|
THE MINISTRY
OF PUBLIC HEALTH
-------
|
SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
----------
|
|
No: 30/2006/QD-BYT
|
Hanoi, September
30, 2006
|
DECISION
PROMULGATING THE REGULATION ON DATA SECURITY
OF DRUG REGISTRATION RECORDS
THE MINISTER OF HEALTH
Pursuant to the June 14, 2005 Pharmacy Law;
Pursuant to the November 29, 2005 Intellectual Property Law;
Pursuant to the Government's Decree No. 103/2006/ND-CP of September 22, 2006,
detailing and guiding the implementation of a number of articles of the
Intellectual Property Law regarding industrial property;
Pursuant to the Government's Decree No. 49/2003/ND-CP of May 15, 2003, defining
the functions, tasks, powers and organizational structure of the Ministry of
Health;
Pursuant to Official Letter No. 200/UB-VP of September 22, 2006, of the
National Committee for International Economic Cooperation, notifying the
results of negotiations with the United States on the protection of test data;
At the proposal of the Director of the Vietnam Drug Administration,
DECIDES:
Article
1.- To promulgate together with this Decision the Regulation on data
security of drug registration records.
Article 2.- This Decision takes effect 15 days after its
publication in "CONG BAO."
Article 3.- The director of the Office and the director of
the Inspectorate of the Health Ministry, the directors of the Vietnam Drug
Administration and the Preventive Medicine Department, heads of units under the
Health Ministry, directors of provincial/municipal Health Services, and heads
of concerned drug-trading establishments, testing establishments and medical
treatment establishments shall implement this Decision.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
MINISTER OF
HEALTH
Tran
Thi Trung Chien
REGULATION
ON DATA SECURITY OF DRUG REGISTRATION RECORDS
(Promulgated together with the Health Minister's Decision No.
30/2006/QD-BYT of September 30, 2006)
Chapter I
GENERAL PROVISIONS
Article
1.- Scope of regulation and subjects of application
1. Scope of regulation: This Regulation provides
the order and procedures related to the security of data of drug registration
records.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Article 2.- Interpretation of terms
In this Regulation, the terms below are
construed as follows:
1. Drug means a substance or a mixture of
substances for human use for the purposes of disease prevention, treatment or
diagnosis or rehabilitation of human physical functions, including finished
drugs, drug materials, vaccines and medical biologicals, except functional
foodstuff.
2. Pharmaceutical substance (also referred to as
active ingredient) means a substance or a mixture of substances having
treatment active-ingredients which are used in drug manufacture.
3. New drug means a drug containing a new
pharmaceutical substance or drug with a new combination of circulated
pharmaceutical substances.
4. Clinical drug test means a scientific
research into drugs on humans in a systematic manner with a view to verifying
clinical efficiency, identifying and discovering harmful effects of the
researched products; the ability of such products to absorb, distribute,
transform or discharge, aiming to determine the safety and effectiveness of
drugs.
5. Additional indication, formula or preparation
form means a new indication, new formula or new preparation form of a new drug
which has been granted a circulation registration number.
6. Business secret means information received
from financial investment or intellectual activities which has not been
revealed and can be used in business activities.
7. Data security means the application of
necessary measures to ensure that data are neither used for unhealthy
commercial purposes nor revealed, unless when the revelation is necessary for
the protection of people.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
1. Test results related to toxicity and clinical
drug test data of new drugs which have never been publicized or revealed.
2. Other data (except additional indications,
formulas and preparation forms) which meet the conditions specified in Article
4 of this Regulation.
Article 4.- Conditions for data to be secured
Data to be secured must fully meet the following
conditions:
1. Being business secrets.
2. Being results of investment of significant
efforts.
3. Being supplied by drug-registering
establishments under current regulations on drug registration.
4. Being requested to be secured by
drug-registering establishments under the provisions of Article 5 of this
Regulation.
