Regulation On Registration Of Drugs

REGULATION ON REGISTRATION OF DRUGS (ISSUED IN CONJUNCTION WITH DECISION NO.1203/BYT-QD,DATED JULY 11TH 1996)

With the aim to unify the governmental administration on production and circulation of Drugs: to assure the safety, efficacy and quality of drugs, the MoH hereby promulgates The Regulation Registration of Drugs.

CHAPTER I GENERAL PROVISIONS Article 1 : All drugs and raw medicinal materials (generally called as drugs) that are Intended to be produced and circulated for prevention and treatment of human diseases and strengthening human health must be registered and must have registration number Granted by the Ministry of Health (MoH). (those drugs that are produced domestically Are called as domestic drugs, those that are produced abroad be called as foreign ones).

Article 2 : Some terms used in this Regulation can be understood as follows:

2.1.Drugs : products that are generated from animals, plants, minerals or biological creatures and processed to be used for human to prevent and cure diseases, to restore and re-adjust the body’s functions, to reduce disease symptoms, to diagnose diseases, to restore and improve people’s health, to relieve the sense of a part or hole of human body, to affect the birth processes and to change the body’s figure. 2.2.Raw medicinal materials : Substances that directly involve in formulation of drug products even active or inactive, changeable or unchangeable in the process of production. 2.3.Moderm drugs include: - Raw pharmaco-chemical and biological materials for manufacturing of drugs. - Pharmace-chemical and biological semi-finished products. - Pharmaco-chemical and biological finished products. 2.4.Finished medicinal products are those that have been processed in all stages of production, including packaging for bringing to the hands of users. 2.5.Traditional medicines include: all forms of traditional medicines, family inherited medicines, ancient medicines, ancient adjusting medicines, new medicines manufactured from plants which are processed with the galenic traditional theories and methods or in combination of traditional and modern methods. 2.6.New drugs: are those that are newly found, having effects for prevention and treatment of diseases, but their formulation and structures have not been scientifically proved and adequately evaluated for safety, efficacy and quality. New drugs also include those that are designed by many components with new galonic techniquesphysically or molecularly combined.

Article 3 : Objects and scope of application : 3.1-All forms of both domestic or foreign enterprises(shortly called as organizations) which are legal persons with the function of manufacturing of drugs. Satisfying all conditions and standards required by the MoH. May applying for producing drugs. 3.2-Disease examination and treatment establishments and medical – pharmaceutical institutions which are not functioned to produce drugs (administrative units) are not subject to application of this Regulation. In the case that they manufacture drugs for interior use, providing for in-and out- patients or for system of their specialized stations, the heads of the drugs. The drugs of this kinde must not be sold in the market. 3.3-Scientific research institutions when successfully finding new drugs. During the course of awaiting for transferring technology to establishments Which are functioned to produce drugs may apply for manufacturing the Found drugs if they have adequate conditions for drug manufacturing. The MoH will consider and grant temporary licences in accordance with This Regulation.

Article 4 : Drug labeling must comply with the Regulation on Labels and Trademarks of Drugs. The Law on Protection of Industrial Intellectual Properties of Vietnam And related international agreements to which Vietnam has signed and participated. Establishments are encouraged to name their products with International Non-proprietary Names. If establishments name their drugs with branch names, the branch names Must not make confusions with other branch names of registered drugs of Other establishments(both domestic of foreign ones).

4.1 – The branch name of drug must not have the same pronunciation or written form as the other registered branch names. 4.2. – The branch names of drugs must not be coincided, confused or similar to initial or final syllable of names of drugs of other establishments, unless the middle syllables can create differences in sound and forms. 4.3 – Branch names of drugs with different indications must not be coincided, or similar in writing or reading that can cause confusions when using. 4.4 – Branch name must not be similar or coincided to cause confusions with International Non-proprietary Names(INNs) : 4.4.1 – Branch names must not be designed by changing or cutting a letter or a syllable from INNs. 4.4.2 – Branch names must not be designed by using origin words of INNs or other branch names. 4.4.3 – Branch names of drug products with various components must not be designed by combining syllables of INNs of each of them. 4.5 – When naming drugs, manufacturing establishments must not apply oppositely against guidance of the MoH. 4.6 – When registering a branch name of drug, the establishment must submit a confirmation letter issued by the Agency for Protection of Industrial Intellectual Properties proving that the branch name is not violated the rights Of industrial intellectual properties regarding branch names of other Establishments. And the establishment must assure to be fully responsible for The branch name of its product. When receiving the certificate of registration for protection of label. Branch Name and industrial model of a drug, the establishment must submit a copy of The certificate to the MoH(Dept of Pharmacy) for management and monitoring.

