registration of the changes included:

a) application application (in template);

b) The case parts are associated with the change: submit the corresponding file sections as specified in Section A-Annex IV issued by this message.

4. renew registration records include:

a) Part I. Administrative records;

b) Part II. Other files include:

-Copy of the offices of the Department of Pharmacology or the Department of Equipment and Medical Works that allow for change, additions in the process of circulation, record copies, documents that have made changes, added in the form of only notification requirements;

-A copy of the specified quality profile at Section A-Annex IV attached this message;

-Records, the diagnostic material for the bio-diagnos in vitro were imported to Vietnam for foreign medicine. The profile, the diagnostic documentation for the diagnostic printing of vitro produced and distributed in Vietnam for domestic drugs.

5. The filing of the registration of other changes must submit to the profile as the first registration carried out in accordance with the instructions in Section B-Annex IV issued to this message.

What? 22. Administrative records and product information.

The administrative records include the following documents:

1. Table of entry;

2. The report on safety, effectiveness after circulation after the number of 3/TT issued with this Notice for the drug requires a safety assessment, effectiveness of the drug when the initial registration level is issued.

3. Summary of product by Form No. 04 /TT issued with this message;

4. License (if available) by Form 05 /TT issued with this message;

5. The registered application number 06 /TT issued with this message;

6. Cover by Form 07 /TT issued with this message;

7. Report the process of circulating the drug on the registration file again according to Form 08 /TT issued with this message;

8. Summary of the history of registration of the drug on the accession register according to Form 09 /TT issued with this message;

9. Product labels (only copy requirements for extended registration records);

10. A production permit, vaccine business, health care provided by the state governing body with foreign jurisdiction over the basis of vaccine registration, foreign health care, or Certificate of Qualified Vaccine, medical delivery to the body of the country ' s health care system. A vaccine registry, Vietnamese medical student.

11. The license to circulate in the country of production to foreign products, does not apply this regulation to the sale of the finished product.

12. The GMP or ISO certification paper or certification certification the equivalent standard of production facilities related to the production process by the competent authority.

13. Certificate of intellectual property, economic contract, other papers (if any).

The requirements of the specified profile are specified in Section A-Annex IV issued by this message.

What? 23. Quality Profile

Quality profile, including:

1. Table of entry;

2. The active ingredients;

3.

4. stability.

The requirements of the specified profile are specified in Section A-Annex IV issued by this message.

What? 24. The diagnostic assessment of the diagnostic product

The effective profile of the diagnostic student includes:

1. The Table of Contour.

2. Research Reports.

The requirements of the specified profile are specified in Section A-Annex IV issued by this message.

Section 3

DRUG REGISTRATION RECORDS FROM PHARMACEUTICALS,

PHARMACY AND DRUG INGREDIENTS

What? 25. The records must file

1. First registration records, including:

a) Administrative records and product information.

b) Quality profile.

c) The safe and effective profile applies only to new drugs, new drug-making ingredients.

2. re-registration records, including:

a) Administrative filings and product information;

b) Quality profile;

3. The profile registers major changes: large changes content and corresponding profiles must submit to the instructions in section I-Section C-Appendix II issued with this message.

4. The profile registers small changes: small changes content and corresponding profiles must submit to the instructions in section II-Section C-Annex II issued to this message.

5. Family registration records include:

a) Part I. Administrative records and product information;

b) Part II. Other files include:

-A copy of the Bureau of Pharmacoists for the change, the addition of the filing process, the record copy, the document that made the change, the addition in the form of only the notification request;

-The standard copy and product test method for medicines not according to the standard of pharmacology;

-Records, medical records imported to Vietnam for foreign medicine. The record, the proof that the drug has produced and distributed in Vietnam to the drug in the country.

6. The profile registers other changes: The file must submit as specified at 1 Article.

What? 26. Administrative records and product information.

The administrative records and product information are carried out by regulation at Article 17 of this.

What? 27. Quality profile

1. Production process:

a) raw material:

-For the drug from the drug, the drug is not required to produce the production of the pills and the materials that are present in the pharmacology, the materials produced by the other manufacturer. Other cases require full description, detailed production process details.

