Circular No. 10/2013/TT-BYT amends and supplements certain provisions of Circular No. 02/2007/TT-BYT dated January 24, 2007, issued by the Minister of Health, guiding in detail the implementation of certain provisions on conditions for pharmaceutical business operations under the Drug Law and Decree No. 79/2006/NĐ-CP dated August 9, 2006, of the Government detailing the implementation of certain provisions of the Drug Law.

CIRCULAR

Amending and supplementing some articles of Circular No. 02/2007/TT-BYT dated January 24, 2007, issued by the Minister of Health guiding in detail the implementation of certain provisions on conditions for pharmaceutical business as stipulated in the Pharmacy Law and Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Pharmacy Law;

tháng 01 năm 2007 của Bộ trưởng Bộ Y tế hướng dẫn chi tiết thi hành

một số Điều về điều kiện kinh doanh thuốc theo quy định của Luật Dược

và Nghị định số 79/2006/NĐ-CP ngày 09 tháng 8 năm 2006 của Chính phủ

quy định chi tiết thi hành một số Điều của Luật Dược

Pursuant to the Medicine Law No. 34/2005-QH-11 dated June 14, 2005;

This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

Pursuant to Decree No. 89/2012/NĐ-CP dated October 24, 2012 of the Government amending and supplementing some articles of Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Pharmacy Law;

At the proposal of the Director of the Drug Administration Department,

The Minister of Health issues this Circular amending and supplementing some articles of Circular No. 02/2007/TT-BYT dated January 24, 2007, issued by the Minister of Health guiding in detail the implementation of certain provisions on conditions for pharmaceutical business as stipulated in the Pharmacy Law and Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Pharmacy Law.

Article 1. Amending and supplementing some articles of Circular No. 02/2007/TT-BYT dated January 24, 2007, issued by the Minister of Health guiding in detail the implementation of certain provisions on conditions for pharmaceutical business as stipulated in the Pharmacy Law and Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Pharmacy Law (hereinafter referred to as Circular No. 02/2007/TT-BYT) as follows:

1. Clause 9 of Section II shall be amended as follows:

"9. Application dossier for issuance, reissuance of Pharmaceutical Practice Certificate

The application dossier for issuance, reissuance of Pharmaceutical Practice Certificate shall be implemented in accordance with Clause 2, Article 1 of Decree No. 89/2012/NĐ-CP dated October 24, 2012 of the Government amending and supplementing some articles of Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Pharmacy Law" (hereinafter referred to as Decree No. 89/2012/NĐ-CP).

2. Clause 10 of Section II shall be amended and supplemented as follows:

"10. Application dossier for issuance, reissuance, extension, and expansion of scope of business in Pharmaceutical Business License

a) The application dossier for issuance, reissuance, extension, and expansion of scope of business in Pharmaceutical Business License shall be implemented in accordance with Clause 6, Article 1 of Decree No. 89/2012/NĐ-CP.

b) In case of application for issuance, reissuance, extension, and expansion of scope of business in Pharmaceutical Business License where the pharmaceutical business entity has already been granted Good Manufacturing Practice (GMP), Good Storage Practice (GSP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP), Good Pharmacy Practice (GPP) certificates corresponding to the form and scope of business, technical documents as prescribed in Clause 6, Article 1 of Decree No. 89/2012/NĐ-CP only need to be certified copies or copies signed by the owner or head of the entity and stamped with confirmation seal (if it is a company).

c) In case of application for issuance, reissuance, extension, and expansion of scope of business in Pharmaceutical Business License (issued consecutively) where the pharmaceutical business entity has not yet been granted Good Manufacturing Practice (GMP), Good Storage Practice (GSP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP), Good Pharmacy Practice (GPP) certificates corresponding to the form and scope of business, the technical documents as prescribed in Clause 6, Article 1 of Decree No. 89/2012/NĐ-CP shall be implemented as follows:

- For drug manufacturing entities: the registration dossier for Good Manufacturing Practice (GMP) inspection shall be implemented in accordance with Decision No. 3886/2004/QĐ-BYT dated November 13, 2004 of the Minister of Health on the implementation of Good Manufacturing Practice (GMP) principles and standards according to the recommendations of the World Health Organization and related guiding documents, amendments, and supplements.

