Chương I Thông tư 22/2009/TT-BYT: Những quy định chung

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation and subjects of application

1. This Circular provides for the registration of human-use drugs for circulation in Vietnam.

2. This Circular applies to domestic and foreign agencies, organizations and individuals conducting activities related to the registration of drugs for circulation in Vietnam.

When a treaty to which the Socialist Republic of Vietnam is a contracting party contains provisions different from those of this Circular, that treaty prevails.

Article 2. Interpretation of terms

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

1. Drug means a substance or a mixture of substances for human use for disease prevention, treatment or diagnosis or adjustment of bodily physiological functions, including finished drugs, drug materials, vaccines and biologicals, except functional foods.

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

3. Drug material means a substance constituting a drug product in the process of manufacture.

4. Drug from medicinal materials means a drug manufactured from a natural material from animals, plants or minerals.

Drugs with pure active ingredients extracted from medicinal materials and drugs with the combination of medicinal materials and synthetic chemical active ingredients are not drugs from medicinal materials.

5. Oriental medicament means a drug prepared from medicinal materials according to traditional medicinal theories and methods of oriental countries.

6. Vaccine means an antigen-containing preparation which can make a body immune and is used for disease prevention.

7. Biological means a product of biological origin which is used for human disease prevention, treatment or diagnosis.

8. Active ingredient means a substance or a mixture of substances with disease treatment activity which is used in the manufacture of drugs.

9. New active ingredient means an active ingredient contained in the composition of a drug registered for the first time for circulation in Vietnam.

10. New drug means a drug registered for the first time in Vietnam, including:

a/ Drugs containing new active ingredients;

b/ Drugs with a new combination of active ingredients already circulated in Vietnam.

11. Finished drug means a drug having gone through all processes of manufacture, including the packing of drugs in final packings and labeling.

12. Generic drug means a finished drug used to replace an invented drug which is manufactured without the inventor's franchise license and put into the market after the patent has or monopolies have expired.

13. Drug manufactured under franchise means a drug already granted a registration number for circulation (in Vietnam or overseas) which the domestic or foreign manufacturer transfers the right to manufacture to another eligible manufacturer in Vietnam.

14. Trade name of a drug means a drug's name different from its original name or international nonproprietary name.

15. ASEAN common technical dossier (ACTD) means a set of documents guiding drug registration dossiers to meet common technical requirements of the Association of Southeast Asian Nations (ASEAN).

16. Re-registration means the submission of a registration dossier for a drug when its circulation registration number becomes invalid.

17. Change means any difference in a drug or drug material already granted a registration number, including changes in formula, method of manufacture, place of manufacture, standards of finished products or materials, packings or labels, and product information.

18. Major change means a change which is likely to affect any of the following elements of a drug already granted a circulation registration number:

a/ Indications:

b/ Route of administration;

c/ Concentration, content;

d/ Changes other than minor changes.

19. Minor change means a change which does not affect any of the following elements of a drug already granted a circulation registration number:

a/ Indications;

b/ Route of administration;

c/ Concentration, content;

d/ Dosage;

e/ Active ingredients.

20. Other change means a change other than those referred to in Clauses 18 and 19 of this Article.

21. Country of origin means a country manufacturing final preparations and/or product lots for ex-factory delivery or a country from which a product is transported to the country of importation.

22. Registration establishment means an establishment applying for a circulation license or submitting updated or modified documents of drugs already granted registration numbers.

23. Manufacturer means an establishment performing at least one stage of manufacture and/ or ex-factory delivery of finished products.

Article 3. Prohibited acts

1. Forging or deliberately modifying dossiers, documents or legal papers of Vietnamese or foreign functional management agencies.

2. Using fake seals or forging signatures or seals of registration establishments, manufacturers or relevant establishments in drug registration dossiers.

Article 4. Provisions on drug registration establishments

1. A drug registration establishment must possess a certificate of eligibility for drug trading in Vietnam, for Vietnamese drug trading establishments, or a registration license for operation in the field of drugs or drug materials in Vietnam, for foreign drug trading establish­ments, under the Health Ministry's regulations.