Article 5.- Required documents for data security
consideration
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
a/ An application for enforcement of data
security (made according to a set form);
b/ A document proving that data which need be
secured fully meet the conditions specified in Clause 1, Article 4 of this
Regulation.
c/ A document proving that data which need be
secured are under lawful ownership of the drug-registering establishment which
requests the enforcement of data security.
2. The application for enforcement of data
security and proof documents specified in Clause 1 of this Article constitute
part of a drug registration dossier and must be submitted together with the
dossier. Applications and documents submitted after drug registration dossiers
shall not be considered.
Article 6.- Forms of applications and documents related to
data security enforcement request
1. An application for enforcement of data
security and enclosed documents must be made in Vietnamese or English, signed
and stamped for certification by the drug-registering establishment on every
page of those documents.
2. Legal documents (diplomas, certificates,
etc.) must be originals or copies notarized in Vietnam. Diplomas and certificates
which are issued, notarized or authenticated by foreign agencies or
organizations must be legalized by consular offices and translated into
Vietnamese. The translations must be notarized in accordance with Vietnamese
law.
3. Parts of a dossier which contain data to be
secured must be sealed and appended with a confidentiality stamp of the
drug-registering establishment.
Chapter II
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Article
7.- Submission of dossiers
1. A drug registration dossier containing data
which need be secured and relevant proof documents shall be submitted directly
at the drug circulation-licensing agency or at the place of receipt of dossiers
designated by the drug circulation-licensing agency, or shall be sent by
registered mail.
2. If, at the time the drug registration dossier
is being submitted (or arriving at the drug circulation-licensing agency), the
parts of data which need be secured no longer have confidentiality signs or
intact seals, the drug circulation-licensing agency shall not be responsible
for data security.
Article 8.- Receipt of dossiers
Upon receiving a drug registration dossier
containing data which need be secured, the drug circulation-licensing agency
shall:
1. Inspect the intactness of the dossier and its
confidentiality seal.
2. Check documents in the dossier against those
listed in the application for enforcement of data security.
3. Append a stamp on the application and all
enclosed documents, certifying the date of receipt of the dossier; and write
down necessary information in the dossier receipt book.
4. Temporarily keep data which need be secured
according to current regulations until it officially accepts or rejects the
application for enforcement of data security.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
RESPONSIBILITIES OF THE DRUG
CIRCULATION-LICENSING AGENCY
Article
9.- Consideration of and reply to a data security enforcement
request
1. Within six months after receiving a drug
registration dossier containing data which need be secured, the drug
circulation-licensing agency shall evaluate the application for enforcement of
data security and relevant documents required in Articles 3, 4, 5 and 6 of this
Regulation and notify in writing the drug-registering establishment of its acceptance
or rejection of the data security enforcement request.
2. If rejecting a data security enforcement
request, the drug circulation-licensing agency shall clearly state the reasons
therefor.
Article 10.- Security enforcement and duration
1. For data to be secured, the drug
circulation-licensing agency shall take necessary security measures as
stipulated in Clause 1, Article 128 of the Intellectual Property Law until
those data no longer meet the conditions specified in Article 4 of this
Regulation.
2. Except the case defined at Point d, Clause 2,
Article 125 of the Intellectual Property Law, within 5 years after the drugs
for which the drug registration dossier containing confidential is submitted to
the drug circulation-licensing agency are granted circulation permits, the drug
circulation-licensing agency may not license any drug-registering
establishments which submit later dossiers with the same confidential data
without consent of the person who has submitted those data.
Article 11.- Processing of data after security duration
At the end of the security duration stipulated
in Article 10 of this Regulation, the submitted data shall be archived by the
drug circulation-licensing agency like data which need not be secured.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
HANDLING OF VIOLATIONS
Article
12.- Handling of violations
Organizations or individuals that violate the
provisions of this Regulation shall, depending on the severity of their
violations, be disciplined, administratively sanctioned or examined for penal
liability in accordance with law.