Our drug license is about to expire. Can brothers and sisters help provide a set of application materials for replacement? Emergency! ! ! ! ! ! ! ! ! ! ! !

Procedures for renewal of drug business license of drug retail (chain) enterprises in Taizhou City

According to Article 19 of the Measures for the Administration of Drug Business License, if the validity period of the Drug Business License expires and it is necessary to continue to operate, the licensed enterprise shall apply for renewal within 6 months before the expiration of the validity period. The replacement procedure is as follows:

First, enterprise applications

The applicant shall apply for a replacement card at the acceptance point of each county (city, district) (sub-bureau) and submit the following materials (A4 paper in duplicate).

1, Taizhou pharmaceutical chain/retail enterprise renewal application (review) form (see table 1 and table 2);

2. The original and photocopy of the Drug Business License, the Certificate of Quality Control of Drug Business, and the original and photocopy of the business license;

3, the legal representative of the enterprise, the person in charge of the identity certificate, certificate of education, resume, certificate and a copy of the original;

4. The identity certificate, education certificate, work resume, employment documents, professional title or qualification certificate of licensed pharmacist, original and photocopy of the registration certificate or practice certificate of pharmaceutical technicians of the person in charge of quality management, the person in charge of quality management institutions and the prescription reviewer;

5. The headquarters of pharmaceutical retail chain enterprises shall provide a roster of enterprise personnel such as quality administrators, inspectors, maintenance workers, salesmen, storekeepers and computer administrators, including names, educational background, professional titles, ID numbers, licensed pharmacists, positions, training and physical examinations (see Table 3);

6. Registered address, warehouse address, and house property right certificate. A copy of the owner's property right certificate and lease agreement shall be provided for the rented house;

7, enterprise self-inspection report;

8. Self-assurance statement of the authenticity of the materials provided by the enterprise.

9. The headquarters of pharmaceutical retail chain enterprises also need to provide a list of their subordinate chain stores, including the name of the enterprise, registered address, legal representative, responsible person, person in charge of quality management, name and position of prescription auditor, and whether there is a business scope of Chinese herbal pieces (see Table 4).

Two. accept

If the materials are complete and meet the requirements, the county bureau will issue a notice of acceptance on the spot. If the application materials are incomplete or do not conform to the statutory form, the applicant shall be informed of the contents that need to be corrected on the spot or within five working days. If it fails to do so within the time limit, it shall be accepted from the date of receiving the application materials.

If the headquarters of a pharmaceutical retail chain enterprise applies for a replacement card, the county-level bureau shall fill in the Internal Circulation Sheet of Administrative License of Taizhou Food and Drug Administration within 3 days after accepting it, and report the relevant materials to the Drug Market Supervision Department of the Municipal Bureau.

Three. review

(1) Data review: mainly review the legality, completeness and authenticity of the materials submitted by enterprises.

(2) On-site inspection: The replacement is not subject to a comprehensive on-site inspection, and the on-site inspection is conducted by combining spot check with key inspection.

In any of the following circumstances, on-site inspection is required:

1. Enterprises with major doubts in data review, simple self-inspection report with no substantive content or inconsistent with facts, and submitting false materials;

2. Enterprises with drug safety credit ratings of C and D in the previous year;

3. Replace the enterprises that are subject to administrative punishment due to violation of laws and regulations in the year;

4. Enterprises that change the licensing conditions without authorization;

5. Enterprises with reports;

6, the food and drug supervision and management departments think it is necessary to conduct on-site inspection of enterprises.

7. Headquarters of pharmaceutical retail chain enterprises.

After the on-site inspection, the inspectors shall fill in the Approval Form for Drug Retail Chain Enterprises or the On-site Inspection Form for Drug Retail Enterprises in Taizhou (Table 5).

Four. agree

Those who meet the requirements after examination shall, within 20 working days from the date of accepting the application for administrative license, withdraw the original certificate and issue a new one. Do not meet the requirements, can be rectified within 3 months. If it still does not meet the requirements after rectification, the original Drug Business License shall be cancelled.

