CIRCULAR

GUIDANCE ON DRUG PROCESSING ACTIVITIES

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

Pursuant to the Commercial Law No.36/2005/QH11 dated June 14, 2005;

Pursuant to Decree No. 12/2006/ND-CP dated  January 23, 2006 of the Government detailing the implementation of the Commercial Law regarding international goods trading and activities of agents, purchase, sale, processing and transit of goods with foreign countries;

Pursuant to Decree No. 79/2006/ND-CP dated August 9, 2006 of the Government detailing the implementation of a number of articles of the Law on Pharmacy;

Pursuant to Decree No. 89/2012/ND-CP dated October 24, 2012 of the Government amending and supplementing a number of articles of Decree No. 79/2006/ND-CP dated August 9, 2006 of the Government detailing a number of articles of the Law on Pharmacy;

Pursuant to Decree No. 63/2012/ND-CP dated August 31, 2012 of the Government stipulating the functions, tasks, powers and structure of the Ministry of Health;

At the proposal of Director of Drug Administration of Vietnam ;

The Minister of Health issues Circular guiding activities of drug processing.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation and subject of application

1. This Circular provides for drug processing, dossier to register drug processing, order and procedures for registration, suspension and withdrawal of registration number of drug process.

2. This Circular applies to domestic and foreign organizations and individuals having activities related to the drug processing and registration for circulation of processed drug in Vietnam.

Article 2. Explanation of term

In this Circular, the terms below are construed as follows:

1. Drug processing is that the processing Party performs work to make products as required by the Ordering Party and the Ordering Party receives products and makes payment of remuneration under the agreement in accordance with the regulations of law.

The processing Party's job is to implement the processing of one, a number or all stages of the drug manufacturing process (receipt of raw materials, processing and packaging including packaging in the final packing and labeling).

2. Drug ordered for processing is the drug issued with Permit for circulation or product export by the pharmaceutical management agency; issued with patent or researched by very ordering Party for drugs without circulation registration number in Vietnam.

3. Ordering Party is the Party submitting application for issuance of Permit for circulation of drug processing.

4. Processing Party is the Party manufacturing and receiving remuneration of manufacturing from the ordering Party. The processing Party may consist of a lot of manufacturers and each manufacturer is involved in one or a lot of stages of manufacturing.

5. Processing contract is the agreement between the Parties, accordingly, the processing Parties perform work to make products as required by the ordering Party which shall receive and make payment of processing remuneration.

6. Transitional processing is the drug processing in which there are a lot of processing parties, thus:

- The processed products of this processing contract shall be used as processing materials for other processing contracts in Vietnam;

- The processed products of processing contract of previous stages shall be delivered to other manufacturers designated by the ordering Party for the processing contract of the following stages.

Chapter II

REGULATIONS ON DRUG PROCESSING

Article 3. Conditions for drug processing

1. Conditions to be the name of the ordering Party

The Vietnamese legal drug business establishments, foreign drug business and manufacturing establishments that have “Operation Permit of foreign enterprises on drugs and drug materials in Vietnam” and drugs whose registration number has been issued by the Vietnam Ministry of Health and is still valid or that are the patent owners or research subjects accepted as prescribed by Vietnam law or product research materials at the processing establishment for drugs without circulation registration number in Vietnam ordered for manufacturing and processing.

2. Conditions to be the name of the processing Party

a) For pharmaceutical chemical drugs, herbal drugs (except for oriental drug), vaccines, sera containing antibodies, biomedical products: manufacturing establishment in Vietnam with certificates of elibility for drug business and certificate of standard satisfaction of "Good manufacturing practice" (GMP) with the dosage form of suitable for drugs intended for processing.

b) For in vitro diagnostic biological products: manufacturing establishment in Vietnam with certificate of eligibility for drug business and certificate of standard satisfaction of "Good manufacturing practice" (GMP) or TCVN ISO 13485 or other equivalent standards with the dosage form of suitable for drugs intended for processing.