2. A drug registration establishment has the following rights and responsibilities:

a/ To be guided on drug registration and provided with information relating to the drugs it registers:

b/ To apply for the withdrawal of registration numbers of the drugs it registers when necessary (made according to a set form):

c/ To lodge complaints about competent agencies' decisions related to the grant of drug circulation registration numbers. The order, procedures and competence to lodge these complaints comply with the law on complaints and denunciations;

d/ To take responsibility for the quality, safety and effectiveness of drugs and ensure the circulation of drugs according to registration dossiers;

e/ To take responsibility for all the information provided in registration applications or documents in dossiers. To ensure the provision of sufficient data, reports and information relating to the effects and dangers of drugs at the time of submission of registration dossiers to the Drug Administration of Vietnam;

f/ To provide information relating to the submitted data or provide additional information for consideration in the process of drug registration and circulation at the request of the Drug Administration of Vietnam;

g/ To report to the Drug Administration of Vietnam on new information relating to drug quality, safety and effects if this information has not yet been updated in the submitted dossiers and/or is being examined by the Drug Administration of Vietnam as well as when the drugs are in market circulation; information on and changes in sold drugs against registration dossiers within the validity duration of circulation registration numbers, including changes not subject to registration under Appendix II to this Circular (not printed herein):

h/ To notify the Drug Administration of Vietnam and concerned state management agencies of the cases in which circulation permits for drugs with valid registration numbers for circulation in Vietnam are revoked in any country in the world, clearly stating the reason;

i/ To coordinate with importers and manufacturers in recalling from the market the drugs which fail to satisfy quality, safety and effect at the request of management agencies or when so detected by the registration establishments or manufacturers; to report recall results and propose solutions;

j/ To annually report in writing to the Drug Administration of Vietnam on the registered drugs in circulation; to explain cases in which drugs have been registered but are not manufactured (for domestic drugs) or imported (for foreign drugs), made according to a set form;

k/ To archive complete dossiers and supply them to competent state management agencies upon request;

l/ To cooperate in and create conditions for the inspection and evaluation of manufacturers at the request of the Drug Administration of Vietnam; to pay funds for such inspection and assessment before or after the drugs are granted registration numbers for circulation in Vietnam.

Article 5. Provisions on drug manufacturers

1. A domestic drug manufacturer must possess a drug trading eligibility certificate and a certificate of satisfaction of "Good manufacture practices (GMP)" standards under the Health Ministry's regulations on and roadmap for GMP application.

2. A foreign drug manufacturer must satisfy "Good manufacture practices" standards which are equivalent to or higher than "Good manufacture practices" principles and standards as recommended by the World Health

Organization (GMP-WHO). In case GMP standard satisfaction certificates or certificates of pharmaceutical products (CPP) do not indicate that manufacturers satisfy GMP-WHO principles and standards, registration establishments shall provide proof that GMP principles and standards they have satisfied are not lower than GMP-WHO principles and standards. For in-vitro diagnosis biologicals, a manufacturer must satisfy GMP or ISO standards or possess another equivalent certificate. When necessary, the Drug Administration of Vietnam shall evaluate and inspect manufacturers before or after the grant of circulation registration numbers.

3. Drugs must be manufactured at establishments possessing manufacture licenses granted by competent agencies, which have been invested and built to satisfy manufacture conditions under Clause 2 of this Article (except drugs manufactured in the form of processing). Drugs must not be manufactured at other establishments in the form of loan license.

4. A drug manufacturer has the following rights and responsibilities:

a/ To be guided on drug registration and provided with information relating to the drugs it manufactures which are registered in Vietnam;

b/ To request the withdrawal of registration numbers of the drugs it manufactures in case of any problem in the quality, safety and effects of the drugs, affecting users' health, without obtaining approval of registration establishments (made according to a set form);

c/ To lodge complaints about competent agencies' decisions relating to the grant of drug circulation registration numbers. The order, procedures and competence to lodge complaints comply with the law on complaints and denunciations;

d/ To take responsibility for the quality, safety and effects of drugs and ensure the manufacture of drugs according to registration dossiers already approved by the Ministry of Health;

