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MINISTRY OF HEALTH
DRUG ADMINISTRATION OF VIETNAM
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.:
5576/QLD-DK
Subject: Publishing list
of drugs for bid and and lists of raw materials for imported drugs without
import permit required
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Hanoi, April 08, 2014
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To:
- Service of
Health of provinces and centrally-affiliated
- Foreign drug registration companies
- Drug production and registration companies
On November 11, 2013, the
Ministry of Health issued Circular No. 37/2013/TT-BYT guiding the bid documents
for drug purchase in the medical facilities according to which, the Drug
Administration of Vietnam shall publish the List of drugs for bid including:
drugs manufactured from the active ingredients issued with ECP Certificate;
drugs manufactured at the drug manufacturing facilities which are issued with WHO-GMP Certificate by the Ministry of Health of Vietnam (Drug Administration of Vietnam) and issued with the circulation
permit by the competent authority of the member countries of ICH;
Then, on November 15, 2013, the
Ministry of Health issued Circular No. 38/2013/TT-BYT, amending and supplementing
a number of articles of Circular No. 47/2010/TT-BYT dated December 29, 2010
guiding the export and import of drugs and drug packaging, according to which,
the Drug Administration of Vietnam shall publish the list of active ingredients
(also known as "pharmaceutical substance") which are allowed to be
imported with no permit required;
In order to implement the
publication of List of drugs for bid in the medical facilities and the List of
raw materials for imported drug with no import license required for drug
manufacturing in the country under the provisions in Circular No.
37/2013/TT-BYT and 38/2013/TT-BYT mentioned above, the Drug Administration of
Vietnam hereby provides temporary guidelines for the publication as follows:
I. Publishing list of drugs
for bid
1. Publishing the List of drugs
manufactured from the active ingredients produced in the member countries of
ICH or the List of drugs manufactured from the active ingredients issued with
CEP Certificate (Certificate of Suitability to the Monographs of the European
Pharmacopoeia):
1.1.
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- GMP Certificate or the
manufacturing Permit of the factory manufacturing the active ingredients in the
member countries of ICH;
- CEP Certificate (Certificate
of Suitability to the Monographs of the European Pharmacopoeia) of the active
ingredients manufactured in the member countries of ICH;
- Circulation Permit of
finished products in the country of origin issued by the competent authority of
the member countries of ICH with the specification of origin of raw materials;
1.2. The
facilities request the publication of List of drugs manufactured from the
active ingredients issued with CEP Certificate under the Form No.02
attached to this official dispatch and accompanied by the CEP Certificate for
demonstration.
1.3. The List requested for
publication only applies for the drugs with registration documents approved
under the guidelines for documents and ASEAN general technical requirements
(ACTD & ACTR) specified in Circular No. 22/2009/TT-BYT dated November 24,
2009 of the Ministry of Health stipulating the drug registration (hereafter
referred to as Circular No. 22/2009/TT-BYT).
Where the drugs with
registration documents that have not been approved under the guidelines for
documents and ASEAN general technical requirements (ACTD & ACTR), in
addition to documents under the Form No.1 or Form No.2 mentioned above,
the grounds for publication and provision of information relating to each
active ingredient requested for publication under the provisions in the ASEAN
general technical requirements (ACTD), the parts from S1 to S7 – Annex I issued
together with Circular No. 22/2009/TT-BYT.
1.4. For
drugs having from two active ingredients or more, only the drugs with all
active ingredients manufactured in the member countries of ICH or the drugs
with active ingredient issued with CEP Certificate are requested for
publication;
1.5. The information requested
for publication must be consistent with the drug registration documents kept at
the Drug Administration of Vietnam. Where the manufacturing facility changes
the origin or quality standard of raw material, it must submit registration
documents for change specified in Annex II issued together with Circular No.
22/2009/TT-BYT and shall only make publication after having document from the
Drug Administration of Vietnam approving the changed/supplemented contents;
2. Publishing the List of drugs
manufactured at the drug manufacturing facilities issued with WHO-GMP Certificate by the Ministry of Health (Drug Administration
of Vietnam) and with circulation Permit by the competent authority of member
countries of ICH: The facilities requests the publication under the Form No.
3 attached to this official dispatch and accompanied with the circulation
Permit issued by the competent authority of member countries of ICH for
demonstration;
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4. Requirements for evidencing
documents for publication of list of drugs for bid;
- For manufacturing Permit,
circulation Permit and GMP Certificate:
+ The facility shall submit the
original with the consular legalization or the copy with prescribed notary
certification. In case of no consular legalization, the facility requesting the
publication must provide information on the link to the website of the agency
having the authority to issue Permit for the Drug Administration of Vietnam to
check it;
+ The Permit or Certificate
must be valid to the time the Drug Administration of Vietnam received document
requesting the publication. Where there is no validity of papers specified, at
the time of evaluation, the Drug Administration of Vietnam only accepts the
papers issued within 24 months from the issue date;
+ If the above documents are
not written by English or Vietnamese, they must be translated into Vietnamese
with notary certification;
- The contents of GMP
Certificate or manufacturing Permit of the raw material manufacturer must be specified
as follows:
+ Name of issuing agency;
+ Certificate of Permit number;
+ Issue date and validity;
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+ Detailed name and address of
manufacturing facility;
+ Applied standards of GMP ;
+ Certified production line;
Where the Certificate only
certifies the facility has achieved GMP for one or a number of stages of
production process, the facility requesting the publication must provide
evidences on the remaining stages in the entire process of raw material
manufacturing that must be done at the facilities achieving GMP standard (at
least WHO-GMP standards) at manufacturing factories of member countries of ICH;
- Contents of the product
circulation Permit must be specified with the following information:
+ Name of issuing agency;
+ Permit number;
+ Issue date and validity of
Permit;
+ Name, signature and title of
the person signing the Permit and seal (if any);
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+ Drug name;
+ Dosage forms, drug formulary
and ingredients;
+ Standard and origin of raw
material;
The dosage form, formulary and
ingredients, standard and origin of active ingredient of the drugs licensed
must be consistent with the dosage form, formulary and ingredients, standard
and origin of active ingredient of the drugs which are being circulated in
Vietnam;
- For the CEP Certificate:
Requesting the facility to submit the original or copy with valid notary
certification issued by the European Directorate for the Quality of Medicines
& HealthCare (EDQM).
