Circular No. 23/2013/TT-BYT of August 13, 2013, guiding drug processing

THE MINISTRY OF HEALTH

Circular No. 23/2013/TT-BYT of August 13, 2013, guiding drug processing

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

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

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

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

Pursuant to the Governments Decree No. 89/2012/ND-CP of October 24, 2012, amending and supplementing a number of articles of Decree No. 79/2006/ND-CP of August 9, 2006;

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

At the proposal of the director of the Drug Administration of Vietnam;

The Minister of Health promulgates the Circular guiding drug processing.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation and subjects of application

1.   This Circular provides drug processing, dossiers for registration of drug processing, order and procedures for registration, suspension and withdrawal of registration numbers of processed drugs.

2.   This Circular applies to domestic and foreign organizations and individuals engaged in drug processing and registration for circulation of processed drugs in Vietnam.

Article 2. Interpretation of terms

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

1.   Drug processing means that the processing party performs work to make products at the request of the ordering party and the ordering party receives products and pays remuneration under the agreement reached in accordance with law.

The processing party’s work is to perform one, several or all of 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 means a drug that has a circulation or export permit granted by the pharmaceutical management agency; has a patent, or has been researched by the very ordering party, for drugs without circulation registration number in Vietnam.

3.   Ordering party means the party submitting the application for a permit for circulation of processed drug.

4.   Processing party means the party manufacturing and receiving remuneration for manufacturing from the ordering party. The processing party may consist of more than one manufacturer, with each manufacturer involved in one, several or all of stages of manufacturing.

5.   Processing contract means the agreement between the parties, under which the processing party performs work to make products at the request of the ordering party while the ordering party receives products and pays processing remuneration.

6.   Transitional processing means the drug processing in which there are more than one processing party, whereby:

-   The processed products of one processing contract are used as processing materials for another processing contract in Vietnam;

-   The processed products of the processing contract of the previous stage are delivered to another manufacturer designated by the ordering party for the processing contract of the subsequent stage.

Chapter II

PROVISIONS ON DRUG PROCESSING

Article 3. Conditions for drug processing

1.   Conditions for acting as the ordering party

Lawful Vietnamese drug trading establishments, foreign drug trading and manufacturing establishments that possess operation licenses of foreign enterprises for drugs and drug materials in Vietnam and have drugs with registration numbers granted by the Vietnamese Ministry of Health and still valid, or that are owners of patents or research subjects already accepted in accordance with Vietnamese law or product research documents at the very processing-ordering establishments, for drugs without circulation registration number in Vietnam ordered for manufacturing and processing.

2.   Conditions for acting as the processing party

a/ For pharma-chemical drugs, herbal drugs (except oriental drugs), vaccines, antibody- containing sera, and medical biologicals: Manufacturing establishments in Vietnam with certificates of eligibility for drug trading and certificates of satisfaction of “Good Manufacturing Practices” (GMP) standards with preparation forms suitable to drugs intended for processing.

b/ For in-vitro diagnostic biologicals: Manufacturing establishments in Vietnam with certificates of eligibility for drug trading and certificates of satisfaction of “Good Manufacturing Practices” (GMP) standards or Vietnam standard TCVN ISO 13485 or other equivalent] standards with preparation forms suitable to drugs intended for processing.

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

1.   For the ordering party:

a/ To own registration numbers and processed products

b/ To order the processing of one or several of manufacturing stages from the processing parties;

c/ To receive processed products according to the method, time limit and terms agreed in the contract;

d/ To register processed drugs according to the order and procedures for registration prescribed in the Minister of Health’s Circular No. 22/2009/TT-BYT of November 24, 2009, stipulating drug registration (below referred to

as Circular No. 22/2009/TT-BYT);

dd/ To exercise the rights and perform the obligations of drug registration establishments prescribed in Circular No. 22/2009/TT-BYT, and the right to import and export as prescribed by the law on import and export of drugs;

e/ To provide manufacturing processes, technical standards and testing methods of original materials, semi-finished and finished products, and other papers related to the drug processing;

g/ To pay processing remuneration as agreed in the contract;

h/ To take responsibility for the quality, safety and efficacy of processed and manufactured drugs during the course of drug circulation;

i/ To take responsibility for issues related to intellectual property of the drug registered for circulation and other rights and obligations under the law on commercial processing.

