Thông tư 44/2014/TT-BYT quy định việc đăng ký thuốc

THE MINISTRY OF HEALTH

Circular No. 44/2014/TT-BYT datedNovember 25, 2014 of the Ministry of Health on drug registration

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

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

At the request of the Director of the Drug Administration of Vietnam and the Director of Department of Medical Equipment and Health Works,

The Minister of Health promulgates a Circular on registration of drugs.

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Circular provides for the registration of drugs for human use permitted for sale in Vietnam.

Article 2. Interpretation of terms

For the purposes of this Circular, these terms below shall be construed as follows:

1. Modern drug means a drug containing active ingredients whose composition, formula and purity have been identified.

2. New active ingredient means an active ingredient contained in the drug which is registered for permission for sale (hereinafter referred to as registered) in Vietnam for the first time.

3. Generic drug means a finished drug, usually intended to be interchangeable with an innovator product, which is manufactured without a franchise agreement from the innovator company and sold after the expiry date of the patent or other exclusive rights.

4. Drug manufactured under a franchise agreement means a drug of a Vietnamese or foreign drug manufacturer bearing a drug registration number in Vietnam or overseas which is manufactured under a franchise agreement between the aforesaid manufacturer and another manufacturer in Vietnam eligible for drug manufacturing.

5. Brand name of drug means the name of a drug other than its generic name or international nonproprietary name.

6. ASEAN common technical dossier (ACTD) means a set of documents providing guidance on drug registration application to meet common technical requirements of the Association of Southeast Asian Nations (ASEAN) as mentioned in Appendix No. I of The ASEAN common technical dossier and technical requirements issued together with this Circular.

7. Major variation means a variation which directly and greatly affects quality, safety and efficacy of a drug, as mentioned in the Appendix II on Major variations, minor variations, and other variations related to drugs bearing drug registration numbers (hereinafter referred to as registered drug) issued together with this Circular.

8. Minor variation means a variation which hardly or slightly affects quality, safety and efficacy of a drug, as mentioned in the Appendix II on major variations, minor variations, and other variations related to registered drugs issued together with this Circular.

9. Other variation means a variation other than major variation or minor variation, as mentioned in the Appendix II on Major variations, minor variations, and other variations related to registered drugs issued together with this Circular.

10. Applicant means a drug establishment applying for a Certificate of free sale, or submitting documents on updated or variations of registered drugs.

11. Drug manufacturer means an establishment engaged in at least one stage of manufacture or quality inspection to produce finished drugs

Article 3. Requirements, rights and obligations of the applicants

1. An applicant must satisfy the following requirements:

a) Obtain a Certificate of eligibility for drug trading in Vietnam if it is a Vietnamese drug-trading establishment.

b) Obtain for License for drug manufacturing and/or trading granted by the foreign competent agency and License for representative office establishment in Vietnam if it is a foreign drug-trading establishment. In case the foreign drug-trading establishment does not obtain any License for representative office establishment, it shall authorize a Vietnamese drug-trading establishment to apply for drug registration.

2. An applicant has rights to:

a) Receive guidance on drug registration and access information about their registered drugs;

b) Apply for revocation of their drug registration numbers using the Form No. 01/TT issued together with this Circular;

c) Lodge complaints about administrative decisions on the issuance of drug registration numbers issued by the competent agency as prescribed in law on complaints.

3. An applicant has obligations to:

a) Ensure the quality, safety and efficacy of drugs and ensure the drugs are sold as prescribed in the drug registration application;

b) Provide sufficient and accurate data, reports and information about drugs during the period in which the application for drug registration is submitted or processed, the drugs are permitted for sale, or at the request of the competent agency;

c) Provide information about quality, safety and efficacy of drugs if it is has not stated in the application which is submitted or processed; information about variations of registered drugs in comparison with the initial application during the validity period of drug registration numbers, including variations other than the variations required to be registered as mentioned in the Appendix II issued together with this Circular;

d) Send a notification to the Drug Administration of Vietnam or the Department of Medical Equipment and Health Works (regarding in vitro diagnostics products – hereinafter referred to as IVD products) and concerned competent agency if the Certificate of free sale whose unexpired drug registration number in Vietnam is revoked in any country in the world and the reason for the revocation of the certificate must be clarified within 07 working days;

dd) Cooperate with drug importers and manufacturers in recalling from the market the drugs which do not satisfy requirements pertaining to quality, safety and efficacy at the request of the competent agency or when so detected by the applicants or drug manufacturers; then send a report on recall results and propose solutions;

e) Every December 15, send a report on registered drugs to the Drug Administration of Vietnam or Department of Medical Equipment and Health Works (regarding IVD products); provide explanation for cases in which the registered drugs may not been manufactured (for domestic drugs) or imported (for foreign drugs) using the form No.2/TT issued together with this Circular.

g) Archive sufficient application and provide application for competent agencies upon request;

h) Cooperate and facilitate the inspection carried out at the manufacturer’s facility at the request of the Drug Administration of Vietnam or the Department of Medical Equipment and Health Works (regarding IVD products);

i) Replace another applicant related to the registered drugs as prescribed in Appendix II issued together with this Circular within 01 month, from the date on which the former applicant shuts down themselves or as required by the competent agency.

k) Cooperate with the drug manufacturer in studies or provision of additional information about the registered drugs if there is some doubt or evidence about the safety of the drug when they are sold at the request of the competent agency.

Article 4. Requirements, rights and obligations of drug manufacturers

1. Every drug manufacturer must satisfy the following requirements:

a) The domestic drug manufacturer must obtain a Certificate of eligibility for drug trading and a Certificate of Good manufacturing practices (GMP) under the roadmap of the Ministry of Health or a Certificate of eligibility for drug trading if the drug manufacturer must be undergone assessment of manufacturing conditions before receiving the Certificate of eligibility for drug trading as prescribed in Clause 8 Article 1 of Decree No. 89/2012/ND-CP dated October 24, 2012 of the Government on amendments to the Government s Decree No. 79/2006/ND-CP dated August 09th 2006 on the guidance of the Law on Pharmacy.

b) The foreign drug manufacturer must satisfy at least “Good Manufacturing Practices” (GMP) requirements as recommended by the World Health Organization (GMP-WHO). In case the GMP certificate or the Certificate of pharmaceutical products (CPP) does not specify that the manufacturer satisfies GMP-WHO requirements, the drug establishment shall provide evidence that it satisfies the GMP requirements which are equivalent to GMP-WHO requirements. With respect to IVD products, the drug manufacturer must satisfy GMP requirements or ISO standards or obtain other equivalent certificates. In case there is some doubt about the manufacturing conditions or quality of the drug, the Drug administration of Vietnam or the Department of Medical Equipment and Health Works (regarding IVD products) shall carry out the inspection at the manufacturer’s facility before or after the drug registration number is granted.

c) The drug must be manufactured at the manufacturer’s facility obtaining the manufacturing license granted by the competent agency, it may not be manufactured at another facility that borrows the license.

2. A drug manufacturer has rights to:

a) Receive guidance on drug registration and access information about the registered drugs in Vietnam;

b) Apply for the revocation of the drug registration numbers without the consent of the applicant in case the drug which is in doubt about the quality, safety and efficacy causes negative effects on the users using the Form No. 01/TT issued together with this Circular;

c) Lodge complaints about administrative decisions on the issuance of drug registration numbers issued by the competent agency as prescribed in law on complaints.

d) Request to replace another applicant related to registered drugs in case the former applicant fails to comply with regulations in Point I Clause 3 Article 3 of this Circular.

3. The drug manufacturer has obligations to:

a) Ensure the quality, safety and efficacy of drugs as mentioned in the registration application approved by the Ministry of Health;

b) Cooperate with the drug importer and applicant in recalling from the market the drugs which do not satisfy requirements pertaining to quality, safety and efficacy at the request of the competent agency or when so detected by the applicant or drug manufacturer; then send a report on recall results and propose solutions;

c) Cooperate with the applicant in the implementation of regulations of Point dd, h and k Clause 3 Article 3 of this Circular.

d) Prepare equipment and working conditions serving the inspection manufacturer’s facility at the request of the Drug Administration of Vietnam or the Department of Medical Equipment and Health Works (regarding IVD products);

Article 5. Requirements applied to franchisors and franchisees of franchise for drug manufacturing and drug manufacturing under outsourcing agreements

1. With regard to modern drugs, vaccines, antibody-containing sera, and biologicals, the franchisor and the franchisee must satisfy at least GMP-WHO requirements; with regard to IVD products: the franchisor and the franchisee must satisfy GMP requirements or ISO standards or other equivalent standards.

2. With regard to oriental medicines, herbal medicines and medicinal materials:

a) The foreign franchisor must satisfy at least GMP-WHO requirements. The domestic franchisor shall follow the roadmap for GMP application of the Ministry of Health;

b) The franchisee shall follow the roadmap for GMP application of the Ministry of Health;

3. The drug manufactured under outsourcing agreements shall comply with regulations as prescribed in the Circular No. 23/2013/TT-BYT dated August 13, 2013 of the Minister of Health on guidance on drug manufacturing under outsourcing agreements

Article 6. Requirements pertaining to drug test reports in the registration application

1. With regard to modern drugs, biologicals, oriental medicines or herbal medicines:

a) The drug manufacturer satisfying GMP requirements shall verify the requirements and test the drug itself and include its drug test report in the registration application to be submitted;

b) In case the domestic drug manufacturer has not satisfied GMP requirements, the applicant shall have the standards appraised and submit the drug test report issued by a drug-testing establishment of the state in central governments or an enterprise providing drug-testing service which is entitled to grant the Certificate of eligibility for drug trading.

2. With regard to vaccines, antibody-containing sera, or IVD products

a) The applicant for registration of vaccines or antibody-containing sera shall have the standards appraised and submit the drug test report granted by the National Institute for Control of Vaccines and Biologicals.

b) If the applicant for registration of IVD products satisfies GMP requirements or other equivalent requirements, it may include its drug test report in the registration application to be submitted; If the drug manufacturer has not satisfied GMP requirements or ISO standards or other equivalent standards, it shall have the standards appraised and submit the drug test report granted by the National Institute for Control of Vaccines and Biologicals.

