PROCEDURE FOR ISSUANCE OF PHARMACY PRACTICE CERTIFICATE

03 positions requiring pharmacy practice certificates

The person responsible for pharmaceuticals expertise of a facility pharmacy business.
The person in charge of quality assurance of a drug or medicinal ingredient manufacturing factory.
The person in charge of clinical pharmacology of a health facility

Conditions for issuance of a pharmacy practice certificate

Has any degree, diplomas, qualification certificate.
Has practise time.
Not be facing a criminal prosecution / serving a court’s sentence or ruling / be suspended from practice…
Has a certificate of suitable health for pharmacy practice.
Foreigners and Vietnamese citizens residing overseas: Satisfy the language requirements in pharmacy.

Application dossier for pharmacy practice certificate

An application form No. 02 in Appendix I, Decree 54/2017/NĐ-CP
Certified true copy of the qualification
Certificate of practise time issued by the head of the establishment at which the applicant serves his/her job according to form No.03 in Appendix I, Decree 54/2017/NĐ-CP
Certificate of completion of training program and updating professional knowledge in pharmacy if the applicant had his/her pharmacy practice certificate revoked.
Certified true copy of the applicant’s ID paper or passport
A criminal record

Application dossier for reissuance of pharmacy practice certificate

An application form No. 04 in Appendix I, Decree 54/2017/NĐ-CP

Application dossier for adjustments to pharmacy practice certificate

An application form No. 05 in Appendix I, Decree 54/2017/NĐ-CP
Copies of documents proving the changes
Copy of the pharmacy practice certificate issued

Procedures for issuing, reissuing and adjusting the pharmacy practice certificate

Step 1: Submit an application directly or by post to:

The Ministry of Health if the pharmacy practice certificate has to be obtained after passing an examination.
The Department of Health of the province if the pharmacy practice certificate may be granted with application form for consideration and approval.

Step 2: After receiving the application documents the receiving authority shall give the receipt form No. 01 in Appendix I Decree 54/2017/NĐ-CP

Step 3: In case there is no modification requirement, the receiving authority shall

Issue: 15 days from the day on which the application is received
Reissue or adjust: 05 days from the day on which the application is received
Reissue due to revoked: 05 days from the day on which the application is received

Step 4: In case there is a modification requirement, the receiving authority shall request the applicant to supplement the application dossier

Issue: within 10 days from the day on which the application is received.
Reissue or adjust: 05 days from the day on which the application is received.

Step 5: After receiving the supplemented application, the receiving authority shall give the receipt form No. 01 in Appendix I Decree 54/2017/NĐ-CP.

Step 6:

– Submit additional documents as requested: Within 06 months from the day on which additional documents are requested.

– The application dossier will be rejected: if the applicant do not submit additional documents as requested within 6 months from the first time it is submitted.

Step 7: The receiving authority shall update the information on its website within 05 days.

Management of pharmacy practice certificates

– A pharmacy practice certificate does not have an expiration date and is recognized nationwide.

– A pharmacy practice certificate expires when:

Its holder is dead
Fails to have the certificate of completion of training program
Do not update professional knowledge in pharmacy within 03 years

Rights of pharmacy practitioners

Be provided with the pharmacy practice certificate when the conditions are full satisfied
Be provided with training in pharmacy; exchange professional knowledge and law about pharmacy.
May authorize who has a pharmacy practice certificate to take charge in his/her stead as prescribed when he/she is absent
May replace drugs in a prescription with other drugs that have the same active ingredients, usage, and dose
Refuse to act against regulations of law

Obligations of pharmacy practitioners

Adhere to the code of ethics for pharmacy practitioners
Only take charge of one pharmacy business establishment at one pharmacy business location
The person in charge of expertise of a drug retailer must be present throughout its operation
Practice pharmacy within the scope written on the pharmacy practice certificate
Complete the training program and updaeting program in pharmacy

Cases in which the pharmacy practice certificate is revoked

The pharmacy practice certificate is issued ultra vires
The holder of the pharmacy practice certificate requests its revocation
The pharmacy practice certificate is incorrect because of the issuing authority
The application dossier for the pharmacy practice certificate contains counterfeit documents
A person has more than one pharmacy practice certificate
The holder of a pharmacy practice certificate rents it, lends it, leases it, borrows it or allows another person to use it
A person issued with the pharmacy practice certificate fails to satisfy any of the conditions for issuance of the pharmacy practice certificate
A person issued with the pharmacy practice certificate fails to practice for 12 consecutive months
A pharmacy practitioner does not have the certificate of completion of training program and updating program in pharmacy within 03 years from the issuance date of the pharmacy practice certificate
The certificate holder violates the code of ethics for pharmacy practitioners
A person has had his/her pharmacy practice certificate revoked more than once for the same violation

Training and updating professional knowledge in pharmacy

The facility offering a training course:

A vocational education institution licensed to provide training in medicine or pharmacy
An education institution licensed to provide training in health science
A research institute licensed to provide training in medicine or pharmacy
An institution licensed to provide training for health workers or a pharmacy association

The training contents include:

Professional knowledge.
Pharmacy law and management.

Duration of a training course: at least 08 hours.