Circular 23/2013/tt-Byt: Drug Processing Operations Guide

Original Language Title: Thông tư 23/2013/TT-BYT: Hướng dẫn hoạt động gia công thuốc

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MINISTRY OF HEALTH
Number: 23 /2013/TT-BYT
THE SOCIALIST REPUBLIC OF VIETNAM.
Independence-Freedom-Happiness
Hanoi, August 13, 2013

IT ' S SMART

Manual Operations Guide

______________

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

Number of Commerce Rules. 36 /2005/QH11 June 14, 2005;

Base of Protocol 12 /2006/NĐ-CP 23 January 2006 of the Government regulates the implementation of the Trade Act of Trade on International Merchandise Purchases and the activities of dealership, purchasing, selling, machinization and transit of goods with foreign countries;

Base of Protocol 79 /2006/NĐ-CP August 9, 2006 of the Government Regulation Law enforcement of certain provisions of the Law of Pharmacy;

Base of Protocol 89 /2012/NĐ-CP October 24, 2012 by the Government amended, adding some of the provisions of the Digital Protocol. 79 /2006/NĐ-CP August 9, 2006, the Government rules certain provisions of the Law of Pharmacy;

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

On the recommendation of the Director of the Department of Pharmacology;

The Minister of Health for the Department of Health,

Chapter I

COMMON RULES

What? 1. Apply Scope and Apply Objects

1. This information provides for the drug family, the medical registration records, the sequence, the registration procedure, pause, and the withdrawal of the number of household drugs.

2. This information applies to organizations, domestic and foreign individuals whose activities are involved in the drug household, registration of household medicines in Vietnam.

What? 2. Explain the word

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

1. The drughouse. is the recipient of the recipient of the work to create a product at the request of the Public Party, while the party recognizes the product and the pay of the TB under the agreement in accordance with the rule of law.

Job recipient ' s job is to perform one, some or the entire segment of the process of drug production (raw materials, processing, packaging, including packaging to the final packaging and label).

2. It's a public order. is the drug that has been administered by the drug governing body that circulated or exported products; patented or drugs that have been studied by the government ' s public reservation for the unregistered drug circulating in Vietnam.

3. Public reservation is the name of the applicant to submit a license to grant the license to the pharmacy.

4. Public recipient is the executive producer and the recipient of the production from the public. The recipient may include many manufacturers, each participating in one, some or more of the production.

5. Company contract. is the agreement between the parties, whereby the recipient of the household does work to create the product at the request of the Public Household, while the party recognizes the product and pays the public.

6. Move forward. It ' s a drug family in which there ' s a lot of public recognition. Follow it:

-The macho product of this contract was used as a macho for other public contracts in Vietnam;

-The macho product of the previous pre-work contract contract was delivered to the other manufacturer by the designation of the public side to the contract for the next section.

Chapter II

DRUG FAMILY REGULATION

What? 3. Drug treatment

1. The condition to be named is the Public Booking

Vietnam ' s legal drug business base, Manufacturing Facility, foreign drug business has "The operational license of foreign enterprises on drugs and drug-making materials in Vietnam" has the drug that has been registered by the Ministry of Health of Vietnam. or a patent owner or research subject that has been obtained under the regulation of Vietnamese law or product research material at the public reservation facility for the unregistered drug circulating in Vietnam.

2. Conditions to be named as Public Recipient

a) For pharmaceuticals drugs, medications from pharmaceuticals (except for the drugs), the vaccine, serum containing antibodies, medical students: the production base in Vietnam has a certificate of sufficient certification of the drug business and the certification certification standard "Good practice." drugs " (GMP) has a conformation form consistent with a macho-intended medication.

b) For the Printed Vitro Diagnosis: the manufacturing facility in Vietnam has a certificate of sufficient drug business and certification certificates to GMP standard or the Vietnamese standard TCVN ISO 13485 or other standard equivalent of a suitable cell form. With the help of the public.