Article 4. Rights and obligations of the ordering Party and the processing Party

1. For ordering Party:

a) Owning registration number and processed products;

b) Ordering the processing of one or a number of manufacturing stage from the processing Party;

c) Receiving the processed products in accordance with the method, time limit and terms agreed in the contract;

d) Taking responsibility for registration of processed drug in accordance with the order and registration procedures prescribed in Circular No. 22/2009/TT-BYT dated November 24, 2009 by the Minister of Health stipulating drug registration (hereafter referred to as Circular No. 22/2009/TT-BYT);

dd) Performing the rights and obligations of drug registration establishment in accordance with Circular No. 22/2009/TT-BYT the right to import and export as prescribed by law on import and export of drug;

e) Providing manufacturing processes, technical standards and testing methods of original materials, semi-finished and finished products, and other papers relating to the drug processing;

g) Making payment of processing remuneration as agreed in the contract;

h) Taking responsibility for the quality, safety and efficiency of processed and manufactured drugs during the course of drug circulation;

i) Taking responsibility for issues relating to intellectual property of drug registered for circulation and the other rights and obligations under the provisions of law on commercial processing.

2. For processing Party:

a) Receiving remuneration as agreed in the contract;

b) Having the right to require the ordering Party to deliver materials with proper amount, quality, time limit and location as agreed in the contract. If the processing Party itself may provide original materials, it must ensure the quality of materials in accordance with the ordering Party’s standards.

c) Having the right to refuse to receive the processing if the ordering Party provide materials which do not meet quality standard as stated in the signed contract;

d) Requiring the ordering Party to provide manufacturing processes, technical standards and testing methods of original materials, semi-finished and finished products, and other papers relating to the drug processing.

dd) Manufacturing drugs in accordance with the process, techniques and drug quality assurance in line with drug registration dossier and ordering Party’s requirements specified in the signed contract;

e) Keeping dossiers, materials and drug samples related to drug manufacturing process and providing those dossiers to the competent state agencies as required;

g) Taking responsibility for product quality testing throughout the manufacturing process and product quality assurance until delivering the processed products to the ordering Party;

h) Processed products, surplus materials, scrap, waste products after completion of the processing contract as agreed by both Parties in accordance with regulations of law;

i) Other rights and obligations as prescribed by law on commercial processing.

Article 5. Drug processing contract

1. Form of drug processing contract

The drug processing contract must be made in writing and comply with regulations of Vietnam law on economic contract.

2. Mandatory contents in a drug processing contract:

a) Agreement on provision of raw materials, provision of manufacturing process, technical standards and testing methods of original materials, semi-finished and finished products and other papers related to the drug processing;

b) Powers and responsibilities of each party to test the quality of raw materials, semi-finished and finished products, packing and labelling process of products and specification of the signing of test card of each batch and product delivery slip;

c) Powers and responsibilities of each party for the keeping of dossier on manufacturing, quality control, distribution and circulation of drugs, the drug sample storage, settlement of problems related to quality, complaints, product recalls on the market;

d) Responsibility of the ordering Party for issues relating to intellectual property of the registered drugs;

dd) Process and procedures for inspecting the processing Party’s manufacturing establishment;

e) Cases of annulment of contract;

g) There must be consent from the manufacturing establishment to the drug processing whose registration number still valid by Vietnam Ministry of Health (in case the registration establishment is different from the manufacturing establishment).

Article 6. General regulation on processed and manufactured drugs

1. Regulation on processed and manufactured drugs:

a) For drugs with circulation registration number in Vietnam: Being manufactured and processed in one, a number or entire stage of the manufacturing process at one or a number of processing manufacturers;

b) For drugs without circulation registration number in Vietnam: Being manufactured and processed in the entire stage of the manufacturing process and placed only at one processing manufacturer.

2. Form of registration for manufacturing and processing: Pharmachemical drugs, biomedical products, sera containing antibodies, in vitro diagnostic biological products, herbal drugs (except for oriental drugs) shallbe registered for manufacturing and processing in the following forms:

a) First registration for processing;

b) Registration for major modification;

c) Registration for minor modification;

d) Re-registration;

dd) Other registration for modification;.

3. Requirements for clinical trials, bioavailability and bioequivalence: The requirements for clinical trials related to new drugs, bioavailability and bioequivalence for processed and manufactured drugs for circulation in Vietnam shall comply with the provisions of the Ministry of Health on clinical trials, bioavailability and bioequivalence of drugs.

4. Production, transportation, and circulation of processed drugs containing narcotic drugs, psychotropic and precursor substances used as drugs (including pure in combination form) shall comply with the provisions of the Ministry of Health on management of narcotic drugs, psychotropic and precursor substances and other regulations of the relevant laws.