3. When the drug registration application is verified, the applicants shall have drug testing methods and standards appraised again at the drug-testing facilities appointed by the Ministry of Health applied to cases as specified in Appendix III issued herewith

Article 7. Requirements pertaining to the drug safety and efficacy

1. If a new drug is registered for permission for sale in Vietnam, it must undergo clinical trials as prescribed in the Circular No. 03/2012/TT-BYT dated February 2, 2012 of the Minister of Health on guidance on clinical drug trials.

2. With regard to the initially registered drug under evaluation of its safety and efficacy when it is sold, the applicant and the health facility using this drug must include a report on the safety and efficacy of the drug in the registration application as follows:

a) The applicant shall cooperate with the drug manufacturer (if the applicant is not a drug manufacturer) in reporting the safety and efficacy of the drug using the form No. 03A/TT issued herewith and send it to the Ministry of Health (the Drug Administration of Vietnam or Department of Medical Equipment and Health Works (regarding IVD products), and archive the relevant documents on the safety and efficacy of the drug.

b) The health facility uses the drug under evaluation of its safety and efficacy shall send a report on the uses of drug using the form No. 03B/TT issued herewith and send it to the Ministry of Health (the Drug Administration of Vietnam or Department of Medical Equipment and Health Works (regarding IVD products); and archive the relevant reports on use of the drug serving the inspection and evaluation of safety and efficacy of the drug.

Article 8. Requirements pertaining to bioavailability and bioequivalence of drugs

The report on figures of bioavailability and bioequivalence of the registered drug shall comply with the Circular No. 08/2010/TT-BYT dated April 26, 2010 of the Minister of Health on reports on figures of bioavailability and bioequivalence in drug registration.

Article 9. Forms of drug registration

Modern drugs, biologicals, vaccines, antibody-containing sera, in-vitro diagnosis, oriental medicines, herbal medicines and medicinal materials shall be registered as follows:

1. Initial registration shall apply to the following drugs:

a) The drug has been not granted drug registration number in Vietnam;

b) The drug has been granted drug registration number in Vietnam and it is still unexpired but there is variation as prescribed in Appendix II issued herewith or the number expires and the initial registration for the drug is required;

c) The drug has been granted drug registration number in Vietnam but it fails to apply for re-registration or registration renewal by the deadline as prescribed in Clause 2 Article 12 of this Circular when the registration number expires.

2. The re-registration shall apply to the registered drug whose registration number expires and it does not satisfy requirements for registration renewal as prescribed in Clause 3 of this Article.

3. Registration renewal shall apply to the initially registered drug or the re-registered drug whose registration number expires and it satisfy the following requirements:

a) With regard to pharmaceutical drugs, oriental medicines, herbal medicines and medicinal materials:

- Their registration numbers are valid for 5 years after applying for initial registration or re-registration and they are sold on the market afterwards.

- The application for initial registration or re-registration shall use the form ACTD or ICH-CTD and ASEAN common technical dossier relating to modern drugs or regulations in the Circular No. 22/2009/TT-BYT dated September 24, 2009 of the Minister of Health on registration of oriental medicines, herbal medicines and medicinal materials (if the application for initial registration is submitted after May 24, 2010 or the application for re-registration is submitted after January 1, 2012).

- They are not subject to cases as prescribed in Article 32 or Article 33 of this Circular.

- There is not any recommendation given by the WHO or the Vietnamese or foreign pharmacy authority about their effectiveness during the period in which the registration renewal is applied.

- There is not any variation on the day on which the application for registration renewal is submitted and during the period in which the application for registration renewal is verified.

b) With regard to vaccines, biologicals, antibody-containing sera and IVD products:

- Their drug registration numbers are valid for 5 years after applying for initial registration or re-registration and they are sold on the market afterwards;

- The application for initial registration or re-registration shall comply with regulations in the Circular No. 22/2009/TT-BYT dated September 24, 2009 of the Minister of Health on registration of drugs (if the application for initial registration is submitted after May 24, 2010 or the application for re-registration is submitted after January 1, 2012).

- They are not subject to cases as prescribed in Article 32 or Article 33 of this Circular;

- There is not any recommendation given by the WHO or the Vietnamese or foreign pharmacy authority about their effectiveness during the period in which the registration renewal application is submitted.

- There is not any variation on the day on which the application for registration renewal is submitted and during the period in which the application for registration renewal is verified.

c) A drug may be considered granting more than one renewal if it satisfy the requirements as prescribed in Point a or Point b of this Clause.

4. Variation shall be registered when the registered drugs have variations during the valid period of their registration numbers as mentioned in Appendix No. II issued herewith.

When there is any variation of registered drug at the request of the Advisory council on drug registration numbers, the applicant shall cooperate with the drug manufacturer in making amendments as mentioned in guidance of the competent agency and take responsibility for the variation without having to submit an application for registration of variations.

Article 10. Drug naming

1. The Ministry of Health encourages applicants to use international nonproprietary names (INN) for drugs.

2. In case a drug is not given an INN, the applicant may use brand names for drugs: The brand name of a drug must follow the rules below:

a) Do not exaggerate the effectiveness of the drug;

b) Do not untruthfully reflect the effectiveness and pharmacological effects of the drug;

c) Do not breach customs and traditions of Vietnam;

d) Do not cause conflicts over protected intellectual property objects of other individuals or organizations;

dd) Do not use names identical or similar for the names of registered drugs of other applicants.

e) Do not use the names identical for the name of the drug having different active ingredients.

g) Do not use different names for the same drug with the same formulation, the same manufacturing process of the same manufacturer.

Article 11. Languages, forms of application, drug samples and fees

1. Languages used in a registration application:

a) The application for domestic drug registration must be written in Vietnamese;

b) The application for foreign drug registration must be written in Vietnamese or English. For application in English, the information stated in the Patient information leaflets (PILs) and the Summary of Product Characteristics must be translated into Vietnamese.

2. The application for drug registration must be produced on A4 paper and securely bound. The application must be arranged in the order of its contents and separated between different parts. Separated parts must be numbered for easy reference; each part is certified by the applicant or the drug manufacturer on its first page.

3. Each drug must have a separate registration application, except the drug containing all the elements below which may be registered in the same application:

a) Name of the drug;

b) Dosage form;

c) Formula for a unit of dosage (for single-dose drugs) or the same concentration and content (for multiple-dose drugs);

d) The manufacturer.

4. Common requirements pertaining to required documents in the application for initial registration, re-registration, registration renewal, or other variation registration:

a) 01 original of documents prescribed in Clause 1 and Clause 2 Article 16 of this Circular relating to modern drugs, vaccines, antibody-containing sera, or biologicals (excluding IVD products), Clause 1 and Clause 2 Article 21 of this Circular relating to IVD products and Clause 1 and Clause 2 Article 25 of this Circular relating to herbal medicines, oriental medicines and medicinal materials;

b) 02 copies of documents including application form for drug registration and finished drug product standards; with regard to vaccines, antibody-containing sera, bioligicals (excluding IVD products), both above documents and 01 copies of the original shall be submitted:

c) Drug label: 02 sets of drug labels. These drug labels shall be attached to A4 paper, borne the stamp of the applicant or the drug manufacturer overlapping onto the adjoining pages. When applying for re-registration, the drug labels are not required to return if there is not any changes in the labels in comparison with the initial registration;

d) Drug information: 01 Patient information leaflet which is equivalent to each type of drug prescribed in the Circular No. 04/2008/TT-BYT dated May 12, 2008 of the Minister of Health on guidance on drug labeling, and bearing the stamp if the applicant or the drug manufacturer. When applying for re-registration, the drug information is not required to return if there is not any changes in the labels in comparison with the initial registration;

dd) Drug samples, drug materials:

- 01 packaging unit equivalent for each registered packaging method;

- Mass of materials which is enough for 03 times of testing

- With regard to vaccines, antibody-containing sera, the applicant shall send the samples stored at the National Institute for Control of Vaccines and Biologicals.

5. Application for variation registration: 01 original of sufficient documents depending on the major variation registration or minor variation registration prescribed in Clause 5 and Clause 6 of this Circular relating to modern drugs, vaccines, antibody-containing sera, biologicals, or Clause 3 and 5 of this Circular relating to IVD products, and Clause 3 and Clause 4 Article 25 of this Circular relating oriental medicines, herbal medicines, or medicinal materials is required.

6. Legal documents:

a) The Certificate of pharmaceutical products (CPP), License for drug trading issued by the foreign competent agency, GMP Certificate, License for representative office establishment in Vietnam or other equivalent certificates relating to IVD products which is permitted in any form of originals, copies, or Vietnamese translation from foreign language must satisfy specific requirements pertaining to each type of certification as prescribed in Point b, c or d of this Clause and the regulations below:

- Submitting the original: The original must bear the signature, full name and title of the signer and the certified stamp of the competent agency of the home country in charge of granting certification; and must be consularly legalized at the Vietnamese diplomatic missions under the law on consular legalization, unless legal documents are granted by competent agencies of the countries that have concluded Mutual legal assistance treaty with Vietnam.

- Submitting the copies: The copies are lawfully authenticated by a Vietnamese competent agency as prescribed in Vietnamese law on authentication of copies according to originals or copies issued from master register. The originals shall be presented where necessary.

- Submitting Vietnamese translations from foreign language: the Vietnamese translations must be notarized as prescribed (notarization means the signature of the translator is notarized by the local notary, diplomatic mission, consular office or another authorized foreign agency (the translator is required to commit to translate accurately from the original as prescribed) and submit it together with the original or the copy of the certification as prescribed.

- The validity period of the licenses or certificates: The validity period must be stated in the certificates or licenses and they are still valid on the date on which they are verified; an official dispatch on granting extension of this certificate is not accepted. If the valid period is not stated in that certificate, only those granted within 24 months from the date of issue may be accepted.

b) Certificate of pharmaceutical products (CPP) must both comply with Point a of this Clause and satisfy the requirements below:

- It is issued by the pharmacy authority (on the WHO list at http://www.who.int) using the WHO form applicable to the Certification scheme on the pharmaceutical products moving in international commerce.

- Certify that drugs are permitted for sale in the country of origin. In case the drugs are not permitted for sale in the country of origin, or the drugs are permitted for sale but they are not actually sold in the country of origin, the applicant must provide the CPP which certifies that drugs are permitted for sale in one of following countries: British, France, Germany, Australia, Canada or countries in the areas of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

c) License for drug trading issued by the foreign competent agency, it must comply with regulations in the first, second and third bullets in Point a of this Clause and contain:

- Name and address of the foreign competent agency.

