Conditions for Opening a Pharmacy According to Legal Regulations

Conditions for opening a pharmacy are important factors in establishing and operating a drug supply service. This ensures safety and quality for consumers and maintains an efficient and orderly healthcare system. This is especially crucial in the context where the access to and use of medications is receiving increasing attention. Let’s look at the key factors in opening a pharmacy according to legal regulations.

Conditions for opening a pharmacy according to legal regulations

Conditions for Opening a Pharmacy According to Legal Regulations

The conditions for opening a pharmacy according to legal regulations include several specific requirements. The Law on Pharmacy 2016 provides detailed regulations on these conditions.

Personnel Conditions

Personnel conditions for opening a pharmacy are specifically regulated in Clause 2, Article 33, and Clause 1, Article 18 of the Law on Pharmacy 2016. Additionally, these conditions are stipulated in Section I, Appendix I-1a of Circular 02/2018/TT-BYT (amended and supplemented by Circular 12/2020/TT-BYT).

• The person responsible for professional activities must have a university degree in pharmacy and 2 years of practical experience.
• Direct pharmacy staff must have at least an intermediate-level pharmacy degree.
• All personnel must not be currently under disciplinary action for professional misconduct. They must be trained in good retail pharmacy practice standards to ensure service quality and consumer safety.

These regulations apply to all types of retail pharmacy establishments. Meeting the personnel conditions is mandatory to obtain an operating license. Businesses must pay attention to recruiting personnel who meet the required standards. Additionally, personnel should regularly update their knowledge to enhance service quality.

Conditions for Business Location

The business location is a crucial factor when opening a pharmacy as specified in Point d, Clause 1, Article 33 of the Law on Pharmacy 2016. Specifically:

• The pharmacy must have a fixed location with a minimum area of 10 square meters and be away from polluted areas.
• The design must include areas for display, storage, sales, and consultation on the use of medicines.
• The storage and sales areas must be separated from other areas.
• The pharmacy should be solidly built to effectively prevent dust.
• Lighting must be sufficient but should not shine directly on the medicines.

These conditions ensure the quality of medicines and a good working environment.

If the pharmacy also sells cosmetics, functional foods, or medical equipment, it must:

• Have separate arrangements for these products.
• Label these products with “this product is not a medicine.”

Adhering to the conditions for the business location helps the pharmacy operate efficiently and ensures consumer safety. Therefore, pharmacy owners need to clearly understand the legal regulations and comply with them.

Conditions for Facilities

The conditions for facilities are specified in Section II, Appendix I-1a of Circular 02/2018/TT-BYT, as amended and supplemented by Circular 12/2020/TT-BYT. These requirements ensure the safe and efficient operation of the pharmacy. The conditions include:

• Drug Storage Equipment: Must prevent damage from insects, temperature, and humidity.
• Pharmacy Counters and Cabinets: Must be sturdy, easy to clean, and aesthetically pleasing for display purposes.
• Equipment for Measuring Humidity and Temperature: The pharmacy must be equipped with self-recording humidity and temperature measuring devices that operate 1-2 times per hour. These devices must be regularly calibrated.
• Lighting: Sufficient lighting is required to prevent confusion between medicines and their labels.
• Storage Conditions: The maximum storage temperature is 30ºC, and the maximum humidity is 75%.

Conditions for opening a pharmacy

Procedure for Registering to Open a Pharmacy

Documents Required for Pharmacy License Application

The documents required for applying for a certificate of eligibility to do business in pharmaceuticals are as follows:

• Application Form: An application for the certificate of eligibility to do business in pharmaceuticals according to Forms 19, 20, 21 in Appendix I of Decree 54/2017/ND-CP.
• Technical Documents: Relevant technical documents for the pharmaceutical business, including those for the location, storage area, storage equipment, technical and professional documents, and personnel. These must comply with the principles of Good Retail Practice for pharmaceuticals.
• A certified copy of the business registration certificate or legal documents proving the establishment of the business.
• A certified copy of the pharmacy practice license.

These requirements are based on Article 38 of the Law on Pharmacy 2016 and Article 32 of Decree 54/2017/ND-CP.

Steps for Registering to Open a Pharmacy

The procedure for registering to open a pharmacy consists of four main steps according to current legal regulations:

Step 1: Submit the Application

The business submits the application for the certificate of eligibility to do business in pharmaceuticals to the Department of Health where the business is located. The Department of Health will issue a receipt for the application. This requirement is based on Point b, Clause 1, Article 33 of Decree 54/2017/ND-CP, amended and supplemented by Decree 88/2023/ND-CP.

Step 2: Department of Health Reviews the Application

The review period for the application is 20 days from the date noted on the receipt. If modifications or additions are needed, the Department of Health will notify the applicant within 7 working days from the date noted on the receipt. This is specified in Article 5 of Decree 155/2017/ND-CP.

Step 3: On-Site Inspection and Issuance of Certificate

The evaluation and processing period is 20 days from the date noted on the receipt of modified or additional documents. If the application does not meet the requirements, the Department of Health will request further modifications or additions. This is based on Article 5 of Decree 54/2017/ND-CP, amended and supplemented by Decree 88/2023/ND-CP.

Step 4: Publication and Update on the Electronic Portal

The Department of Health will publish the certificate information on the electronic portal. The certificate will be issued in two copies: one for the business and one retained at the Department of Health. This is based on Article 33 of Decree 54/2017/ND-CP, amended and supplemented by Decree 88/2023/ND-CP, and Clause 12 of Article 5 of Decree 155/2018/ND-CP.

Pharmacy Business License Registration Services

Pharmacy business license registration services assist businesses in completing the legal procedures. This process requires strict adherence to the Law on Pharmacy 2016 and related guiding documents. Long Phan’s professional services support clients with the following tasks:

• Advising on the license registration process, including document preparation, application submission, and progress monitoring.
• Consulting on personnel and facility requirements for the business.
• Assisting clients in preparing and filling out the registration documents.
• Accepting authorization to represent the business in completing the pharmacy opening procedures.
• Assisting clients with maintaining and renewing the business license after the initial registration process is complete.
• Providing consultation and support for related procedures after thepharmacy has been established.

Consulting services for pharmacy business license registration

Long Phan has detailed the conditions for opening a pharmacy according to current regulations. With our experience and dedication, we ensure a smooth and quick business license registration process. For assistance, please call Hotline 0906.735.386 for specific consultation.