Article 5 : Those drugs that are registered, during the period of validity of registration. Are required to process re-registration application in cases of one of the following changes : 5.1 / in formulation and compositions of drug (active ingredient, recipients…) 5.2 / in dosage form 5.3 / in quality specifications and analysis methods. 5.4 / in route of administration. 5.5 / in galenic and preparation methods 5.6 / of manufacturer. When such changes to be taken place, application file must be prepared as Required according to Articles in Chapter II of this Regulation for domestic Drugs, Chapter III of this Regulation for foreign ones.

Article 6 : Those drugs that are registered, during the period of validity of registration. Are required to be approved by the MoH in cases of one of changes in the Following points: 6.1 / in indications or having new indications. 6.2 / in doses. 6.3 / in shape or size of dosage form. 6.4 / in name 6.5 / in styles of packages and containers, label and trademark. 6.6 / of the register. When applying for such changes, the establishments must submit the Following documents : - forms 1,2,3,4 or 10 for domestic drugs ; forms 1,7,8,9 or 10 for foreign ones. - study reports regarding the applied changing points. - for foreign drugs, a legal free sale certificate for that changes issued by the responsible authority of the country of origin.

Article 7 : - After being registered, the registration number must be stated on the lable of the drug. - The registration is valid for 5 years from the date of issuance. The MoH will set appropriate measures for specified special cases. Six months prior to expiration date, the bearer of the registration, if wishing to continually manufacture and circulate the drug in Vietnam, must renew the registration: 7.1 / For domestic drugs : - In the case of no changes as the previous registration, it is only required to fill the application form(form 1.1.); or follow the particular guidance of the MoH. - In cases of one of the changes provided for in Article 5, the files must be prepared completely following guidance specified in Chapter III of this Regulation and form 11. - In cases of one of the changes provided for in Article 6, the files must include : + Forms 1, 11 ; + Study reports explaining the changes ; + A new legal free sale certificate issued by the responsible authority of the country of origin.

Article 8 : The shelflife or stability stated in the label of products must be shorter than The real rernaining shelflife of raw materials, or the researched stability of Finished drugs. 8.1 / For domestic drugs : - must not under 30 months for raw materials, 24 months for modern finished drugs raw materials generated from plants or biology. - must not under 12 months for modem extemal drugs and traditional medicines. - for other special drugs, the MoH will consider individual specific cases. 8.2/For foreign drugs: - must not under 36 months for raw materials, 24 months for modem finished drugs. - must not under 18 months for modem extemal drugs, and traditional medicines. - for other special drugs, the MoH will consider individual specific cases.

Article 9 : Registration application files regarding domestic and foreign drugs must be Prepared in three sets among which at least one comprises the original or notarized papers for legal documents (for foreign drugs, the files must be in English or in Vietnamese). Files must be carefully made to avoid missing, to be easily distinguished between composing parts, chapters, items… Files must be clearly printed, easily read and carefully covered. Article 10 : Those establishments that firstly apply for drug manufacturing must submit certificate for status of legal persons and for standardization for drug manufacturing.

Article 11 : After receiving complete legal files, the MoH will evaluate and announce the results after at maximum 3 months for domestic drugs and 12 months for foreign ones.

Article 12 : The registration applying units must pay a fee in conformity with current regulations.

CHAPTER Ⅱ PROVISIONS ON DOMESTIC DRUGS

Article 13 : Files for registration of raw medicinal mateials include : 13.1 / Covering page (form 1) 13.2 / List of contents (form 2) 13.3 / Registration application form (form 3) 13.4 / Manufacturing process (fully detailed) 13.5 / Quality specifications and analysis methods : correctly in conformity with the regulation on standardization 13.6 / Analysis certificate for the samples submitted for registration : must be released by Central Institute or Sub-institure of Drug Quality control 13.7 / Study reports on : 13.7.1 / Stability (including conclusion regarding shelflife based on results of stability study or least 3 lots of finished products) 13.7.2 / Toxicity. 13.7.3 / Experimental pharmacology. 13.7.4 / Clinical pharmacology. 13.8 / Label design : is the painting design applied for official circulation and the package inserts (form 5) 13.9 / Raw medicinal material samples : 3 sachets (quantity of each sachet must be adequate for 4 times of analysis) The papers provided for at 13.7.2; 13.7.3; 13.7.4 are only obligated for raw materials which are newly found or newly manufactured at the establishments.

