Chương III Thông tư 44/2014/TT-BYT: Hồ sơ đăng ký thuốc

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.