What? 4. Rights, the obligations of the Left and the recipient of the pharmacy

1. For the Public Reservation:

a) The number of registration and household products;

b) Be entitled to the one or some of the production work at the Public Recipient Parties;

c) Being recognized by the product in accordance with the method, the deadline and the conditions agreed in the contract;

d) in charge of the registration of the public medicine according to the correct order, the registration procedure specified in the Digital Information 22 /2009/TT-BYT November 24, 2009, of the Secretary of Health for the registration of the drug registration (the following call is Digital). 22 /2009/TT-BYT);

) Implement the right and obligations of the prescribed drug registry facility at Digital Private Information. 22 /2009/TT-BYT, power to export, to import under the rule of the law of export, import of drugs;

e) Providing the manufacturing process, technical standards, and initial materials testing methods, selling finished products and products, other papers related to the delivery of the drug;

) Pay the right to the public according to the agreement in the contract;

h) responsible for the quality, safety, effectiveness of household production drugs throughout the course of the drug;

i) is responsible for matters relating to intellectual property of the applied register and the rights, other obligations under the regulation of the law on the public in trade.

2. For Public Recipient:

He received his vengeance according to the agreement of the contract.

b) The right to the right to the right of the household, the quality, the quality, the term, the place, as agreed in the contract. If the recipient of the initial supply of the original material is required to ensure the quality of the raw material according to the standard of the Public Hand.

c) Is entitled to refuse to accept the public if the Contracting Party of the supply of raw materials does not reach the standard of quality as signed in the contract;

d) Request for the household to provide a production process, technical standards, and method of initial material testing, sale of products and products, other papers related to the household of the drug;

) Conducting the production of medicines in accordance with the procedure, engineering and ensuring the quality of the drug according to the correct drug registration records and the requirements of the Contracting Party specified in the signed contract;

e) Save the records, documents, samples related to the process of producing the drug and provide that case to the state governing body having jurisdiction when asked;

g) is responsible for testing product quality throughout the production process and ensuring the quality of the product until the publication of the household product to the Public Booking;

h) Public product, raw materials, scrap, scrap, after completion of the contract contract execution by the agreement of the two parties in accordance with the provisions of the law;

i) Other rights and obligations under the provisions of the law on the trade in commerce.

What? 5. Drug Contract

1. The form of a drug contract

The contract of the pharmacy must be written and must follow the provisions of the Vietnamese law on the economic contract.

2. The mandatory content in the contract of the drug:

a) The provision of the supply of materials, the provision of manufacturing processes, technical standards, and methods of initial material testing, sale of products, products, and other papers related to the production of the household;

b) The powers and responsibilities of each party to examine the quality of the raw materials, sell finished products, products, packaging processes, product labels, and clear rules for the testing of each batch of finished goods and coupons;

c) The powers and responsibilities of each party on the retention of record records of production, quality testing, distribution, drug circulation, drug sampling, solving of problems related to quality, complaints, product recovery on the market;

d) The responsibility of the Contracting Party on matters relating to the intellectual property of the registered drug;

Process, procedures for inspection of the public recipient's production facility;

e) The cases of cancellation of contract;

) There must be a production of the production facility on the household of the drug that has been registered by the Ministry of Health of Vietnam (the case of other registration facilities).

What? 6. General Regulation of Public Manufactured Medicine

1. Regulation of household drugs:

a) For the drug that already has the number of registered registration in Vietnam: Being produced by one, some or all of the work of the production process in one or some of the public manufacturers;

b) For the unregistered medicine in Vietnam: It is produced in the entire production process and is only placed at a public manufacturer.

2. Form of public production registration: Medication of pharmaceuticals, medical students, vaccines, blood serum containing antibodies, In vitro diagnos, medications from pharmaceuticals (except for a medical drug) are registered to produce machinists in the following forms:

a) First public registration;

b) Subscription changes;

c) Subscription is minor;

d) Subscription;

Register change.

3. Requiment for clinical trials, bioavailability and bioequities: Clinical testing requirements involving new medicines; bioavailability and bioequities for household production drugs to circulate in Vietnam in accordance with the procedure. of the Ministry of Health on clinical trials, the availability and the biological equivalent of the drug.

4. Production, transportation, household drug storage containing drug-induced drugs, mental guidance, prescriptions for drugs (both forms of substance or coordination) must follow the correct procedure of the Ministry of Health on drug management, mental guidance, precurment. and other regulations of relevant legislation.

5. Public registration registration level:

a) The public medicine is given the number of registration with a maximum validity of the year (05) of the year since the date of the issue of the decision to issue the registration number and is not longer than the validity of the number of registered drug subscriptions. The validity of the number of public medicine regioners is correct for the remainder of the previous job registration number effect. In the special case, the Board of Consultative Consultative Committee-the Ministry of Health will consider, propose the Minister of Health to decide.

