Note when applying for a license to open a pharmacy

When applying for a license to open a pharmacy, it is important to clearly understand the necessary regulations and conditions from the law and prepare documents carefully. Complying with regulations and preparing documents carefully, opening a pharmacy will become easier. The article below will provide detailed and useful information about points to keep in mind during the process of applying for a permit to open a pharmacy. Please join and refer to have a comprehensive view on this topic.

Conditions for applying for a license to open a pharmacy

Conditions for persons in charge of expertise and personal selling drugs

The following two conditions must be met simultaneously:

• Have a university diploma in pharmacy (Pharmacy degree).
• Have 02 years of professional practice at a suitable pharmacy facility.

Based on the content specified in: Article 18 of the Law on Pharmacy 2016.

Conditions for locations to open pharmacies

Drug retail establishments must have a location, storage area, storage equipment, technical documents and personnel that meet Good Drug Retail Practices.

Pursuant to the content specified in: Point d, Clause 1, Article 33 of the Law on Pharmacy 2016.

Good Pharmacy Practice (GPP) in retail pharmacy is a set of rules and standards established to ensure quality and safety in the provision of medical services and medicines to consumers.

The main purpose of GPP is to control and manage activities related to the pharmaceutical business, ensuring that these businesses comply with regulations on food hygiene and safety, drug storage and other factors related to public health. In this way, GPP helps protect the health of consumers and ensure the safety of drug use in the community.

Procedures for applying for a license to open a pharmacy

File

To open a pharmacy, business owners need a Certificate of eligibility for pharmaceutical business. Accordingly, the application file for a certificate of eligibility for pharmaceutical business is regulated to include:

• Application for issuance of certificate of eligibility for pharmaceutical business according to Form No. 19,20, 21, Appendix I, Decree 54/2017/ND-CP.
• Technical documents corresponding to pharmaceutical business establishments.
• Technical documentation corresponds to changing business conditions.
• Certified copy of business registration certificate or legal document proving the establishment of the file.
• Certified copy of pharmacy practice certificate.

Procedural procedure

Step 1: Submit application for Certificate of eligibility for pharmaceutical business.

The business establishment prepares a set of documents and submits it directly or by mail to the Department of Health where the business establishment is located.

Pursuant to the content specified in: Point b, Clause 1, Article 33 of Decree 54/2017/ND-CP.

Step 2: Receive applications for Certificate of eligibility for pharmaceutical business.

After receiving the dossier, the dossier-receiving agency returns to the business establishment requesting the dossier receipt slip for issuance of a Certificate of eligibility for pharmaceutical business.

Step 3: Appraise the application for issuance of Certificate of eligibility for pharmaceutical business.

• In case there is no request for amendment or supplementation (Skip step 4): The agency issues the Certificate of eligibility for pharmaceutical business within 20 days from the date recorded on the application receipt slip.
• In case of request for amendment or supplementation: The dossier receiving agency shall send a request for amendment and supplementation within 07 working days from the date recorded on the dossier receipt slip.

Based on the content specified in: Article 5 of Decree 155/2017/ND-CP.

Step 4: Actual appraisal and issuance of Certificate of eligibility for pharmaceutical business.

• In case the amended or supplemented dossier meets the requirements: The agency receiving the dossier conducts an actual assessment and issues a Certificate of eligibility for pharmaceutical business within 20 days from the date recorded on the dossier receipt slip. amendments and supplements.
• In case the amended or supplemented dossier does not meet the requirements: The dossier-receiving agency continues to send a request for amendment and supplementation.

Based on the content specified in: Article 5 of Decree 54/2017/ND-CP.

Step 5: Update information.

The receiving agency shall publish and update the relevant information on the unit’s electronic portal after issuing the Certificate of eligibility for pharmaceutical business, according to the provisions of the law.

According to regulations, the Certificate of eligibility for pharmaceutical business is made into 02 copies: 01 copy is issued to the requesting establishment and 01 copy is kept at the issuing agency.

Pursuant to the content specified in: Article 33 of Decree 54/2017/ND-CP, Clause 12, Article 5 of Decree 155/2018/ND-CP.

Authority to issue licenses

The authority to issue certificates of eligibility for pharmaceutical business belongs to the Director of the Department of Health.

Pursuant to the content specified in: Clause 2, Article 37 of the Law on Pharmacy 2016.

Cost of pharmacy business license

Currently, Vietnamese law does not have clear instructions on specific costs related to applying for a pharmacy business license. For more accurate and specific information about the cost of a pharmacy business license, you should contact the local health agency or competent authority directly for detailed advice.

Note when opening a pharmacy

When opening a pharmacy, there are a few things to keep in mind:

• Compliance with legal regulations: Ensure full compliance with legal regulations and conditions on western medicine business.
• Understand the regulations on conditions to open a pharmacy: Mastering these regulations will help you avoid legal risks and ensure your business activities are conducted legally and effectively.
• Prepare complete documents: Prepare a complete and accurate set of documents when applying for a pharmacy business license.
• Improve professional knowledge: Ensure the person responsible for pharmacy expertise in the pharmacy has the necessary knowledge and skills to provide information and advice to customers.
• Advertising and public relations: Build an effective advertising and public relations strategy to promote and develop the pharmacy’s brand.

Service for applying for a pharmacy business license

With a team of experienced experts and lawyers, Long Phan can provide support services for applying for a pharmacy business license to customers specifically as follows:

• Consulting on issues related to applying for a pharmacy business license.
• Assist in preparing documents and drafting necessary documents.
• Contact and carry out procedures to apply for a pharmacy business license with state agencies according to the provisions of law.
• Support in resolving other issues that arise (if any).

Thus, when applying for a license to open a pharmacy, compliance with regulations and notes is extremely important. From ensuring you have enough qualifications and certifications to locate the pharmacy in the right location and ensuring the facilities are up to standard, it all plays a decisive role in the success of your business.

Seriousness and respect for the law are indispensable factors to ensure business activities take place smoothly and sustainably.

We hope that the above information has helped answer some of your questions. If you need advice, please contact Long Phan via the hotline 0906735386 for quick and dedicated support.