Article 14 : Files for registration of modem drugs include : 14.1 / Covering page (form 1) 14.2 / List of contents (form 2) 14.3 / Registration application form (form 4) 14.4 / Manufacturing process (fully detailed) 14.5 / Quality standards and analysis methods : correctly in conformity with the regulation on standardization. 14.6 / Certificate of analysis of the samples submitted for registration : must be released by Central Institute or Sub-institute of Drug Quality Control 14.7 / Study reports on : 14.7.1 / Stability (including conclusion regarding shelflife based on results of stability tests on at least 3 lots of finished products) 14.7.2 / Toxicity(acute, sub-chronic, chronic, special) : only required for new drugs. 14.7.3 / Experimental pharmacology : only required for new drugs. 14.7.4 / Cllinical pharmacology (correctly in conformity with the Regulation on Clinical Trials; only required for new drugs). Note: - A copy of the reference material that the galenic formulation follows must be subitted. - The injectables and infusions that are firstly manufactured at an establishment are required to be supported by reports of trials on human with at least 30 patients of provincial hospitals or hospitas and research institutions direcyly dependent on the MoH to assure the safety and efficacy of the drug for treatment of patients diseases. - Other special cases will be specified and set requirements regarding clinical trials. 14.8 / Label design : is the painting design of thelabel applied for official circulation and the package insert (form 5). 14.9 / Drug samples : 3 packing unis as the one applied for circulation.

Article 15 : Files for registration of traditional medicines include : 15.1 / Covering page (form 1) 15.2 / List of contents (form 2) 15.3 / Registration application form (form 4) 15.4 / Manufacturing process (fully detailed) 15.5 / Quality specifications and analysis methods : in conformity with the regulation on standardization. 15.6 / Certificate of analysis of the samples submitted for registration : must be released by the Central Institute or Sub-institute of Drug Quality Control or quality control laboratories of the provinces, cities directly dependent on the Govemment. 15.7 / Stydy reports on : - Stability (including conclusion regarding shelflife based on results of stability tests on at least 3 lots of finished products) - Toxicity (acute, sub-chronic, required only in the cases that the medicines compose a toxic plants, or following the guidance of the MoH). 15.8 / Papers regarding the orgin of the formulation of the medicine. 15.9 / papers proving the clinical effects of the midicine : only required for new remedies (of which the origins of formulations are not available, ancient adjusting medicines, new medicines or following the guidance of the MoH) 15.10 / Label design : is the painting esign of the official label applied for circulation, package insert. 15.11 / Drug samples : 3 packing units as the ones applied for circulation. 15.12 / Family inherited medicines must be supported by certificate issued by health offices of the provinces, cities directly dependent on the Govemment in cases of enterprises, corporations and individuals to produce medicines and being managed by the provincial authorities.

CHAPTER Ⅲ PROVISIONS ON FOREIGN DRUGS

Article 16 : Files for registration of raw medicinal materials include : 16.1 / Covering page (form 1) 16.2 / List of contents (form 7) 16.3 / Registration application form (form 8) 16.4 / Certificate of free sale in the country of origin issued by the responsible authority of that country. 16.5 / Certificate of Good Manufacturing Practices for the factory issued by the responsible authority of the country of origin 16.6 / Quality specifications and analysis methods (fully detailed) 16.7 / Certificate of analysis for the lot of samples submitted for registration : released by the quality control laboratory of the manutacturer. 16.8 / Manufacruring process (fully detailed). 16.9 / Study reports on : 16.9.1 / Stability (including conclusion regarding shelflife based on results of stability tests on at least 3 lots of finished products). 16.9.2 / Toxicity. 16.9.3 / Experimental pharmacology. 16.10 / Label design : is the official label design applied for circulation. In English or Vitnamese, label on immediate container and on the outside package (form 5). 16.11 / Products samples : 3 sachets (the quantity of each sachet is adequate for 4 times of analysis.