Verb (short for verb) others

If an enterprise is investigated by the food and drug supervision and administration department for illegal operation, but the case has not been closed, or an administrative punishment decision has been made and the punishment has not been fulfilled, the application for license renewal shall be suspended, and the drug operation shall be stopped after the expiration of the original license.

Schedule 1:

Taizhou Drug Retail Chain Enterprise License Renewal Application Form (Audit Form)

Enterprise name

Instructions to applicants

1. Before applying, you should read the Drug Administration Law of People's Republic of China (PRC), the Regulations for the Implementation of the Drug Administration Law of People's Republic of China (PRC) and the Measures for the Administration of Drug Business License, so as to know exactly the rights and obligations enjoyed by the applicant.

2. The applicant shall be responsible for the authenticity of the documents and certificates submitted.

3. The documents and certificates submitted by the applicant shall be originals and photocopies.

4. The documents, certificates and materials submitted by the applicant shall be A4 paper.

5. The applicant shall use a pen, brush or signature pen to fill in or sign neatly.

6. This form is in duplicate. If all the listed contents cannot be filled in, a separate page can be attached.

7. This form can be downloaded directly from the website of Taizhou Municipal Government of US Food and Drug Administration.

Website:.

Date of enterprise application, year month day.

Taizhou made by US Food and Drug Administration.

Materials submitted by pharmaceutical retail chain enterprises to apply for renewal.

certificate

Serial number material name

1 Taizhou drug retail/chain enterprise renewal application form (review)

2. The original and photocopy of the Drug Business License, the Certificate of Quality Control of Drug Business, and the original and photocopy of the business license.

3. The original and photocopy of the identity certificate, education certificate, resume and employment documents of the legal representative and responsible person of the enterprise.

The identity certificate, education certificate, work resume, employment documents, professional title or qualification certificate of licensed pharmacist, original and photocopy of the registration certificate or practice certificate of pharmaceutical technicians of the person in charge of quality management, the person in charge of quality management institutions and the prescription reviewer.

5 quality management personnel, inspectors, maintenance personnel, sales personnel, storekeepers, computer administrators and other enterprise personnel roster (including name, education, professional title, ID number, licensed pharmacist, post, training and physical examination).

6. Registered address, warehouse address, and house title certificate. A copy of the owner's title certificate and lease agreement shall be provided for the rented house.

7 enterprise self-inspection report *

Self-assurance statement of the authenticity of the materials provided by the enterprise

9 The headquarters of pharmaceutical retail chain enterprises also need to provide a list of franchise chains, including the name of the enterprise, registered address, legal representative, person in charge, person in charge of quality management, names and titles of prescription auditors, and whether there is a formula business scope of Chinese herbal pieces (see Table 4, which can be downloaded from the municipal government website).

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Note: Except for the original and duplicate of the Pharmaceutical Trading License, other originals will be returned to the enterprise after verification.

Basic situation of pharmaceutical retail chain enterprises

Enterprise name

Telephone number postal code

registered address

Warehouse address one

two

three

Is the distribution method a self-built distribution center?

Whether all consigned distribution consigned distribution units.

Is it partially entrusted to deliver?

Enterprise type annual sales (ten thousand yuan) registered capital

(ten thousand yuan)

Personnel situation

Job title, professional title and education

legal representative

Person in charge of enterprise

QA Supervisor

Person in charge of quality management organization

scope of business

Quality management organization information

Number of departments, number of licensed pharmacists, number of other pharmacists, number of pharmacists or personnel without pharmaceutical technical titles

Quality management department

Acceptance team

Maintenance group

Business premises, warehouses, computer management systems, facilities and equipment, etc.

Business area ㎡ curing room area ㎡ cold storage volume m3

Total warehouse area ㎡ Normal temperature warehouse area ㎡ Refrigerated warehouse area ㎡.