2.   For the processing party:

a/ To receive remuneration as agreed in the contract;

b/ To request the ordering party to deliver materials in quantities, of quality, within time limits and at locations as agreed in the contract. If providing original materials by itself, to ensure the quality of materials up to the ordering party’s standards.

c/ To refuse to receive the processing if the ordering party provides materials which do not meet quality standard as stated in the contract;

d/ To request the ordering party to provide manufacturing processes, technical standards and testing methods of original materials, semi- finished and finished products, and other papers related to the drug processing;

dd/ To manufacture drugs in accordance with the process and techniques and assure drug quality according to the drug registration dossier and the ordering party’s requirements specified in the signed contract;

e/ To keep dossiers, documents and drug samples related to the drug manufacturing process and provide those dossiers to competent state management agencies upon request;

g/ To inspect product quality throughout the manufacturing process and assure product quality until delivery of processed products to the ordering party;

h/ To ensure that processed products, redundant materials, scrap and waste products after completion of the processing contract comply with the agreement of the two parties stated in the contract in accordance with law;

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

Article 5. Drug processing contract

1.   Form of drug processing contract

A drug processing contract must be established in writing and comply with Vietnamese regulations on economic contracts.

2.   Mandatory contents in a drug processing contract:

a/ Agreement on provision of materials, the 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 materials, semi-finished and finished products, packaging and labeling of products and the signing of test cards of each batch of finished products and product ex-work slips;

c/ Powers and responsibilities of each party for the preservation of dossiers on manufacturing, quality control, distribution and circulation of drugs, storage of drug samples, and settlement of problems related to quality, complaints and recall of marketed products;

d/ Responsibility of the ordering party for issues related to intellectual property of the registered drugs;

dd/ The process and procedures for inspecting the processing party’s manufacturing establishments;

e/ Cases of contract cancellation;

g/ Consent of the manufacturing establishment, for the processing of drugs whose registration numbers issued by Vietnamese Ministry of Health are still valid (in case the registering establishment is different from the manufacturing establishment).

Article 6. General provisions on processed and manufactured drugs

1.   Provisions on processed and manufactured drugs:

a/ For drugs with circulation registration numbers in Vietnam: Being manufactured and processed in one, several or all of stages of the manufacturing process at one or several processing manufacturers;

b/ For drugs without circulation registration number in Vietnam: Being manufactured and processed in all of stages of the manufacturing process and ordered only at one processing manufacturer.

2.   Form of registration for manufacturing and processing: Pharma-chemical drugs, medical biologicals, antibody-containing sera, in-vitro diagnostic biologicals and herbal drugs (except oriental drugs) may be 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 comply with the regulations of the Ministry of Health on clinical trials, bioavailability and bioequivalence of drugs.

4.   Manufacture, transportation and circulation of processed drugs containing habit-forming drugs, psychotropic and precursor substances used as drugs (including single or combined substances) comply with the regulations of the Ministry of Health on management of habit-forming drugs, psychotropic and precursor substances and other relevant laws.

5.   Issuance of circulation registration numbers of processed drugs:

a/ A processed drug is issued with a registration number which is valid for five (5) years at most from the date of signing of the decision on issuance of registration number and must not be longer than the validity term of the registration number of the drug ordered for processing. The validity of the registration number of a transitionally processed drug must be equal to the remaining time of the validity term of the registration number of the drug ordered in the previous stage. In special cases, the advisory council for grant of drug registration numbers of the Ministry of Health shall consider and make a proposal to the Minister of Health for decision.