Article 17 : Files for registration of modern drugs include : 17.1 / Covering page (form 1) 17.2 / List of contents (form 7) 17.3 / Registration application form (form 9) 17.4 / Certificate of free sale in the country of origin issued by responsible authority of that country. 17.5 / Certificate of Good Manufacturing Practices issued by responsible authority of th country of origin. 17.6 / Quality specifications and analysis methods (fully detailed) 17.7 / Certificate of analysis for the lot of samples submitted for registration : released by the quality control laboratory of the manufacturer. 17.8 / Manufacturing process (fully detailed) 17.9 / Stydy reports on : 17.9.1 / Stability (including conclusion regarding shelflife based on results of stability tests on at least 3 lots of finsished products) 17.9.2 / Toxicity. 17.9.3 / Experimental pharmacology. 17.9.4 / Clinical pharmacology. (the papers provided for 17.9.2 to 17.9.5 are only required in cases of new drugs). 17.10 / Label design : is the official label applied for registration, in English of Vietnamese, label on immediate package and on the outside package and a package insert in Vietnamese (form 5)

17.11 / Drug sample : 3packing units as applied for circulation.

Article 18 : Files for registration of traditional medicines : 18.1 / Covering page (form 1) 18.2 / List of contents (form 7) 18.3 / Registration appication form (form 9) 18.4 / Certificate of free sale in the country of origin issued by the responsible authority of that country. 18.5 / Quality specifications and analysis methods. 18.6 / Certificate of analysis for the lot of samples submitted for registration : released by the quality control laboratory of the manufacturer. 18.7 / Manufacturing process (fully detailed). 18.8 / Study reports on : 18.8.1 / Formulation of the medicine : clcarly state the components. Excipients constructing the formulation, explaining the combination of the formulation (names of components must be in Latin). 18.8.2 / Stability *including conclusion regarding shelflife based on results of stability tests on at least 3 lots of finished products). 18.8.3 / Toxicity. 18.8.4 / Papers regarding the origin of the medicine. 18.8.5 / Clinical pharmacology. 18.9 / Label design : is the official label applied for circulation. In English or Vietnamese, label on the immediate package and on outside containers and adding an package insert in Vietnamese (form 5). 18.10 / Drug sample : 3 packing units as applied for circulation.

CHAPTER Ⅳ PROVISIONS ON DRUG PRODUCTION UNDER LICENCES Article 19 : Production under licence is an action of a licensed drug manufacturing establishment, or of a drug that has been registered for circulation in some countries (called as the licensed establishment) to transfer its licence for drug manufacturing to another establishment who has also the function of manufacturing of drug (the under licensed establishment). - The under licensed establishment must satisfy to the standards as of the licensed one. - The licensed establishment must transfer all the records regarding the registered drug, guide the under licensed establishment to receive the production technology in order to assure the quality of the drug - The under licensed establishment must process the application for new registration (must not use the registration number that was granted to the licensed one).

Article 20 : For the under licensed domestic drugs, files for registration include : 20.1 / Covering page (form 1). 20.2 / List of contents (form 2). 20.3 / Application form for transferring the manufacturing licence (form 6) 20.4 / Contract of licence transference 20.5 / Circulating licence of the product applied for transference. 20.6 / Certificate of standards of the under licensed establishment issued by responsible authority confirming that it has adequate standards to produce the transferred products. 20.7 / Specifications and analysis methods : the original copy of the licensed establishment. 20.8 / Certificate of analysis for the samples submitted for registration : must be released by Central Institute or Sub-institute of Drug Quality Control. 20.9 / Manufacturing process : the original copy of the licensed establishment 20.10 / Label design : the painting design of the llabel officially applied for circulation(glued on form 5); must state clearly the names of the licensed as well as the under licensed establishments in Vietnamese (the name of the under licensed must be bigger than the one of the licensed). In case of wishing to state the international trade name, this name must be one second(1/2) compared with Vietnamese name. 20.11 / Drug samples : 3 packing units as the one applied for circulation.