Department and situation of computer quantity use

Location name, specification and model of warehouse equipment in production enterprise

Equipment for automatic monitoring, adjustment, display, recording temperature status and automatic alarm;

Equipment name:

Model:

Production enterprise:

Efficacy:

Name, model and efficacy of maintenance equipment in production enterprises

transportation equipment

Signature of legal representative:

Signature of the person in charge on year month day:

Contact telephone number:

date month year

Drug business license matters

origin

allow

can

certificate

about

inside

allow

、

material

Name of project enterprise

registered address

warehouse address

Legal representative, person in charge and person in charge of quality of the enterprise.

Operation type

scope of business

License number License serial number

The validity period of the license is from YY to YY.

exchange

certificate

After ...

allow

can

certificate

about

inside

allow

、

material

Name of project enterprise

registered address

warehouse address

Legal representative, person in charge and person in charge of quality of the enterprise.

Operation type

scope of business

License number License serial number

The validity period of the license is from YY to YY.

Note: The contents and items of the license after replacement shall be filled in by the examination and approval unit.

Schedule 2:

Application (Audit) Form for Certificate Renewal of Pharmaceutical Retail Enterprises in Taizhou City

Enterprise name

Instructions to applicants

1. Before applying, you should read the Drug Administration Law of People's Republic of China (PRC), the Regulations for the Implementation of the Drug Administration Law of People's Republic of China (PRC) and the Measures for the Administration of Drug Business License, so as to know exactly the rights and obligations enjoyed by the applicant.

2. The applicant shall be responsible for the authenticity of the documents and certificates submitted.

3. The documents and certificates submitted by the applicant shall be originals and photocopies.

4. The documents, certificates and materials submitted by the applicant shall be A4 paper.

5. The applicant shall use a pen, brush or signature pen to fill in or sign neatly.

6. This form is in duplicate. If all the listed contents cannot be filled in, a separate page can be attached.

7. This form can be downloaded directly from the website of Taizhou Municipal Government of US Food and Drug Administration.

Website:.

Date of enterprise application, year month day.

Taizhou made by US Food and Drug Administration.

Materials and certificates submitted by pharmaceutical retail enterprises to apply for renewal.

Serial number material name

1 Taizhou Drug Retail/Chain Enterprise Renewal Application Form (Review)

2. The original and photocopy of the Drug Business License, the Certificate of Quality Control of Drug Business, and the original and photocopy of the business license.

3. The original and photocopy of the identity certificate, education certificate, resume and employment documents of the legal representative and responsible person of the enterprise.

The identity certificate, education certificate, work resume, employment documents, professional title or qualification certificate of licensed pharmacist, original and photocopy of the registration certificate or practice certificate of pharmaceutical technicians of the person in charge of quality management, the person in charge of quality management institutions and the prescription reviewer.

5. Registered address, warehouse address, and house title certificate. A copy of the owner's title certificate and lease agreement shall be provided for the rented house.

6 enterprise self-inspection report

Self-assurance statement of the authenticity of the materials provided by the enterprise

Other 8 people

Note: Except for the original and duplicate of the Pharmaceutical Trading License, other originals will be returned to the enterprise after verification.

Basic situation of pharmaceutical retail enterprises

Enterprise name management mode

Registered address business field

Warehouse address warehouse area

Postal Code Phone Number Original License Number Zhejiang

Registered capital of enterprise type

(ten thousand yuan) Last year's sales

(ten thousand yuan)

scope of business

The names, academic qualifications and professional titles of relevant personnel are all licensed pharmacists.

Title registration unit

legal representative

Person in charge of enterprise

QA Supervisor

Other employees (if it is impossible to fill in, attach a page)

Title, surname, education, professional title, whether there is a work permit.

Facility equipment

Signature of legal representative (person in charge):

Customer's signature on year, month and day:

date month year

Note: The examiner should carefully check the above contents.

Every place may be a little different, so it's best to check on the website of the local food and drug administration! !