e/ To coordinate with drug importers and registration establishments in withdrawing from the market drugs which fail to ensure quality, safety and effects at the request of management agencies or when so detected by the registration establishments or manufactures; to report withdrawal results and propose solutions;

f/ To coordinate with registration establishments in reporting to the Drug Administration of Vietnam and concerned agencies on any new information relating to the quality, safety and effects of drugs if this information has not yet been updated in the submitted dossiers and/or is being examined at the Drug Administration of Vietnam as well as when the drugs are in market circulation; and on changes in drugs currently in circulation against registration dossiers within the validity duration of circulation registration numbers, including changes not subject to registration under Appendix II to this Circular (not printed herein);

g/ To notify cases in which circulation permits for drugs with valid circulation-registration numbers are revoked in any country in the world to the Drug Administration of Vietnam and concerned state management agencies, clearly stating the reason:

h/ To archive sufficient dossiers of manufactured drugs and supply them to competent state management agencies upon request;

i/ To prepare sufficient working facilities and conditions for the inspection and assessment of manufacturers at the request of the Drug Administration of Vietnam; to coordinate with drug registration establishments in paying funds for such inspection and assessment before or after the drugs are granted registration numbers for circulation in Vietnam.

Article 6. Provisions on establishments franchising or franchised to manufacture drugs: and on processed drugs

1. For pharmaceutical drugs, vaccines, antigen-containing sera and biologicals, franchising and franchised establishments must at least satisfy GMP-WHO standards: for in-vitro diagnosis biologicals. these establishments must satisfy GMP. ISO or other equivalent standards.

2. For oriental medicaments, drugs from medicinal materials and drug materials:

a/ Overseas franchising establishments must at least satisfy GMP-WHO standards. Domestic franchising establishments shall comply with the Health Ministry's roadmap for GMP application;

b/ Franchised establishments shall comply with the Health Ministry's roadmap for GMP application.

3. For drugs manufactured in the form of processing, franchising and franchised establishments shall comply with the Health Ministry's current regulations on drug processing.

Article 7. Requirements on drug test slips

1. For pharmaceutical drugs, biologicals, oriental medicaments and drugs from medicinal materials:

a/ Drug manufacturers satisfying GMP standards shall themselves conduct standard-based appraisal and tests and include their test slips in the registration dossiers to be submitted;

b/ In case domestic drug manufacturers do not yet satisfy GMP standards, drug registration establishments shall conduct standard-based appraisal at any of central state drug-testing establishments or drug-test service providers possessing drug trading eligibility certificates and satisfying professional criteria prescribed by the Ministry of Health.

2. For vaccines, antigen-containing sera and in-vitro diagnosis biologicals:

a/ Establishments registering vaccines or antigen-containing sera shall conduct standard-based appraisal and submit test slips of the National Institute for Control of Vaccines and Biologicals.

b/ Manufacturers registering in-vitro diagnosis biologicals may use their test slips in the circulation registration dossiers to be submitted if they satisfy GMP or other equivalent standards. In case manufacturers do not yet satisfy GMP. ISO or other equivalent standards, registration establishments shall conduct standard-based appraisal and submit test slips of the National Institute for Control of Vaccines and Biologicals.

3. In the process of appraising drug registration dossiers, drug registration establishments shall, at the request of the Drug Administration of Vietnam, re-appraise standards and testing methods at testing establishments designated by the Ministry of Health. Cases subject to re-appraisal are specified in Appendix IV to this Circular (not printed herein).

Article 8. Clinical trial requirements relating to registration of new drugs

Upon registration for circulation in Vietnam, new drugs are subject to clinical trial under the Health Ministry's regulations on clinical trial.

Article 9. Requirements on drug bioavailability and bioequivalence

The submission of research reports and data on bioavailability and bioequivalence of drugs to be registered for circulation complies with the Health Ministry's regulations on submission of research reports and data on bioavailability and bioequivalence.

Article 10. Provisions on languages, form of dossiers, drug samples and fees

1. Languages used in registration dossiers:

a/ Dossiers of registration of domestically manufactured drugs must be written in Vietnamese;

b/ Dossiers of registration of foreign drugs must be written in Vietnamese or English. For dossiers in English, information in use instruction sheets, summary of product properties or information for patients must be in Vietnamese.