In the time of six (06) months before v µ 6 (06) months after the number of successful drug registration expired, the facility could file a reregistration file. Over the specified deadline, the facility must submit to the case as for the first registered household medication;

b) For the drug that already has the number of registered registration in Vietnam: the validity of the old registration number will end after three (03) months from the date of the successful family registration date; the pre-production drug predates the old registration number. The expiration of the pill.

6. Export of the prescribed public medicine in the legal text instruct the implementation of the Commercial Law of Trade in International Procurement and the activities of dealership, purchasing, selling, machinization and transit of goods with foreign countries; regulation. The Ministry of Health's current practice of management, importing drugs and other legal documents is relevant.

Chapter III

PUBLIC PHARMACY REGISTRY

What? 7. General Regulation of Public Drug Registration Profile

1. The language used in the registration profile:

Public drug registration records must be written in Vietnamese (except for a test report which results in biological equivalent results and clinical records).

2. The drug registration filing must be prepared on the A4 paper gauge, closing the book for sure. 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 must be filed in the first public drug registration records, reregistration and records recommend other changes as follows:

a) A (01) of the original is full of the prescribed sections at this Article 8;

b) Two (02) copies of documents including drug registration and finished product standard;

c) drug labels: two (02) design label sets. These labels are attached on the A4 paper stamped the hybrid of the registry facility;

d) Product information: The Guide to Use or Information for the Patient or Summary of the Product of the Product as prescribed for each of the corresponding drugs that stamped the hybrid of the registry;

Sample:

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

-For the vaccine, the serum contains antibodies, the registration base sent the sample at the National Institute of Vaccine Control and Medical Biocare;

e) Summary of the product.

5. Big change registration records, minor changes and other changes.

The request to submit a (01) of the original is full of documents, namely:

a) For pharmaceutical drugs, vaccines, blood serum containing antibodies, medical students: Regulation in paragraph 4, 5, and paragraph 6 Articles 17 Digital. 22 /2009/TT-BYT;

b) For the diagnosis of In vitro: Implemendation of regulation at paragraph 3 and paragraph 4 Article 22 metrics 22 /2009/TT-BYT;

c) For the drug from the pharmacy (except for the pill): Done by regulation at paragraph 3, 4 and paragraph 5 Article 26 Digital 22 /2009/TT-BYT.

6. Legal Profile Regulations

Legal filings follow regulations at 6 Articles 10 Digital News. 22 /2009/TT-BYT and paragraph 1, 2 Articles 10 of the 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 No. 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 guide the export operation, drug imports and direct contact packaging with the drug (the following call for a Digital Digital). 45 /2011/TT-BYT).

7. Regulation for other administrative records:

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

b) The authorization paper is required to submit in the following cases:

-The commission signed the name on the drug registration filing when the director of the registered drug registration facility for Head Office of the Drug Registration facility in Vietnam;

-The mandate to use the name of the drug registered the goods label when the owner of the brand label was not a drug registry.

Each case must submit to one (01) a major copyrights or copy of the registered copy of the registered basis or of the representative office in Vietnam.

8. Regulation for quality profile, preclinical record and clinical records:

a) Quality profile: applicable under the ASEAN General Technical Profile (ACTD) and the prescribed technical guidelines at Digital Information (ACTD). 22 /2009/TT-BYT In it:

-Technical standards, drug testing methods, drug production processes provided by the party;

-The test of a public pharmacy issued by the recipient of the recipient.

b) Clinical preclinical records and clinical records: applicable under the ASEAN General Technical Profile (ACTD) and prescribed technical guidelines at Digital Information (ACTD). 22 /2009/TT-BYT.

c) For the household medication for export (not to circulate in the water):

-Quality records include: Technical standards, drug testing methods, drug production processes, stability research materials (accepted research results at the aging rate of extrapolation extrapolation) provided by the Household Reservation; Testing It's a public pharmacy.

-Do not require a report of the data equivalent of biological equivalent research, pre-clinical and clinical records.

9. Drug label regulation and product information:

a) Domestic domestic medicine: The content of the label and the product information are carried out by regulation at paragraph 8 Article 10 of the Digital Information 22 /2009/TT-BYT.

b) Public medicine for export: The content of the label and the product information made by regulation in the country of imports. The macho and household facilities are responsible for the contents of the label on the label and the product information.