-For the ingredients of the medicine: the full description requirement, the production process details.

b)

-The formula for the smallest packaging unit: the raw material name including the main component and the general pharmacy; the quantity or concentration of each raw material; the standard of application of the material; if the high production must specify the amount of the corresponding pharmacy;

-Formula for a batch, batch production: the ingredient name including the main ingredient and the dozen pharmacy; the volume or volume of each raw material;

-The production process scheme consists of all stages in the production process;

-Description of the production process: full description, detail of each phase in the production;

-Catalogue of equipment, use tools: device names, parameters, use purposes;

-Control in the process of production: Full description, details of test indicators, control during production.

2. Quality standards and methods of testing.

a) For the making of the drug made in the dictionary, require a specific record of the name of the generic name and the publishing year; for the non-medicinal materials not present in the pharmacology, the requirement for a full description, the index details and the test method.

b)

-The formula for the smallest packaging unit: The ingredient name includes the main component and the dozen pharmaceuticals; the concentration or concentration of each raw material; the applicable standard of the material; if the high production must specify the amount of the corresponding pharmaceutical.

-Title criterion: Full description, details of the product's indicators and tests.

c) The standard of packaging packaging: The full description, the indicator details and the test method.

d) A prescribed drug test prescribed in Article 6 of this.

The study of stability studies, including:

-Stability for stability.

-The number of research is stable.

-Conclusions of stability study.

What? 28. Safe Profile, effective.

The safety profile, the effectiveness of the new drug in accordance with the provisions for the clinical trial of the Ministry of Health, includes:

1. The toxication reports.

2. Clinical research reports, do not apply this regulation to the material register.

Chapter IV

THE PROCEDURE, THE PROCEDURE FOR DRUG REGISTRATION AND JURISDICTION,

SUSPEND THE REGISTRATION NUMBER

What? 29. Presentation, procedure for receiving and appraisal of drug registration records

1. The Bureau of Pharmacy is responsible:

a) Continue to receive the drug registration records that are submitted directly or sent through the postal route to the following cases:

-The first registered drug registration record, registration, extension, except for the registration of vitro-based diagnostic and drug registration records in the country specified in Annex V issued by this message.

-Big change registration records, minor changes, other changes in the time the drug registration number is valid for the drugs already registered, except for the registration of the vitro-based diagnostic.

b) The organization of the appraisal, the Board of Consultative Consultative Consultative of the Health Ministry for the first registration records and re-registration, or the Minister of Health approved the registration of the number of registered drugs for the registration of the registration number for the specified registration records. At the top of the first line, this one thing.

c) The organization of the appraisal and answer by writing of a large, change-change registration record, changes in the other to the drugs that have been given the number of regioners while the validity is taken as prescribed at the beginning of the second line.

2. The equipment and medical work is responsible:

a) Continue to receive the diagnostic product registration records in vitro directly filed or sent via post-mail to the first registered vitro-registered student registration records, re-registration, renew registration and major change registration records, small changes, different changes to the diagnostic in vitro diagnos have been given the number of registration in effect;

b) The organization of the appraisal and presentation of the number of medical subscriptions for the registration of the Health Ministry for the first time in vitro registration records, registration again;

c) The organization of the appraisal and the Minister for the approval of the list of diagnostic students in vitro registration extension;

d) The organization of the appraisal and reply by writing of major change registration records, minor changes, other changes to the diagnostic products in vitro have been given the number of regioners in effect.

3. The Department of Health of the Provinces, the central city-based city where there is a responsible production facility:

a) Continue to receive the first registration record, reregistration, accession registration is submitted directly or sent to the post office on the foreign-produced medications specified in Annex V issued by this message;

b) The organization for the appraisal of records is taken as prescribed at this point and sends the document accompanying the prescribed drug portfolio to the Department of Pharmacology to rank the registration number.

What? 30. Registration Level Authority

1. The Minister of Health authorized the Secretary of the Bureau of Pharmacy Management Decision to issue a drug portfolio registered by the number of registered in the following cases:

a) A drug registration filing issued by the Bureau of Pharmacology, the prescribed appraisal at the point b 1 Article 29 This message;

b) Drug registration filing taken by the Department of Health, which is set to be defined by the regulations at the Article 3 Article 29.

2. Minister of Health authorized for the Chief of the Equipment and Medical Works Department for the decision to issue a registered product portfolio in vitro to be registered to the registration records of the diagnostic in vitro in accordance with the Regulation 2 Article 29. This is private.

