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Pharmaceutical wholesale enterprises" drug business license" replacement program
查看:2411  发稿日期:2012/7/24 16:29:13

Pharmaceutical wholesale enterprises" drug business license" replacement program

See:6release date: 2012-7-1917:57:13

Pharmaceutical wholesale enterprises" drug business license" replacement program

Project Name: license of pharmaceutical wholesale enterprises" drug business license" replacement

The legal subject of implementation : the food and Drug Administration of Shaanxi Province

Basis.

1," the people's Republic of China (" the drug administration law of the people's Republic of China Presidential Decree No. forty-fifth of fourteenth)

2," the people's Republic of China (" Drug Administration Law of the people's Republic of China State Council Decree No. 360th of seventeenth)

3," drug business license management approach" ( the State Food and Drug Administration Decree No. sixth of nineteenth)

Fee: free.

Total time: from the date of acceptance of35 working days ( excluding the rectification period ).

Scope: within the administrative area of the province of pharmaceutical wholesale enterprises" drug business license" expires, needs renewal" drug business license", the enterprise should be in" drug business license" before expiration of the validity term of6 months, to the provincial food and Drug Administration application.

Licensed program:

One, accept

The applicant must submit the following application materials:

( a ) drug business license application form ( the form of a signature are required in addition to print, shall not be filled manually ). Format to the food and Drug Administration of Shaanxi province government website, web site: www.sxfda.gov.cn

( two)" drug business license"," a copy of GSP certificate"," business license copy" and" drug business license" is a copy of the original. And the subordinate units and certification of branches, not separately issued by certification, can provide the subordinate units certificate copy.

( three) the legal representative of the enterprise, the person in charge of the enterprise the copy of ID card, resume.

( four) the person in charge of quality, quality management is responsible for identity cards, academic certificates, office documents, licensed pharmacist qualification certificate, certificate of incorporation and resume.

( five) the quality of the administrator, acceptance, maintenance staff, sales personnel, clerk, a computer administrator and other enterprises roster, including name, degree, title, ID number, pharmacist, post, training.

( six) enterprise registered address and address warehouse property cards, rental housing should provide owners permit and lease agreement.

( seven) the self-check report.

( eight) within the past five years by the administrative punishment cases.

( nine) where the application materials are true guarantee statement. Format to the food and Drug Administration of Shaanxi province government website, web site: www.sxfda.gov.cn

( ten) where the application enterprise application materials, the applicant is not the legal representative or person in charge of the enterprise shall submit himself," power of attorney" in 1 copies; format to the food and Drug Administration of Shaanxi province government website, web site: www.sxfda.gov.cn

( eleven) where the enterprise city ( area) the food and Drug Administration signed the certificate for the opinions of preliminary examination.

(twelve ) in accordance with the application order of binding materials.

(thirteen ) also need to change the" drug business license approval", change the material and replacement materials can be declared at the same time, change and renewal review work together, change the approval time to change card approval time limit shall prevail.

Standard:

1, the application materials shall be complete, clear, use A4 paper to print or copy, in accordance with the application order of binding materials.

In 2, where the application materials are required to submit a copy of the, shall in the copy of the official seal of the unit.

Position responsible person: the provincial food and Drug Administration acceptance office executive.

Responsibility and authority:

In 1, according to the standard inspection application materials.

2, if the application materials are complete, consistent with the form of review the requirements, should be accepted in time, fill in" acceptance notice", the" Notice of acceptance to the applicant as" acceptance certificate.

3, the application materials and incomplete or inconsistent with the statutory form, it shall immediately or within5 working days to bid" notice" supplementary materials, the one-time inform all the contents to be supplemented. If it fails to do so, since the date of receiving the application materials is accepted.

4, the application does not belong to the authority range or the subject matter of the application without the need of administrative license, shall not be accepted, fill out the" inadmissible notice", and explain the reasons, and notify the applicant is entitled to apply for administrative reconsideration or bring an administrative lawsuit as well as the complaint channel.

Two, application materials to the

Executive standard: the application materials will be finishing, presented by the people to handle handover within 2 working days after accepting the transfer market supervision department review staff.

Job responsibility: acceptance office and market supervision department review staff.

Job responsibilities and authority: material accurate, clear procedures.

Three, review

Standard: according to" drug business license management approach"," provincial ' drug business license ' ID scheme" and" on the reissue of ' drug business license ' work notice" review.

Position responsible person: market supervision department review, review and replacement inspector.

Responsibility and authority:

In 1, according to review the application materials review.

2, select drug GSP inspector inspection group to the enterprise site acceptance.

3, review staff signed review opinions, the application materials to reexamine personnel.

4, review staff to review comments after reexamination opinions signed to audit staff.

Time limit: 23 working days.

In four, the audit

Standard:

1, whether the program meets the requirements of the relevant provisions;

2, whether or not completed within the stipulated time period;

In 3, the material review and on-site inspection results are confirmed;

4, signed the audit opinion.

Position responsible person: market supervision division.

Responsibility and authority:

1, in accordance with the requirements for examiners over to examine the application materials.

2, to meet the requirements of the audit opinion, signed by authorized personnel, turn. Do not meet the requirements, and review, review of personnel exchange of views, sign does not agree with the approved comments, material transfer acceptance office. On the requirements for 3 months after the rectification rectification, still do not meet the conditions, the cancellation of the original" drug business license", to authorized personnel.

Time limit: 2 working days

In five, the validation

Standard:

In 1, the audit opinion confirmation.

2, issued by the examining opinion.

Position responsible person: the provincial food and Drug Supervision Bureau in charge of the secretary.

Responsibility and authority:

1, in accordance with the standards of audit staff over the application materials.

In 2, agreed to audit opinion, signed consent through validation opinion; do not agree to audit opinions, and audit staff exchange of views, signed by authorized opinion disagree.

Time limit: 2 working days

In six, the material transfer

Position responsible person: market supervision department review staff, acceptance office playing cards or staff.

Responsibility and authority:

In 1, agreed to accept the license, do certificate personnel.

2, do not agree to keep archives, material, according to the grant license notice to accept office staff.

Time limit: 1 working days ( time limit for transfer )

Seven, the system permits, served

Position responsible person: acceptance office playing card and staff.

Standard:

1, making" drug business license", the material returns market review staff.

2, timely, accurate results inform the applicant permission.

3," drug business license" renewal of the relevant information in the province bureau website announcement.

Job responsibilities and authority: service window is responsible for notifying applicant license results.

Time limit: 5 working days

shaanxi river pharmaceutical Co., LTD opyright 2012 To address: ten way entirely different regional climate xian industrial park