Within six (6) months before and six (6) months after the registration number of a processed drug expires, the establishment may submit a dossier for re-registration. Beyond this time limit, the establishment shall re-submit a dossier as for processed drugs registered for the first time;

b/ For drugs with circulation registration numbers in Vietnam ordered for processing, the validity of the old registration number will terminate after three (03) months from the date the processing registration number takes effect; drugs ordered for processing before the expiration of the old registration number may be circulated until the expiry date of drugs.

6. The import and export of processed drugs comply with legal documents detailing the implementation of the Commercial Law regarding international goods trading, and agency, 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

DOSSIERS FOR REGISTRATION OF PROCESSED DRUGS

Article 7. General provisions on dossiers for registration of processed drugs

1.   Language used in the registration dossier:

A dossier for registration of a processed drug must be made in Vietnamese (except dossiers of bioequivalence testing reports and clinical dossiers).

2.   A registration dossier must be made on A4 paper and firmly bound. Documents in a dossier must be arranged in the sequence of the table of content with a separation between sections. The separated sections must be numbered for easy reference and attested by the drug-registering or manufacturing establishment in the first page of each section of the entire dossier.

3.   Each drug must have a separate registration dossier, except drugs with the same following factors that may be registered in the same dossier:

a/ Drug name;

b/ Preparation form;

c/ Formula for a dose unit (for single-dose drugs) or the same concentration (for multi- dose drugs);

d/ Manufacturer.

4.   General requirements for documents included in a dossier for first-time registration or re-registration of processed drug and a dossier to request other modifications:

a/ One (1) original including all parts specified in Article 8 of this Circular;

b/ Two (2) copies of documents, including the application for drug registration and standards of finished products;

c/ Drug label: Two (2) sample sets of the label. These labels are mounted on A4 paper appended with the adjoining stamp of the registering establishment;

d/ Product information: Use instruction or information sheet for patients or summary of product characteristics as prescribed for each corresponding type of drug, appended with the adjoining stamp of the registering establishment;

dd/ Drug sample:

- One (1) packing unit per registered circulation specification;

-   For vaccines and antibody-containing sera, the registering establishment shall send samples to the National Institute for Control of Vaccines and Biologicals (NICVB) for filing;

e/ Product summary.

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

One (01) original dossier with all documents specified below must be submitted:

a/ For pharma-chemical drugs, vaccines, antibody- containing sera and medical biologicals: To comply with Clauses 4,5 and 6, Article, ft of Circular No. 22/2009/TT-BYT;

b/   in-vitro diagnostic biologicals: To comply-With Clauses 3 and 4, Article 22 of Circular No. 22/2009/TT-BYT;

c/ For herbal drugs (except oriental drug):

To comply with Clauses 3, 4 and 5, Article 26 of Circular No. 22/2009/TT-BYT.

6.   Provisions on legal dossier

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

7.   Provisions on other administrative dossiers:

a/ The application for registration must be directly signed and stamped (if any) by the director of the drug-registering establishment or its authorized representative. The stamped signature is not acceptable.

b/ A power of attorney is required for a person who:

-   Is authorized to sign the dossier for drug registration when the director of the drug- registering establishment authorizes the head of the representative office of the drug-registering establishment in Vietnam;

-   Is authorized to use the drug name already registered as a trademark when the owner of the trademark is not the drug-registering establishment.

Each dossier must have one (1) original or certified true copy of the power of attorney of the drug-registering establishment or representative office in Vietnam.

8.   Provisions on quality dossier, pre-clinical and clinical dossiers:

a/ Quality dossier: To use the ASEAN Common Technical Dossier (ACTD) and technical guidelines as prescribed in Circular No. 22/2009/TT-BYT, including:

-    Technical standards and drug testing methods and the drug manufacturing process provided by the ordering party;

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

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

c/ For drugs processed for export (not for domestic circulation):

-    A quality dossier specifying technical standards, drug testing methods, drug manufacturing process, materials of stability research (accepting research results under the condition of accelerated aging of extrapolated lifespan) provided by the ordering party; processed drug testing slip provided by the processing party.

