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Regulations in Article 15 of Decree No. 79/2006/ND-CP, Clause 1 clearly state that a person granted a Pharmacy Practice Certificate must have one of the following degrees depending on the requirements for each form of pharmaceutical business organization:
a) Bachelor's degree in Pharmacy;
b) High school diploma in Pharmacy;
c) Diploma of pharmacy assistant;
d) High school diploma in Medicine;
d) University degree in medicine or university degree in biology;
e) University or high school diploma in traditional medicine;
g) Diplomas in traditional medicine, herbal medicine, certificates of traditional medicine and professional qualifications in traditional medicine and pharmacy.
The types of diplomas specified in Point g, Clause 1 of this Article shall be prescribed by the Minister of Health in accordance with the socio-economic conditions and medical examination and treatment needs of the people in each locality in each period.
Article 14. Certificate of pharmaceutical practice
1. A pharmacy practice certificate is granted to a professional pharmacy manager of a drug business establishment in accordance with each form of business organization. A person granted a pharmacy practice certificate must satisfy the conditions specified in Clause 1, Article 13 of the Law on Pharmacy and the provisions of this Decree.
2. Each individual is only granted one Pharmacy Practice Certificate and is only allowed to professionally manage one form of pharmaceutical business organization.
3. The authority to grant Pharmacy Practice Certificates shall comply with the provisions of Clause 3, Article 13 of the Law on Pharmacy.
Article 15. Diplomas, professional certificates, and practice time for granting Pharmacy Practice Certificates
1. A person granted a Pharmacy Practice Certificate must have one of the following qualifications depending on the requirements for each form of pharmaceutical business organization:
a) University degree in pharmacy;
b) High school diploma in pharmacy;
c) Diploma of pharmacy assistant;
d) High school medical diploma;
d) Medical university degree or university degree in biology;
e) University or high school diploma in traditional medicine;
g) Diplomas in traditional medicine, herbal medicine, certificates of traditional medicine and professional qualifications in traditional medicine and pharmacy.
The types of diplomas specified in Point g, Clause 1 of this Article shall be prescribed by the Minister of Health in accordance with the socio-economic conditions and medical examination and treatment needs of the people in each locality in each period.
2. Conditions on qualifications and practice time for pharmaceutical professional managers of drug manufacturing facilities:
a) The pharmaceutical professional manager of a drug manufacturing enterprise must have the diploma specified in Point a, Clause 1 of this Article and have at least 5 years of practice at a legal pharmaceutical facility;
b) The professional manager of pharmaceuticals of a vaccine and medical biological products manufacturing enterprise must have one of the diplomas specified in Point a, Clause 1 of this Article and have at least 5 years of practice at a legal pharmaceutical facility;
c) The professional pharmacy manager of a cooperative or individual business household producing medicinal herbs, oriental medicine, or medicine from medicinal herbs must have one of the diplomas specified in Points a, b, e, g, Clause 1 of this Article and at least 02 years of practice at a legal pharmaceutical establishment.
3. Conditions on qualifications and practice time for professional managers of pharmaceutical wholesale establishments:
a) The professional pharmacy manager of a drug wholesale enterprise must have the diploma specified in Point a, Clause 1 of this Article and at least 03 years of practice at a legal pharmacy facility;
b) The professional manager of pharmaceuticals of a vaccine and medical biological products wholesale enterprise must have one of the diplomas specified in Point a, Clause 1 of this Article and at least 03 years of practice at a legal pharmaceutical facility;
c) The professional pharmacy manager of an enterprise, cooperative, or individual household trading in medicinal herbs, oriental medicine, or medicine from medicinal herbs must have one of the diplomas specified in Points a, b, e, or g, Clause 1 of this Article and at least 02 years of practice at a legal pharmaceutical establishment;
d) The professional pharmacy manager of a vaccine and medical biological products sales agent must have one of the degrees specified in Points a, b, d, and dd, Clause 1 of this Article and at least 02 years of practice at a legal pharmaceutical facility.