Article 21 : For foreign drugs : A foreign company may transfer manufacturing technology to a domestic pharmaceutical manufacturing enterprise if satisfies the following requirements : - The tow sides sign the contract of agreement on technology transference : - The domestic pharmaceutical manufacturing enterprise has the production line appropriate for the under licensed products that meet the GMP and GLP (for the quality control laboratory) standards of the country of the licensed company, approved by the licensed company. - The domestic enterprise (under licensed one) must submit the file including : 21.1 / Covering page (form 1). 21.2 / List of contents (form 2) 21.3 / Application form for transference of the manufacturing licence (form 6). 21.4 / Circulating licence of the product applied for transference issued by the responsible authority of the country of origin. 21.5 / Certificate of GMP standards of the licensed company issued by the responsible authority of country of origin. 21.6 / Certificate of GMP standards of the under licensed domestic enterprise issued by the responsible authority. 21.7 / Contract of licence transference between the tow sides. 21.8 / Manufacturing process : of the licensed drug (the original and a notarized Vietnamese translation). 21.9 / Specifications and analysis methods : of the licensed drug (the original and anotarised Vietnamese translation). 21.10 / Certificate of analysis for the samples suvmitted for registration : must be released by Central Institute or Sub-institute of Drug Quality Control or by the laboratory of the GMP standardized establishment. 21.11 / Label design : the painting design of the label officially applied for circulation (form 5); must state clearly the names of the licensed as well as the under licensed establishment in Vietnamese (the name of the under licensed must be bigger than the one of the licensed). In case of wishing to state the international trade name, this name must be one second (1/2) compared with Vietnamese name; if the drug is to be sold in Vietnam, there must be a package insert in Vietnamese. 21.12 / Drug samples : 3 packing units as the one applied for circulation.

CHAPTER Ⅴ PROVISIONS ON APPLICATION FILES FOR CLINICAL TRIALS OF DRUGS

Article 22 : Clinical trials of drugs are activities of bringing new drugs into using on human in conformity with such stages as the international required clinical trials of drugs, aiming at confirming the effects, indications, contra- indications, dosage, toxicity, pharmacokinetic, side-effects, drug interactions, therapeutic regimen of drugs.

Article 23 : All newly researched drugs must be clinically tried : must be submitted reports and approved by the MoH. All newly researched drugs must have been evaluated and reviewed by authorities leveled from ministerial up may be brought into clinical trials.

Article 24 : Establishments who wish to carry out a clinical trial are those approved by the MoH : that are hospitals, Institutes, researching centres with patient beds, having adequate conditions, facilities, equipment and qualified staff to carry out each stage of trials and to treat incident when occurred. The sponsoring side of tried durg is the establishment who produces the drug. The drug sponsor and trying sides both must be fully responsible for the quality, safety and the process of clinical trial of the drug.

Article 25 : Files submitted for clinical trial must prepared in three sets among which, at least one set is of originals or notarized copies. Each set contains : 25.1 / Application form for clinical trial. 25.2 / Contract for clinical trial between the two sides : drug sponsor and the institution who carry out the trial. 25.3 / Trial protocol : must be built correctly according to stages of trial ; manner for carrying out; methods to treat incident if occurred. The protocol must be designed by the professional staff who manages the trial, reviewed by the scientific committee of the institution who carry out the trial, with signatures of the two sides. 25.4 / Toxicity reports on experimented animals : obligatedly with acute toxicity, sub-chronic toxicity, mutagenicity, carcinogenicity. 25.5 / Pharmacology reports officially accepted by the ministerial scientific committee 25.6 / Researching reports on galenic (fully detailed). 25.7 / Specifications and analysis methods (fully detailed). 25.8 / Certificate of analysis for the lot of samples submitted for application. 25.9 / Drug samples: 3 packing units as applied for clinical trial

CHAPTER Ⅵ VIOLATION SETTLEMENTS

Article 26 : Registered drugs, during the period of validity of the registration, will be cancelled from manufacturing, or circulating, recalled and being punished if falling into one of the following cases : - The drugs that are moving in the market do not conform with the registration files submitted to the MoH (regarding names, labels, quality specifications, manufacturing process, packing standards, stength…). - The lots of drugs that do not meet the requirements of quality. - MoH will temporarily or officially suspend the registration of the drugs or withdraw the registration certificate of the drugs according to levels of violation. 26.1 / Registration of drug will be withdrawn in the following cases : - An item of drug which has three times of violation regarding the quality of drug within one year (quality analysis does not meet registered quality standards). - An item of drug that are moving in the market not in conformity with registered files. 26.2 / A manufacturing establishment will be suspended in the following cases : - The establishment is a recidivist of many times. - The establishment has many items of drugs violated the quality.