5. Issuance of circulation registration number of processed drugs:

a) The processed drugs are issued with registration number which is valid for five (05) years from the date of signing the decision on issuance of registration number and must not be longer than the validity of registration number of drug ordered for processing. The validity of registration number of transitional processed drugs shall be equal to the remaning time of validity of registration number of drug ordered in the previous stage. In special cases, the Advisory Council shall issue the drug registration number – the Ministry of Health shall consider and make proposal to the Minister of Health for decision.

Within six (06) months before and six (06) months after the registration number of processed drug expires, the establishment may apply for re-registration. Beyond the time limit specified above, the establisment shall re-submit such dossier the same as processed drugs registered for the first time;

b) For drugs with circulation registration number in Vietnam ordered for processing: the validity of old registration number shall terminate after three (03) months from the date the processing registration number takes effect; drugs ordered for processing before the expiry of the old registration number shall be circulated to the expiration of drug.

6. Import and export of processed drugs shall comply with provisions of legal documents detailing the implementation of the Commercial Law on international goods trading and activities of agents, purchase, sale, processing and transit of goods with foreign countries; the current regulations of the Ministry of Health on the management of import and export of drugs and other relevant legal documents.

Chapter III

DOSSIER FOR PROCESSED DRUG REGISTRATION

Article 7. General provision on dossier for processed drug registration

1. Language used in registration dossier:

Dossier for processed drug registration must be written in Vietnamese (except for dossier for bioequivalence testing report and clinical dossier).

2. Dossier for drug registration shall be prepared on A4 size paper and firmly bound. Dossier shall be arranged in the sequence of the catalog with the separation between sections. The separated sections must be numbered for easy reference and confirmed by registration establishment or drug manufacturing establishment in the first page of each section of the entire dossier.

3. Each drug must have separate registration dossier, except that the drug has the same factors likely registered in the same dossier as follows:

a) Drug name;

b) Dosage form;

c) Formula for a dose unit (for drug form of single dose) or the same concentration levels (for multi-dose drug);

d) Manufacturer;

4. General requirements for materials to be submitted in the dossier for registration of processed drug for the first time, re-registration and dossier to request the other modifications as follows:

a) One (01) orginal including all parts specified in Article 8 of this Circular;

b) Two (02) copies of materials including application for drug registration and standard of finished products;

c) Drug group: two (02) sample sets of design label. These labels are mounted on A4 paper with the affixed seal of the registration establishment;

d) Product information: Instruction or information sheet for patient or Summary of product characteristics as prescribed for each type of corresponding drug with the affixed seal of the registration establishment;

dd) Drug sample:

- One (01) packing unit for circulation registration specification;

- For vaccines and sera containing antibodies, the registration establishment shall send sample at the National Institute for vaccines and biomedical products;

e) Summary of product.

5. Dossier for registration of major modification, minor modification and other modifications ;

One (01) original with all materials is required submitting as follows :

a) For pharmachemical drug, vaccines and sera containing antibodies, biomedical products: Complying with provisions in Clause 4, 5 and 6, Article 17 of Circular No. 22/2009/TT-BYT;

b) For in vitro diagnostic biological products: Complying with provisions in Clause 3 and 4, Article 22 of Circular No. 22/2009/TT-BYT;

c) For herbal drug (except for oriental drug): Complying with provisions in Clause 3, 4 and 5, Article 26 of Circular No. 22/2009/TT-BYT;

6. Regulation on legal dossier

The legal dossier complies with the provisions in Clause 6, Article 10 of Circular No. 22/2009/TT-BYT and Clause 1 and 2, Article 10 of Circular No. 45/2011/TT-BYT dated December 21, 2011 of the Minister of Health amending and supplementing a number of articles of Decision No. 1570/2000/QD-BYT dated May 22, 2000 of the Minister of Health on application of principle “Good Laboratory Practice”; Decisison No. 2701/2001/QD-BYT dated June 29, 2001 of the Minister of Health on application of principle “Good Storage Practice”; Circular No. 06/2004/TT-BYT dated May 28. 2004 guiding the drug manufacturing and processing; Decision No. 3886/2004/QD-BYT dated November 13, 2004 of the Ministry of Health on application of principle and standard ”Good Manufacturing Practice” as recommended by the World Health Organization; Circular No. 13/2009/TT-BYT dated September 01, 2009 of the Ministry of Health guiding activities of drug advertising and information; Circular No. 22/2009/TT-BYT dated November 24, 2009 of the Ministry of Health on drug registration; Circular No. 47/2010/TT-BYT dated December 29, 2009 guiding the import and export of drug and packaging in direct contact with the drug (hereinafter referred to as Circular No. 45/2011/TT-BYT)

