The pharmaceutical industry is a specific industry that has a direct impact on human health. Therefore, individuals and organizations that intend to open drugstores need to understand the conditions and procedures prescribed by law to be able to do it themselves. If you are looking to open a private pharmacy but have no experience and are worried about the procedure to open a private pharmacy in Vietnam? Please refer to the following article of Lawyer X to find out the answer!
Legal grounds
Pharmacy Law 2016
Circular 02/2018/TT-BYT
Decree 54/2017/ND-CP
Consulting content
To open a pharmacy; First of all, organizations and individuals must establish an enterprise or register a business household. This is a conditional business line, so organizations and individuals must fully meet the conditions as prescribed.
Conditions of physical facilities and equipment of drugstores
About construction and design
- drugstores must have a fixed location; arranged in a dry, cool, safe place, far away from pollution sources.
- Be segregated from other activities.
- The drugstore is firmly built; with dustproof ceiling; walls and floors must be easy to clean; enough light but do not expose the medicine to direct sunlight.
About the area
- Area suitable to business scale but at least 10m2; There must be an area for displaying and storing drugs and an area for drug buyers to contact and exchange information on drug use with retailers.
- Additional areas must be arranged for other activities such as:
The retail area for medicines no longer has direct contact with the packaging to sell directly to patients.
Separate drug storage warehouse (if necessary).
Private consultation room or area for drug purchasers/patients.
- In case of additional business of cosmetics, functional foods, and medical instruments, there must be a separate area, which is not displayed for sale together with the drug and does not affect the drug; There must be a sign in the area stating “This product is not a medicine”.
In case the pharmacy has a retail room, there is no packaging in direct contact with the drug.
- Room must have dustproof ceiling; floors and walls made of materials that are easy to clean; Disinfection can be performed when necessary. In addition, there must be a place to wash hands, wash and preserve packaging.
Documents to be prepared to carry out the procedure to open a private pharmacy
The number of documents to be prepared is 02 sets.
Pursuant to Article 38 of the Law on Pharmacy 2016 and Article 32 of Decree 54/2017/ND-CP, the application file includes:
- An application form for the Certificate of eligibility for pharmacy business (made according to the form).
- The original copy of the pharmacy practice certificate of the professional pharmacy manager suitable to the form of business organization.
Each pharmacy will have its own professional responsible person. This individual must have the professional qualifications specified at Point a, Clause 1, Article 13 of the Law on Pharmacy and have 2 years of professional practice at an appropriate pharmacy establishment.
This not only helps your pharmacy to ensure legal records. But above all, when the person in charge of expertise, has solid experience. Then the support to make prescriptions, sell drugs to users. Will also be efficient, accurate. Since then, the pharmacy is also more reputable.
- A certified copy of the certificate of individual business household registration or the certificate of business registration, or a copy signed by the establishment owner and stamped for certification (if it is an enterprise).
For drug retail establishments, business registration is required in the form of a household. According to regulations, the certificate of pharmaceutical business registration is registered at the business registration office of the district where the business location is located.
- Certificate of Good Practice at the business location (if any).
Technical documents on locations, storage areas, storage equipment, professional and technical documents and personnel according to the principles of Good Practice at drug retailers, including:
Personnel chart, list of personnel, names, titles, professional qualifications;
Layout drawings of retail premises;
List of equipment (including information about computer systems and network management software);
List of regulations, records, documents, standard operating procedures;
Self-inspection on Good practice of drug retailers according to the checklist specified in Appendix II – 2a or 2b or 2c attached to Circular 02/2018/TT-BYT for establishments applying for a Certificate meet the corresponding pharmaceutical business conditions.
Note: According to the provisions of Clause 2, Article 5 of Circular 02/2018/TT-BYT; In case the drug retailer applies for a GPP Certificate together with the Certificate of eligibility for pharmacy business, the drug retailer needs to clearly state this content in the application for the Certificate of eligibility for business medicine.
Current order and procedures for opening a private pharmacy
Step 1: Submit your application
To be able to open a private pharmacy, you need to prepare a set of documents to apply for a Certificate of eligibility for pharmacy business as instructed above. Then, submit it directly or by post to the Department of Health where your business establishment is located as prescribed in Clause 1, Article 39 of the Law on Pharmacy 2016 and Clause 1, Article 33 of Decree 54/2017/ ND-CP.
Step 2: Receipt of application
After receiving the dossier, the application-receiving agency shall return the dossier-receiving form to the requesting establishment according to Form No. 01 in Appendix I issued together with Decree 54/2017/ND-CP.
Step 3: Verify your profile
In case there is no request to amend or supplement the dossier, the agency issuing the Certificate of eligibility for pharmacy business shall:
Issuing a Certificate of eligibility for pharmacy business within 30 days; from the date stated on the application receipt for the case of physical facilities; technical and personnel have been checked; response assessment Good practice appropriate to the business scope; not organize the actual assessment at the establishment applying for the Certificate of eligibility for pharmacy business.
Organize the actual assessment at the establishment applying for the Certificate of eligibility for pharmacy business within 20 days; from the date indicated on the application receipt.
If there is a request to amend or supplement the dossier, within 10 working days; from the date stated on the application receipt; the application-receiving agency shall send a written request to the applicant. In which, it must specify the documents and contents that need to be amended and supplemented.
After receiving the revised and supplemented dossier; the application-receiving agency shall return the revised application receipt to the requesting establishment; supplemented according to Form No. 01 in Appendix I issued together with Article 33 of Decree 54/2017/ND-CP.
Step 4: Actual assessment and issuance of Certificate of eligibility for pharmacy business
After the actual assessment of the establishment, the agency issuing the Certificate of eligibility for pharmacy business is responsible for:
Issuing a Certificate of eligibility for pharmacy business within 10 working days; from the date of completion of the actual assessment in the case of no request; fix, repair.
Issue a written notice of the contents to be remedied; repair within 05 working days; from the date of completion of the actual assessment in case of request, remedy or repair.
According to the provisions of Clause 11 Article 33 of Decree 54/2017/ND-CP; The Certificate of eligibility for pharmacy business is made in 02 copies according to Form No. 22 in Appendix I issued together with Decree 54/2017/ND-CP: 01 copy is issued to the applicant for the Certificate of eligibility. pharmaceutical business case; 01 copy is kept at the agency issuing the Certificate of eligibility for pharmacy business.
In addition, your facility case has been assessed for Good Practice; The agency issuing the Certificate of eligibility for pharmaceutical business shall issue the Certificate of Good Practice if the establishment requests the Certificate of Good Practice (GPP).
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Frequently asked questions
If you open a pharmacy in the form of a household business, you will have to pay PIT and VAT according to the presumptive method if your turnover is over 100 million VND/year. If your turnover is 100 million VND/year or less, you will not have to pay these two taxes.
According to the provisions at Point b, Clause 2, Article 52 of Decree 117/2020/ND-CP; acts of trading in drugs without a pharmacy practice certificate will be administratively sanctioned. The fine amount is from 5,000,000 VND to 10,000,000 VND
Conclusion: So the above is Procedures for opening a private pharmacy in Vietnam. Hopefully with this article can help you in life, please always follow and read our good articles on the website: lsxlawfirm.com