- Name and address of the drug-trading establishment. .

- Scope.

- The validity period of the Certificate, which minimum remaining period is 24 months from the day on which it is verified. In case the validity period is not regulated, the foreign drug-trading establishment must provide the certificate certified that it still operates in the pharmacy field by the competent agency; only the certificate granted within 24 months from the date of issue is accepted.

d) GMP-WHO certificates, ISO certificates or equivalent certificates must be granted by competent agencies of countries of origin, which certify the names and addresses of manufacturers.

dd) Certificate of eligibility for drug trading of the applicant, a certified true copy or a copy certified by the enterprise (if the applicant is not a drug manufacturer) is accepted.

e) Certificates, protection titles and transfer contracts for ownership of industrial property objects in drug registration application (if any), granted or certified by industrial property authorities, must certified true copies bearing stamps of applicants.

7. Other administrative dossiers:

a) An application form must be signed by the director of the applicant or authorized representative of the applicant and borne the stamp (if any) of the applicant, a signature stamp is not accepted.

b) A Power of attorney using the form No. 05/TT issued herewith, which is required when another person is authorized by the applicant to:

- Act as the applicant using the form No.5A issued herewith.

- Sign the drug registration application when the applicant authorizes the representative office of the applicant in Vietnam using the form No. 5B issued herewith;

- Use the name of drug to register a trademark when the owner of the trademark is not the applicant using the form No.5C issued herewith.

Each application must be enclosed with an original copy or a certified true copy of the letter of attorney issued by the applicant or the applicant’s representative office in Vietnam.

c) A certified true copy of franchise agreement pertaining to the drug manufacturing under franchise agreements.

8. Drug label and drug information:

The content of the drug label and drug information shall comply with the Circular No. 04/2008/TT-BYT dated May 12, 2008 of the Minister of Health on guidance on drug labeling.

9. Fees for drug registration:

The applicant must pay fees for drug registration and sale, verification and observation of GMP requirements applying to the drug manufacturer as prescribed in law on fees and charges.

Article 12. Validity of the drug registration number and deadline for application for re-registration or registration renewal

1. The maximum validity period of the drug registration number is 05 years, from the day on which the Decision on issuance or renewal of drug registration number is made. If the Advisory council for drug registration number of the Ministry of Health request to keep evaluating safety and efficacy of the drug, the maximum validity period of the drug registration number is 03 years, from the day on which the Decision on issuance of the drug registration number is made.

2. Deadline for application for re-registration or registration renewal:

a) Within 06 months before the expiry date of the drug registration number, the applicant may apply for the registration renewal. The Drug administration of Vietnam shall send a notification which provide explanation for the application which does not satisfy requirements for registration renewal as prescribed in Clause 2 Article 9 of this Circular, the applicant may apply for re-registration as prescribed and the application shall be verified right after it is submitted.

b) Within 12 months proceeding and 06 months succeeding the expiry date of the drug registration numbers, the applicant may apply for the re-registration. If the applicant has applied for the re-registration, it may not apply for registration renewal.

Chapter II

INTELLECTUAL PROPERTY RIGHTS TO REGISTERED DRUGS

Article 13. General rules

1. The applicant shall take responsibility for intellectual property pertaining to its registered drugs.

2. The applicant establishes intellectual property rights or looks up related intellectual property objects before applying for drug registration in Vietnam.

3. In case there is any dispute about intellectual property when the application is processed, the objector to the issuance of drug registration number subject to dispute must provide the conclusion of the intellectual property authority or intellectual property enforcement body on infringement of intellectual property rights. The Ministry of Health shall not issue drug registration numbers to the drugs which are subject to infringement of intellectual property rights of other individuals or organizations according to good basis.

4. In case there is any dispute about intellectual property rights after the drug registration number is issued, the Ministry of Health shall decide to revoke the registration number or suspend the sale of the drug as prescribed in Clause 6 Article 23 or Clause 2 Article 33 of this Circular at the request of holder of intellectual property rights or a third-party beneficiary and pursuant to the judicial decision or final conclusion of the intellectual property authority or the intellectual property enforcement body on infringement of intellectual property rights.

Article 14. Patents on registered drugs

1. Regarding a drug containing active ingredients which are under the period of intellectual property protection, the applicant may provide related legal documents on condition of protection and intellectual property rights (patent) on registered drugs (if any).

2. Within 02 years before the expiry date of the period of patent protection, the applicant may submit the application for registration of generic drug together with documents proving that drug protection period will expire soon and clarify the request in the application using the form No.6A/TT issued herewith.

Article 15. Data security applied to registration application

The applicant wishes to secure data on application for new drug as prescribed in regulations on data securities applied to registration application as prescribed in the Circular No. 05/2010/TT-BYT dated March 1, 2010 of the Minister of Health on guidance on pilot data securities pertaining to drug registration must clarify the request in the application using form No. 6A/TT issued herewith.

Chapter III

APPLICATION FOR DRUG REGISTRATION

Section 1. APPLICATION FOR REGISTRATION OF MODERN DRUGS, VACCINES, ANTIBODY-CONTAINING SERA, OR BIOLOGICALS

Article 16. Required documents

1. An application for initial registration of new modern drugs, vaccines, antibody-containing sera, or biologicals includes:

a) Part I. An administrative dossier and drug information;

b) Part II. A quality report;

c) Part III. A pre-clinical report;

d) Part IV. A clinical report;

2. An application for initial registration of generic drugs (only apply to modern drugs), includes:

a) Part I. An administrative dossier and drug information;

b) Part II. A quality report;

3. An application for re-registration includes:

a) Part I. An administrative dossier and drug information;

b) Part II. A quality report: If the application for initial registration is submitted according to the ASEAN common technical dossier (ACTD) or using the form of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and satisfy the ACTD requirements, only the standard and method of finished product testing is required when applying for re-registration;

4. An application for registration renewal includes:

a) Part I. An administrative dossier and drug information;

b) Part II. Other documents include:

- A copy of Official Dispatches of Drug administration of Vietnam or Department of Medical Equipment and Health Works on permission for variations, copy of documents about the variations not subject to permission;

- A copy of standards and methods finished drug products pertaining to drugs not meeting requirements of the pharmacopoeia;

- Documentary evidence for exported drugs in Vietnam regarding foreign drugs. Documentary evidence for drugs manufactured and distributed in Vietnam regarding domestic drugs.

5. An application for major variation registration:

a) Part I. An administrative dossier and drug information;

b) Part II. A quality report;

d) Part IV. A clinical report;

The major variations and required equivalent application shall follow guidance of Appendix II of this Circular.

6. An application for minor variation registration:

a) Part I. An administrative dossier and drug information;

b) Part II. A quality report;

The minor variation and required equivalent application shall follow guidance of Appendix II issued herewith.

7. An application for other variation registration: the required application prescribed in Clause 1 of this Article.

8. Application prescribed in Clause 1, 2 , 3, 4 and Clause 5 of this Article shall comply with regulations below:

a) Apply regulations in Appendix I issued herewith, including:

- ASEAN common technical dossier (ACTD);

-Guidance on research on stability;

-Guidance on assessment of manufacturing process;

-Guidance on assessment of analysis method;

-Guidance on research on bioavailability and bioequivalence;

b) Follow the forms of ACTD. In case the new modern drugs, vaccines, antibody-containing sera, biologicals may not be arranged according to ACTD or ICH-CTD.

9. Regarding to processed drugs, request required documents as prescribed in the Circular No.23/2013/TT-BYT dated August 13, 2013 of the Minister of Health on guidance on processed drugs.

Article 17. Administrative dossiers and drug information

An administrative dossier and drug information includes:

1. Table of contents;

2. A report on safety and efficacy of drugs after putting into market using the form No.03/TT issued herewith regarding drugs required to evaluate their safety and efficacy when applying for initial registration.

3. A summary of Product using the form No.04/TT issued herewith;

4. A Power of attorney (if any) using form No.05/TT issued herewith;

5. An application form using the form No.06/TT issued herewith;

6. A cover using the form No.07/TT issued herewith;

7. A report on drugs relating to application for re-registration using form No.08/TT issued herewith;

8. A summary of history of drug registration relating to application for registration renewal using the form No.09/TT issued herewith;

9. A Certificate of eligibility for drug trading relating to Vietnamese drug-trading establishment and it is submitted once pertaining to all the drugs within the validity period of the Certificate.

10. A License for drug trading issued by the foreign competent agency regarding the foreign applicant and it is submitted once to all application for drug registration within the validity period of the Certificate.

11. A CPP using the form No.01/ACTD issued herewith pertaining to foreign drugs.

12. A GMP certificate of the foreign drug manufacturer if the CPP certification does not certify the GMP requirements. In case there are many manufacturers involving in the drug manufacturing process, the applicant submits the GMP certificates of all applicants involving in the finished drug manufacturing process.

13. A drug label, only a copy of the approved drug label is required pertaining to application for registration renewal;

14. Drug information Patient information leaflets prescribed in the Circular on guidance on drug labeling, only the copy of the application for registration renewal is required;

15. A Summary of Product Characteristics pertaining to modern drugs, vaccines, antibody-containing sera and biologicals using the form No.02/ACTD issued herewith (the application for registration renewal is not required);

16. A franchise agreement on drug manufacturing. Outsourcing agreement on drug manufacturing.

17. Certificates, protection titles and transfer contracts for ownership of industrial property objects (if any).

18. Other legal documents (if any).

19. A GMP certificate of manufacturer of primary package as prescribed in the Circular No.14/2012/TT-BYT dated August 31, 2012 of the Minister of Health on GMP for pharmaceutical package or equivalent certificate of manufacturing conditions of the manufacture of primary package.