7. Provision on other administrative dossier:

a) Application for registration must be directly signed and sealed (if any) by the Director of drug registration establishment or its authorized representative. The stamp signature is not acceptable;

b) Power-of-attorney is required in the following cases:

- Authorized to sign dossier for drug registration when director of drug registration establishment authorizes the Head of representative of drug registration establishment in Vietnam;

- Authorized to use drug name the drug name registered as a trademark when the owner of trademark is not the drug registration establishment.

Each dossier must have one (01) original or certified copy of power-of-attorney of the registration establishment or representative office in Vietnam.

8. Provision on quality dossier, pre-clinical and clinical dossier :

a) Quality dossier : applies with the ASEAN Common Technical Dossier (ACTD) and technical guidelines as prescribed in Circular No. 22/2009/TT-BYT particluarly :

- Technical standards and methods of drug testing, drug manufacturing process provided by the ordering Party;

- Drug testing slip of processed drug provided by the processing Party.

b) Pre-clinical and clinical dossier : applies with the ASEAN Common Technical Dossier (ACTD) and technical guidelines as prescribed in Circular No. 22/2009/TT-BYT.

c) For drugs processed for export (no domestic circulation):

- Quality dossier consists of : Technical standards, methods of drug testing, drug manufacturing process, materials of stabilit research (acceptable research result in terms of speed aging of extrapolated life expectancy) provided by the ordering Party; processed drug testing slip provided by the processing Party.

- The report on bioequivalence research data, the pre-clinical and clinical dossier are not required submitting.

9. Provision on drug group and product information :

a) Processed drugs in domestic circulation: the content of drug group and product information comply with the provisions of Clause 8, Article 10 of Circular No. 22/2009/TT-BYT.

b) Drugs processed for export : The content of drug label and product information comply with regulations of importing country. The procesing establishment and ordering Party are responsible for the contents on drug label and product information.

10. Provision on charges

The drug registration establishment shall make payment of charges relating to the drug registration and circulation as prescribed by law on fees and charges.

11. Provisions on processed drug naming: complies with provisions on drug naming in Article 11 of Circular No. 22/2009/TT-BYT.

Article 8. Provision on dossier for registration of processed drug for circulation in Vietnam

1. Dossier for registration of processed drug of the drug with valid circulation registration number

a) Administrative dossier and product information:

- Cover page - (Form 1/GC)

- Table of Contents;

- Application for registration specifying each stage of production, including processing stages with names and addresses of respective manufacturers (01 original + 02 copies)- (Form 2a/GC);

- Power-of-attorney (if any) - (Form 3a/GC) or (Form 3b/GC);

- Certificate of eligibility for drug trading if being Vietnamese drug business establishment (copy with certification of establishment):

- Drug group (03 originals) ;

- Product information : (03 originals) ;

- Drug sample;

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

- Certificate, title of protection, transfer contract of related objects of industrial property rights (if any);

- Other legal papers (if any).

b) Quality dossier (including technical standards and methods of drug testing: 01 original + 02 copies).

- For pharmachemical finished drugs, vaccines, sera containing antibodies, biomedical products: complying with the provisions of Clause 1, 2, 3 and 4, Article 19 of Circular No. 22/2009/TT-BYT.

- For diagnostic biological products: complying with provisions in Article 24 of Circular No. 22/2009/TT-BYT.

- For herbal drugs (except for oriental drugs) : complying with the provisions in Article 28 of Circular No. 22/2009/TT-BYT.

- For drugs on the list of drugs locally manufactured: submitting registration dossier at the local Service of Health: complying with the provisions of Annex V of the Circular No. 22/2009/TT-BYT.

c) Drug processing contract : complying with provisions in Article 5 of this Circular.