4. Conditions on diploma and practice time for retail drug store owners:
a) Pharmacy owners in centrally-run cities, cities and towns under provinces must have the qualifications specified in Point a, Clause 1 of this Article and at least 05 years of practice at a legal pharmacy; for other locations, they must have the qualifications specified in Point a, Clause 1 of this Article and at least 02 years of practice at a legal pharmacy. University pharmacists who have graduated from a specialized training program are proposed to be granted a Certificate of Practice immediately after graduation;
b) The pharmacy owner must have a diploma from a vocational secondary school of pharmacy or higher and have at least 02 years of practice at a legal pharmacy;
c) The owner of a drug sales agent of an enterprise must have a degree in pharmacy or higher and at least 02 years of practice at a legal pharmaceutical facility;
d) The manager of the medical station's medicine cabinet must have a professional qualification of pharmacist assistant or higher and have at least 02 years of pharmacy practice at a legal pharmacy facility; in case there is no person with a professional qualification of pharmacist assistant or higher, there must be a person with a professional qualification of physician or higher in his/her name.
5. Conditions on qualifications and practice time for pharmaceutical professional managers of drug export and import enterprises:
a) A person granted a Pharmacy Practice Certificate by an enterprise that meets the conditions specified in Clause 1, Article 24 of this Decree is considered a professional pharmacy manager of a drug importing enterprise;
b) A person granted a Pharmacy Practice Certificate by a drug business establishment is considered the professional pharmacy manager of the drug exporting establishment.
6. Conditions on qualifications and practice time for pharmaceutical professional managers of enterprises providing drug preservation services:
a) The professional pharmacy manager of a pharmaceutical storage service enterprise must have the diploma specified in Point a, Clause 1 of this Article and at least 03 years of practice at a legal pharmaceutical facility;
b) The professional pharmacy manager of an enterprise providing vaccine and medical biological product preservation services must have one of the diplomas specified in Point a and d, Clause 1 of this Article and at least 03 years of practice at a legal pharmaceutical facility.
7. Conditions on qualifications and practice time for pharmaceutical professional managers of enterprises providing drug testing services:
a) The professional pharmacy manager of a drug testing service enterprise must have the diploma specified in Point a, Clause 1 of this Article and at least 5 years of practice at a legal pharmaceutical facility;
b) The professional pharmacy manager of an enterprise providing vaccine and medical biological product testing services must have one of the diplomas specified in Point a and d, Clause 1 of this Article and at least 5 years of practice at a legal pharmaceutical facility.
Article 16. Application dossier for issuance, exchange, extension, re-issuance of Pharmacy Practice Certificate
1. Application for a Pharmacy Practice Certificate for Vietnamese citizens, including:
a) Application for a Certificate of Pharmacy Practice;
b) Legal copies of professional qualifications;
c) A CV certified by the Chairman of the People's Committee of the commune, ward or town where the applicant for a Certificate of Practice resides or by the Head of the agency where the applicant is working, if he/she is a cadre or civil servant;
d) Certificate of good health to practice issued by a medical examination and treatment facility as prescribed by the Ministry of Health within 06 months from the date of issue;
d) Certificate of internship period at a legal pharmaceutical facility issued by the head of that facility;
e) Commitment to comply with the provisions of relevant legal documents on pharmaceuticals;
g) Notarized or certified copy of Identity Card;
h) 02 portrait photos size 4cm x 6cm.
2. Application for a Pharmacy Practice Certificate for foreigners and Vietnamese people residing abroad, including:
a) Documents specified in points a, b, d, dd, e and h, Clause 1 of this Article;
b) Judicial record certified by competent authority of the host country;
c) Work permit or certificate of being a member of the Board of Directors or Board of Management of the drug business establishment;
d) A notarized copy of the passport or confirmation by the diplomatic representative agency of the country of which they are citizens.
Professional diplomas in pharmacy and other documents as prescribed in Point b, Clause 1 and Point b Clause 2 of this Article issued or notarized or certified by foreign agencies or organizations must be consularly legalized and translated into Vietnamese; the translation must be notarized in accordance with the provisions of Vietnamese law.