Article 18. Quality reports

1. A quality report shall comply with Part II – ACTD and include the documents below

a) Table of contents;

b) A summary of overview of quality;

c) Content and figures;

d) Reference materials;

e) General documents of the drug manufacturer using the form No.10/TT issued herewith. In case a drug is manufactured through multiple stages, the general documents are documents of all manufacturer involving in the drug manufacturing before it is put on the market

2. The quality report in the application for registration of drug manufacturing under franchise agreement shall include sufficient content as prescribed in Clause 1 of this Article. The content and figures of the quality report:

a) Content and figures related to drug manufactured before it is under franchise agreement provided by the franchisor:

- Active ingredients (S): General information (S1); Characteristics (S3) and active ingredient inspection (S4), excluding result of quality inspection of batches of active ingredients which are used for manufacture of lots of finished drug products at the franchisees’ facility for registration of drugs manufactured under franchise agreement;

- Finished drug products (P): Description and ingredient (P1); pharmacological development (P2); manufacture, excluding P3.4. Assessment and/or evaluation process; excipient inspection (P4); finished product inspection (P5), excluding analysis of lots (P5.4); packaging system (P7).

b) Content and figures related to drug manufactured under franchise agreement provided by the franchisor:

- Active ingredient (S): Manufacture (S2); Titrant or reference materials (S5); Packaging system (S6) and Stability (S7);

- Finished product (P): Assessment and/or evaluation process (P3.4); Analysis of lots (P5.4); Titrant or reference materials (P6); Stability (S8) and Interchangeability (P9).

c) In case the drugs manufactured under franchise agreement are different from drugs manufactured before it is under franchise agreement in terms of content and figures provided in the application as prescribed in Point a Clause 2 of this Article: The franchisee must declare sufficient variation in the application form using the form No.6D issued herewith and relevant documents prescribed in Appendix II pertaining to equivalent variation.

Article 19. Pre-clinical reports;

A pre-clinical report shall comply with guidance in Part III-ACTD and include the documents below:

1. Table of contents;

2. Overview of pre-clinical studies;

3. A summary of pre-clinical studies ;

4. A pre-clinical study report;

5. References.

Article 20. Clinical reports;

A clinical report shall comply with Part IV-ACTD and include the documents below:

1. Table of contents;

2. Overview of clinical reports;

3. A summary of clinical reports;

4. A list of clinical studies;

5. A clinical study report;

6. References.

Section 2. APPLICATION FOR REGISTRATION OF IVD PRODUCTS

Article 21. Required application

1. An application for initial registration of IVD products, including semi-finished drug products, consists of:

a) Part I. Administrative dossiers:

b) Part II. Quality reports;

c) Part III. Reports on effective diagnosis, the semi-finished drug products are not subject to this regulation;

2. An application for re-registration includes:

a) Part I. Administrative dossiers:

b) Part II. Quality reports;

3. An application for variation registration includes:

a) An application form;

b) The documents related to the variations: submit the documents in accordance with Section A-Appendix IV issued herewith.

4. An application for registration renewal includes:

a) Part I. Administrative dossiers:

b) Part II. Other application includes:

- A copy of Official Dispatch of Drug administration of Vietnam or Department of Medical Equipment and Health Works on permission for the variation when the drug is sold, copies of document about the variations not subject to permission ;

- A copy of the quality report prescribed in Section A - Appendix IV issued herewith.

- Documentary evidence for IVD products imported in Vietnam regarding foreign drugs. Documentary evidence for IVD products manufactured and distributed in Vietnam regarding domestic drugs.

5. An application for other variation registration shall be submitted similarly to the application for initial registration as prescribed in Section B – Appendix IV issued herewith.

Article 22. Administrative dossiers and drug information;

An administrative dossier includes:

1. Table of contents;

2. A report on the safety and efficacy of drug after it is sold using the form No.3/TT issued herewith pertaining to the drug subject to assessment of drug safety and efficacy when its drug registration number is initially granted.

3. A summary of product using the form No.04/TT issued herewith;

4. A Power of attorney (if any) using the form No.05/TT issued herewith;

5. An application form using the form No.06/TT issued herewith;

6. A cover using the form No.07/TT issued herewith;

7. Reports on the sale of drugs applied to the application for re-registration using the form No.08/TT issued herewith;

8. A summary of drug registration history pertaining to the application for registration renewal using the form No.09/TT issued herewith;

9. A drug label (only the copy of the application for registration renewal is required);

10. A License for trading in vaccines, biologicals which is granted to the foreign establishments registering vaccines, biologicals or a Certificate of eligibility for trading in vaccines, biologicals which is granted to the Vietnamese establishments registering vaccines or biologicals the foreign competent agency

11. A License for free sale in the country of origin pertaining to foreign drugs, the semi-finished drug products is not subject to this regulation.

12. A GMP-WHO certificate, ISO certificate or an equivalent certificate which is granted to the drug manufacturer by the competent agency.

13. A Certificate of intellectual property, business contracts, or other documents (if any).

The application shall comply with Section A – Appendix IV issued herewith .

Article 23. Quality reports

A quality report includes:

1. Table of contents;

2. Active ingredients;

3. Finished drug products;

4. Stability.

The application shall comply with Section A – Appendix IV issued herewith .

Section 24. Reports on assessment of efficacy of IVD product

A report on assessment of IVD product efficacy includes:

1. Table of contents;

2. Study reports;

The application shall comply with Section A – Appendix IV issued herewith .

Section 3. APPLICATION FOR REGISTRATION OF HERBAL MEDICINES, ORIENTAL MEDICINES AND MEDICINAL MATERIALS

Article 25. Required application

1. An application for re-registration includes:

a) An administrative dossier and drug information;

b) A quality report;

c) A report on safety and efficacy applied to new drugs and materials used for manufacture of new drugs.

2. An application for re-registration includes:

a) An administrative dossier and drug information;

b) A quality report;

3. An application for major variations: the documents on major variations and required document shall comply with Part I - Section C – Appendix II issued herewith.

4. An application for minor variations: the documents on minor variations and required relevant document shall comply with Part II - Section C – Appendix II issued herewith.

5. An application for registration renewal includes:

a) Section I. An administrative dossier and drug information;

b) Part II. Other documents include:

- A copy of Official Dispatch of Drug administration of Vietnam or Department of Medical Equipment and Health Works on permission for variation when the drug is sold, copies of documents about the variations not subject to permission;

- A copy of standards and method of testing of finished products pertaining to drugs not meeting requirements of the pharmacopoeia;

- Documentary evidence for exported drugs in Vietnam regarding foreign drugs. Documentary evidence for drugs manufactured and distributed in Vietnam regarding domestic drugs.

6. An application for other variations registration: required application prescribed in Clause 1 of this Article.

Article 26. Administrative dossiers and drug information

The administrative report and drug information shall comply with Article 17 of this Circular.

Article 27. Quality reports

1. Manufacturing process:

a) Materials:

- Regarding herbal medicines and oriental medicines: there are not any requirements pertaining to manufacturing process applying to excipients and materials in pharmacopoeia, drug materials manufactured by another manufacturer. Other cases are required to describe sufficiently and specifically the material manufacturing process.

- Regarding drug materials: describe sufficiently and specifically the material manufacturing process.

b) Finished drug products:

- A formula for smallest packaging unit: names of materials including major components and excipients; content or concentration of each material; standards applying to materials; quantity of each ingredient must be specified if the drug is derived from bone glue;

- A formula for one manufacturing lot or batch: names of materials including major components and excipients; mass and volume of each material;

- A diagram of manufacturing process includes all stages in the manufacturing process;

- A description of manufacturing process: describe sufficiently and specifically every stage in the manufacturing process;

- A list of equipment or tools: name of equipment, parameter, and use purposes;

- Control of manufacturing process: describe sufficiently and specifically criteria of the inspection of manufacturing process.

2. Quality standards and testing methods.

a) Regarding the materials stated in the pharmacopoeia, the name of pharmacopoeia and publishing year must be specifically written; regarding the material not stated in the pharmacopoeia, the criteria and testing methods must be specifically described.

b) Finished drug products;

- Formula for smallest packaging unit: names of materials including major components and excipients; content or concentration of each material; standards applying to materials; quantity of each ingredient must be specified if the drug is derived from bone glue;

- Finished drug product standards: Describe sufficiently and specifically criteria and testing methods of the finished drug products.

c) Packaging standards: Describe sufficiently and specifically criteria and testing methods.

d) The drug testing report shall comply with Article 6 of this Circular.

dd) Documents on stability studies include:

- Draft of stability study includes:

- Figures for stability study include:

- Conclusion on stability study includes:

Article 28. Reports on safety and efficacy

Reports on safety and efficacy of new drugs shall comply with regulation on clinical testing of the Ministry of Health, including:

1. Reports on toxicology.

2. Reports on clinical studies, the application for material registration is not subject to this regulation.

Chapter IV

PROCEDURES FOR DRUG REGISTRATION AND COMPETENCY IN ISSUANCE, SUSPENSION OF ISSUANCE OR REVOCATION OF DRUG REGISTRATION NUMBERS

Article 29. Procedures for receipt and verification of the application for drug registration

1. The Drug Administration of Vietnam shall:

a) Receive application for tax registration sent directly or by post regarding the cases below:

- The application for initial registration, re-registration, registration renewal, excluding the application for IVD product registration and application for registration of topical administration drugs manufactured domestically prescribed in Appendix V issued herewith.

- The application for major, minor, or other variation during the validity period of the drug registration number relating to registered drugs, excluding application for IVD product registration.

b) Verify the application for initial registration and re-registration, then send it to the Advisory council for drug registration number of the Ministry of Health; or verify the application for registration renewal, then request the Minister of Health to approve the list of drugs applying for renewal, these application must be sent directly or by post.

c) Verify and give response to the application for major, minor or other variation registration pertaining to registered drugs whose drug registration numbers are still valid which is sent directly or by post.

2. The Department of Medical Equipment and Health Works shall:

a) Receive the application for initial registration, re-registration, registration renewal of IVD products sent directly or by post; and application for minor, major, or other variation registration applying IVD products whose drug registration numbers are still valid;

b) Verify the application for initial registration and re-registration of IVD products, then send it to the Advisory council for drug registration number of the Ministry of Health;

c) Verify the application for registration renewal of IVD products, then send it to the Minister of Health for approval;

d) Verify and give response to the application for major, minor or other variation registration of IVD products whose drug registration numbers are still unexpired.

3. Services of Health of central-affiliated cities and provinces where the drug manufacturers are located shall:

a) Receive the application for initial registration, re-registration, or registration renewal of topical administration drugs manufactured domestically which is sent directly or by post as prescribed in Appendix V issued herewith;

b) Verify the application received as prescribed in Point a of this Clause, then send a official dispatch enclosed with the approved list of drugs to the Drug Administration of Vietnam in order to issue drug registration numbers.

