The most standard procedures for opening a private pharmacy in 2024

Open a private pharmacy following the correct process not only helps businesses operate legally but also increases customer trust, attracts more patients and ensures service quality. A qualified pharmacy will take advantage of medical support policies from the state, while minimizing legal risks. Owning a standard pharmacy helps investors develop sustainably, increase competitiveness and reputation in this potential pharmaceutical industry.

Conditions for opening a private pharmacy

Necessary conditions to open a private pharmacy are specified in Article 33 of the Law on Pharmacy 2016, Article 5 of Decree 155/2018/ND-CP, and a number of other documents. Specifically, the requirements include:

Business location: The pharmacy must have a clear, fixed address, ensuring the surrounding environment. This condition helps ensure hygiene and safety standards for pharmaceuticals.

Storage equipment: Pharmacies need to be equipped with standard storage equipment such as refrigerators, shelves, racks and tools to support medicine preservation at the correct temperature and humidity requirements. This meets Good Retail Practice (GPP) requirements for medicine storage.

Qualified personnel: According to the provisions of Article 33, Clause 2 and Article 18 of the Law on Pharmacy 2016, the person in charge of expertise should have:

• University pharmacist degree.
• Minimum 02 years of experience in the pharmaceutical industry at a suitable pharmacy facility.
• Pharmacy practice certificate, issued by a competent authority, proves professional capacity and professional ethics.

These conditions are intended to ensure that the pharmacy is capable of providing safe and effective pharmaceuticals, while meeting the strict requirements of Vietnamese law.

Application for a license to open a private pharmacy

According to Article 38 of the Law on Pharmacy 2016, Article 32 of Decree 54/2017/ND-CP, the application for a pharmacy business license includes the necessary documents for the management agency to review and ensure the conditions for pharmaceutical business. Components in the profile include:

• Application for issuance of Certificate of eligibility for pharmaceutical business according to form No. 19, Appendix I, Decree 54/2017/ND-CP;
• Documents on location, storage area, storage equipment, technical documents and personnel according to the principles of Good Pharmacy Practice;
• A certified copy of the Business Registration Certificate or legal documents proving the establishment of the establishment;
• Certified copy of Pharmacy Practice Certificate.

These documents are mandatory requirements to evaluate the pharmacy’s capacity in terms of facilities, personnel and legality of business operations.

Procedures for opening a private pharmacy

According to Article 33 of Decree 54/2017/ND-CP and Clause 12, Clause 79, Article 5 of Decree 155/2018/ND-CP, procedures for opening a private pharmacy are carried out through the following main steps:

Step 1: Submit application

• You can submit an application for a Certificate of eligibility for pharmaceutical business at the Department of Health of the province/city where you plan to locate the pharmacy.
• Applications can be submitted in person or by post.

Step 2: Receive documents and review additional information

• After receiving the application, the Department of Health will check its completeness and validity. If the dossier is missing or has errors, the agency will send a notice requesting amendments within 07 working days from the date of receipt of the dossier.
• You need to submit additional or edit documents as required to ensure completion of the review process.

Step 3: Appraisal and actual assessment at the facility

• If the application meets the requirements, the Department of Health will conduct an appraisal within 20 days from the date of receipt of the complete application.
• If necessary, the Department of Health can send an appraisal team directly to the business location to assess the facility’s suitability according to GPP standards.

Step 4: Issue Certificate of eligibility for pharmaceutical business

• After completing the appraisal and assessment, if eligible, the Department of Health will issue a Certificate of eligibility for pharmaceutical business.
• Within 05 days from the issuance of the certificate, information about the pharmacy will be published on the electronic information system of the health agency.

Consulting service on procedures for opening a private pharmacy in the most standard way in 2024 in Long Phan

Long Phan provides consulting services to support customers on procedures and processes for opening private pharmacies, especially in high-demand areas such as rural areas and towns. Main services include:

• Assist in preparing documents, ensuring they are complete, accurate, and consistent with the requirements of the Department of Health, avoiding the need for multiple additions or modifications.
• Consulting on facility standards and storage equipment.
• Support GPP registration to fully meet the conditions for safe drug business.
• Consulting on related issues after establishment.

With support from Long Phan, customers can rest assured about licensing procedures and focus on pharmacy business operations. For detailed support in the process of opening a private pharmacy and ensuring compliance with regulations, please contact Long Phan via the hotline 0906735386.