3. Application for changing the Pharmacy Practice Certificate due to damage or tearing; change of permanent address of the individual registering to practice pharmacy, including:
a) Application for change of Pharmacy Practice Certificate;
b) A legal copy of the document approving the change of permanent address from the competent authority in case of change of permanent address of the individual registering to practice pharmacy;
c) Original copy of issued Pharmacy Practice Certificate;
d) 02 photos 4cm x 6cm.
4. Application for renewal of Pharmacy Practice Certificate:
a) Application for renewal of Pharmacy Practice Certificate;
b) Certificate of good health to practice issued by a medical examination and treatment facility as prescribed by the Ministry of Health within 06 months from the date of issue.
c) Copy of issued Pharmacy Practice Certificate;
d) 02 photos 4cm x 6cm.
5. Application for re-issuance of a lost Pharmacy Practice Certificate, including:
a) Application for re-issuance of Pharmacy Practice Certificate;
b) Notice of loss of Pharmacy Practice Certificate certified by the police agency at the ward or commune level where the person lost the Pharmacy Practice Certificate.
c) 02 photos 4cm x 6cm.
Article 17. Value and duration of Pharmacy Practice Certificate
1. The pharmacy practice certificate is valid for 05 years from the date of issue. 03 months before the expiration date, if the individual wishes to continue practicing, he/she must submit an application for renewal according to the provisions of Article 16 of this Decree. The maximum renewal period is 05 years and there is no limit on the number of renewals.
2. Value of Pharmacy Practice Certificate:
a) The pharmacy practice certificate issued and renewed by the Minister of Health is valid for practice registration nationwide.
b) The pharmacy practice certificate issued and renewed by the Director of the Department of Health is valid within the province or centrally-run city where the Certificate is issued.
In case of changing the place of practice to another province or city, the individual registering to practice pharmacy must submit an application for a new Certificate of Practice of Pharmacy. The application for a Certificate of Practice of Pharmacy at the new place of move is as prescribed in Clause 1, Article 16 of this Decree, accompanied by the original certificate of termination of practice as a professional manager of pharmacy of a drug business establishment or owner of a drug retail establishment, and the Certificate of Practice of Pharmacy must be returned to the Department of Health where it was issued or renewed. Within 5 days from the date of receipt of the application for confirmation of termination of practice to carry out procedures for changing the place of practice, the local Department of Health where the Certificate of Practice of Pharmacy was issued must have a written response.
3. The validity period of a reissued Pharmacy Practice Certificate due to loss or exchange is equivalent to the remaining validity period of the lost or exchanged Pharmacy Practice Certificate.
Article 18. Procedures and authority for granting, re-granting, changing and extending Pharmacy Practice Certificates
1. Within 30 days from the date of receipt of a valid application for issuance, re-issuance, exchange or extension of a Pharmacy Practice Certificate, the agency receiving the application must organize an appraisal to issue, exchange or extend the Pharmacy Practice Certificate; if the application is not issued, re-issued, exchanged or extended, the agency receiving the application must issue a written response stating the reasons.
2. The authority to issue, reissue, change, and extend the Pharmacy Practice Certificate shall comply with the provisions of Clause 3, Article 13 of the Law on Pharmacy. The Pharmacy Practice Certificate shall be made in two copies: one copy shall be kept at the issuing authority, and one copy shall be given to the individual requesting the issuance, reissue, change, or extension.
3. The Ministry of Health prescribes the form of Pharmacy Practice Certificate.
Article 19. Revocation of Pharmacy Practice Certificate
1. The pharmacy practice certificate is revoked in the following cases:
a) Granted without proper authority;
b) A person who is granted a Certificate of Pharmacy Practice but later falls into one of the cases specified in Clause 2, Article 13 of the Law on Pharmacy;
c) The person granted the Certificate of Pharmacy Practice dies or is declared dead by the Court.
2. When detecting violations requiring revocation of the Pharmacy Practice Certificate as prescribed in Clause 1 of this Article, the authority issuing the Pharmacy Practice Certificate shall decide to revoke it.