Article 30. Competency in issuance of drug registration numbers

1. The Minister of Health shall authorize the Director of the Drug Administration of Vietnam to sign the Decision on issuance of list of drugs entitled to obtain drug registration numbers in the cases below:

a) The application for drug registration received and verified by the Drug Administration of Vietnam as prescribed in Point b Clause 1 Article 29 of this Circular;

b) The application for drug registration received and verified by the Service of Health as prescribed in Clause 3 Article 29 of this Circular;

2. The Minister of Health shall authorize to Director of Department of Medical Equipment and Health Works to sign the Decision on issuance of list of IVD products entitled to obtain drug registration numbers as prescribed in Clause 2 Article 29 of this Circular.

Article 31. Deadline for issuance or response to application for major, minor, other variation registration

1. The Drug Administration of Vietnam or Department of Medical Equipment and Health Works (regarding IVD products) shall consider issuing drug registration numbers within 06 months regarding the application for initial registration, re-registration and within 03 months regarding application for registration renewal from the day on which the satisfactory application is received . In case the application is rejected, the Ministry of Health shall provide explanation in writing.

2. Within 03 months from the day on which the satisfactory application is received, the Service of Health shall verify and send a Official dispatch enclosed the list of drugs applying for drug registration numbers with regard to application received by the Service of Health as prescribed in Clause 3 Article 29 of this Circular to the Drug Administration of Vietnam for issuance; if the application is rejected, the Service of Health shall provide explanation in writing.

3. From the day on which the satisfactory application is received, the Drug Administration of Vietnam or Department of Medical Equipment and Health Works (regarding IVD products) shall respond to the application for major or minor variation registration with the deadline as follows:

a) 90 days for registration of 02 or more major or minor variations that need approving; 60 days for registration of 01 minor variation that need approving.

b) Within 20 days regarding application for minor variation not subject to permission, if there is not any request of the competent agency.

4. Regarding the application for other variation registration, the application shall comply with regulation similarly to the application for initial registration and deadline for response prescribed in Clause 1 and Clause 2 of this Article.

5. The Drug Administration of Vietnam or Department of Medical Equipment and Health Works (regarding IVD products) shall consider issuing drug registration numbers or responding in writing before the deadline as prescribed in Clause 1 and Clause 3 of this Article at the request of the applicant in the Application form using the form No.06/TT issued herewith in the cases below:

a) The drugs serving the special treatment in the List of scarce drugs issued by the Minister of Health;

b) The drugs serving the treatment in the state of emergency, natural disaster, or epidemic;

c) Domestical drugs manufactured on the new assembly line meeting GMP requirements within 18 months, from the day on which the GMP certificate is issued.

d) The vaccines passed the pre-evaluation conducted by WHO and issued the drug registration number through the reduced process formulated and issued by the Drug Administration of Vietnam.

Article 32. Revocation of drug registration numbers

Within the validity period of the drug registration numbers, the Ministry of Health shall consider deciding to withdraw the drug registration number of the registered drug (including IVD products) if:

1. The drug is manufactured in contravention of application for registration approved by the Ministry of Health.

2. The drug has 02 manufacturing lots not meeting quality standards or the drug committing violations against quality standards 01 time but the drug quality authority conclude that violation is serious.

3. The drug manufacturer or applicant applies for revocation of drug registration numbers in Vietnam.

4. The drug whose drug registration number is withdrawn in the home country.

5. The drug contains active ingredients which are unsafe for users as recommended by WHO or Vietnamese or foreign competent agency.

6. The drug infringes intellectual property rights according to a conclusion of the competent agency.

7. The applicant is not replaced as prescribed in Point I Clause 3 Article 3 or Point d Clause 2 Article 4 of this Circular after 02 months, from the day on which the applicant shuts down itself or by the competent agency.

Article 33. Suspension of receipt of new application for drug registration and suspension of issuance of drug registration numbers

The Ministry of Health shall suspend the receipt of new application for drug registration and suspend the issuance of drug registration numbers (including IVD products) if:

1. The applicant or drug manufacturer has at least 02 lots of drugs not meeting quality standards before being sold or suspended from sale within 01 year.

2. The applicant or drug manufacturer having the drug whose drug registration number is revoked as prescribed in Clause 1 Article 32 of this Circular; or one of cases in Clause 4, Clause 5 or Clause 6 Article 32 of this Circular but it fails to notify the Ministry of Health.

3. The applicant or drug manufacturer forges or intentionally modifies legal documents of competent agencies; or uses fake seals or forges signatures and/or seals of applicants, drug manufacturers and related establishments in the application;

4. The applicant or drug manufacturer provides documents, data, or information relating to technical dossier including reports on quality standards, manufacturing methods, stability without depending on the studies, experiment, or actual manufacture of the at the manufacturer’s facility or at the applicant’s facility;

5. The applicant or drug manufacturer provides documents, data, or information about the effect, safety and efficacy of the drug without any proved materials or scientific evidence;

6. The applicant or drug manufacturer submits the sample of the registered drug not studied or manufactured themselves which is stated in the application for manufacturing registration.

7. The applicant fails to update the drug information at the request of the Drug Administration of Vietnam as prescribed in Clause 4 Article 9 of this Circular.

Article 34. Competency in decision, notification and deadline for revocation of drug registration numbers, suspension of receipt of application and suspension of issuance of drug registration numbers

1. The Minister of Health shall authorize the Director of the Drug Administration of Vietnam to decide to revoke drug registration numbers, suspend the receipt of application, suspend the issuance of drug registration numbers and the Director of Department of Medical Equipment and Health Works to decide to revoke drug registration numbers, suspend the receipt of application, and suspend the issuance of drug registration numbers applying to IVD products nationwide.

2. The Service of Health of central-affiliated city or province or other health authorities shall notify the decision of the Ministry of Health (the Drug Administration of Vietnam or Department of Medical Equipment and Health Works regarding IVD products) on revocation or suspension of receipt of application and suspension of issuance of drug registration number in the province.

3. The maximum period in which the receipt of new application or the issuance of drug registration numbers is suspended is 02 years regarding cases prescribed in Clause 1, Clause 2 and Clause 3 Article 33 of this Circular, from the day on which the Decision on revocation of drug registration number or suspension of the second drug sale or the decision issued by the competent agency as prescribed in Clause 3 Article 33 of this Circular is issued.

4.The maximum period in which the receipt of new application or the issuance of drug registration numbers is suspended regarding cases prescribed in Clause 4, Clause 5 and Clause 6 Article 33 of this Circular is 01 year, from the day on which the final notification on violations against the above regulations committed by the applicant is issued.

5.The maximum period in which the receipt of new application or the issuance of drug registration numbers is suspended regarding cases prescribed in Clause 7 Article 33 of this Circular is 06 months, from the day on which the final notification on violations against the above regulations committed by the applicant is issued.

Chapter V

ORGANIZATION AND OPERATION OF ASSESSMENT EXPERTS AND ADVISORY COUNCIL FOR DRUG REGISTRATION NUMBERS

Article 35. Organization and operation of Advisory council for drug registration numbers

1. The Ministry of Health shall set up the Advisory council for drug registration numbers (including IVD products).

2. The Advisory council for drug registration numbers shall advise the Minister of Health about the issuance of drug registration numbers in Vietnam; policies on harmonization of registration of drugs with local countries and countries in the world; policies on manufacture, import and sale of drug in Vietnam including the drug used on the Vietnamese to assess the safety and efficacy of the drug where necessary.

3. The Advisory council for drug registration numbers operates following rule below: the advice of the Advisory council for drug registration numbers must ensure legal and scientific basis and it is stated in the Minutes of the meetings of the advisory council of drug registration numbers. The Advisory council for drug registration numbers shall take responsibility to the Minister of Health for advice on drug registration.

4. The Drug Administration of Vietnam shall cooperate with Department of Medical Equipment and Health Works in advising the Minister of Health against issuance of regulations of organization and operation of the Advisory council for drug registration numbers, cooperation mechanism between the Advisory council for drug registration numbers and assessment expert group in the process of issuance of drug registration numbers.

Article 36. Organization and operation of experts and expert groups of assessment of application for drug registration

1. The Ministry of Health shall authorize the Drug Administration of Vietnam or Department of Medical Equipment and Health Works to establish expert groups of assessment of application for drug registration (hereinafter referred to as assessment expert group).

2. The assessment expert group shall advise to Drug administration of Vietnam against assessment of application for drug registration, request to issue, supplement or not issue drug registration numbers.

3. The assessment expert group operates following rule below: the advice of the Advisory council for drug registration numbers must ensure legal and scientific basis and it is stated in the Record of assessment of application for drug registration. The assessment experts shall take responsibility to the Director of the Drug Administration of Vietnam, the Director of Department of Medical Equipment and Health Works (regarding IVD products) for advice against the assessment of application for drug registration.

4. The Drug Administration of Vietnam or the Department of Medical Equipment and Health Works shall formulate and promulgate regulations on selection criteria, organization and operation of expert groups of assessment of application for drug registration; conclude contracts annually with assessment experts; assess and collect the assessment results, then send it to the Advisory council; provide training course to the assessment experts; evaluate professional qualification and adherence to regulations in order to supplement appropriate experts.

Chapter VI

IMPLEMENTATION

Article 37. Effect

1. This Circular shall come into force from January 15, 2015.

2. The major, minor, other variation applying to the registered drugs prescribed in Appendix II issued herewith shall be applied from April 1, 2015.

3. The Circular No.22/2009/TT-BYT dated November 24, 2009 of the Minister of Health on drug registration, the Article 6 of the Circular No.45/2011/TT-BYT dated December 21, 2011 of the Minister of Health on amendments to the Decision No.1570/2000/QD-BYT dated May 22, 2000 of the Minister of Health on implementation of GMP requirements for drug testing; the Decision No.2701/2001/QD-BYT dated June 29, 2001 of the Minister of Health on implementation of GMP requirements for drug storation; the Decision No.06/2004/TT-BYT dated May 28, 2004 on guidance on drug processing; the Decision No. 3886/2004/QD-BYT dated November 13, 2004 of the Ministry of Health on implementation of GMP requirements for drug manufacturing recommended by WHO; the Circular No.13/2009/TT-BYT dated September 1, 2009 of the Ministry of Health on drug advertisement; the Circular No.22/2009/TT-BYT dated November 24, 2009 of the Ministry of Health on drug registration; the Circular No. 47/2010/TT-BYT dated December 29, 2010 on importation and exportation of drugs and packages in physical contact with medicinal products shall be annulled from the effective date of this Circular.