- For drug testing service business entities: the registration dossier for Good Laboratory Practice (GLP) inspection shall be implemented in accordance with Decision No. 1570/2000/QĐ-BYT dated May 22, 2000 of the Minister of Health on the implementation of Good Laboratory Practice (GLP) principles and related guiding documents, amendments, and supplements.

- For drug storage service business entities: the registration dossier for Good Storage Practice (GSP) inspection shall be implemented in accordance with Decision No. 2701/2001/QĐ-BYT dated June 29, 2001 of the Minister of Health on the implementation of Good Storage Practice (GSP) principles and related guiding documents, amendments, and supplements.

- For drug import entities: the registration dossier for Good Storage Practice (GSP) inspection shall be implemented in accordance with Decision No. 2701/2001/QĐ-BYT dated June 29, 2001 of the Minister of Health on the implementation of Good Storage Practice (GSP) principles and related guiding documents, amendments, and supplements (entities with foreign direct investment shall follow separate guiding documents).

- For drug wholesale entities: the registration dossier for Good Distribution Practice (GDP) inspection shall be implemented in accordance with Circular No. 48/2011/TT-BYT dated December 21, 2011 of the Minister of Health promulgating Good Distribution Practice (GDP) principles.

- For drug retail entities: the registration dossier for Good Pharmacy Practice (GPP) inspection shall be implemented in accordance with Circular No. 46/2011/TT-BYT dated December 21, 2011 of the Minister of Health promulgating Good Pharmacy Practice (GPP) principles and standards.

- For drug manufacturing entities from medicinal materials: the application dossier for issuance of Pharmaceutical Business License shall be implemented in accordance with Circular No. 16/2011/TT-BYT dated April 19, 2011 of the Minister of Health stipulating Good Manufacturing Practice (GMP) principles for drug manufacturing from medicinal materials and the timeline for applying Good Manufacturing Practice (GMP) principles and standards for drug manufacturing entities from medicinal materials (hereinafter referred to as Circular No. 16/2011/TT-BYT).

- For drug retail entities that have not yet implemented Good Pharmacy Practice (GPP) according to the timeline for implementing Good Pharmacy Practice (GPP) principles and standards as stipulated by the Ministry of Health, technical documents include: Declaration Form for Location and Equipment of Business Premises (Form No. 07/KKĐĐ-TTB); Declaration Form for Staff List and Professional Qualifications (Form No. 06/KKNS)."

3. Clause 11 of Section II shall be amended and supplemented as follows:

"11. Procedures and authority for issuance, reissuance of Pharmaceutical Practice Certificate

a) Procedures and authority for issuance, reissuance of Pharmaceutical Practice Certificate shall be implemented in accordance with Clause 4, Article 1 of Decree No. 89/2012/NĐ-CP.

b) The Ministry of Health delegates to the Provincial Health Departments the authority to issue, reissue, and revoke the Drug Practice Certificate for individuals applying to practice pharmacy with foreign investment capital for business forms including: drug production, drug storage services, drug testing services, and drug importation.

c) The Provincial Health Departments shall establish Advisory Boards to review and submit to the Director of the Provincial Health Department for issuance, reissuance of the Drug Practice Certificate for individuals in accordance with point b of this clause and point b of Clause 3, Article 13 of the Pharmacy Law.

4. Add Clause 11b to Section II as follows:

"11b. Procedures and formalities for returning the Drug Practice Certificate to individuals applying to practice pharmacy.

The competent state management agency authorized to issue the Certificate of Eligibility for Pharmaceutical Business Operations (hereinafter referred to as the competent agency) shall return the original Drug Practice Certificate of the professional manager of the pharmaceutical business operation entity in the following cases:

a) The pharmaceutical business operation entity changes its professional manager:

- In the case where the head of the entity applies for reissuance of the Certificate of Eligibility for Pharmaceutical Business Operations according to Clause 6, Article 1 of Decree No. 89/2012/ND-CP due to changing the professional manager, the competent agency shall return the original Drug Practice Certificate of the former professional manager to the entity together with the newly issued Certificate of Eligibility for Pharmaceutical Business Operations.

