Circular No. 23/2013/TT-BYT on guiding the production of pharmaceutical manufacturing

CIRCULAR

Guidelines on Processing Pharmaceutical Products

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

Pursuant to the Government Decree No. 81/2018/NĐ-CP dated May 22, 2018, detailing the Trade Law on trade promotion activities;

Pursuant to the Government Decree No. 12/2006/NĐ-CP dated January 23, 2006 detailing the implementation of the Law on Trade regarding international trade activities and agency, purchase, sale, processing, and transit of goods with foreign countries;

Pursuant to Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Medicine Law;

Pursuant to the Government Decree No. 89/2012/NĐ-CP dated October 24, 2012 amending and supplementing certain articles of the Government Decree No. 79/2006/NĐ-CP dated August 9, 2006 detailing certain provisions of the Law on Medicines;

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

At the proposal of the Director of the Drug Administration Department;

The Minister of Health issues this Circular guiding the processing of pharmaceutical products,

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

1. This Circular regulates the processing of pharmaceutical products, the registration dossier for processing pharmaceutical products, the procedures and formalities for registration, suspension, and withdrawal of the registration number for processed pharmaceutical products.

2. This Circular applies to organizations and individuals both within and outside Vietnam involved in the processing of pharmaceutical products and the registration for circulation of processed pharmaceutical products in Vietnam.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. Processing drugs It refers to the situation where the processing party carries out work to produce a product according to the requirements of the commissioning party, and the commissioning party receives the product and pays remuneration in accordance with the agreement in compliance with the law.

The work of the processing party involves carrying out one, several, or all stages of the pharmaceutical production process (receiving raw materials, processing stages, packaging including final packaging and labeling).

2. Drug placed for processing It refers to medicines that have been granted a permit for circulation or export by the drug management authority; those protected by patents or medicines researched by the commissioning party for medicines without a registration number for circulation in Vietnam.

3. Commissioning Party It refers to the party named in the application for a permit for the circulation of processed pharmaceutical products.

4. Processing Party It refers to the party conducting production and receiving remuneration for production from the commissioning party. The processing party may include multiple manufacturers, each participating in one, several, or many production stages.

5. Processing Contract It refers to the agreement between the parties, whereby the processing parties carry out work to produce a product according to the requirements of the commissioning party, and the commissioning party receives the product and pays processing remuneration.

6. Intermediate Processing It refers to the processing of pharmaceutical products involving multiple processing parties. Accordingly:

- The processed product of this processing contract is used as raw material for another processing contract in Vietnam;

- The processed product of the previous stage contract is handed over to another manufacturer designated by the commissioning party for the subsequent stage contract.

Chapter II

REGULATIONS ON PROCESSING OF PHARMACEUTICAL PRODUCTS

Article 3. Conditions for Processing Pharmaceutical Products

1. Conditions for being named as the Commissioning Party

A legal pharmaceutical business entity in Vietnam, a foreign pharmaceutical production and trading establishment holding a "License for Foreign Enterprises' Activities in Pharmaceuticals and Drug Ingredients in Vietnam," having medicines already registered by the Vietnamese Ministry of Health with valid registration numbers, or being the owner of a patent or research topic approved according to Vietnamese law, or having research documentation for the product at the commissioning site for medicines without a registration number for circulation in Vietnam intended for processing.

2. Conditions for being named as the Processing Party

a) For chemical drugs, herbal drugs (excluding traditional Chinese medicine), vaccines, serum containing antibodies, medical diagnostic reagents: a domestic production facility possessing a certificate of qualification for pharmaceutical business operations and a certificate of compliance with Good Manufacturing Practice (GMP) standards suitable for the type of processed pharmaceutical product.

b) For in vitro diagnostic medical devices: a domestic production facility possessing a certificate of qualification for pharmaceutical business operations and a certificate of compliance with GMP standards or Vietnamese standard TCVN ISO 13485 or equivalent standards suitable for the type of processed pharmaceutical product.