Article 38. Transitional provisions

1. The application for registration submitted before the effective date of this Circular shall be processed and granted as prescribed in the Circular No. 22/2009/TT-BYT dated November 24, 2009 of the Ministry of Health on drug registration.

2. The foreign applicant may use the License for operating in drugs or medicinal materials in Vietnam which is granted before the effective date of this Circular to apply for drug registration until the Certificate expires.

Article 39. Reference provisions

In case legislative documents and regulations in this Circular is amended or replaced, they shall apply to new legislative documents.

Article 40. Implementation

1. The Drug Administration of Vietnam or Department of Medical Equipment and Health Works within their competence of roadmap of ASEAN harmonization in drug registration shall:

a) Provide guidance and implementation of this Circular.

b) Update, edit and issue the ACTD, technical requirements and guidance on registration of ASEAN

c) Update the list of drugs granted drug registration numbers periodically by the Ministry of Health and other registration information about drugs on website of the Drug Administration of Vietnam or website of the Ministry of Health about IVD products.

d) Formulate and implement SOPs, QM, and reduced process of verification and issuance of drug registration numbers certified by WHO;

2. Services of Health of central-affiliated cities and provinces shall inspect the implementation of this Circular applied to pharmacy enterprises within their competence.

3. The Ministry of Health affiliated units, Vinapharm, other drug-trading establishments, foreign enterprises obtaining operation license in the pharmacy field shall implement this Circular.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (the Drug Administration of Vietnam and the Department of Medical Equipment and Health Works regarding IVD products) for consideration./.

For the Minister

The Deputy Minister

Pham Le Tuan

APPENDIX III

RE-APPRAISAL OF DRUG TESTING STANDARDS AND METHODS
(Issued together with the Circular No. 44 / 2014 /TT-BYT dated November 25, 2014)

1. The figures of method appraisal cannot prove the feasibility of analytical method.

2. The figures of method appraisal cannot prove the specificity of the analytical methods (such as qualitative analysis, quantitative analysis, purity analysis, impurity purity analysis, etc.) applying to one active ingredient which is not affected by other active ingredients as well as recipients in the same formula.

3. New methods or new techniques used for quality assessment of a dosage form not applied in Vietnam.

4. New methods or new techniques used for an active ingredients not applied in the actual testing in Vietnam.

APPENDIX IV

APPLICATION FOR IN VITRO DIAGNOSTIC PRODUCTS
(INCLUDING SEMI-COMMERCIAL PRODUCTS)
(Issued together with the Circular No. 44 / 2014 /TT-BYT dated November 25, 2014)

A. For application for initial registration, re-registration, registration renewal and variation registration

1. Administrative and/or legal dossier:

2. Dossier on quality:

3. Dossier on effective diagnosis:

Notes: -“+”:required

 - “-“: not required.

 - “*”: depending on cases.

 - Variation registration: only documents related to the variation are required.

B. Other variation required application for initial registration

1. Variation in active ingredients: ingredients, concentration, content;

2. Change in manufacturer/ Packaging facility (from a manufacturer to another manufacturer);

3. Variation in dosage form.

APPENDIX V

LIST OF DOMESTICALLY PRODUCED DRUGS APPLYING FOR REGISTRATION IN SERVICES OF HEALTH
(Issued together with the Circular No. 44/2014/TT-BYT dated November 25, 2014)

Application for drug registration shall include:

1. Application form (Form 06/TT)

2. Summary of drug characteristics (Form 02/ACTD)

3. Expected label for sale

4. Instruction for use prescribed in the Circular on drug labeling

5. Quality standards and testing methods

6. Drug testing report

7. Manufacturing process

8. Dossier on stability study

FORM 1/TT:      APPLICATION FORM FOR REVOCATION OF DRUG REGISTRATION NUMBER

Hereby request the Ministry of Health to revoke the drug registration number below:

Formula of a smallest package:

* Reasons for revocation of drug registration number:Detailed reasons and enclosed documents (if any)

*Wehereby commit ourselves to comply with regulations on revocation of drug registration numbers and take full legal responsibility for our commitment.

FORM 2/TT:      ANNUAL REPORT ON MANUFACTURE/SALE OF REGISTERED DRUG

FORM 2A: DOMESTIC DRUG

(Applicant for domestic drug registration shall use this form from the issue date to the expiry date of drug registration number).

ANNUAL REPORT ON DRUG MANUFACTURE

REPORTING YEAR: 200…

Applicant’s name:

Address:

* If the drug is granted registration number but it has not/is not manufactured, the applicant must provide explanation in writing.

We hereby declare that the above statements are truthful and we shall take full responsibility for our declaration./.

FORM 2B: FOREIGN DRUG

(Applicant for foreign drug registration shall use this form from the issue date to the expiry date of drug registration number).

ANNUAL REPORT ON DRUG IMPORT

REPORTING YEAR: 200…

Applicant’s name:

Address:

* If the drug is granted registration number but it has not/is not imported, the applicant must provide explanation in writing.

We hereby declare that the above statements are truthful and we shall take full responsibility for our declaration./.

FORM 3A/TT:    REPORT ON DRUG SAFETY AND EFFICACY

(Apply to drugs subject to reports on safety and efficacy)

To: The Ministry of Health (The Drug Administration of Vietnam)

To comply with regulations on drugs subject to reports on safety and efficacy when they are sold and they are re-registered, [applicant s name]............sends a report on the use of the drug as follows:

1. Applicant’s name                         Manufacturer’s name         

     Address:                                                  Address:

2. Drug name:

3. Dosage form:

4. Formula, ingredients:

5. Registered number            Issue date:                    Expiry date:

6. A summary of report on adverse drug reactions sent to National Centers of Drug Information and Adverse Drug Reactions Monitoring after the drug has been sold on Vietnam market(enclosed with copies of reports using forms of National Centre of Drug Information and Adverse Drug Reactions Monitoring)

7. A summary of report on drug use at health facilities nationwide (enclosed with reports certified by every health facility using form No. 3B) including:

- Information about health facilities using the drug (their names and addresses):

- Total number of used drugs:

- Total number of patients using the drug:

- Drug use duration:

8. A summary of update on the safety and efficacy of the drug when it is sold (updates approved by the Drug Administration of Vietnam; updates used for notification; or updates prescribed in Official Dispatches of the Drug Administration of Vietnam (if any).

9. A summary of clinical study reports carried out in Vietnam (if any).

10. * Assessment of drug benefits and the drug-related risks when it is sold; recommendations (if any).

We hereby declare that the above statements are truthful. We shall take full responsibility for our declaration./.

Notes:(*): apply to re-registration

FORM 3B/TT:    REPORT ON USE OF DRUG

(Apply to drugs required reports on safety and efficacy)

To: The Ministry of Health (the Drug Administration of Vietnam)

To comply with regulations on drugs subject to reports on safety and efficacy when they are re-registered, [health facility s name]............sends a report on the drug use as follows:

1. Drug name

2. Drug registration number

3. Dosage form

4. Active ingredients, content/concentration

5. Total number of used drugs

6. Total number of patients using the drug

7. Drug use duration:

8. Evaluation of safety and efficacy of used drug (enclosed figures)

9. Adverse drug reactions: ADR symptoms, number of cases, results of ADR treatment (enclosed figures)

10. Suggestion (whether to keep using the drug at the health facility).

We hereby declare that the above statements are truthful and we shall take full responsibility for our declaration./.

FORM 4/TT:      SUMMARY OF PRODUCT

FORM 4A – INITIAL REGISTRATION

SUMMARY OF PRODUCT

Formula(of a smallest divided dose or a smallest package)

Ingredients:    

Packaging

Drug applied for priority consideration:□registered as prescribed in Clause 5 Article 31 of the Circular on guidance on drug registration (detailed reasons). 

Drug whose dossier on bioequivalence is submitted             □

Drug whose dossier on clinic is submitted                             □

Drug whose dossier on data security is submitted                 □

Notes

*:Correct names of active ingredients (salts/ esters/other derivatives thereof).

(**) If the dose is calculated according to the active radical (base radical, etc.), the content of active ingredients converted into active radicals must be specified.    

***: If pharmacopoeia is used as standard, its version must be specified.

****: If the active ingredient is used in the form of semi-commercial products formulated alongside excipients, it is required to specify all exipients in the formula of the semi-commercial products containing that active ingredient.

FORM 4B – Re-registration

SUMMARY OF PRODUCT

Formula (of a smallest divided dose or a smallest package)

Ingredients:    

Packaging

Drug applied for priority consideration:□registered as prescribed in Clause 5 Article 31 of the Circular on guidance on drug registration (detailed reasons). 

Drug whose dossier on bioequivalence is submitted  □

Drug whose dossier on clinic is submitted                               □

Notes

*:Correct names of active ingredients (salts/ esters/other derivatives thereof).

**: If the dose is calculated according to the active radical (base radical, etc.), the content of active ingredients converted into active radicals must be specified.    

***: If pharmacopoeia is used as standard, its version must be specified. 

****: If the active ingredient is used in the form of semi-commercial products formulated alongside excipients, it is required to specify all exipients in the formula of the semi-commercial products containing that active ingredient. 

FORM 4C – Registration renewal of drug manufactured under franchise agreement

SUMMARY OF PRODUCT

Formula (of a smallest divided dose or a smallest package)

Ingredients:    

Packaging

Drug applied for priority consideration:□registered as prescribed in Clause 5 Article 31 of the Circular on guidance on drug registration (detailed reasons). 

Drug whose dossier on bioequivalence is submitted  □

Drug whose dossier on clinic is submitted                              □

Notes

*: Correct names of active ingredients(salts/ esters/other derivatives thereof).

**: If the dose is calculated according to the active radical (base radical, etc.), the content of active ingredients converted into active radicals must be specified.    

***: If pharmacopoeia is used as standard, its version must be specified. 

****: If the active ingredient is used in the form of semi-commercial products formulated alongside excipients, it is required to specify all exipients in the formula of the semi-commercial products containing that active ingredient. 