2. Dossier for registration of processed drug of the drug without circulation registration number in Vietnam:

a) Administrative dossier and product information:

- Cover page – (Form 1/GC)

- Table of contents;

- Application for registration (01 original + 02 copies) - (Form 2b/GC);

- Power of attorney (if any) - (Form 3a/GC) or (Form 3b/GC);

- Certificate of eligibility for drug trading if being Vietnamese drug business establishment (copy with certification of establishment):

- Certificate of Pharmaceutical Product (CPP) or Certificate of Free Sale (FSC) (if without CPP);

- Drug label (03 originals);

- Product information: (03 originals);

- Drug sample;

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

- Patent or drug research materials at the ordering establishment ;

- Certificate, title of protection, transfer contract of related objects of industrial property rights (if any);

- Other legal papers (if any).

b) Quality dossier : (technical standards, methods of drug testing : 01 original + 02 copies).

- For pharmachemical finished drugs, vaccines, sera containing antibodies, biomedical products: complying with the provisions of Clause 1, 2, 3 and 4, Article 19 of Circular No. 22/2009/TT-BYT.

- For diagnostic biological products: complying with provisions in Article 24 of Circular No. 22/2009/TT-BYT.

- For herbal drugs (except for oriental drugs) : complying with the provisions in Article 28 of Circular No. 22/2009/TT-BYT.

- For drugs on the list of drugs locally manufactured: submitting registration dossier at the local Service of Health: complying with the provisions of Annex V of the Circular No. 22/2009/TT-BYT.

c) Drug processing contract : complying with provisions in Article 5 of this Circular.

d) Pre-clinical and clinical dossier (if new drug) ;

- For pharmachemical finished drugs, vaccines, sera containing antibodies, biomedical products: complying with the provisions of Article 20 and  21 of Circular No. 22/2009/TT-BYT.

- For in vitro diagnostic biological products: Complying with provisions in Article 25 of Circular No. 22/2009/TT-BYT;

- For herbal drugs (except for oriental drugs) : complying with the provisions in Article 29 of Circular No. 22/2009/TT-BYT.

3. Dossier for re-registration of processed drugs :

a) Administrative dossier and product information :

- Cover pate (Form 1/GC);

- Table of contents;

- Application for registration (01 original + 02 copies) (Form 2c/GC);

- Power of Attorney (if any) (Form 3a/GC or 3b/GC);

- Certificate of eligibility for drug trading if being Vietnamese drug business establishment (copy with certification of establishment):

- Drug label (03 originals);

- Product information: (03 originals);

- Drug sample;

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

Certificate, title of protection, transfer contract of related objects of industrial property rights (if any);

- Other legal papers (if any).

b) Quality dossier (including technical standards and methods of drug testing: 01 original + 02 copies).

- For pharmachemical finished drugs, vaccines, sera containing antibodies, biomedical products: complying with the provisions of Clause 1, 2, 3 and 4, Article 19 of Circular No. 22/2009/TT-BYT.

If the dossiers registered for the first time have followed the ASEAN Common Technical Dossier (ACTD), only standard and method of finished product testing are required submitting upon re-registration.

- For diagnostic biological products: complying with provisions in Article 24 of Circular No. 22/2009/TT-BYT.

- For herbal drugs (except for oriental drugs) : complying with the provisions in Article 28 of Circular No. 22/2009/TT-BYT.

- For drugs on the list of drugs locally manufactured: submitting registration dossier at the local Service of Health: complying with the provisions of Annex V of the Circular No. 22/2009/TT-BYT.

c) Drug processing contract : complying with provisions in Article 5 of this Circular.

d) Report on drug circulation (Form 5/GC).

Article 9. Provision on dossier for registration of processed drug for export (No circulation in Vietnam)

1. Dossier for registration of processed drug for the first time not circulating in Vietnam:

a) Administrative dossier and product information:

- Cover page - (Form 1/GC)

- Table of Contents;

- Application for registration (01 original + 02 copies) (Form 4a/GC);

- Power-of-attorney (if any) - (Form 3a/GC) or (Form 3b/GC);

- Certificate of eligibility for drug trading if being Vietnamese drug business establishment (copy with certification of establishment):

- Drug label (03 original);

- Product information: (03 original);

- Drug sample;

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

- Certificate, title of protection, transfer contract of related objects of industrial property rights (if any);

- Other legal papers (if any).

b) Quality dossier : complying with the provisions at Point c, Clause 8, Article 7 of this Circular (technical standard and methods of drug testing : 01 original + 02 copies).

c) Drug processing and manufacturing contract : complying with provisions in Article 5 of this Circular.

d) Undertaking that drugs manufactured under processing contract shall not be circulated in Vietnam (Form 6/GC).