Article 27 : The MoH (Department of Pharmacy) will announce the decision to suspend and recall from circulation the substandard drugs. And drugs manufactured not in conformity with registration files in the whole country. Provincial Health Offices will announce the so decision within the territory of their provinces, cities directly dependent on the Govemment. When such decisions become available, responsible authorities (pharmaceutical professional inspectorates) will inspect, take measures and give punishments against violating establishments in compliance with set regulations of the Govemment.

Article 28 : When receiving the decision regarding the suspension and recall of the substandard drugs, and of drugs manufactured not in conformity with registration files, the trading and manufacturing establishments concemed must promptly and timely take the measures to recall the drugs, and be responsible for reporting to managing authorities and announcing to their customers for acknowledgementm, and then recall the drugs in conformity with set regulations. - Making out the recalling records : Name of drug, lot number, quantity, sources, quality status of the drug before, during and after the recall. - Reporting the happenings, results caused by the lot of drug. - Reporting on the recall to higher managing authorities (MoH, provincial health office) - Taking measure according to current set regulations.

Article 29 : The establishments who have the recalled drugs must be fully responsible for the lots of drugs, and ready to be applied all forms of violation settlements as set rules.

Article 30 : All the establishments must take initiative measures to monitor, voluntarily discover and actively recall their drugs that are moving in the market with violation regarding the quality and other current regulations and promptly report to higher managing authorities.

CHAPTER Ⅶ REGULATION ENFORCEMENT MEASURES

Article 31 : Department of Pharmacy is the standing body of Dug Evaluation Committee who is responsible for organization of activities of receiving drug registration files, checking and organize meetings of the Committee and other activities concerning the drug registration.

Article 32 : All the establishments who wish to manufacture and circulate drugs in Vietnam must comply with this Regulation. All violations against this Regulation will bear the settlement measures set by this Regulation.

FOR THE MINISTER OF HEALTH VICE MINISTER (signed)

Prof. LE VAN TRUYEN Form 1

DRUG FILE FOR REGISTRATION

Name and address of the register : Name and address of the manufacturer : Name of drug : Dosage form : Strength, concentration : Form 2

LIST OF DOCUMENTS FOR REGISTRATION OF DOMESTIC DRUGS

1. Application form : □

2. Manufacturing process □

3. Quality specifications □

4. Quality control analysis □

5. Study reports on :

5.1. Stability □

5.2. Experiment pharmacology □

5.3. Toxicology □

5.4. Clinical pharmacology □

5.5. Galenic techniques □

6. Lable □

7. Other documents

7.1. Documents regarding origin of formulation □ 7.2. Certificate for clinical use of the traditional medicine (duration) □

7.3. Certificate for clinical use of the family inherited medicine □ Form 3

APPLICATION FORM FOR REGISTRATION OF RAW MEDICINAL, MATERIALS

To : The Ministry of Health of S.R.Vietnam 138 A Giangvo str. – Hanoi

Name of the manufacturer :

Address :

Tel number :

Fax number :

Name of raw medicinal material :

Scientific name :

Applied specifications :

Shelflife : months.

Storage conditions :

Packing standards :

Price for sale :

Confirmation of head Date : Of direct managing authority Director of the register company (signature, stamp)

Form 4

APPLICATION FORM FOR REGISTRATION OF DOMESTIC DRUGS

To : The Ministry of Health 138 A Giangvo str. – Hanoi

Trade name Generic name Price : Dosage form : Strength, concentration :

Name of the manufacturer : Address : Tel, number : Fax, number : Storage conditions Shelflife Preseription drug Narcotie drug

Essential drug as Classilication of Route of Specification sign Specified by Moll drug administration

Galenie formulation (of one smallest packing unit) : Composition Quantity ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… The origin of the formulation : Indications. Doses : Contraindication. Side-effects : Packing styles No. Brief prescription of packing styles Confirmation of head Date : Of direct managing authority Director of the register company (signature, stamp) Form 5

PROPOSED LABEL

1. Intermediate lable :

2. Immediate label on the smallest packing unit :

3. Package insert :

Director of the register company (signature, stamp) Form 6

APPLICATION FORM FOR TRANSFERENCE OF LICENCES FOR DRUG PRODUCTION

To : The Ministry of Health -138 A Giangvo str. – Hanoi

Name of drugs Generic name Dosage form : Strength, concentration :