2. Drug registration dossiers must be made in A4-size papers and securely bound. A dossier must be arranged in the order of its contents and separated between different parts. Separated parts must be numbered for easy reference, each part having the certification of the drug registration establishment or manufacturer on its first page.

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

a/ Name of the drug;

b/ Form of preparation;

c/ Formula for a unit of dosage (for drugs with single dosage) or the same concentration and content (for drugs with multiple dosages);

d/ Manufacturer;

4. Common requirements for documents to be submitted in the first-time registration dossiers, re-registration dossiers and dossiers of request for other changes:

a/ One set of originals, for all dossiers specified in Clauses 1 and 2, Article 17, for pharmaceutical drugs, vaccines, antigen-containing sera and biologicals (except in-vitro diagnosis biologicals); Clauses 1 and 2, Article 22, for in-vitro diagnosis biologicals; or Clauses 1 and 2, Article 26, for drugs from medicinal materials, oriental medicaments and drug materials;

b/ Two copies of documents, comprising drug registration applications and finished-product standards;

c/ Drug labels: 2 sets of design specimen labels; for foreign drugs, drug labels must be accompanied by one set of original labels of the drugs currently in circulation in the country of origin. These labels shall be stuck on A4-size papers with seals appended on every two adjacent pages by the drug registration establishment or manufacturer;

d/ Product information: use instructions or information for patients or a summary on product properties comply with regulations applicable to each type of drug, with seals appended on every two adjacent pages by the drug registration establishment or manufacturer;

e/ Drug samples, drug materials:

- One unit of packing, for each specification registered for circulation;

- A volume sufficient for 3 times of testing, for drug materials;

- For vaccines and antigen-containing sera, registration establishments shall deposit their samples at the National Institute for Control of Vaccines and Biologicals;

f/ Summary on products (made according to a set form).

5. For dossiers of registration of major and minor changes: one set of originals of documents, depending on major or minor changes under Clauses 4 and 5, Article 17. for pharmaceutical drugs, vaccines, antigen-containing sera and biologicals; Clauses 3 and 4, Article 22, for in-vitro diagnosis biologicals; or Clauses 3 and 4, Article 26, for drugs from medicinal materials, oriental medicaments and drug materials.

6. Provisions on legal dossiers:

a/ For certificates of pharmaceutical products (CPP), free sale certificates (FSC), certificates of satisfaction of GMP standards or certificates of satisfaction of equivalent standards for in-vitro diagnosis biologicals, their originals, copies or Vietnamese translations may be submitted, but specific provisions of Points b. c or d of this Clause applicable to each kind of certificate and the following general provisions must be complied with:

- For submitted originals: The original must bear the signature, full name and title of the signer and the certification seal of the certificate-granting competent agency of the host country; and must be consularly legalized at the Vietnamese diplomatic representative mission under the law on consular legalization, unless legal papers are granted by competent agencies of the countries that have signed judicial assistance agreements with Vietnam.

- For submitted copies: They shall be lawfully certified by a Vietnamese competent agency under Vietnamese law on certification of copies from originals.

- For submitted Vietnamese translations of foreign-language certificates: They must be certified under regulations by a notary public (i.e., local notary public office, diplomatic representative mission, consular office or another authorized foreign agency, which certifies the translator's signature under law) and enclosed with the originals or copies of certificates under the above regulations.

- The validity term of a certificate must be indicated in the certificate and must remain valid at the time of appraisal; an official letter extending this certificate is not accepted. For certificates not indicating a validity term, only those granted within 24 months from the date of grant may be accepted.

b/ In addition to the requirements specified at Point a of this Clause, a CPP must satisfy the following conditions:

- It must bear a certification that drugs are permitted for circulation in the country of origin. If drugs are not circulated in the country of origin, the registration establishment must explain the matter to the Ministry of Health for consideration;

