Pharmacy business license: Conditions & Application procedures

A pharmacy business license is a mandatory condition for pharmaceutical businesses to operate legally in Vietnam. The process of applying for this certification requires compliance with business conditions regarding personnel, facilities, techniques and administrative procedures. This article will provide detailed information about the requirements and process for applying for a pharmacy business license, helping customers prepare complete documents and carry out the procedure smoothly.

Conditions for granting a pharmacy business license

To be granted a pharmacy business license, the establishment needs to meet the conditions specified in the Law on Pharmacy 2016 and Appendix I-1a of Circular 02/2018/TT-BYT. Specifically, the conditions include:

Personnel conditions

1. The person in charge of the profession must have a university diploma in pharmacy and must have a pharmacy practice certificate.
2. The pharmacy has appropriate human resources (quantity, qualifications, professional experience) to meet the scale of operations.
3. Employees directly involved in selling drugs, delivering and receiving drugs, preserving drugs, managing drug quality, and preparing drugs must have professional qualifications and professional practice time appropriate to the assigned work, including:

• Persons directly retailing drugs must have a pharmacy professional diploma of intermediate level or higher.
• People who directly prepare drugs and people who work in clinical pharmacy must have a university diploma in pharmacy.
• All employees in this case 3 must not be under disciplinary action from a warning or higher related to medical and pharmaceutical expertise.
• Staff must receive initial and updated training in Good Retail Medicine Practice standards.

Conditions of physical and technical facilities

Construction and design:

• Fixed location, high, airy, safe, far from sources of pollution.
• The operating area is separate from other activities.
• Solid construction, dust-proof ceiling, easy-to-clean walls and floors, adequate lighting, avoiding direct sunlight.

Acreage:

• The area is suitable for the business scale but is at least 10m², there must be an area for displaying and storing drugs and an area for drug buyers to contact and exchange information about drug use with retailers.
• Arrange additional areas for other activities such as preparation room (if any), medicine retail area, storage warehouse (if necessary), and private consulting room.
• Additional business of cosmetics, functional foods, and medical equipment must have a separate area, not displayed for sale with drugs, and have a clear sign “This product is not a medicine”.
• Dispensing rooms and drug retailing rooms must have dust-proof ceilings, easy-to-clean floors and walls, hand washing facilities, mixing tools, packaging, and no seating for buyers.

Medicine storage equipment:

• Have enough equipment to preserve drugs to avoid the adverse effects of light, temperature, humidity, pollution, and insect intrusion;
• Compliant with storage requirements stated on the drug label. Storage conditions at room temperature: temperature does not exceed 30°C, humidity does not exceed 75%;
• There are retail tools and packaging suitable for drug preservation requirements;
• Medicine labeling.

Records, books and professional documents:

• Updated drug use instructions, current pharmaceutical regulations, and notices from regulatory agencies;
• Books or computers manage import, export, storage, and track batch numbers, expiration dates, and drug origins.
• Drug information, origin, transport facility, quantity imported, sold, in stock, buyer (for special drugs);
• There must be equipment and information technology applications to control the origin, price, and origin of drugs;
• Records and books are kept for at least 1 year from the expiration date of the drug;
• Comply with regulations in Article 43 of Decree 54/2017/ND-CP and related documents for specially managed drugs;
• Develop and follow written standard operating procedures for all professional activities for all employees to apply.

Application for a pharmacy business license

Dossier to apply for a pharmacy business license includes:

• Application for issuance of Certificate of eligibility for pharmaceutical business;
• Documents on location, storage area, storage equipment, technical documents and personnel according to the principles of Good Practice for drug retail establishments;
• Business registration certificate or legal document proving the establishment of the establishment;
• Certificate of pharmacy practice.

Procedures for applying for a pharmacy business license

To apply for a pharmacy business license, you need to follow these steps:

Step 1: Submit application

Submit your application to the Department of Health where your business is located through one of the following methods:

• Direct;
• By post.

After receiving the dossier, the dossier-receiving agency issues a dossier receipt slip to the business establishment

Step 2: Appraisal of documents

In case there is no request to amend or supplement documents:

• Issue a Certificate of eligibility for pharmaceutical business within 30 days from the date recorded on the application receipt form in cases where the facilities, techniques and personnel have been inspected and assessed to meet Good Practices appropriate to the scope of business, without having to organize an actual assessment at the proposed facility;
• Organize an on-site assessment at the facility requesting the issuance of a Certificate of eligibility for pharmaceutical business within 20 days from the date recorded on the Application Receipt Form.

In case of request to amend or supplement documents:

• Within 10 working days from the date recorded on the application receipt form, the application receiving agency will send a document to the request base.
• In case the amended or supplemented dossier does not meet the requirements, the agency receiving the dossier will notify the facility in writing.
• In case there is no request to amend or supplement the amended or supplemented dossier, the dossier-receiving agency shall comply with the provisions of Clause 3, Article 33 of Decree 54/2017/ND-CP.

Step 3: Actual appraisal and issuance of certificate

After the actual assessment of the facility, the Certificate-issuing agency is responsible for:

• Issue the Certificate of eligibility for pharmaceutical business within 10 working days from the date of completion of the actual assessment for cases where there are no requests, remedies or repairs.
• Issue a written notice of the contents that need to be remedied or repaired within 05 working days from the date of completion of the actual assessment in case of request, remediation or repair.
• Within 20 days from the date of receipt of the written notice and documents proving the completion of remediation and repair of the requesting facility, the agency issuing the Certificate of eligibility for pharmaceutical business shall issue a Certificate of eligibility for pharmaceutical business or respond to the reason for not issuing it.

Step 4: Update information

Within 05 working days from the date of issuance of the Certificate of eligibility for pharmaceutical business, the agency receiving the application shall publish and update it on the unit’s electronic information portal.

Consulting and support services for applying for a professional pharmacy business license

Long Phan provides consulting and support services for applying for a professional pharmacy business license, helping customers complete procedures quickly and effectively. Our Services include:

• Consulting on conditions for granting pharmacy business licenses;
• Consulting with competent licensing agencies;
• Consulting, supporting in drafting and completing license application documents;
• Instructions on the order and procedures for applying for a pharmacy business license;
• Representing customers to apply for a fast and reputable pharmacy business license;
• Consulting, explanation guidance or additional documents (if any);
• Consulting and answering other issues related to pharmacy business.

A pharmacy business license is a requirement to ensure legal business operations. Understanding the conditions, documents and licensing procedures is extremely important. Hopefully this article has provided customers with useful information. If you have any questions, please contact the hotline: 0906735386 for timely advice and support.