Article 4. Rights and Obligations of the Commissioning Party and the Processing Party for Medicines

1. For the Commissioning Party:

a) Has ownership of the registration number and the processed products;

b) Has the right to commission processing of one or several production stages at the Processing Parties;

c) Receives the processed products according to the agreed method, time frame, and conditions stipulated in the contract;

d) Bears responsibility for registering the processed medicines in accordance with the procedures and formalities prescribed in Circular No. 22/2009/TT-BYT dated November 24, 2009, issued by the Minister of Health on medicine registration (hereinafter referred to as Circular No. 22/2009/TT-BYT);

đ) Performs the rights and obligations of the registration entity as stipulated in Circular No. 22/2009/TT-BYT, and the rights of export and import as prescribed by laws on the export and import of medicines;

e) Provides the production process, technical standards, and testing methods for initial raw materials, semi-finished products, and finished products, as well as other relevant documents related to the processing of medicines;

g) Pays the processing fee according to the agreement in the contract;

h) Bears responsibility for the quality, safety, and efficacy of the processed medicines throughout their circulation period;

i) Bears responsibility for intellectual property issues related to registered circulating medicines and other rights and obligations as prescribed by laws on processing in commerce;

2. For the Processing Party:

a) Receives payment according to the agreement in the contract;

b) Has the right to request the Commissioning Party to supply raw materials in the correct quantity, quality, time frame, and location as agreed in the contract. If the Processing Party supplies its own initial raw materials, it must ensure that the quality of the raw materials meets the standards set by the Commissioning Party;

c) Has the right to refuse to accept processing if the Commissioning Party provides raw materials that do not meet the agreed quality standards;

d) Requests the Commissioning Party to provide the production process, technical standards, and testing methods for initial raw materials, semi-finished products, and finished products, as well as other relevant documents related to the processing of medicines;

đ) Conducts the production of medicines according to the specified process, technology, and ensures the quality of the medicines in accordance with the registration dossier and the requirements of the Commissioning Party as stipulated in the signed contract;

e) Keeps records, documents, and samples related to the production process of medicines and provides these records to competent state management authorities upon request;

g) Bears responsibility for quality control during the entire production process and ensures the quality of the product until the processed product is returned to the Commissioning Party;

h) Disposes of surplus raw materials, waste, and by-products after completing the processing contract in accordance with the agreement between both parties in the contract, in compliance with applicable laws;

i) Other rights and obligations as prescribed by laws on processing in commerce;

Article 5. Processing Contract for Medicines

1. Form of the Processing Contract for Medicines

The processing contract for medicines must be in writing and must comply with the provisions of Vietnamese law on economic contracts.

2. Mandatory contents in the processing contract for medicines:

a) Agreement on the supply of raw materials, provision of production processes, technical standards, and testing methods for initial raw materials, semi-finished products, finished products, and other relevant documents related to the processing of medicines;

b) Rights and responsibilities of each party regarding the inspection of raw material quality, semi-finished product quality, finished product quality, packaging procedures, and product labels, and clearly defining the signing of test certificates for each batch of finished products and dispatch certificates for products;

c) Rights and responsibilities of each party regarding the retention of records on production, quality inspection, distribution, circulation of medicines, sample retention, and resolution of issues related to quality, complaints, and market product recalls;

d) Responsibilities of the Commissioning Party regarding intellectual property issues related to registered medicines;

đ) Procedures and formalities for inspecting the production facilities of the Processing Party;

e) Circumstances under which the contract may be terminated;

g) Must have the consent of the production facility for the processing of medicines that have been granted valid registration numbers by the Ministry of Health of Vietnam (in cases where the registration entity differs from the production facility).