10. Rules of charge

The basis of the drug registration must submit the fees associated with registration and circulation of the drug in accordance with the laws of fees and fees.

11. Regulation on the naming of a household drug: Impleminment of the drug naming regulations at Article 11 Digital 22 /2009/TT-BYT.

Article 8. The regulation of the public drug registration records to circulate in Vietnam

1. The drug-drug registration record of the drug has had the number of registered registration numbers in Vietnam in effect:

a) Administrative records and product information:

-Page cover-(Form 1/GC)

-The entry.

-The register has a clear record of the production, including the public sector with the name, address of the respective manufacturers (01 main + 02 copies)-(Form 2a/GC);

-authorization papers (if any)-(Form 3a/GC) or (Form 3b/GC);

-The certificate is sufficient for the drug business if it is a Vietnamese drug business facility (a certificate of the facility);

-Drug label (03 main);

-Product information: (03 major);

-The sample.

-Summary of Product (Form 7a/GC);

-Certificate of certification, protection diploma, contract transfer of the relevant industrial ownership object (if any);

-Other legal papers (if any).

b) Quality profile: (in which Technical Standards, drug testing method: 1 main + 02 copies).

-For pharmaceutical drugs, vaccines, blood serum-containing antibodies, medical products: Regulation at paragraph 1, 2, 3 and paragraph 4 Articles 19 Digital. 22 /2009/TT-BYT.

-For a diagnostic student: Implemenation of regulation at Article 24 Digital News 22 /2009/TT-BYT.

-For the drug from the pharmacy (except for the medical pill): Regulation done at Article 28 Digital 22 /2009/TT-BYT.

-For the drug in the category of drug-produced drugs in the country filing registration records at the local Department of Health: executed by regulation at Annex V No. 22 /2009/TT-BYT.

c) Contract of the drug: Done by regulation at this Article 5.

2. The public drug registration records of the drug have not yet been registered in Vietnam:

a) Administrative records and product information:

-Page cover-(Form 1/GC)

-The entry.

-Single registration (01 copy + 02 copies)-(Form 2b/GC);

-authorization papers (if any)-(Form 3a/GC) or (Form 3b/GC);

-The certificate is sufficient for the drug business if it is a Vietnamese drug business facility (a certificate of the facility);

-Certificate of Pharmaceutical Products (CPP) or Free Circulation Permit (FSC) (if no CPP);

-Drug label (03 main);

-Product information: (03 major);

-The sample.

-Summary of Product (Form 7b/GC);

-Patent or drug research document at the construction facility;

-Certificate of certification, protonation, contracts to transfer the rights to the relevant industrial property (if any).

-Other legal papers (if any).

b) Quality profile: (in which Technical Standards, drug testing method: 1 main + 02 copies).

-For pharmaceutical drugs, vaccines, blood serum-containing antibodies, medical products: Regulation at paragraph 1, 2, 3 and paragraph 4 Articles 19 Digital. 22 /2009/TT-BYT.

-For a diagnostic student: Implemenation of regulation at Article 24 Digital News 22 /2009/TT-BYT.

-For the drug from the pharmacy (except for the medical pill): Regulation done at Article 28 Digital 22 /2009/TT-BYT.

-For the drug in the category of drug-produced drugs in the country filing registration records at the local Department of Health: executed by regulation at Annex V No. 22 /2009/TT-BYT.

c) Contract of the drug: Done by regulation at this Article 5.

d) Clinical preclinical records and clinical records (if new drugs).

-For pharmaceutical drugs, vaccines, blood serum-containing antibodies, medical students: Do in accordance with Regulation 20 and Article 21 Digital. 22 /2009/TT-BYT.

-For a diagnostic student: Implemenation of regulation at Article 25 Digital News 22 /2009/TT-BYT.

-For the drug from the drug (except for the pill): Done by regulation at Article 29 Digital 22 /2009/TT-BYT.

3. The profile resigns the public pill:

a) Administrative records and product information:

-Cover page (Form 1/GC);

-The entry.

-Single registration (1 copy + 02 copies) (Form 2c/GC);

-Authorization (if available) (Form 3a/GC or 3b/GC);

-The certificate is sufficient for the drug business if it is a Vietnamese drug business facility (a certificate of the facility);

-Drug label (03 main);

-Product information: (03 major);

-The sample.

