What materials are needed for pharmacy certification?
With the standardized development of the pharmaceutical industry, pharmacy certification has become an important link that operators must face. Whether it is a newly opened pharmacy or the qualification renewal of an existing pharmacy, complete materials need to be prepared to pass the review of the relevant departments. This article will detail the list of materials required for pharmacy certification to help you complete the certification process efficiently.
1. Basic materials for pharmacy certification
Pharmacy certification usually involves the application or renewal of a "Drug Business License". The following is a list of necessary materials:
| Material type | Specific requirements |
|---|---|
| business license | Originals and copies are required, and the business scope must include pharmaceutical sales. |
| Proof of identity of legal representative | Original and copy of ID card, power of attorney from legal person (if on behalf of an agent) |
| Certificate of pharmacy business premises | Real estate certificate or lease contract, the area must meet local requirements (usually ≥40㎡) |
| Pharmacy Technician Qualifications | Licensed pharmacist qualification certificate, registration certificate and employment certificate |
| quality management documents | Including management systems for drug procurement, storage, sales, etc. |
2. Additional materials for special drug operations
If the pharmacy sells prescription drugs, medical devices or traditional Chinese medicine pieces, the following additional materials need to be submitted:
| Business category | Additional materials |
|---|---|
| prescription drugs | Prescription drug sales management system, prescription review personnel qualification certificate |
| medical device | "Medical Device Business License" and Registration Form (depending on the category) |
| Chinese medicine pieces | Special management documents for the procurement, acceptance and storage of traditional Chinese medicine pieces |
3. Certification process and precautions
1.Material submission: Submit an application to the local market supervision department or drug administration. Online submission is supported in some areas.
2.On-site verification: After passing the review, the relevant departments will conduct an on-site inspection of the pharmacy site, facilities, and staffing.
3.Approval and issuance of certificates: After passing the verification, a "Drug Business License" will generally be issued within 15-30 working days.
Things to note:
• The materials must be stamped with the official seal, and the copies must be marked “consistent with the originals.”
• Licensed pharmacists must be on-the-job and cannot be affiliated.
• Different regions may have detailed requirements. It is recommended to consult the local authorities in advance.
4. Frequently Asked Questions
Q: How long is pharmacy certification valid?
A: Usually it is 5 years. You need to apply for certificate renewal 6 months in advance before expiration.
Q: Can individuals apply for pharmacy certification?
A: Yes, but you need to meet the qualification requirements (such as hiring a licensed pharmacist) and register as a business entity.
Q: How to deal with missing materials?
A: The review department will inform you of the supplementary and correction contents at one time, and the supplements must be completed within the specified period.
Through the above structured checklist and process description, we hope to help you successfully complete pharmacy certification. It is recommended to plan the material preparation time in advance to avoid delaying the opening or operation due to omissions.
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