Article 6. General Provisions on Contract Manufacturing Drugs

1. Provisions on Contract Manufacturing Drugs:

a) For drugs that have registration numbers for circulation in Vietnam: They can be contract manufactured for one, several, or all stages of the production process at one or several contract manufacturers;

b) For drugs that do not have registration numbers for circulation in Vietnam: They can be contract manufactured for all stages of the production process and can only be placed with one contract manufacturer.

2. Forms of Registration for Contract Manufacturing: Chemical drugs, medical biological products, vaccines, serum containing antibodies, in vitro diagnostic biological products, and drugs from medicinal materials (excluding traditional medicine) shall be registered for contract manufacturing in the following forms:

a) Initial contract manufacturing registration;

b) Major change registration;

c) Minor change registration;

d) Re-registration;

đ) Other change registrations.

3. Requirements for Clinical Trials, Bioavailability, and Bioequivalence Testing: The requirements for clinical trials related to new drugs; bioavailability and bioequivalence testing for contract manufactured drugs intended for circulation in Vietnam shall be carried out in accordance with the Ministry of Health's regulations on clinical trials, bioavailability, and bioequivalence testing of drugs.

4. Production, Transportation, and Circulation of Contract Manufactured Drugs Containing Narcotic Drugs, Psychotropic Substances, Precursors Used in Medicines (including both single substances or combinations) must be conducted strictly in accordance with the Ministry of Health's regulations on managing narcotic drugs, psychotropic substances, precursors, and other relevant laws.

5. Issuance of Registration Numbers for Contract Manufactured Drugs:

a) Contract manufactured drugs shall be issued registration numbers valid for a maximum of five (05) years from the date of issuance of the decision granting the registration number and shall not exceed the validity period of the registration number of the drug being contract manufactured. The validity period of the registration number for contract manufactured drugs will transfer exactly the remaining time of the validity period of the registration number of the drug being contract manufactured. In special cases, the Advisory Council for Drug Registration Numbers of the Ministry of Health will consider and propose the Minister of Health to make a decision.

Within six (06) months before and six (06) months after the expiration of the registration number for contract manufactured drugs, the entity may submit an application for re-registration. Beyond this specified period, the entity must resubmit the application as if it were for initial contract manufacturing registration;

b) For drugs that already have registration numbers for circulation in Vietnam and are being contract manufactured: The validity of the old registration number will terminate three (03) months after the effective date of the contract manufacturing registration number; drugs produced before the old registration number expires may continue to circulate until their expiry date.

6. Import and Export of Contract Manufactured Drugs shall be carried out in accordance with the detailed implementation regulations of the Law on Trade regarding international trade activities and agency, purchase, sale, contract manufacturing, and transit goods with foreign countries; current regulations of the Ministry of Health on drug import and export management and other relevant laws.

Chapter III

APPLICATION FOR REGISTRATION OF CONTRACT MANUFACTURED DRUGS

Article 7. General Provisions on Application for Registration of Contract Manufactured Drugs

1. Languages used in the application dossier:

The application for registration of contract manufactured drugs must be written in Vietnamese (except for the report on the results of bioequivalence testing and the clinical report).

2. The application for registration of drugs must be prepared on A4 paper size, bound securely into a volume. The documents must be arranged in accordance with the table of contents, with clear divisions between sections. Each section division must be numbered for easy reference and confirmed by the registering entity or the drug manufacturing entity on the first page of each section throughout the entire application.

3. Each medicine must have its own separate application dossier, except in cases where medicines share all of the following factors and can be registered in the same dossier:

a) Medicine name;

b) Formulation type;

c) Formula for a single dose (for single-dose formulations) or the same concentration (for multi-dose formulations);

d) Manufacturer;

4. General Requirements for Documents to be Submitted in the Initial Application for Registration of Contract Manufactured Drugs, Re-application, and Applications for Other Changes as follows:

a) One (01) original copy including all parts as stipulated in Article 8 of this Circular;

b) Two (02) copies of the documents including the drug registration form and finished product standards;

c) Drug labels: two (02) sets of sample label designs. These labels must be attached to A4 paper stamped with the seal of the registering entity;

d) Product information: the Instructions for Use or Information for Patients or Summary of Product Characteristics according to the corresponding type of drug, stamped with the seal of the registering entity;

đ) Drug samples:

- One (01) unit of packaging for each registered circulation specification;

- For vaccines, serum containing antibodies, the registering entity must send samples for storage at the National Institute of Vaccines and Medical Biological Products;

e) Summary of the product.