- In the case where the professional manager unilaterally submits an application to reclaim the original Drug Practice Certificate, the professional manager must notify the head of the pharmaceutical business operation entity about the request to change the professional manager. Within five working days from the date of receiving the application from the professional manager, the competent agency shall notify the head of the pharmaceutical business operation entity about the need to change the professional manager. After thirty working days from the date the competent agency issues the notification, if the business operation entity does not proceed with the procedures to change the professional manager, the competent agency will return the original Drug Practice Certificate to the professional manager while simultaneously initiating the procedures to revoke the Certificate of Eligibility for Pharmaceutical Business Operations.

b) The pharmaceutical business operation entity ceases operations:

Within five working days from the date of receiving the notice from the pharmaceutical business operation entity regarding cessation of operations or revocation of the Certificate of Eligibility for Pharmaceutical Business Operations according to Article 31 of Decree No. 79/2006/ND-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Pharmacy Law (hereinafter referred to as Decree No. 79/2006/ND-CP), the competent agency shall revoke the Certificate of Eligibility for Pharmaceutical Business Operations and return the original Drug Practice Certificate to the professional manager (except in cases where the professional manager's Drug Practice Certificate is revoked according to Article 19 of the Pharmacy Law).

c) The business operation entity submits an application for issuance of the Certificate of Eligibility for Pharmaceutical Business Operations but receives a reply stating that it will not be issued from the agency receiving the application:

The competent agency shall return the original Drug Practice Certificate submitted by the entity in the application along with a letter explaining the reasons for not issuing the Certificate of Eligibility for Pharmaceutical Business Operations.

d) In the case of an individual applying for reissuance of the Drug Practice Certificate:

At least sixty days before the Drug Practice Certificate of the professional manager expires, the pharmaceutical business operation entity must submit an application to reclaim the original Drug Practice Certificate (Form No. 03/ĐĐN-NCC) to the competent agency.

Within five working days from the date of receiving the application to reclaim the Drug Practice Certificate from the pharmaceutical business operation entity, the competent agency shall return the original Drug Practice Certificate to the entity and simultaneously inform the entity that it has been issued the Certificate of Eligibility for Pharmaceutical Business Operations, requiring the applicant for registration as a professional manager to continue practicing until the expiration date stated on the Drug Practice Certificate. Before the old Drug Practice Certificate expires, the pharmaceutical business operation entity must submit the newly issued Drug Practice Certificate. If the Drug Practice Certificate of the professional manager expires without the submission of a new Drug Practice Certificate or the completion of procedures to change the professional manager, the competent agency will revoke the Certificate of Eligibility for Pharmaceutical Business Operations according to point b of Clause 1, Article 31 of Decree No. 79/2006/ND-CP.

5. Clause 12 of Section II is amended and supplemented as follows:

"12. Procedures and authorities for issuing, reissuing, extending, and supplementing the scope of business in the Certificate of Eligibility for Pharmaceutical Business Operations. a) The procedures and authorities for issuing, reissuing, extending, and supplementing the scope of business in the Certificate of Eligibility for Pharmaceutical Business Operations shall be carried out in accordance with Clause 8, Article 1 of Decree No. 89/2012/ND-CP.

b) In cases where the pharmaceutical business operation entity has not yet obtained a Good Manufacturing Practice (GMP), Good Storage Practice (GSP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP), or Good Production Practice (GPP) certificate appropriate to the form and scope of business, the procedures for issuing, reissuing, extending, and supplementing the scope of business in the Certificate of Eligibility for Pharmaceutical Business Operations shall apply to the case requiring assessment of the pharmaceutical business operation entity (interim issuance).

c) In cases where the application for issuance, reissuing, extending, and supplementing the scope of business in the Certificate of Eligibility for Pharmaceutical Business Operations already has a valid Good Manufacturing Practice (GMP), Good Storage Practice (GSP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP), or Good Production Practice (GPP) certificate appropriate to the form and scope of business, the procedures for issuing, reissuing, extending, and supplementing the scope of business in the Certificate of Eligibility for Pharmaceutical Business Operations shall apply without the need for assessment of the pharmaceutical business operation entity according to Clause 8, Article 1 of Decree No. 89/2012/ND-CP.

d) In cases of reissuance of the Certificate of Eligibility for Pharmaceutical Business Operations stipulated in point 4 of Clause 6, Article 1 of Decree No. 89/2012/ND-CP, the procedures for issuing, reissuing, extending, and supplementing the scope of business in the Certificate of Eligibility for Pharmaceutical Business Operations shall apply without the need for assessment of the pharmaceutical business operation entity according to Clause 8 of Decree No. 89/2012/ND-CP."