2. Dossier for re-registration of processed drugs not circulating in Vietnam:

a) Administrative dossier and product information :

- Cover page - (Form 1/GC)

- Table of Contents;

- Application for registration (01 original + 02 copies) (Form 4a/GC);

- Power-of-attorney (if any) - (Form 3a/GC) or (Form 3b/GC);

- Certificate of eligibility for drug trading if being Vietnamese drug business establishment (copy with certification of establishment):

- Drug label (03 original);

- Product information: (03 original);

- Drug sample;

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

- Certificate, title of protection, transfer contract of related objects of industrial property rights (if any);

- Other legal papers (if any).

b) Quality dossier : complying with the provisions at Point c, Clause 8, Article 7 of this Circular (technical standard and methods of drug testing : 01 original + 02 copies).

c) Drug processing and manufacturing contract : complying with provisions in Article 5 of this Circular.

d) Undertaking that drugs manufactured under processing contract shall not be circulated in Vietnam (Form 6/GC).

Chapter IV

ORDER, PROCEDURES FOR DRUG REGISTRATION, SUSPENSION AND WITHDRAWAL OF REGISTRATION NUMBER OF PROCESSED DRUGS

Article 10. Order, procedures for registration of processed drugs

1. The order, procedures for domestic registration of processed drugs (excluding drugs specified in Annex V of Circular No. 22/2009/TT-BYT) and registration for modification.

a) Receipt : The Drug Administration of Vietnam – Ministry of Health shall receive dossiers for registration of processed drugs directly submitted or sent via post for the following cases :

- Dossier for first registration, re-registration concerning dossiers for registration of processed drugs

- Dossier for registration of major modification, minor modification and other modifications during the time the registration number of processed drug is still valid for all drugs with registration number.

b) Appraisal and approval:

- The Drug Administration of Vietnam shall appraise and request the Advisory Council to issue the circulation registration number of drug – Ministry of Health (hereafter referred to as Advisory Council) for:

+ Processed drugs of the drugs ordered for processing without circulation registration number

+ Processed drugs of the drugs ordered for processing with valid circulation registration number but their registration dossiers have not followed the ASEAN Common Technical Dossier (ACTD) ;

+ Processed drugs are re-registered but their dossiers for registration of processed drug for the first time have not followed the ASEAN Common Technical Dossier (ACTD) ;

- The Drug Administration of Vietnam shall appraise to issue registration number (without submission to the Advisory Council) for:

+ Processed drug re-registered but their dossiers for registration of processed drug for the first time have followed the ASEAN Common Technical Dossier (ACTD);

+ Drugs processed for the first time of the drugs ordered for processing already have their valid circulation registration number but their dossiers for registration have followed the ASEAN Common Technical Dossier (ACTD);

+ Drugs processed for export

2. Order and procedures for registration of drugs used other than domestic processing are specified in Annex V of Circular No.22/2009/TT-BYT.

a) Service of Health of provinces and centrally-affiliated cities where the manufacturing establishments are located shall receive dossiers for first registration, re-registration submitted directly or via post.

b) Within three (03) months after receiving valid dossiers, the Service of Health shall appraise and send the Ministry of Health (Drug Administration of Vietnam) official dispatch together with list of drugs to propose the issuance of registration number for processed drugs whose dossiers have been received by the Service of Health so that the Ministry of Health may review and issue registration numbers. If there is not sufficient grounds to propose the issuance of registration numbers, the Service of Health shall reply in writing to the registration establishment stating the reasons

3. Competence to issue registration number of processed drugs :

a) The Minister of Health shall authorize the Director of Drug Administration of Vietnam to sign the decision on issuance of list of drugs to be issued with processing registration number for drugs detailed in Paragraph 1, Point b, Clause 1 and 2 of this Article;

b) The Director of Drug Administration of Vietnam shall sign the decision on issuance of list of drugs to be issued with processing and manufacturing registration number for drugs detailed in Paragraph 2, Point b, Clause 1 of this Article;

c) The Drug Administration of Vietnam shall respond in writing to the proposed modification for valid processed drugs and settle issues relating to the manufacturing, registration and circulation of processed drugs.