5. Application for Major Changes, Minor Changes, and Other Changes

One (01) original copy with complete documents, specifically as follows:

a) For chemical drugs, vaccines, serum containing antibodies, medical biological products: Follow the provisions of Clause 4, Clause 5, and Clause 6 of Article 17 of Circular No. 22/2009/TT-BYT;

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

c) For drugs from medicinal materials (excluding traditional medicine): Follow the provisions of Clause 3, Clause 4, and Clause 5 of Article 26 of Circular No. 22/2009/TT-BYT.

6. Legal Document Requirements

Legal documents shall be implemented in accordance with the provisions of Clause 6 of Article 10 of Circular No. 22/2009/TT-BYT and Clause 1 and Clause 2 of Article 10 of Circular No. 45/2011/TT-BYT dated December 21, 2011, amending and supplementing some articles of Decision No. 1570/2000/QĐ-BYT dated May 22, 2000, of the Minister of Health on implementing Good Laboratory Practice for Pharmaceutical Testing; Decision No. 2701/2001/QĐ-BYT dated June 29, 2001, of the Minister of Health on implementing Good Storage Practice for Pharmaceuticals; Circular No. 06/2004/TT-BYT dated May 28, 2004, guiding contract manufacturing of drugs; Decision No. 3886/2004/QĐ-BYT dated November 13, 2004, of the Ministry of Health on implementing Good Manufacturing Practice for Pharmaceuticals according to the World Health Organization's recommendations; Circular No. 13/2009/TT-BYT dated September 1, 2009, of the Ministry of Health guiding pharmaceutical advertising activities; 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, 2010, guiding pharmaceutical export and import activities and direct contact packaging (hereinafter referred to as Circular No. 45/2011/TT-BYT).

7. Provisions for Other Administrative Documents:

a) The registration form must be signed directly by the director of the drug registration entity or an authorized representative of the registration entity on the form and stamped (if applicable) by the registration entity, with no acceptance of signature stamps.

b) Power of attorney shall be submitted in the following cases:

- Granting authority to sign the drug registration dossier when the director of the drug registration entity authorizes the head of the representative office of the drug registration entity in Vietnam;

- Granting authority to use the name of a registered trademarked drug when the owner of the trademark is not the drug registration entity.

Each dossier must be accompanied by one (01) original power of attorney or a certified copy thereof from the registration entity or from the representative office in Vietnam.

8. Provisions for quality dossiers, preclinical dossiers, and clinical dossiers:

a) Quality dossier: apply according to the ASEAN Common Technical Dossier (ACTD) and technical guidelines as stipulated in Circular No. 22/2009/TT-BYT, wherein:

- Technical standards, drug testing methods, and drug production processes provided by the Contracting Party;

- Test reports of the contracted drugs provided by the Contractee.

b) Preclinical and clinical dossiers: apply according to the ASEAN Common Technical Dossier (ACTD) and technical guidelines as stipulated in Circular No. 22/2009/TT-BYT.

c) For exported processed drugs (not circulating domestically):

- The quality dossier includes: technical standards, drug testing methods, drug production processes, stability research documentation (accepting accelerated aging study results extrapolating shelf life) provided by the Contracting Party; test reports of the contracted drugs provided by the Contractee.

- No submission of bioequivalence study data reports, preclinical, and clinical dossiers is required.