What? 31. The registration of registration levels or answers to major change registration records, small changes, different changes, and changes.

1. Bureau of Pharmacology, Equipment and Medical Works Department (for the diagnostic in vitro) review the registration of the drug circulating for the first registration records, the record resigns in the maximum time of the maximum 6 (six) months and the extended registration profile. for a maximum of 3 (3) months from the date of receiving valid records. Where the registration records are not or did not meet the regulation to be given the registration number or renew the registration number, the Ministry of Health has the written answer and specifies the reason.

2. In the time of 3 (three) months from the date of receiving a valid profile, the Health Department is responsible for organizing the appraisal and sending in the Office of Public Pharmacology accompanying the category of prescription offers registered to the medicines issued by the Health Department. No. 3 Article 29 This information to the Bureau of Pharmacology review, the registration level is filed; the case is not yet sufficient to recommend the registration level, the Health Department must have the text answer the registration base and specify the reason.

3. Since the date of receiving valid records, the Bureau of Pharmacology, the Department of Equipment and Medical Works (for the diagnostic in vitro) review responses to the major change registration records, small changes in the maximum minimum term are as follows:

a) 90 days for a large change registry or a small change register to approve before the execution comes from 2 (two) the offer content changes back up and 60 days for small change profiles that need approval before execution has a changing content.

b) 20 days for small change records only require notice, if no opinion of the state governing body is allowed to do so.

4. For other change offers, the current implementation profile is as for the first registration record and the specified real-time execution time at paragraph 1 and 2 This.

5. Bureau of Pharmacology, Equipment Affairs and Medical Works (for a student-in vitro diagnostic) review the registration level or written answer prior to the specified deadline at paragraph 1 and 3 This when there is a recommendation of the registration facility stating in the Process Registry. to the order number 06 /TT issued with this Notice for the following cases:

a) The drug meets special treatment needs under the Rare Code of Health issued by the Minister of Health;

b) Drugs meet the need for treatment in emergencies, natural disasters, epidemics; and more.

c) The domestic drug produced on the new chains reached the GMP standard for no more than 18 months, since the date was issued by the GMP certificate.

d) The vaccine was evaluated by the World Health Organization and was reviewed by the registration level under a shortened process by the Department of Pharmacology, enacted.

What? 32. Drug registration cases

In the time of the validity of the registration, the Ministry of Health will consider, the decision to withdraw the registration number for the drug (including the diagnostic in vitro) has been granted the registration number in one of the following cases:

1. The drug produced is not true with the registered registration record that has been reviewed by the Ministry of Health.

2. The drug has 02 (two) of the production batch that does not reach the standard of quality or quality violation of the quality standard 01 (one) a time but is serious due to the state regulatory authority on the quality of the drug concluded.

3. The production facility or registration facility offers to withdraw registration registration in Vietnam.

4. The drug was withdrawn from registration in the country.

5. The medication that contains the activity of the World Health Organization or the competent authorities of Vietnam or abroad recommends that it is not safe for the user.

6. The drug that has been concluded by authorities is to violate intellectual property rights.

7. The drug does not make changes to the regulatory registry at a point of 3 Article 3 or point 2 Article 4 This April after a deadline of 2 (two) months, since that registration base is stopped or was terminated by the state governing body. It's an operation.

What? 33. The suspended cases receive new drug registration records and stop the registration of registration of the drug circulating for the filing filed.

The Ministry of Health will temporarily stop receiving new drug registration records and suspend the registration of the drug circulation registration (including in vitro diagnos) for the records filed when belonging to one of the following cases:

1. The registry, the basis of the production of drugs from 2 (two) of the drug or not to reach the standard of quality before circulation or has been suspended for circulation in the first round of 1 (one) years.

2. The registration facility, the production facility with the prescribed medication prescribed at 1 Article 32 of this Notice; or belonging to one of the specified cases at paragraph 4, paragraph 5 or paragraph 6 Article 32 This information but does not inform the Ministry of Health.