4. Time limit for issuance of registration number or response to registrations dossiers :

a) Within six (06) months after fully receiving valid dossiers, the Drug Administration of Vietnam shall issue registration number or answer in writing specify the reasons if the dossiers do not satisfy the conditions for issuance of registration number for the drugs :

- Processed drugs of the drugs ordered for processing without circulation registration number;

- Processed drugs of the drugs ordered for processing with valid circulation registration number but their registration dossiers have not followed the ASEAN Common Technical Dossier (ACTD) ;

- Processed drugs are re-registered but their dossiers for registration of processed drug for the first time have not followed the ASEAN Common Technical Dossier (ACTD) ;

b) Within two (02) months after fully receiving valid dossiers, the Drug Administration of Vietnam shall issue registration number or respond in writing stating the reasons if the dossiers have not met the conditions for issuance of registration number to the following drugs :

- The processed drugs re-registered whose dossiers for registration of processed drug for the first time have followed the ASEAN Common Technical Dossier (ACTD) ;

- The processed drugs registered for the first time with their valid circulation registration number but their dossiers have followed the ASEAN Common Technical Dossier (ACTD);

- Drugs processed for export;

c) Within two (02) months after fully receiving valid dossiers, the Drug Administration of Vietnam shall review and respond to dossiers for registration of major modification, minor modification ;

d) The time limit for issuing registration number or responding to dossiers for other modifications shall comply with the provisions specified at Point a, Clause 4 fo this Article.

dd) Within 20 working days after receiving official dispatch from Service of Health, the Drug Administration of Vietnam shall consider and issue circulation registration number. If there are not sufficient grounds to issue the registration number, the Ministry of Health shall respond in writing to the Service of Health clearly stating the reason.

Article 11. Suspension and withdrawal of registration number of processed drugs

1. During the time the registration number of processed drugs is valid, if both Parties terminate their contract , the ordering Party shall report to the Drug Administration of Vietnam to withdraw its circulation registration number in Vietnam.

2. Other cases of suspension and withdrawal of registration number of processed drugs shall comply with the provisions in Article 33, 34 of Circular No. 22/2009/TT-BYT.

Chapter V

IMPLEMENTATION PROVISION

Article 12. Effect

This Circular takes effect on October 01, 2013.

Annulling Circular No. 06/2004/TT-BYT dated May 28, 2004 of the Minister of Health guiding the manufacturing and processing of drugs and annulling Article 3 of Circular No. 45/2011/TT-BYT dated December 21, 2011 of the Minister of Health amending and supplementing a number of articles of Decision No. 1570/2000/QD-BYT dated May 22, 2000 of the Minister of Health on application of principle “Good Laboratory Practice”; Decision No. 2701/2001/QD-BYT dated June 29, 2001 of the Minister of Health on application of principle “Good Storage Practice”; Circular No. 06/2004/TT-BYT dated May 28, 2004 guiding the drug manufacturing and processing; Decision No. 3886/2004/QD-BYT dated November 13, 2004 of the Ministry of Health on application of principle and standard ”Good Manufacturing Practice” as recommended by the World Health Organization; Circular No. 13/2009/TT-BYT dated September 01, 2009 of the Ministry of Health guiding activities of drug advertising and information; Circular No. 22/2009/TT-BYT dated November 24, 2009 of the Ministry of Health on drug registration; Circular No. 47/2010/TT-BYT dated December 29, 2009 guiding the import and export of drug and packaging in direct contact with the drug from the effective date of this Circular.

Article 13. Transitional provision

Dossiers for registration of processed drugs submitted before the effective date of this Circular shall be appraised and issued with registration number as prescribed in Circular No. 06/2004/TT-BYT dated May 28, 2004 of the Minister of Health guiding the manufacturing and processing of drugs.

Article 14. Reference provision

In case the legal normative documents and provisions cited in this Circular have modifications, supplementation or supersession, the new legal normative documents shall apply.

Article 15. Responsibility for implementation

1. The Drug Administration of Vietnam shall guide the implementation of provisions of this Circular ; assume the prime responsibility for or coordinate with Ministry of Health Inspector, Departments and Administrations to examine and inspect the implementation of this Circular for pharmaceutical manufacturing and business units nation-wide.

2. Service of Health of provinces and centrally-affiliated cities are responsible for examination and inspection of implementation of this Circular for pharmaceutical manufacturing and business units under their management.

3. Units directly under the Ministry of Health, Vietnam Pharmaceutical Corporation, pharmaceutical manufacturing and business units, foreign companies having Operation Permit in pharmaceutical area are liable to execute this Circular.

Any problem arising during the course of implementation should be reported to the Ministry of Health (Drug Administration of Vietnam) for consideration and settlement.