Download 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 outpatients 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, contraindications,
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
professional
available,
inspectorates)
responsible
will
inspect,
authorities
take
(pharmaceutical
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
Page
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
Of direct managing authority
Date :
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.
Confirmation of head
Of direct managing authority
Brief prescription of packing styles
Date :
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
(signature, stamp)
Director of the under licensed establishment
(signature, stamp)
Confirnation of head of direct managing authority
Form 7
LIST OF DOCUMENTS FOR REGISTRATION OF DOMESTIC DRUGS
Page
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
To : The Ministry of Health -138 A Giangvo str. – Hanoi
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 :
Storage conditions
Shelflife
Preseription drug
Narcotie drug
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
(signature, stamp)
Director of the under licensed establishment
(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 :
Storage conditions
Shelflife
Preseription drug
Narcotie drug
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
(signature, stamp)
Director of the register
(signature, stamp)
Form 10
APPLICATION FORM FOR TRANSFERENCE OF
THE REGISTRATION NUMBERS OF DRUGS
To : The Ministry of Health -138 A Giangvo str. – Hanoi
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
Direct managing authority
(signature, stamp)
Director of the licensed
Director of the under
establishment
licensed establishment
(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
Of direct managing authority
Date :
Director of the register compay
(signature, stamp)