Name of the licensed establishment : Name of the under licensed establishment

Address : Address : Tel : Tel : Fax : Fax :

Storage conditions Shelflife Preseription drug Narcotie drug

Essential drug as Classilication of Route of Specification sign Specified by Moll drug administration

Galenie formulation (of one smallest packing unit) : Composition Quantity ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… The origin of the formulation : Indications. Doses : Contraindication. Side-effects : Date : Director of the licensed establishment Director of the under licensed establishment (signature, stamp) (signature, stamp)

Confirnation of head of direct managing authority Form 7

LIST OF DOCUMENTS FOR REGISTRATION OF DOMESTIC DRUGS

1. Application form : □

2. Certificate of free sale issued by the responsible authority of the □ country of origin

3. Certificate of GMP issued by the responsible authority of the □ country of origin for the manufacturer.

4. Quality specifications and analysis methods □

5. Certificate of analysis for the lot of samples submitted for registration □

6. Label on the smallest packing unit : □ Label on internediate container □ Package insert in Vietnamese □

7. Study reports on : □

7.1. Stability □

7.2. Experiment pharmacology □

7.3. Toxicology □ 7.4. Clinical pharmacology □

7.5. Galenic techniques □

Form 8

APPLICATION FORM FOR REGISTRATION OF FOREIGN RAW MEDICINAL MATERIALS

Name of the raw medicinal materials : Scientific name :: Price :

Name of themanufacturer : Name of the register : Name of Rep. Offices in Vietnam (if any) : Address : Address : Address : Tel : Tel : Tel : Fax : Fax : Fax :

Code of essential OTC classification Route of Quality Drug accord to Accord to WHO administration specifications WHO

Packing styles No. Brief prescription of packing styles

Date : Director of the licensed establishment Director of the under licensed establishment (signature, stamp) (signature, stamp)

Form 9

APPLICATION FORM FOR REGISTRATION OF FOREIGN DRUGS To : The Ministry of Health -138 A Giangvo str. – Hanoi Trade name: Generic name Price : Dosage form : Strength, concentration :

Name of the manufacturer: Name of the register : Name of Rep. Offices in Vietnam (if any) : Address : Address : Address : Tel : Tel : Tel : Fax : Fax : Fax :

Code of essential OTC classification Route of Quality Drug accord to Accord to WHO administration specifications WHO Galenie formulation : Composition Quantity ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… Indications, doses :

Contraindication, side-effects : Packing styles No. Brief prescription of packing styles Date : Director of the manufacturer Director of the register (signature, stamp) (signature, stamp) Form 10

APPLICATION FORM FOR TRANSFERENCE OF THE REGISTRATION NUMBERS OF DRUGS

Trade name : Generic name

Dosage form : Strength, concentration :

Name of the manufacturer: Name of the register : Name of Rep. Offices in Vietnam (if any) : Address : Address : Address : Tel : Tel : Tel : Fax : Fax : Fax :

Date of the registration Registration number Expiration date of the issuance Registration

Date : Confirnation of the head of the Director of the licensed Director of the under Direct managing authority establishment licensed establishment (signature, stamp) (signature, stam) (signature, stamp) Form 11 APPLICATION FORM FOR RE-REGISTRATION OF DRUGS To : The Ministry of Health -138 A Giangvo str. – Hanoi Trade name : Generic name Dosage form : Strength, concentration : Name of the manufacturer : Address : Tel : Fax : Storage conditions Shelflife Prescription drug Narcotic drug Date of file Date of reg Registration Expiration date of submission issuance number Reg. Code of essential Classification of Route of Quality Drug accord. To drugs administration specifications MoH Galenic formulation (for the smallest packing unit) : Composition Quantity ……………………………………………………………………………………………………………… Origin of the formulation : Indications doses : Contraindication, side-effects : Packing styles : No. Brief prescription of packing styles

Reasons for re-registration 1. The registration becomes invalid □ 2. Change in composition of drug □ 3. Change in dosage form □ 4. Change in quality specifications of drug □ 5. Change in route of administration □ 6. Change in indications or having more indications □ 7. change in doses □ 8. change in shape and size of the dosage form □ 9. change in name of drug □ Confirnation of head Date : Of direct managing authority Director of the register compay (signature, stamp)