3. The pharmacy practice certificate previously issued by the Ministry of Health, according to the provisions of this Decree, is under the authority of the Department of Health. When revoked according to the provisions of Clause 1 of this Article, the Department of Health is responsible for revoking, preserving and reporting to the Ministry of Health.
a) Bachelor's degree in Pharmacy;
b) High school diploma in Pharmacy;
c) Diploma of pharmacy assistant;
d) High school diploma in Medicine;
d) University degree in medicine or university degree in biology;
e) University or high school diploma in traditional medicine;
g) Diplomas in traditional medicine, herbal medicine, certificates of traditional medicine and professional qualifications in traditional medicine and pharmacy.
The types of diplomas specified in Point g, Clause 1 of this Article shall be prescribed by the Minister of Health in accordance with the socio-economic conditions and medical examination and treatment needs of the people in each locality in each period.
Article 14. Certificate of pharmaceutical practice
1. A pharmacy practice certificate is granted to a professional pharmacy manager of a drug business establishment in accordance with each form of business organization. A person granted a pharmacy practice certificate must satisfy the conditions specified in Clause 1, Article 13 of the Law on Pharmacy and the provisions of this Decree.
2. Each individual is only granted one Pharmacy Practice Certificate and is only allowed to professionally manage one form of pharmaceutical business organization.
3. The authority to grant Pharmacy Practice Certificates shall comply with the provisions of Clause 3, Article 13 of the Law on Pharmacy.
Article 15. Diplomas, professional certificates, and practice time for granting Pharmacy Practice Certificates
1. A person granted a Pharmacy Practice Certificate must have one of the following qualifications depending on the requirements for each form of pharmaceutical business organization:
a) University degree in pharmacy;
b) High school diploma in pharmacy;
c) Diploma of pharmacy assistant;
d) High school medical diploma;
d) Medical university degree or university degree in biology;
e) University or high school diploma in traditional medicine;
g) Diplomas in traditional medicine, herbal medicine, certificates of traditional medicine and professional qualifications in traditional medicine and pharmacy.
The types of diplomas specified in Point g, Clause 1 of this Article shall be prescribed by the Minister of Health in accordance with the socio-economic conditions and medical examination and treatment needs of the people in each locality in each period.
2. Conditions on qualifications and practice time for pharmaceutical professional managers of drug manufacturing facilities:
a) The pharmaceutical professional manager of a drug manufacturing enterprise must have the diploma specified in Point a, Clause 1 of this Article and have at least 5 years of practice at a legal pharmaceutical facility;
b) The professional manager of pharmaceuticals of a vaccine and medical biological products manufacturing enterprise must have one of the diplomas specified in Point a, Clause 1 of this Article and have at least 5 years of practice at a legal pharmaceutical facility;
c) The professional pharmacy manager of a cooperative or individual business household producing medicinal herbs, oriental medicine, or medicine from medicinal herbs must have one of the diplomas specified in Points a, b, e, g, Clause 1 of this Article and at least 02 years of practice at a legal pharmaceutical establishment.
3. Conditions on qualifications and practice time for professional managers of pharmaceutical wholesale establishments:
a) The professional pharmacy manager of a drug wholesale enterprise must have the diploma specified in Point a, Clause 1 of this Article and at least 03 years of practice at a legal pharmacy facility;
b) The professional manager of pharmaceuticals of a vaccine and medical biological products wholesale enterprise must have one of the diplomas specified in Point a, Clause 1 of this Article and at least 03 years of practice at a legal pharmaceutical facility;
c) The professional pharmacy manager of an enterprise, cooperative, or individual household trading in medicinal herbs, oriental medicine, or medicine from medicinal herbs must have one of the diplomas specified in Points a, b, e, or g, Clause 1 of this Article and at least 02 years of practice at a legal pharmaceutical establishment;
d) The professional pharmacy manager of a vaccine and medical biological products sales agent must have one of the degrees specified in Points a, b, d, and dd, Clause 1 of this Article and at least 02 years of practice at a legal pharmaceutical facility.