9. Provisions regarding drug labels and product information:

a) Processed drugs circulating domestically: the content of drug labels and product information shall comply with the provisions of Clause 8, Article 10 of Circular No. 22/2009/TT-BYT.

b) Processed drugs for export: the content of drug labels and product information shall comply with the regulations of the importing country. The processing entity and the Contracting Party shall be responsible for the contents recorded on the drug labels and product information.

10. Provisions regarding fees:

The drug registration entity must pay related registration and circulation fees in accordance with the laws on fees and charges.

11. Provisions regarding naming processed drugs: implement according to the provisions on drug naming in Article 11 of Circular No. 22/2009/TT-BYT.

Article 8. Provisions for the registration dossier of processed drugs for circulation in Vietnam

1. Registration dossier of processed drugs that already have valid registration numbers in Vietnam:

a) Administrative documents and product information:

- Cover page – (Form No. 1/GC)

- Table of contents;

- Registration form detailing each production stage, including processing stages with the names and addresses of corresponding manufacturers (one original + two copies) – (Form No. 2a/GC);

- Power of attorney (if applicable) – (Form No. 3a/GC) or (Form No. 3b/GC);

- Certificate of eligibility to operate pharmaceuticals if it is a Vietnamese pharmaceutical business (photocopy with confirmation from the entity);

- Drug labels (three originals);

- Product information (three originals);

- Sample of the drug;

- Product summary (Form No. 7a/GC);

- Certificates, intellectual property rights certificates, and transfer agreements of intellectual property rights (if applicable);

- Other legal documents (if applicable).

b) Quality dossier: (including technical standards and drug testing methods: one original + two copies).

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

- For diagnostic products: comply with the provisions of Article 24 of Circular No. 22/2009/TT-BYT.

- For drugs derived from medicinal herbs (excluding traditional Chinese medicine): comply with the provisions of Article 28 of Circular No. 22/2009/TT-BYT.

- For drugs listed in the national production category requiring registration at local Health Departments: comply with the provisions of Appendix V of Circular No. 22/2009/TT-BYT.

c) Processing contract: comply with the provisions of Article 5 of this Circular.

2. Registration dossier of processed drugs that do not have valid registration numbers in Vietnam:

a) Administrative documents and product information:

- Cover page – (Form No. 1/GC)

- Table of contents;

- Registration form (one original + two copies) – (Form No. 2b/GC);

- Power of attorney (if applicable) – (Form No. 3a/GC) or (Form No. 3b/GC);

- Certificate of eligibility to operate pharmaceuticals if it is a Vietnamese pharmaceutical business (photocopy with confirmation from the entity);

- Product certification (CPP) or Free Sale Certificate (FSC) (if there is no CPP);

- Drug labels (three originals);

- Product information (three originals);

- Sample of the drug;

- Product summary (Form No. 7b/GC);

- Patent or drug research documentation at the contracting party;

- Certificates, intellectual property rights certificates, and transfer agreements of intellectual property rights (if applicable).

- Other legal documents (if applicable).

b) Quality dossier: (including technical standards and drug testing methods: one original + two copies).

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

- For diagnostic products: comply with the provisions of Article 24 of Circular No. 22/2009/TT-BYT.

- For drugs derived from medicinal herbs (excluding traditional Chinese medicine): comply with the provisions of Article 28 of Circular No. 22/2009/TT-BYT.

- For drugs listed in the national production category requiring registration at local Health Departments: comply with the provisions of Appendix V of Circular No. 22/2009/TT-BYT.

c) Processing contract: comply with the provisions of Article 5 of this Circular.

d) Preclinical and clinical dossiers (if it is a new drug).

- For finished chemical drugs, vaccines, sera containing antibodies, medical products: comply with the provisions of Articles 20 and 21 of Circular No. 22/2009/TT-BYT.

- For diagnostic products: comply with the provisions of Article 25 of Circular No. 22/2009/TT-BYT.

- For drugs derived from medicinal herbs (excluding traditional Chinese medicine): comply with the provisions of Article 29 of Circular No. 22/2009/TT-BYT.