3. The registration facility, the basis of the production of drugs that perform forgery conduct, voluntarily fixes document records, legal papers of state agencies with authority or use of false seals, signatures of signatures, registration facilities, production facilities, and facilities available to the facility. other related to registration records;

4. The registration facility, the basis of the production of drugs that provides records, data, information related to technical records including quality standard profile, production method, stability, which is not based on the basis of research, experimental, actual production of the manufacturing facility. or the basis of the drug registry;

5. The registration facility, the basis of the production of the drug that provides the records, data, information about the effects, safety and effectiveness of the drug without the documents, scientific evidence to prove;

6. The registration facility, the basis of the production of the registered drug is not due to the basis of the research or production facility in the production registration filing.

7. The registration facility does not perform an update of the drug information at the request of the Department of Pharmacy Regulation at paragraph 4 This Article 9.

What? 34. The decision to make a decision, the responsibility to inform and the deadline to withdraw the registration registration, suspend the records, suspend the registration level.

1. The Minister of Health authorized the Secretary of the Department of Health Management to decide the withdrawal of the registration number, suspend the records, suspend the number of drug registration and the Secretary of the Equipment Page and the medical work decision to withdraw the registration registration number, suspend the report. You know, we take the records, suspend the number of registered in vitro diagnos in the country.

2. The Department of Health of the Provinces, the Central City of the Central, Health of the Department of Health ' s decision-making announcements (Bureau of Pharmacy or Department of Equipment and Medical Works for the diagnostic in vitro) withdrew registration or suspended records, paused. The number of registrers on the field, the management desk.

3. A temporary period of cessation of drug registration records and suspended registration of the drug circulation registration for records filed a maximum of 2 (two) years for the specified cases at paragraph 1, paragraph 2 and paragraph 3 Article 33 This information, since the date of the decision signing. the registration number or suspension of the second drug (two) or the decision-making of the state governing body has jurisdiction over the basis of carrying out a 3-Article 33-Article 3 violation.

4. The deadline for the cessation of a new drug registration record and a pause in the number of registration records for the records filed against the specified cases at point 4, paragraph 5 and paragraph 6 Article 33 This is maximum of 01 (one) year, since the date of the text. The final announcement of the regulations on the basis of the registration of the drug is filed.

5. The deadline for the pause of a new drug registration filing and temporary registration of the registration of the drug circulating for records filed against the specified cases at 7 Article 33 This is maximum of 06 (six) months, since the date with the final text message. violation of the upper regulations of the registry registry facility.

Chapter V.

ORGANIZATION, THE ACTIVITY OF THE APPRAISAL AND THE

REGISTRATION OF THE NUMBER OF REGISTERED MEDICINES

What? 35. Organization, Operations of the Advisory Board of the Registration Number

1. The Ministry of Health set up the Advisory Board for Medication Registration (including in vitro diagnos).

2. The Advisory Board of the Digital Registration is tasked with advising the Minister of Health in granting the registration number to the drug circulating in Vietnam; the advocates of the regulation of drug registration with countries in the region and in the world; the policy of manufacturing. Exporting and circulating drugs in Vietnam include the use of medicines on Vietnamese people to assess the safety, effectiveness of drugs when needed.

3. Consultative Advisory Council operates in principle: the advisory opinion of the Board of Consultative Consultative Advisory Board must guarantee the legal base, the scientific basis and must be expressed in the Editorial Board of the Consultative Advisory Council Meeting. The Consultative Advisory Council is responsible to the Minister of Health for the Consultative Consultative, the Consultative Consultative of the Drug Registry.

4. The Department of Pharmaceutical Management Coordinated the Department of Equipment Equipment and Health Works for the Minister of Health in the issuing of the organization and operation of the Drug Registration Level Advisory Council, the coordination mechanism between the Board of the Consultative Consultative Consultative Council and the You know, groups of experts in the process of registering drug circulation.

What? 36. The organization, the activity of the expert and expert groups appraisal of drug registration records

1. The Ministry of Health delivery of the Department of Pharmacology, Equipment Equipment and Functional Base Health Work, the assignment is responsible for the establishment of specialist groups that are assigned to the application of the drug registry (the latter is called the appraisal group).

2. The appraisal team is tasked with advising the Department of Pharmacology in the appraisal of the drug registration filing and proposing the granting of registration or addition or not the number of drug subscriptions.

3. The expert group is active in principle: The comments or suggestions of the appraisal expert must secure the legal base, the scientific basis and must be shown in the Periodic File of the Drug Registration. The appraisal expert is responsible to the Director of the Bureau of Pharmacology, the head of the Department of Equipment and the Health Works (for the diagnostic of in vitro) of the content, advice and suggestions regarding the work on the appraisal of the drug registry.