4. Conditions on diploma and practice time for retail drug store owners:
a) Pharmacy owners in centrally-run cities, cities and towns under provinces must have the qualifications specified in Point a, Clause 1 of this Article and at least 05 years of practice at a legal pharmacy; for other locations, they must have the qualifications specified in Point a, Clause 1 of this Article and at least 02 years of practice at a legal pharmacy. University pharmacists who have graduated from a specialized training program are proposed to be granted a Certificate of Practice immediately after graduation;
b) The pharmacy owner must have a diploma from a vocational secondary school of pharmacy or higher and have at least 02 years of practice at a legal pharmacy;
c) The owner of a drug sales agent of an enterprise must have a degree in pharmacy or higher and at least 02 years of practice at a legal pharmaceutical facility;
d) The manager of the medical station's medicine cabinet must have a professional qualification of pharmacist assistant or higher and have at least 02 years of pharmacy practice at a legal pharmacy facility; in case there is no person with a professional qualification of pharmacist assistant or higher, there must be a person with a professional qualification of physician or higher in his/her name.
5. Conditions on qualifications and practice time for pharmaceutical professional managers of drug export and import enterprises:
a) A person granted a Pharmacy Practice Certificate by an enterprise that meets the conditions specified in Clause 1, Article 24 of this Decree is considered a professional pharmacy manager of a drug importing enterprise;
b) A person granted a Pharmacy Practice Certificate by a drug business establishment is considered the professional pharmacy manager of the drug exporting establishment.
6. Conditions on qualifications and practice time for pharmaceutical professional managers of enterprises providing drug preservation services:
a) The professional pharmacy manager of a pharmaceutical storage service enterprise must have the diploma specified in Point a, Clause 1 of this Article and at least 03 years of practice at a legal pharmaceutical facility;
b) The professional pharmacy manager of an enterprise providing vaccine and medical biological product preservation services must have one of the diplomas specified in Point a and d, Clause 1 of this Article and at least 03 years of practice at a legal pharmaceutical facility.
7. Conditions on qualifications and practice time for pharmaceutical professional managers of enterprises providing drug testing services:
a) The professional pharmacy manager of a drug testing service enterprise must have the diploma specified in Point a, Clause 1 of this Article and at least 5 years of practice at a legal pharmaceutical facility;
b) The professional pharmacy manager of an enterprise providing vaccine and medical biological product testing services must have one of the diplomas specified in Point a and d, Clause 1 of this Article and at least 5 years of practice at a legal pharmaceutical facility.
Article 16. Application dossier for issuance, exchange, extension, re-issuance of Pharmacy Practice Certificate
1. Application for a Pharmacy Practice Certificate for Vietnamese citizens, including:
a) Application for a Certificate of Pharmacy Practice;
b) Legal copies of professional qualifications;
c) A CV certified by the Chairman of the People's Committee of the commune, ward or town where the applicant for a Certificate of Practice resides or by the Head of the agency where the applicant is working, if he/she is a cadre or civil servant;
d) Certificate of good health to practice issued by a medical examination and treatment facility as prescribed by the Ministry of Health within 06 months from the date of issue;
d) Certificate of internship period at a legal pharmaceutical facility issued by the head of that facility;
e) Commitment to comply with the provisions of relevant legal documents on pharmaceuticals;
g) Notarized or certified copy of Identity Card;
h) 02 portrait photos size 4cm x 6cm.
2. Application for a Pharmacy Practice Certificate for foreigners and Vietnamese people residing abroad, including:
a) Documents specified in points a, b, d, dd, e and h, Clause 1 of this Article;
b) Judicial record certified by competent authority of the host country;
c) Work permit or certificate of being a member of the Board of Directors or Board of Management of the drug business establishment;
d) A notarized copy of the passport or confirmation by the diplomatic representative agency of the country of which they are citizens.
Professional diplomas in pharmacy and other documents as prescribed in Point b, Clause 1 and Point b Clause 2 of this Article issued or notarized or certified by foreign agencies or organizations must be consularly legalized and translated into Vietnamese; the translation must be notarized in accordance with the provisions of Vietnamese law.
3. Application for changing the Pharmacy Practice Certificate due to damage or tearing; change of permanent address of the individual registering to practice pharmacy, including:
a) Application for change of Pharmacy Practice Certificate;
b) A legal copy of the document approving the change of permanent address from the competent authority in case of change of permanent address of the individual registering to practice pharmacy;
c) Original copy of issued Pharmacy Practice Certificate;
d) 02 photos 4cm x 6cm.