3. Registration dossier for re-registration of processed drugs:

a) Administrative documents and product information:

- Cover page (Form No. 1/GC);

- Table of contents;

- Registration form (one original + two copies) (Form No. 2c/GC);

- Power of attorney (if applicable) (Form No. 3a/GC or 3b/GC);

- Certificate of eligibility to operate pharmaceuticals if it is a Vietnamese pharmaceutical business (photocopy with confirmation from the entity);

- Drug labels (three originals);

- Product information (three originals);

- Sample of the drug;

- Product summary (Form No. 7c/GC);

- Certificates, intellectual property rights certificates, and transfer agreements of intellectual property rights (if applicable).

- Other legal documents (if applicable).

b) Quality dossier: (including technical standards and drug testing methods: one original + two copies).

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

In case the initial registration dossier was prepared according to the ASEAN Common Technical Dossier (ACTD), only the final product standards and testing methods need to be submitted upon re-registration.

- For diagnostic products: comply with the provisions of Article 24 of Circular No. 22/2009/TT-BYT.

- For drugs derived from medicinal herbs (excluding traditional Chinese medicine): comply with the provisions of Article 28 of Circular No. 22/2009/TT-BYT.

- For drugs listed in the national production category requiring registration at local Health Departments: comply with the provisions of Appendix V of Circular No. 22/2009/TT-BYT.

c) Processing contract: comply with the provisions of Article 5 of this Circular.

d) Drug circulation report (Form No. 5/GC).

Article 9. Provisions on the registration dossier for processed drugs for export (not circulating in Vietnam)

1. The initial registration dossier for processed drugs not circulating in Vietnam:

a) Administrative documents and product information:

- Cover page (Form No. 1/GC);

- Table of contents;

- Application form (one original + two copies) (Form No. 4a/GC);

- Power of attorney (if any) (Form No. 3a/GC or Form No. 3b/GC);

- Certificate of eligibility to operate pharmaceuticals if it is a Vietnamese pharmaceutical business (photocopy with confirmation from the entity);

- Drug labels (three originals);

- Product information (three originals);

- Sample of the drug;

- Product summary (Form No. 7b/GC);

- Certificates, intellectual property rights certificates, and transfer agreements of intellectual property rights (if applicable);

- Other legal documents (if applicable).

b) Quality dossier: To be implemented according to Point c Clause 8 Article 7 of this Circular (wherein Technical standards and drug testing methods: one original + two copies).

c) Processing production contract: To be implemented according to Article 5 of this Circular.

d) Commitment that the processed drugs produced under the contract will not circulate in Vietnam (Form No. 6/GC).

2. Resubmission dossier for processed drugs not circulating in Vietnam:

a) Administrative documents and product information:

- Cover page (Form No. 1/GC);

- Table of contents;

- Application form (one original + two copies) (Form No. 4b/GC);

- Power of attorney (if any) (Form No. 3a/GC or Form No. 3b/GC);

- Certificate of eligibility to operate pharmaceuticals if it is a Vietnamese pharmaceutical business (photocopy with confirmation from the entity);

- Drug labels (three originals);

- Product information (three originals);

- Sample of the drug;

- Product summary (Form No. 7c/GC);

- Certificates, intellectual property rights certificates, and transfer agreements of intellectual property rights (if applicable).

- Other legal documents (if applicable).

b) Quality dossier: To be implemented according to Point c Clause 8 Article 7 (wherein Technical standards and drug testing methods: one original + two copies).

c) Processing contract: comply with the provisions of Article 5 of this Circular.

d) Commitment that the processed drugs produced under the contract will not circulate in Vietnam (Form No. 6/GC).