FORM 5/TT:      LETTER OF ATTORNEY

FORM 5A –Authorization to register

FORM 5B - Authorization to sign the application for drug registration

FORM 5C - Authorization to use registered drug name

FORM 5A

AUTHORIZATION TO REGISTER

Title of company (name, address of the principal)

LETTER OF ATTORNEY

We, the undersigned, _________________________________________

                                    (Name and address of the product’s owner)

Hereby appoint ______________________________________________

                                    (Name and address of registering facility )

To register following product in our name:

                                    Product’s name:

                                    Dosage form, content:

In the Ministry of Health (the Drug Administration of Vietnam or Department of Medical Equipment and Health Works regarding in vitro diagnostics products) in Vietnam.

[Company’s name]…………- the attorney-in-fact – shall be the owner of drug registration number and take responsibility before the Ministry of Health (the Drug Administration of Vietnam or Department of Medical Equipment and Health Works regarding in vitro diagnostics products) for all matters related to this product in Vietnam.

FORM 5B

AUTHORIZATION TO SIGN THE APPLICATION FOR DRUG REGISTRATION

Title of company (name, address of the principal)

LETTER OF ATTORNEY

We, the undersigned, __________________________________________________

                                    (Name and address of product’s owner/ registering facility)

Hereby appoint Mr./Ms…………

Head of our representative office at……………, Vietnam to sign and affix the representative office’ seal on the product dossier on our behalf:

                                    Product s name:

                                    Dosage form, content:

In the Ministry of Health (the Drug Administration of Vietnam or Department of Medical Equipment and Health Works regarding in vitro diagnostics products) in Vietnam.

Validity of the letter of attorney:

The attorney-in-fact, the undersigned, shall take responsibility before the Ministry of Health (the Drug Administration of Vietnam or Department of Medical Equipment and Health Works regarding in vitro diagnostics products) for all matters related to this product in Vietnam.

FORM 5C

AUTHORIZATION TO USE REGISTERED DRUG NAME

(If the owner of the drug name is not the drug registering facility).

Title of company (name and address of company)

LETTER OF ATTORNEY

We, the undersigned, ________________________________________

(Name and address of owner of registered drug name - the principal)

Hereby application: __________________________________________

(Name and address of  the attorney-in-fact)

Scope of authority: 

Validity of the letter of attorney: this authority shall be valid from…to…

We hereby declare that [attorney in fact]……………….shall use the registered drug name without any infringement of intellectual property rights of a third person. We shall take full responsibility for our declaration in case of any disputes.

FORM 06/TT:    APPLICATION FOR DRUG REGISTRATION

FORM 6A INITIAL REGISTRATION

A. Information about applicant and manufacturer

1. Applicant (the owner of Certificate of free sale-CFS)

Applicant’s name

1.2. Address:                                                                 Website(if any)

1.3. Phone number:                                                        Fax:

       E-mail:  

1.4. Name and address of representative office and contact person in Vietnam:

Name:                                                              

Home phone:                                                     Mobile phone:

Address:

2. Manufacturer (*)

2.1. Manufacturer’s name

2.2. Address:                                                                 Website (if any)

2.3. Phone number:                                                        Fax:

       E-mail:  

(*) = Last manufacturer takes responsibility for consignment

a. Other manufacturers:

(**) =" processing of semi-commercial products”, “packaging”, “granulation”, “production of crude dosage forms”, “contract of study organization”, franchise,…

B. Details of product

1. Product’s name, dosage form and content

1.1. Brand name:

1.2. Dosage form:

1.3. Active ingredient, content

2. Description:

2.1. Description of dosage form:

2.2. Description of packaging:

2.3. Classification.

2.4. Quality standard:

2.5. Shelf life:

2.6. Storage condition:

3. Generic name and formula (including content of active ingredients and excipients) of asmallest divided dose or a smallest package

*: If pharmacopoeia is used as standard, its version must be specified.

C. Technical documents

1. Part II: ACTD - Quality

2. Part III: ACTD – Safety (Pre-clinic)

3. Part IV: ACTD – Efficacy (Clinic)

Notes: The documents (Part II and/or III and/or IV) shall be submitted according to classification of products or product groups.

D. Special request for registered drug

1. Drug having confidential data. □

Request the Drug Administration of Vietnam to ensure the confidentiality of the data enclosed with the application for drug registration below:

□          Toxicity test data                       (Document No…..)

□          Data on clinical drug trials           (Document No…..)

We hereby declare that the above data comply with regulations on confidential data requirements as prescribed in law and we shall perform demonstration obligation at the request of the competent agencies.

2. Drug registered as prescribed in Article 14 of                            □

    the Circular on drug registration

    (registered by the expiration date of the patent).                                    □

3. Drug registered as prescribed in Clause 5 Article 31 of  

    the Circular on drug registration

    (request for priority consideration, detailed explanation). 

DD. Enclosed documents on intellectual property  

E. Enclosed legal documents of applicant/manufacturer

G. Declaration of applicant

We hereby declare that:

1. All documents in this application are checked, signed and borne seal and those are lawful and truthful. We shall take full legal responsibility if there is any false and misleading information

2. The drug is manufactured in conformity with this application.

3. We shall notify and request for permit as prescribed if there is any change in the application regarding to registered drug.

4. We shall take full responsibility for the intellectual property issues related to the drug.

FORM 6B VARIATION REGISTRATION

A. INFORMATION ABOUT APPLICANT AND MANUFACTURER 

1. Applicant (the owner of CFS)

Applicant’s name

1.2. Address:                                                                 Website (if any)

1.3. Phone number:                                                        Fax:

       E-mail:  

1.4. Representative office and contact person in Vietnam:

Name:                                                              

Home phone:                                                     Mobile phone:

Address:

2. Manufacturer (*)

2.1. Manufacturer’s name

2.2. Address:                                                                 Website (if any)

2.3. Phone number:                                                        Fax:

       E-mail:  

(*) = Last manufacturer takes responsibility for consignment

2.4. Other manufacturers:

(**) = " processing of semi-commercial products”, “packaging”, “granulation”, “production of crude dosage forms”, “contract of study organization”, franchise,…

B. DETAILS OF PRODUCT

1. Product’s name, dosage form and content

1.1. Brand name:

1.2. Dosage form:

1.3. Active ingredient, content

1.4. Registerednumber              issue date                         expiry date

2. Description:

2.1. Description of dosage form:

2.2. Description of packaging:

2.3. Classification.

2.4. Quality standard:

2.5. Shelf life:

2.6. Storage condition:

3. Generic name and content of active ingredients and excipients

*: If pharmacopoeia is used as standard, its version must be specified.

C. MAJOR VARIATION/ MINOR VARIATION AND VARIATION (enclosed with reasons for variation)

D. ENCLOSED TECHNICAL DOCUMENTS

DD. DECLARATION

We hereby declare that all documents in this application are checked, signed and borne seal and those are lawful and truthful. We shall take full legal responsibility if there is any false and misleading information.

FORM 6C: RE-REGISTRATION

A. Information about applicant and manufacturer

1. Applicant (the owner of CFS)

1.1. Applicant s name

1.2. Address:                                                    Website(if any)

1.3. Phone number:                                              Fax:

       Email:  

1.4. Representative office or contact person in Vietnam:

Name:                                                              

Home phone:                                          Mobile phone:

Address:

2. Manufacturer (*)

2.1. Manufacturer’s name

2.2. Address:                          Website (if any)

2.3. Phone number:                       Fax:

       Email:  

(*) = Last manufacturer takes responsibility for consignment

2.4. Other manufacturers:

(**) ="processing of semi-commercial products”, “packaging”, “granulation”, “production of crude dosage forms”, “contract of study organization”, franchise,…

B. Details of product:

1. Product’s name, dosage form and content

1.1. Brand name:

1.2. Dosage form:

1.3. Active ingredient, content:

1.4. Old registerednumber                   issue date:                      expiry date:

2. Description:

2.1. Description of dosage form:

2.2. Decryption of packaging

2.3. Classification:

2.4. Quality standards:

2.5. Shelf life:

2.6. Storage condition:

3. Generic and content of active ingredients and excipients

*:If pharmacopoeia is used as standard, its version must be specified.

C. Technical documents

Part II: Quality - ACTD

Notes: The documents of Part II shall be submitted according to classification of products or product groups.

D. Drug applied for priority consideration :registered as prescribed in Clause 5 Article 31 of the Circular on guidance on drug registration (detailed reasons). 

DD. Documents on intellectual property

E. Enclosed legal documents of applicant and/or manufacturer

G. DECLARATION

We hereby declare that:

All documents in this application are checked, signed and borne seal and those are lawful and truthful. We shall take full legal responsibility if there is any false and misleading information.

- The drug is manufactured in conformity with this application.

- We shall notify and request for permit as prescribed if there is any change in the application regarding to registered drug.

We shall take full responsibility for the intellectual property issues related to the drug.

FORM 6D: REGISTRATION RENEWAL

A. INFORMATION ABOUT APPLICANT AND MANUFACTURER

1. Applicant (the owner of CFS)

Applicant’s name

1.2. Address:                                                           Website(if any)

1.3. Phone number:                                                Fax:

       Email:  

1.4. Representative office or contact person in Vietnam:

Name:                                                              

Home phone:                                              Mobile phone:

Address:

2. Manufacturer (*)

2.1. Manufacturer’s name

2.2. Address:                              Website (if any)

2.3. Phone number:                        Fax:

       Email:  

(*) = Last manufacturer takes responsibility for consignment

2.4. Other manufacturers:

(**) = “ processing of semi-commercial products”, “packaging”,“granulation”, “production of crude dosage forms”, “contract of study organization”, franchise,…<

B. DETAILS OF PRODUCT

1. Product’s name, dosage form and content

1.1. Brand name:

1.2. Dosage form:

1.3. Active ingredients, content:

1.4. Registerednumber:                  issue date:                           expiry date:

2. Description of product

2.1. Description of dosage form:

2.2. Description of packaging:

2.3. Classification:

2.4. Quality standards:

2.5. Shelf life:

2.6. Storage condition:

3. Generic name and content of active ingredients and excipients

*: if pharmacopoeia is used as standard, its version must be specified.