4. Application for renewal of Pharmacy Practice Certificate:
a) Application for renewal of Pharmacy Practice Certificate;
b) Certificate of good health to practice issued by a medical examination and treatment facility as prescribed by the Ministry of Health within 06 months from the date of issue.
c) Copy of issued Pharmacy Practice Certificate;
d) 02 photos 4cm x 6cm.
5. Application for re-issuance of a lost Pharmacy Practice Certificate, including:
a) Application for re-issuance of Pharmacy Practice Certificate;
b) Notice of loss of Pharmacy Practice Certificate certified by the police agency at the ward or commune level where the person lost the Pharmacy Practice Certificate.
c) 02 photos 4cm x 6cm.
Article 17. Value and duration of Pharmacy Practice Certificate
1. The pharmacy practice certificate is valid for 05 years from the date of issue. 03 months before the expiration date, if the individual wishes to continue practicing, he/she must submit an application for renewal according to the provisions of Article 16 of this Decree. The maximum renewal period is 05 years and there is no limit on the number of renewals.
2. Value of Pharmacy Practice Certificate:
a) The pharmacy practice certificate issued and renewed by the Minister of Health is valid for practice registration nationwide.
b) The pharmacy practice certificate issued and renewed by the Director of the Department of Health is valid within the province or centrally-run city where the Certificate is issued.
In case of changing the place of practice to another province or city, the individual registering to practice pharmacy must submit an application for a new Certificate of Practice of Pharmacy. The application for a Certificate of Practice of Pharmacy at the new place of move is as prescribed in Clause 1, Article 16 of this Decree, accompanied by the original certificate of termination of practice as a professional manager of pharmacy of a drug business establishment or owner of a drug retail establishment, and the Certificate of Practice of Pharmacy must be returned to the Department of Health where it was issued or renewed. Within 5 days from the date of receipt of the application for confirmation of termination of practice to carry out procedures for changing the place of practice, the local Department of Health where the Certificate of Practice of Pharmacy was issued must have a written response.
3. The validity period of a reissued Pharmacy Practice Certificate due to loss or exchange is equivalent to the remaining validity period of the lost or exchanged Pharmacy Practice Certificate.
Article 18. Procedures and authority for granting, re-granting, changing and extending Pharmacy Practice Certificates
1. Within 30 days from the date of receipt of a valid application for issuance, re-issuance, exchange or extension of a Pharmacy Practice Certificate, the agency receiving the application must organize an appraisal to issue, exchange or extend the Pharmacy Practice Certificate; if the application is not issued, re-issued, exchanged or extended, the agency receiving the application must issue a written response stating the reasons.
2. The authority to issue, reissue, change, and extend the Pharmacy Practice Certificate shall comply with the provisions of Clause 3, Article 13 of the Law on Pharmacy. The Pharmacy Practice Certificate shall be made in two copies: one copy shall be kept at the issuing authority, and one copy shall be given to the individual requesting the issuance, reissue, change, or extension.
3. The Ministry of Health prescribes the form of Pharmacy Practice Certificate.
Article 19. Revocation of Pharmacy Practice Certificate
1. The pharmacy practice certificate is revoked in the following cases:
a) Granted without proper authority;
b) A person who is granted a Certificate of Pharmacy Practice but later falls into one of the cases specified in Clause 2, Article 13 of the Law on Pharmacy;
c) The person granted the Certificate of Pharmacy Practice dies or is declared dead by the Court.
2. When detecting violations requiring revocation of the Pharmacy Practice Certificate as prescribed in Clause 1 of this Article, the authority issuing the Pharmacy Practice Certificate shall decide to revoke it.
3. The pharmacy practice certificate previously issued by the Ministry of Health, according to the provisions of this Decree, is under the authority of the Department of Health. When revoked according to the provisions of Clause 1 of this Article, the Department of Health is responsible for revoking, preserving and reporting to the Ministry of Health.