Chapter IV

PROCEDURE AND REGULATIONS FOR THE REGISTRATION OF PROCESSED DRUGS, TEMPORARY SUSPENSION

AND WITHDRAWAL OF THE REGISTRATION NUMBER OF PROCESSED DRUGS

Article 10. Procedure and regulations for the registration of processed drugs

1. Procedure and regulations for the registration of processed drugs within the country (excluding those specified in Appendix V of Circular No. 22/2009/TT-BYT) and changes in registration.

a) Acceptance: The Department of Drug Management - Ministry of Health shall be responsible for accepting registration dossiers for processed drugs submitted directly or sent via postal service in the following cases:

- Initial registration dossiers and resubmission dossiers for processed drugs;

- Large change, small change, and other change dossiers during the validity period of the registration number of processed drugs for all drugs already having a registration number.

b) Review and approval:

- The Department of Drug Management shall organize reviews and submit to the Advisory Council for issuing the registration number for circulating drugs - Ministry of Health (hereinafter referred to as the Advisory Council) in the following cases:

+ Processed drugs of drugs placed for processing without a registration number for circulation;

+ Processed drugs of drugs placed for processing with an existing valid registration number but the registration dossier has not been carried out according to the ASEAN Common Technical Dossier (ACTD);

+ Resubmitted processed drugs where the initial registration dossier has not been carried out according to the ASEAN Common Technical Dossier (ACTD);

- The Department of Drug Management shall organize reviews to issue the registration number (without submitting to the Advisory Council) in the following cases:

+ Resubmitted processed drugs where the initial registration dossier has been carried out according to the ASEAN Common Technical Dossier (ACTD);

+ Initial processed drugs of drugs placed for processing with an existing valid registration number where the registration dossier has been carried out according to the ASEAN Common Technical Dossier (ACTD);

+ Processed drugs for export.

2. Procedure and regulations for the registration of drugs used outside of domestic processing as stipulated in Appendix V of Circular No. 22/2009/TT-BYT.

a) Provincial Departments of Health where there are production facilities shall be responsible for accepting initial and resubmission dossiers submitted directly or sent via postal service.

b) Within three (03) months from the date of receiving a valid dossier, the Provincial Department of Health shall be responsible for organizing reviews and sending a letter to the Ministry of Health (Department of Drug Management) along with a list of drugs proposed for issuance of a registration number for processed drugs received by the Provincial Department of Health for the Ministry of Health to consider and issue a registration number for circulation; if there is insufficient basis to propose issuance of a registration number, the Provincial Department of Health must provide a written response to the registering entity and clearly state the reasons.

3. Authority to issue the registration number for processed drugs:

a) The Minister of Health authorizes the Director of the Department of Drug Management to sign decisions promulgating lists of drugs granted a registration number for processing for drugs specified in Subpoint 1 Point b Clause 1 and Clause 2 of this Article.

b) The Director of the Department of Drug Management signs decisions promulgating lists of drugs granted a registration number for production processing for drugs specified in Subpoint 2 Point b Clause 1 of this Article.

c) The Department of Drug Management shall be responsible for providing written responses to requests for changes for processed drugs still in effect and handling matters related to the production, registration, and circulation of processed drugs.

4. Time limit for issuing the registration number or responding to registration dossiers:

a) Within six (06) months from the date of receiving a complete valid dossier, the Department of Drug Management shall issue the registration number or provide a written response clearly stating the reasons if the dossier does not meet or is not sufficient to issue the registration number for the following drugs:

- Processed drugs of drugs placed for processing without a registration number for circulation;

- Processed drugs of drugs placed for processing with an existing valid registration number but the registration dossier has not been carried out according to the ASEAN Common Technical Dossier (ACTD);

- Resubmitted processed drugs where the initial registration dossier has not been carried out according to the ASEAN Common Technical Dossier (ACTD);

b) Within two (02) months from the date of receiving a complete valid dossier, the Department of Drug Management shall issue the registration number or provide a written response clearly stating the reasons if the dossier does not meet or is not sufficient to issue the registration number for the following drugs:

- Resubmitted processed drugs where the initial registration dossier has been carried out according to the ASEAN Common Technical Dossier (ACTD);

- Initial processed drugs of drugs placed for processing with an existing valid registration number where the registration dossier has been carried out according to the ASEAN Common Technical Dossier (ACTD);

- Processed drugs for export;

c) Within two (02) months from the date of receiving a complete valid dossier, the Department of Drug Management shall review and respond to large change, small change dossiers.

d) The time limit for issuing the registration number or responding to dossiers requesting other changes shall be implemented according to Point a Clause 4 of this Article.