4. Report on number of imported or manufactured consignments

C. ENCLOSED DOCUMENTS (to prove that the drug meet all requirements for registration renewal)

D. ENCLOSED LEGAL DOCUMENTS OF APPLICANT AND/OR MANUFACTURER

DD. DECLARATION

We hereby declare that:

- The drug has been sold on the market.

- When the drug is sold, there is not any violations against regulations on registration and sale of the drug and other regulations of law.

- All documents in this application are verified and those are truthful. Enclosed documents are the same with those submitted at the Drug Administration of Vietnam. We shall take full legal responsibility if there is any false and misleading information.

- We shall take full responsibility for the intellectual property issues related to the drug.

FORM 6DD: REGISTRATION OF DRUG MANUFACTURED UNDER FRANCHISE AGREEMENT

A. Information about applicant, franchisor and franchisee

1. Applicant (the owner of CFS)

Applicant’s name

1.2. Address:                              Website (if any)

1.3. Phone number:                        Fax:

       Email:  

1.4. Representative office or contact person in Vietnam:

Name:                                                              

Home phone:                       Mobile phone:

Address:

2. Franchisor:

2.1 Franchisor’s name:

2.2. Address:                              Website (if any)

2.3. Phone number:                        Fax:

       Email:  

3. Franchisee (manufacturer) (*)

3.1 Franchisee’s name:

3.2. Address:                              Website (if any)

3.3. Phone number:                        Fax:

       Email:  

B. Details of product

1. Product’s name, dosage form and content

Brand name:

1.2. Dosage form:

1.3. Active ingredients, content:

2. Description of product:

Description of dosage form:

2.2. Description of packaging:

2.3. Classification:

2.4. Quality standards:

2.5. Shelf life:

2.6. Storage condition:

3. Generic name and content of active ingredients and excipients of a smallest divided dose or a smallest package

*: if pharmacopoeia is used as standard, its version must be specified.

C. Technical documents

1. Part II: ACTD - Quality

2. Part III: ACTD – Safety (Pre clinic)

3. Part IV: ACTD – Efficacy (Clinic)

Notes: The documents (Part II and/or III and/or IV) shall be submitted according to classification of products or product groups.

D. Variation between drug manufactured at the franchisee premises and drug manufactured before franchising (excluding change in manufacturer)

DD. Special requests regarding registered drugs

1. Drug having confidential data. □

Request the Drug Administration of Vietnam to ensure the confidentiality of the data enclosed with the application for drug registration below:

Toxicity test data                                  (Document No…..)

Data on clinical drug trials                               (Document No…..)

We hereby declare that the above data comply with regulations on confidential data requirements as prescribed in law and we shall perform demonstration obligation at the request of the competent agencies.

2. Drug registered as prescribed in Article 14 of                                        □

    the Circular on drug registration

    (registered by the expiration date of the patent).

3. Drug registered as prescribed in Clause 5                                             □

Article 31 of the Circular on drug registration.

    (request for priority consideration, detailed explanation). 

E. Enclosed documents on intellectual property

G. Enclosed legal documents of applicant and/or manufacturer

H. Declaration

We hereby declare that:

1. All documents in this application are checked, signed and borne seal and those are lawful and truthful. We shall take full legal responsibility if there is any false and misleading information.

2. The drug is manufactured in conformity with this application.

3. We shall notify and request for permit as prescribed if there is any change in the application regarding to registered drug.

4. We shall take full responsibility for the intellectual property issues related to the drug.

FORM 6E: RE-REGISTRATION OF DRUG MANUFACTURED UNDER FRANCHISE AGREEMENT

A. Information about applicant, franchisor and franchisee

1. Applicant (the owner of CFS)

Applicant’s name

1.2. Address:                              Website (if any)

1.3. Phone number:                        Fax:

       Email:  

1.4. Representative office or contact person in Vietnam:

Name:                                                              

Home phone:                       Mobile phone:

Address:

2. Franchisor:

2.1 Franchisor’s name:

2.2. Address:                              Website (if any)

2.3. Phone number:                        Fax:

       Email:  

3. Franchisee (manufacturer) (*)

3.1 Franchisee’s name:

3.2. Address:                              Website (if any)

3.3. Phone number:                        Fax:

       Email:  

B. Details of product

1. Product’s name, dosage form and content

Brand name:

1.2. Dosage form:

1.3. Active ingredients, content:

1.4. Registered number:         issue date:              expiry date:

2. Description of product

2.1. Description of dosage form:

2.2. Description of packaging:

2.3. Classification:

2.4. Quality standards:

2.5. Shelf life:

2.6. Storage condition:

3. Generic name and content of active ingredients and excipients of a smallest divided dose or a smallest package}

*: if pharmacopoeia is used as standard, its version must be specified.

C. Technical documents

1. Part II: ACTD - Quality

2. Part III: ACTD – Safety (Pre clinic)

3. Part IV: ACTD – Efficacy (Clinic)

Notes: The documents (Part II and/or III and/or IV) shall be submitted according to classification of products or product groups.

D. Special requests regarding registered drug

Drug registered as prescribed in Clause 5 Article 31 -                                □

the Circular on drug registration.

    (request for priority consideration, detailed explanation). 

DD. Enclosed documents on intellectual property

E. Enclosed legal documents of applicant and/or manufacturer

D. Declaration

We hereby declare that:

1. All documents in this application are checked, signed and borne seal and those are lawful and truthful. We shall take full legal responsibility if there is any false and misleading information.

2. The drug is manufactured in conformity with this application.

3. We shall notify and request for permit as prescribed if there is any change in the application regarding to registered drug.

4. We shall take full responsibility for the intellectual property issues related to the drug.

FORM 6G: REGISTRATION RENEWAL OF DRUG MANUFACTURED UNDER FRANCHISE AGREEMENT

A. INFORMATION ABOUT APPLICANT, FRANCHISOR AND FRANCHISEE

1. Applicant (the owner of CFS)

1.1. Applicant’s name

1.2. Address:                              Website (if any)

1.3. Phone number:                        Fax:

       Email:  

1.4. Representative office or contact person in Vietnam:

Name:                                                              

Home phone:                       Mobile phone:

Address:

2. Franchisor:

2.1 Franchisor’s name:

2.2. Address:                              Website (if any)

2.3. Phone number:                        Fax:

       Email:  

3. Franchisee (manufacturer) (*)

3.1 Franchisee’s name:

3.2. Address:                              Website (if any)

3.3. Phone number:                        Fax:

       Email:  

B. DETAILS OF PRODUCT

1. Product’s name, dosage form and content

Brand name:

1.2. Dosage form:

1.3. Active ingredients, content:

1.4. Registered number:     issue date:       expiry date:

2. Description of product

2.1. Description of dosage form:

2.2. Description of packaging:

2.3. Classification:

2.4. Quality standards:

2.5. Shelf life:

2.6. Storage condition:

1. Generic name and content of active ingredients and excipients of a smallest divided dose or a smallest package

*: if pharmacopoeia is used as standard, its version must be specified.

2. Report on number of imported or manufactured consignments

C. ENCLOSED DOCUMENTS (to prove that the drug meet all requirements for registration renewal)

D. ENCLOSED LEGAL DOCUMENTS OF APPLICANT AND/OR MANUFACTURER

DD. DECLARATION

We hereby declare that:

- The drug has been sold on the market.

- When the drug is sold, there is not any violations against regulations on registration and sale of the drug and other regulations of law.

- All documents in this application are verified and those are lawful and truthful. Enclosed documents are the same with the documents submitted at the Drug Administration of Vietnam. We shall take full legal responsibility if there is any false and misleading information.

- We shall take full responsibility for the intellectual property issues related to the drug.

FORM NO. 07/TT:         COVER

APPLICATION FOR DRUG REGISTRATION

Name and address of applicant:

Name and address of manufacturer:

Drug name – Concentration, content.

Dosage form:

Type of registered drug: pharmaceutical/vaccine, serum containing antibodies/bio-medical/traditional medicines/ herbal medicines/medicinal materials.

Type of registration: initial registration/ re-registration/ registration renewal/major variation registration/ minor variation registration.

FORM 08/TT:    REPORT ON SALE OF DRUG

 (From issue date of initial registered number to date of re-registration)

1. Applicant’s name:                            Manufacturer’s name:

Address:                                                      Address:

2. Name of registered drug:

3. Dosage form:

4. Formula:

5. Registered number:                                       date of initial issue:      

6. The drug is sold on the market:

Yes      □                          No    □

7. Violations against quality standards:

Yes      □                          No    □

If yes:

- Number of violations:

- Type of violations:

8. Violations against regulations on drug registration and sale.

Yes      □                          No    □

If yes:

- Number of times committing violations:

- Type of violations:

9. Variation when the registered number stay unexpired as mentioned in the application:

Yes      □                          No    □

If there is any variation, enclose a copy of permission with the application.

10. Variation in case of re-registration (the registered number expires) as mentioned in the application:

Yes      □                          No    □

If there is any variation, it must be specified.

We hereby declare that there is not any variation in comparison with the approved application excluding variation as mentioned in the Section 8 of the aforesaid report on sale of drug.

FORM 09/TT:    SUMMARY OF DRUG REGISTRATION HISTORY

(Apply to drugs applied for registration renewal)

Applicant’s name

Address:

Manufacturer’s name

Address:

Name of packaging facility (if any):

Address:

1. Information about drug registration

2. Variation during the sale of drug

FORM 10/TT:    GENERAL INFORMATION OF MANUFACTURER

1. Manufacturer’s name:

2. Office:

Address:

Phone number:                                            Website:

Fax:                                                              Email:

3. Plant:

Address:

Phone number:

Fax:                               Email:

4. Permitted business lines in the home country:

5. Types of dosage forms permitted to manufacture and granted GMP:

6. Groups of manufactured products:

7. Countries to which the plant s products are exported:

8. List of products permitted to manufacture in home country:

9. Foundation year:

10. Certificate of eligibility to manufacture No.:                             Expiry date:

11. Licensing authority of home country:

Address:

Phone number:                                              Fax:

12. Number of employees of plant:

13.  Number of employees specialized in chemistry:

14. Director of applicant:

Name:

Qualification:

Phone number:

Fax:                               Email:

Signature:

15. Employee in charge of quality assurance/quality inspection:

Name:

Qualification:

Phone number:

Fax:                               Email:

Signature:

I hereby declare that the above statements are truthful. I shall take full responsibility for my declaration.