The official letter 5576/QLD-ĐK Publishing list of drugs for bid and and lists of raw materials for imported drugs without import permit required

The official letter 5576/QLD-ĐK Publishing list of drugs for bid and and lists of raw materials for imported drugs without import permit required

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:

1. Publishing list of drugs for bid
2. 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.

The facilities request the publication of List of drugs manufactured from the active ingredients manufactured from the member countries of ICH under the Form No.01 attached to this official dispatch and accompanied by one of the following documents for demonstration:

– 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.

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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;

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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;
3. Regulations on member countries of ICH: These countries shall comply with Clause 7, Article 2 of the Joint Circular No. 36/2013/TTLT-BYT-BTC dated November 11, 2013 of the Inter-Ministry of Health and Finance and updated and posted on the website of the Drug Administration of Vietnam www.dav.gov.vn (Section of drug price management/Information on bid)
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;

+ Name, signature and title of the person signing the Certificate of Permit and seal (if any);

+ 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);

+ Detailed name and address of manufacturing facility;

+ 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).

1. 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;
2. 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.

1.2. The information to be published 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 import after having document from the Drug Administration of Vietnam approving the changed/supplemented contents;

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: dangkythuocqld@gmail.com.

– 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;

The Drug Administration of Vietnam hereby notifies the above contents to the Service of Health of provinces and centrally-affiliated cities and the facilities registering and manufacturing drugs for implementation. Any difficulty or problem arising during the implementation should be promptly reported to the Drug Administration of Vietnam for timely settlement./.

Form No. 5: Requesting official dispatch

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:

– …………………………………

– …………………………………

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;

The official letter 5576/QLD-ĐK Publishing list of drugs for bid and and lists of raw materials for imported drugs without import permit required