4. Bureau of Pharmacology, Equipment Equipment and Functional Base Health Work, the assignment to be built and enacted regulations on the selection criteria, organization and operation of expert groups appraisal of drug registration records; signing a yearly contract with the Department of Health. an appraisal expert; the organization of the appraisal, aggregation of the appraisal of the Advisory Council; organizes training courses, training for the appraisal expert; conduct of professional competability assessment and compliance with regulations for adjustment, expert supplements The appraisal appraisal.

Chapter VI

THE ORGANIZATION.

What? 37.

1. This message has been in effect since 15 January 2015.

2. Big changes, minor changes, other changes apply to the drug that has been issued by the number of registered registered registers at Annex II issued by the same Act as applicable since 1 April 2015.

3. Repeal Digital 22 /2009/TT-BYT November 24, 2009 by the Minister of Health rules the registration of the drug and repel Article 6 Digital News. 45 /2011/TT-BYT December 21, 2011 by the Minister of Health amendments to add some of the provisions of the Digital Decision. 1570 /2000/QĐ-BYT May 22, 2000, of the Minister of Health on the implementation of the implementation of the principle of "Good Practice of Drug Testing"; Decision No. 1. 2701 /2001/QĐ-BYT June 29, 2001, of the Minister of Health on the implementation of the implementation of the principle of "Good Practice Protection"; Digital News. 06 /2004/TT-BYT May 28, 2004 guide the production of the drugmaker; Decision 3886 /2004/QĐ-BYT November 13, 2004, of the Ministry of Health on the implementation of the implementation of the principle, the "Good Practice of Manufacturing Practice" standard according to the World Health Organization recommendation; Digital News. 13 /2009/TT-BYT September 1, 2009 of the Ministry of Health Guide to Active Drug Advertising; Digital News 22 /2009/TT-BYT November 24, 2009 of the Ministry of Health regulations on drug registration; Digital News. 47 /2010/TT-BYT December 29, 2010 guidelines for exporting, importing drugs and packaging directly to the drug since the date of this date is valid.

What? 38. transfer clause

1. The registration records filed before this date of this date have the enforced effect of being determined and the registration level is prescribed in the Digital Information. 22 /2009/TT-BYT November 24, 2009, of the Secretary of Health, regulations on the registration of the drug.

2. Foreign drug registration facilities with a license to register activities in the field of drugs, the materials made in Vietnam issued before the date of this date are valid for registration of the medication for the expiration of the validity period on the license.

What? 39. Terms of reference

In the case of legal rule texts and regulations that are invoked in this Notice of Change, additions or replacements are applicable in accordance with the new law of law.

What? 40.

1. Bureau of Pharmacology, Equipment Equipment and Functional Base Health Work, the assignment to be delivered and the ASEAN integrated route in the registration of the drug, which is responsible:

a) Organization of the guidelines and implementation of the provisions of this Information;

b) Updated, edited and enacted the ASEAN Joint Technical Profile (ACTD), technical guidelines and guidelines related to ASEAN ' s drug registry so that the relevant subjects implement;

c) An update of the category of medicines registered by the Ministry of Health in accordance with each batch and other drug registration information on the Department of Information Administration (website) of the Department of Pharmacology or the Department of Health Information Portal for the diagnosis of in vitro.

d) Construction, implementation of the implementation of the implementation of standard processes (SOPs), drug registration guidelines (QM), appraisal process and shortfall registration level for the vaccine was evaluated by the World Health Organization.

2. The Department of Health of the Provinces, the Central City of the Central City, is responsible for the inspection, inspector for the implementation of this information on the production units, the pharmaceutical business within the management range.

3. The units of the Ministry of Health, the Vietnam Pharmacy Corporation, the drug business facilities, foreign companies that have a permit to operate in the pharmaceutical sector are responsible for doing this.

In the course of implementation if there is difficulty, entangrium, agencies, organizations, individuals reflect on the Ministry of Health (Bureau of Pharmacology and the Department of Equipment and Medical Works for the diagnostic in vitro) to review the ./.

KT. MINISTER.
Chief.

(signed)

Mr. Lê Tuan