-    The report on bioequivalence research data, pre-clinical and clinical dossiers are not required.

9.   Provisions on drug label and product information:

a/ Processed drugs for domestic circulation:

The content of drug label and product information are prescribed in 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 the importing country. The processing establishment and ordering party are responsible for the contents on drug label and product information.

10. Provisions on fees

Drug-registering establishments shall pay fees related to the drug registration and circulation as prescribed by the law on charges and fees.

11. Naming of processed drugs: To comply with Article 11 of Circular No. 22/2009/TT- BYT.

Article 8. Provisions on dossiers for registration of processed drugs for circulation in Vietnam

1. A dossier for registration of processed drugs for drugs with valid circulation registration numbers in Vietnam:

a/ Administrative dossier and product information:

-   Cover page - (Form 1/GC);

-   Table of contents;

-   Application for registration specifying every stage of manufacture, including processing stages with names and addresses of respective manufacturers (1 original + 2 copies) - (Form 2a/GC);

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

-   Certificate of eligibility for drug trading, for Vietnamese drug trading establishments (copy with certification of the establishment):

-   Drug label (3 originals);

-   Product information (3 originals);

-   Drug sample;

-   Product summary (Form 7a/GC);

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

-   Other legal papers (if any).

b/ Quality dossier (specifying technical standards and drug testing methods: 1 original + 2 copies):

-   For pharma-chemical finished drugs, vaccines, antibody-containing sera and medical biologicals: To comply with Clauses 1, 2, 3 and 4, Article 19 of Circular No. 22/2009/ TT-BYT.

-   For diagnostic biologicals: To comply with Article 24, Circular No. 22/2009/TT-BYT.

-    For herbal drugs (except oriental drugs): To comply with Article 28 of Circular No. 22/2009/TT-BYT.

-    For drugs on the list of locally manufactured drugs: To submit the registration dossier to the provincial-level Health Department as prescribed in Appendix V to Circular No. 22/2009/TT-BYT.

c/ Drug processing contract: To comply with Article 5 of this Circular.

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

a/ Administrative dossier and product information:

-   Cover page - (Form 1/GC);

-   Table of contents;

-   Application for registration (1 original + 2 copies) - (Form 2b/GC);

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

-   Certificate of eligibility for drug trading, for Vietnamese drug trading establishments (copy with certification of the establishment):

-   Certificate of pharmaceutical product (CPP) or certificate of free sale (FSC) (if having no CPP);

-   Drug label (3 originals);

-   Product information (3 originals);

-   Drug sample;

-   Product summary (Form 7b/GC);

-   Patent or documents on drug research at the ordering establishment;

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

-   Other legal papers (if any).

b/ Quality dossier (specifying technical standards and drug testing methods: 1 original + 2 copies):

-   For pharma-chemical finished drugs, vaccines, antibody-containing sera and biologicals: To comply with Clauses 1, 2, 3 and 4, Article 19 of Circular No. 22/2009/ TT-BYT.

-   For diagnostic biologicals: To comply with Article 24 of Circular No. 22/2009/TT-BYT.

-   For herbal drugs (except oriental drugs): To comply with Article 28 of Circular No. 22/2009/TT-BYT.

-   For drugs on the list of locally manufactured drugs: To submit the registration dossier to the provincial-level Health Department as prescribed in Appendix V to Circular No. 22/2009/TT-BYT.

c/ Drug processing contract: To comply with Article 5 of this Circular.

d/ Pre-clinical and clinical dossiers (for new drugs):

-   For pharma-chemical finished drugs, vaccines, antibody containing sera, biologicals: To comply with Articles 20 and 21 of Circular No. 22/2009/TT-BYT.

-   For in-vitro diagnostic biologicals: To comply with Article 25 of Circular No. 22/2009/TT-BYT;

-   For herbal drugs (except oriental drugs): To comply with Article 29 of Circular No. 22/2009/TT-BYT.