-Summary of Product (Form 7c/GC);

-Certificate of certification, protonation, contracts to transfer the rights to the relevant industrial property (if any).

-Other legal papers (if any).

b) Quality profile: (in which Technical Standards, drug testing method: 1 main + 02 copies).

-For pharmaceutical drugs, vaccines, blood serum-containing antibodies, medical products: Regulation at paragraph 1, 2, 3 and paragraph 4 Articles 19 Digital. 22 /2009/TT-BYT.

The first registration case case was done according to the General ACTD Technical Profile, when the registration required only the standard filing requirements and the finished testing method.

-For a diagnostic student: Implemenation of regulation at Article 24 Digital News 22 /2009/TT-BYT.

-For the drug from the pharmacy (except for the medical pill): Regulation done at Article 28 Digital 22 /2009/TT-BYT.

-For the drug in the category of drug-produced drugs in the country filing registration records at the Local Health Service: Regulation at Annex V No. 22 /2009/TT-BYT.

c) Contract of the drug: Done by regulation at this Article 5.

d) Drug circulation report (Form 5/GC).

Article 9. The regulation of household drug registration records for export (not to circulate in Vietnam)

1. The first drug registry records do not circulate in Vietnam:

a) Administrative records and product information:

-Cover page (Form 1/GC);

-The entry.

-Single registration (1 copy + 2 copies) (Form 4a/GC);

-authorization paper (if available) (Form 3a/GC or Form 3b/GC);

-The certificate is sufficient for the drug business if it is a Vietnamese drug business facility (a certificate of the facility);

-Drug label (03 main);

-Product information: (03 major);

-The sample.

-Summary of Product (Form 7b/GC);

-Certificate of certification, protection diploma, contract transfer of the relevant industrial ownership object (if any);

-Other legal papers (if any).

b) Quality profile: Regulation at Point 8 Article 7 This message (in which Technical Standards and Drug testing method: 01 itself + 02 copies).

c) Contract production contract: In accordance with regulation at this Article 5.

d) Committed the manufacture of non-circulated public contracts in Vietnam (Form 6/GC).

2. The record for reregistration of uncirculated public medicine in Vietnam:

a) Administrative records and product information:

-Cover page (Form 1/GC);

-The entry.

-Single registration (1 copy + 02 copies) (Model 4b/GC);

-authorization paper (if available) (Form 3a/GC or Form 3b/GC);

-The certificate is sufficient for the drug business if it is a Vietnamese drug business facility (a certificate of the facility);

-Drug label (03 main);

-Product information: (03 major);

-The sample.

-Summary of Product (Form 7c/GC);

-Certificate of certification, protonation, contracts to transfer the rights to the relevant industrial property (if any).

-Other legal papers (if any).

b) Quality profile: Regulation at point c 8 Article 7 (in which Technical Standards and Drug testing method: 01 itself + 02 copies).

c) Contract of the drug: Done by regulation at this Article 5.

d) Committed the manufacture of non-circulated public contracts in Vietnam (Form 6/GC).

Chapter IV

ORDER, PROCEDURE FOR DRUG REGISTRATION, PAUSE

AND THE PUBLIC DRUG REGISTRATION NUMBER

What? 10. Sequence, Public Drug Registry

1. The procedure, the procedure for registering domestic drugs in the country (except for the medicines prescribed at Annex V Digital) 22 /2009/TT-BYT ) And the registration changes.

a) Continue: The Department of Pharmacology-the Ministry of Health has a responsibility to take on the household drug registration records that are directly filed or sent through the postal route to the following cases:

-First registration records, reregistration for household drug registration records;

-Big change registration records, minor changes, other changes in the time the number of public pharmacy registration is valid for all the drugs that have registered numbers.

b) appraise:

-The Department of Drug Administration appraisal and the Board of Consultative Consultative Management (later called the Advisory Board) to:

+ The public pharmacy of the public pharmacy has not yet had the registration number circulating;

+ The machinworker of the public order drug has had the number of circulating registration remaining in effect but registration records have not performed according to the ASEAN Joint Technical Profile (ACTD);

+ The public pharmacy resigns but the first public drug registration record has not been done according to the ASEAN Joint Technical Profile (ACTD);

-The Department of Pharmacology organizes the appraisal to rank the registration number (the Advisory Council) to:

+ The public medicine resigns that the initial public drug registration record has done according to the ASEAN Joint Technical Profile (ACTD);

+ The first public household drug of household medicine has had the number of registered registration numbers in effect that the registration filing has done according to the ASEAN general technical portfolio (ACTD);

+ Public medicine for export.