đ) Within twenty working days from the date of receipt of the letter from the Provincial Department of Health, the Department of Drug Management shall review and issue the registration number for circulation. If there is insufficient basis to issue the registration number, the Ministry of Health must provide a written response to the Provincial Department of Health and clearly state the reasons.

Article 11. Temporary suspension, withdrawal of the registration number for processed drugs

1. During the validity period of the registration number for processed drugs, if both parties terminate the contract, the party placing the processing must report to the Department of Drug Management to withdraw the registration number for circulation in Vietnam.

2. Other cases of temporary suspension and withdrawal of the registration number for processed drugs shall be implemented according to Articles 33 and 34 of Circular No. 22/2009/TT-BYT.

Chapter V

IMPLEMENTING PROVISIONS

Article 12. Effectiveness

This Circular takes effect from October 1, 2013.

Repeal Circular No. 06/2004/TT-BYT dated May 28, 2004, issued by the Minister of Health guiding the production and processing of medicines, and repeal Article 3 of Circular No. 45/2011/TT-BYT dated December 21, 2011, issued by the Minister of Health amending and supplementing certain provisions of Decision No. 1570/2000/QĐ-BYT dated May 22, 2000, issued by the Minister of Health on implementing the principle of "Good Laboratory Practice"; Decision No. 2701/2001/QĐ-BYT dated June 29, 2001, issued by the Minister of Health on implementing the principle of "Good Storage Practice for Medicines"; Circular No. 06/2004/TT-BYT dated May 28, 2004, guiding the production and processing of medicines; Decision No. 3886/2004/QĐ-BYT dated November 13, 2004, issued by the Ministry of Health on implementing the principles and standards of "Good Manufacturing Practice for Medicines" as recommended by the World Health Organization; Circular No. 13/2009/TT-BYT dated September 1, 2009, issued by the Ministry of Health guiding the activities of drug advertising information; Circular No. 22/2009/TT-BYT dated November 24, 2009, issued by the Ministry of Health stipulating the registration of drugs; Circular No. 47/2010/TT-BYT dated December 29, 2010, guiding the export and import of drugs and direct contact pharmaceutical packaging from the date this Circular takes effect.

Article 13. Transitional Provisions

Drug processing registration files submitted before the effective date of this Circular shall be reviewed and assigned registration numbers in accordance with the provisions of Circular No. 06/2004/TT-BYT dated May 28, 2004, issued by the Minister of Health guiding the production and processing of medicines.

Article 14. Cross-reference provisions

In case the regulatory legal documents and provisions cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the new regulatory legal documents.

Article 15. Responsibility for Implementation

1. The Drug Administration Department shall be responsible for guiding the implementation of the provisions of this Circular; taking the lead or coordinating with the Ministry of Health Inspectorate, relevant Departments, and Units to organize inspections and audits of the implementation of this Circular for pharmaceutical production and trading units nationwide.

2. Provincial Health Departments shall be responsible for inspecting and auditing the implementation of this Circular by pharmaceutical production and trading units within their jurisdiction;

3. Units under the Ministry of Health, Vietnam Pharmaceutical Corporation, pharmaceutical production and trading enterprises, and foreign companies with permits to operate in the pharmaceutical sector shall be responsible for implementing this Circular.

In the course of implementation, if there are any difficulties, units shall report to the Ministry of Health (Drug Administration Department) for consideration and resolution./.