- In case a drug is manufactured through various stages in different countries, making it impossible to identify the sole country of origin, the drug registration establishment shall submit the CPP of the country manufacturing the final preparations or of the country of ex-factory delivery of the drug lots. If no CPP of these countries of origin is available, the Ministry of Health shall consider and accept the CPP of the country from which the products are transported to the country of importation;

- If no CPP of the above countries is available, only CPP granted by a competent agency of the UK, France, Germany, the US, Japan, Australia or Canada, or by an European Medicine Agency (EMEA);

It is issued by the competent pharmaceutical management agency (on the WHO list at http://www.who.int) of the country of origin according to WHO form, applicable to the system of quality certification of pharmaceutical products sold in international trade.

c/ In addition to the requirements specified at Point a of this Clause, an FSC must satisfy the following conditions:

- It must bear a certification that drugs are permitted for circulation in the country of origin. If drugs are not circulated in the country of origin, the registration establishment must explain the matter to the Ministry of Health for consideration;

- It is granted by a competent agency of the country of origin, containing sufficient information on the composition and form of preparation of the drugs and the validity term of the FSC.

d/ GMP-WHO certificates, ISO certificates or certificates of satisfaction of equivalent standards must be granted by competent agencies of countries of origin, with their certification of the names and addresses of manufacturers.

e/ Drug trading eligibility certificates must remain valid and be originals or copies certified by competent state certification agencies in Vietnam and granted by competent agencies under current regulations.

f/ Foreign enterprises' operation licenses for drugs and drug materials in Vietnam must remain valid and be originals or copies certified by overseas registration establishments or their Vietnam-based representative offices;

g/ Certificates, protection titles and ownership transfer contracts for related industrial property objects in drug registration dossiers (if any), granted or certified by competent industrial property agencies, must be originals or copies appended with seals of drug registration establishments.

7. Provisions on other administrative dossiers:

a/ Registration applications must be hand-signed by directors or authorized representatives of drug registration establishments and appended with seals (if any) of these establishments. Seal-engraved signatures are not accepted.

b/ Authorization papers shall be made according to Form 3/TT to this Circular (not printed herein) and submitted in the following cases:

- Authorization in the name of the registration establishment (form 3A);

- Authorization by the drug registration establishment for its Vietnam-based representative office to sign the drug registration dossier (form 3B);

- Authorization for the use of names of the drugs with registered trademarks in case the trademark owner is other than the drug registration establishment (form 3C).

Each dossier must be enclosed with an authorization paper, which is the original or a copy certified as true copy by the drug registration establishment or its Vietnam-based representative office.

c/ Copies of franchise contracts, for drugs manufactured under franchise.

8. Provisions on drug labels and product information:

The details of drug labels and product information comply with the Health Ministry's current regulations on labeling of drugs and/or ACTD regulations.

9. Provisions on fees:

Drug registration establishments shall pay fees related to drug registration and circulation under the current law on charges and fees.

Article 11. Provisions on naming of drugs

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

2. In case a drug is not given an INN, the drug registration establishment may use trade name but shall adhere to the following principles:

a/ Not exaggerating the drug's treatment effect;

b/ Not untruthfully reflecting the drug's treatment effect; not causing confusion about the drug's pharmaco-physical effects. Drugs with different active ingredients must have different names;

c/ Not breaching Vietnam's fine customs and traditions;

d/ Not causing conflicts to protected intellectual property objects of other individuals or organizations;

e/ Not being identical with or similar to the names of other establishments' drugs already granted registration numbers.

Article 12. Forms of drug registration

Pharmaceutical drugs, biologicals, vaccines, antigen-containing sera, in-vitro diagnosis biologicals. oriental medicaments, drugs from medicinal materials and drug materials shall be registered in the following forms:

1. First-time registration;

2. Registration of major changes;

3. Registration of minor changes;

4. Re-registration.

Article 13. Validity of drug registration numbers

The maximum validity duration of a drug circulation registration number is 5 years from the signing date of the decision to grant such number. In special cases, the Ministry of Health shall consider and issue separate regulations. Within 6 months before or after a circulation registration number becomes invalidated, an establishment may submit a re-registration dossier. Past this time limit, the establishment shall submit dossiers like in the case of first-time registration.