2. The procedure, the procedure for registration of external domestic drugs in the regulation country at Annex V Digital 22 /2009/TT-BYT.

a) The Department of Health of the Provinces, the Central City of the Central Committee where a production facility is responsible for receiving the first registration records, registration is filed directly or sent through the mail line.

b) During the period of three (03) months from the date of receiving a valid case, the Health Department was responsible for organizing the appraisal and sent to the Ministry of Health (Bureau of Pharmacology) with a portfolio of prescription drugs registered to the public medicines issued by the Health Department. to the Ministry of Health review, the number of registered registration levels; 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. The authority to license the number of public medicines:

a) The Minister of Health authorized the Secretary of the Department of Pharmacology to issue a licensed drug portfolio issued to the prescribed medicines at 1 point b 1 and paragraph 2 This.

b) The Secretary of the Bureau of Pharmacology decided to issue a drug portfolio issued by the number of public production registers for the prescribed drugs in the 2-point b 1 Article 1 Article.

c) The Department of Pharmacology is responsible for responding in written response to the proposed changes to the effective public medicines and to address the work involved in the production, registration, and circulation of the public.

4. The deadline for the registration of registration or response to registration records:

a) In the time of the six (06) months from the date of receiving valid records, the Bureau of Pharmaceutical Management registers or has a written response stating the reason if the profile is not or is not eligible for the registration number for the drugs:

-The public pharmacy of the public pharmacy has no circulation number;

-The machinworker ' s public pharmacy has had the number of registered registration number remaining in effect but registration records have not performed according to the ASEAN Joint Technical Profile (ACTD);

-The public pharmacy is reregistered but the first public drug registration record has not been done according to the ASEAN Joint Technical Profile (ACTD);

b) In the period of two (02) months from the date of receiving a valid record, the Bureau of Pharmaceutical Management registers or has a written response stating the reason if the profile is not or is not eligible for the registration number for the drugs:

-Registered medication that the initial public drug registry has done according to the ASEAN Joint Technical Profile (ACTD);

-The first public drug of household medicine has had the number of registered registration numbers in effect that the registration filing has done according to the ASEAN general technical portfolio (ACTD);

-The public medicine for export.

c) In the term 2 (02) months from the date of receiving valid records, the Bureau of Pharmacology considers answers to the major change registration records, small changes.

d) The duration of the registration of the registration or response to the other proposed change recommended profile is specified at the point of a paragraph 4 This.

During a 20-day period of work since the date of receiving the Department of Health, the Bureau of Pharmacy considers, the number of registered subscribers. In the absence of sufficient basis for the number of regioners, the Ministry of Health must have the Office to respond to the Health Department and specify the reason.

What? 11. Suspended, public drug registration number

1. During the time the number of public pharmacy registration is valid, if the two sides terminate the contract, the party must report to the Department of Pharmacology to withdraw its registration number in Vietnam.

2. The temporary cases, the withdrawal of other public drug registration carried out by regulation at Article 33, Article 34 of the Digital 22 /2009/TT-BYT.

Chapter V.

EXECUTION CLAUSE

What? 12. Performance Performance

It has been in effect since 1 October 2013.

Digital Abolition 06 /2004/TT-BYT May 28, 2004, of the Minister of Health directed the production of the drug and repel Article 3 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 No. 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? 13. Transfer clause

The pre-paid drug registration records submitted before the date of this date have the enforced effect and the registration level according to the regulation at the Digital Information. 06 /2004/TT-BYT May 28, 2004, of the Minister of Health, instruct the production of the drug.

What? 14. Reference clause

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? 15. Responsibility for execution

1. The Department of Pharmacology is responsible for guiding the provisions of this Smart; presiding or in coordination with the Health Inspection Inspection, the Department of Cases, Inspection of Enforcement, Inspection of this Information. In the whole country.

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 pharmaceutical business that produces pharmaceutical business, foreign companies with a permit to operate in the pharmaceutical sector are responsible for doing this.

In the course of execution if anything is entangled, the Department of Health (Department of Health) reports to review the ./.

Minister.

(signed)

Nguyen Thi Kim