II. Publishing the List of
active ingredients (except for raw materials in the List of narcotic or
psychotropic drug, precursor substance used as drug) imported with permission
without the import Permit required;
1. For drugs issued with the
registration number before July 01, 2014 (the registration number is still
valid to the time of requested publication):
1.1. The domestic drug
manufacturing facilities request the publication of list of active ingredients
under the Form No. 04 with this official dispatch for the drugs with
registration documents approved under the guidelines for documents and ASEAN
general technical requirements (ACTD & ACTR) specified in Circular No.
22/2009/TT-BYT.
Where the drugs with
registration documents that have not been approved under the guidelines for
documents and ASEAN general technical requirements (ACTD & ACTR), in
addition to documents under the Form No.4 mentioned above, the grounds for
publication and provision of information relating to each active ingredient
requested for publication under the provisions in the ASEAN general technical
requirements (ACTD), the parts from S1 to S7 – Annex I issued together with
Circular No. 22/2009/TT-BYT.
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2. For the drugs issued with
registration number after July 01, 2014, the Drug Administration of Vietnam
shall publish the active ingredients under the List of of medicinal raw
materials imported with permission (no Permit required) within 30 working days,
from the date of issue of drug registration number.
III. Document for requested
publication:
1. Document for requested
publication is made into 01 copy and filled in with all information under the
form, signed by the competent person and sealed by the facility requesting the publication
and sent to the Drug Administration of Vietnam, including:
- Official dispatch requesting
the publication under the Form No.5
- List of drugs/raw materials
requesting the publication corresponding to the Forms No. 1,2,3,4 is
attached to this official dispatch or downloaded from the website of the Drug
Administration of Vietnam at www.dav.gov.vn. In addition, the facility shall
enclose a file of list of drugs/raw materials requested for publication to the
email address: [email protected].
- Evidencing documents as
required for each list requesting the publication;
- Copy of official dispatch of
the Drug Administration of Vietnam permitting the change of origin of raw
material with the seal of the facility requesting the publication (if any);
2. The Drug Administration of
Vietnam shall compare or evaluate documents and publish the list of drugs for
bid or the list of active ingredients:
If the documents requesting the
publication meet the requirements, the Drug Administration of Vietnam shall
publish the list of raw materials or drugs and related information on the
website of the Drug Administration of Vietnam at www.dav.gov.vn. If these
documents fail to satisfy the requirements, the Drug Administration of Vietnam
shall send a written notice to the facilities requesting the publication;
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FOR THE DIRECTOR
DEPUTY DIRECTOR
Nguyen Van Thanh
Form No.
5: Requesting official dispatch
Company’s name: .............
Address:...............................
............................................
SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
REQUESTING THE PUBLICATION OF LIST OF DRUGS FOR BID/ IMPORTED RAW
MATERIAL WITHOUT IMPORT PERMIT REQUIRED
To:
Drug Administration of Vietnam – Ministry of Health
As guided in the official
dispatch No. .........../QLD-ĐK ngày ........./....../2014 on publication of
list of drugs for bid and list of active ingredients for import without import
permit required, our company……..hereby request the Drug Administration of
Vietnam to consider and publish the lists of drugs/raw materials as follows:
1Drugs manufactured from the
active ingredients manufactured in the member countries of ICH (if any); □
2. Drugs
manufactured from the active ingredients issued with CEP Certificate
(Certificate of Suitability to the Monographs of the European Pharmacopoeia)
(if any); □
3. Drugs manufactured at the
drug manufacturing facilities issued with WHO-GMP
Certificate by the Ministry of Health (Drug
Administration of Vietnam) and issued with the circulation Permit by the
competent authority of the member countries of ICH (if any); □
4. Active ingredients for drug
manufacturing have been issued with the valid circulation registration number
(if any) □
Attached documents:
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Note:
- List of drugs/raw materials
mentioned above must be done under the Forms specified by the Drug
Administration of Vietnam in the official dispatch;
- Please mark on the list
which shall be published
Our company hereby undertake
and take responsibility before law for the accuracy of contents requested for
publication compared with the drug registration documents kepts at the Drug
Administration of Vietnam and we guarantee that the drugs are manufactured from
the very raw materials published;
..................., date ....... month ......... 2014
Director of company
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66