3. Dossier for re-registration of processed drug:

a/ Administrative dossier and product information:

-   Cover page (Form 1/GC);

-   Table of contents;

-   Application for registration (1 original + 2 copies) (Form 2c/GC);

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

-   Certificate of eligibility for drug trading, for Vietnamese drug trading establishments (copy with certification of the establishment);

-   Drug label (3 originals);

-   Product information (3 originals);

-   Drug sample;

-   Summary of product (Form 7c/GC);

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

-   Other legal papers (if any).

b/ Quality dossier (specifying1 technical standards and drug testing methods: 1 original + 2 copies):

-   For pharma-chemical finished drugs, vaccines, antibody-containing sera and biologicals: To comply with Clauses 1, 2, 3 and 4, Article 19 of Circular No. 22/2009/ TT-BYT.

If the dossier registered for the first time has followed the ASEAN Common Technical Dossier (ACTD), only the standards and methods of testing of finished product are required upon re-registration.

-   For diagnostic biologicals: To comply with Article 24 of Circular No. 22/2009/TT-BYT.

-   For herbal drugs (except oriental drugs): To comply with Article 28 of Circular No. 22/2009/TT-BYT.

-   For drugs on the list of locally manufactured drugs: To submit the registration dossier to the provincial-level Health Department as provided in Appendix V to Circular No. 22/2009/TT- BYT.

c/ Drug processing contract: To comply with Article 5 of this Circular.

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

Article 9. Provisions on dossiers for registration of processed drugs for export (not for circulation in Vietnam)

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

a/ Administrative dossier and product information:

-   Cover page - (Form 1/GC);

-   Table of contents;

-   Application for registration (1 original + 2 copies) (Form 4a/GC);

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

-   Certificate of eligibility for drug trading, for Vietnamese drug trading establishments (copy with certification of the establishment);

-   Drug label (3 originals);

-   Product information (3 originals);

-   Drug sample;

- Product summary (Form 7b/GC);

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

-   Other legal papers (if any).

b/ Quality dossier: To comply with Point c, Clause 8, Article 7 of this Circular (technical standard and drug testing methods: 1 original + 2 copies).

c/ Drug processing and manufacturing contract: To comply with Article 5 of this Circular.

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

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

a/ Administrative dossier and product information:

-   Cover page - (Form 1/GC);

-   Table of contents;

-   Application for registration (1 original 2 copies) (Form 4a/GC);

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

-   Certificate of eligibility for drug trading for Vietnamese drug trading establishments (copy with certification of the establishment),

-   Drug label (3 originals);

-   Product information (3 original);

-   Drug sample;

-   Product summary (Form 7b/GC);

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

-   Other legal papers (if any).

b/ Quality dossier: To comply with Point c, Clause 8, Article 7 of this Circular (technical standard and drug testing methods: 1 original + 2 copies).

c/ Drug processing and manufacturing contract: To comply with Article 5 of this Circular.

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

Chapter IV

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

Article 10. Order and procedures for registration of processed drugs

1. The order and procedures for registration of locally processed drugs (excluding drugs specified in Appendix V to Circular No. 22/2009/ TT-BYT) and registration for modifications.

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

-   Dossiers for first-time registration or re- registration, for dossiers for registration of processed drugs;

-   Dossiers for registration of major modification, minor modification and other modifications during the time the registration numbers of processed drugs are still valid, for all drugs with registration numbers.

b/ Appraisal and approval:

-   The Drug Administration of Vietnam shall appraise and submit to the Advisory Council for Issuance of Circulation Registration Numbers of Drugs of the Ministry of Health (below referred to as the Advisory Council) for:

+ Processed drugs of drugs offered for processing without circulation registration number;

+ Processed drugs of drugs ordered for processing with valid circulation registration numbers but their registration dossiers failing to follow the ASEAN Common Technical Dossier (ACTD);

+ Processed drugs which are re-registered but their dossiers for registration of processed drugs for the first time failing to follow the ASEAN Common Technical Dossier (ACTD).

