Chương I Thông tư 44/2014/TT-BYT: Những quy định chung

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.