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

+ Processed drugs which are re-registered and have their dossiers for registration of processed drugs for the first time  following the ASEAN Common Technical Dossier (ACTD);

+ Drugs processed for the first time of drugs ordered for processing with valid circulation registration numbers and their dossiers for registration following the ASEAN Common Technical Dossier (ACTD);

+ Drugs processed for export.

2. The order and procedures for registration of drugs other than locally processed ones are provided in Appendix V to Circular No. 22/2009/TT-BYT.

a/ The Health Departments of provinces or centrally run cities where the manufacturing establishments are located shall receive dossiers for first registration or re-registration submitted directly or by post.

b/ Within three (3) months after receiving valid dossiers, the provincial-level Health Department shall appraise and send an official letter together with the list of drugs to propose the issuance of registration numbers for processed drugs it has received their dossiers to the Ministry of Health (the Drug Administration of Vietnam) for the latter to consider and issue registration numbers. If there are insufficient grounds to propose the issuance of registration numbers, the provincial-level Health Department shall reply in writing clearly stating the reason to the registering establishments.

3. Competence to issue registration numbers of processed drugs :

a/ The Minister of Health shall authorize the director of the Drug Administration of Vietnam to sign the decision on issuance of a list of drugs to be issued with processing registration numbers, for drugs specified at Item 1, Point b, Clause 1, and Clause 2 of this Article.

b/ The director of the Drug Administration of Vietnam shall sign the decision on issuance of the list of drugs to be issued with processing and manufacturing registration numbers, for drugs specified at Item 2, Point b, Clause 1 of this Article.

c/The Drug Administration of Vietnam shall reply in writing to the proposed modification for valid processed drugs and settle issues related to the manufacture, registration and circulation of processed drugs.

4. Time limit for issuance of registration numbers or reply to registrations dossiers:

a/ Within six (6) months after receiving complete and valid dossiers, the Drug Administration of Vietnam shall issue registration numbers or reply in writing clearly stating the reason if the dossiers do not satisfy the conditions for issuance of registration numbers for the drugs below:

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

-   Processed drugs of drugs ordered for processing with valid circulation registration numbers but their registration dossiers failing to follow the ASEAN Common Technical Dossier (ACTD);

-   Processed drugs which are re-registered and have their dossiers for registration of processed drugs for the first time failing to follow the ASEAN Common Technical Dossier (ACTD);

b/ Within two (2) months after receiving complete and valid dossiers, the Drug Administration of Vietnam shall issue the World Health Organization; Circular No.

13/2009/TT-BYT of September 1, 2009, guiding activities of drug advertising and information; Circular No. 22/2009/TT-BYT of November 24, 2009, on drug registration; and Circular No. 47/2010/TT-BYT of December 29, 2009, guiding the import and export of drug and packagings in direct contact with drugs 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 must be appraised and issued with registration numbers under the Minister of Health’s Circular No. 06/2004/TT-BYT of May 28, 2004, guiding the manufacturing and processing of drugs.

Article 14. Reference provision

In case the legal documents and provisions cited in this Circular are revised or replaced, the new legal documents shall apply.

Article 15. Implementation responsibility

1. The Drug Administration of Vietnam shall guide the implementation of this Circular; assume the prime responsibility for, or coordinate with the Ministry of Health Inspectorate and related departments and administrations in, examining and inspecting the implementation of this Circular by pharmaceutical manufacturers and traders nationwide.

2. Provincial-level Health Departments shall examine and inspect the implementation of this Circular by pharmaceutical manufacturers and traders under their management.

3. Units directly under the Ministry of Health, Vietnam Pharmaceutical Corporation, pharmaceutical manufacturers and traders, foreign companies having pharmaceutical operation licenses shall implement this Circular.

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

Minister of Health

NGUYEN THI KIM TIEN