d) Trường hợp cấp lại Giấy chứng nhận đủ điều kiện kinh doanh thuốc quy định tại điểm 4 Khoản 6 Điều 1 Nghị định số 89/2012/NĐ-CP áp dụng trình tự không phải thẩm định cơ sở kinh doanh theo quy định tại Khoản 8 Nghị định số 89/2012/NĐ-CP.

d) Procedures, authority to issue, reissue, extend, and supplement the scope of business in the Certificate of Eligibility for Drug Business for drug manufacturing facilities from herbal materials according to the implementation schedule of the Good Manufacturing Practice (GMP) principles and standards: carried out in accordance with Circular No. 16/2011/TT-BYT.

e) In cases requiring facility assessment, the Ministry of Health or the People's Committee of Health shall establish a facility assessment team for drug businesses. The assessment results shall be submitted to the leadership of the Ministry of Health or the People's Committee of Health for consideration on whether to issue or not issue the Certificate of Eligibility for Drug Business without the need to establish an Advisory Council.”

6. Supplement Clause 13 to Section II:

“13. Apply certain contents of the "Good Pharmacy Practice" principles and standards to retail establishments that are currently implementing good practices (not yet mandatory application of GPP)

Conditions for the operation of drug agents, pharmacy cabinets at health stations, retail establishments selling traditional medicine and herbal drugs shall be implemented in accordance with Circular No. 46/2011/TT-BYT dated December 21, 2011 issued by the Minister of Health on Principles and Standards of "Good Pharmacy Practice" (hereinafter referred to as Circular No. 46/2011/TT-BYT), except for the provisions at Point b, d Clause 2; Point b Clause 3, Point c Clause 4 Section II Chapter II and Point b, đ Clause 1 Section III Chapter II Principles and Standards of "Good Pharmacy Practice" promulgated together with Circular No. 46/2011/TT-BYT.

Composition of the inspection team: apply Article 4 of Circular No. 46/2011/TT-BYT.”

7. Supplement Clause 14 to Section II:

“14. Issue the following forms along with this Circular:

a) Application for issuance and reissuance of the Pharmaceutical Practice Certificate (Form No. 1a/ĐĐN-CC, Form No. 1b/ĐĐN-CLCC);

b) Application for recovery of the Pharmaceutical Practice Certificate (Form No. 2a/ĐĐN-LCC; 02b/ĐĐN-LCC);

c) Confirmation of working time (Form No. 3/GXN);

d) Application for issuance, supplementation, extension, and reissuance of the Certificate of Eligibility for Drug Business (Form No. 4a-4b-4c-4d/ĐĐN-ĐĐK);

đ) Model receipt for application file for issuance of the Pharmaceutical Practice Certificate/Certificate of Eligibility for Drug Business (Form No. 5a/BNHS, 5b/BNHS);

e) Declaration form for personnel list and professional qualifications (Form No. 6/KKNS); Declaration form for business location and equipment (Form No. 7/KKĐĐ-TTB)

g) List of individuals granted, reissued, or revoked Pharmaceutical Practice Certificates within the management of the People's Committee of Health (Form No. 8a/BC-CCHN); List of drug business establishments granted, reissued, extended, or supplemented scope of business in the Certificate of Eligibility for Drug Business (Form 8b/BC-GCNĐKKD).

h) Pharmaceutical Practice Certificate (Form No. 9a/CCHN, 9b/CCHN-CL);

i) Certificate of Eligibility for Drug Business (Form 10a/GCN-ĐKKD, 10b/GCN-ĐKKD-CL, 10c/GCN-ĐKKD, 10d/GCN-ĐKKD-CL).”

Article 2. Transitional Provisions

1. Transitional provisions shall be implemented in accordance with Article 2 of Decree No. 89/2012/NĐ-CP.

2. Pharmaceutical Practice Certificates and Certificates of Eligibility for Drug Business issued before the effective date of this Circular shall remain valid until the expiration date indicated on the Pharmaceutical Practice Certificate or Certificate of Eligibility for Drug Business.

3. Drug business establishments already holding Certificates of Eligibility for Drug Business in wholesale form and Certificates of Good Storage Practices for Drugs who are currently importing drugs may continue to import drugs within the scope and duration specified on the Certificate of Good Storage Practices for Drugs. Drug manufacturing establishments already holding Certificates of Eligibility for Drug Business and Certificates of Compliance with Good Manufacturing Practices (GMP) may import raw materials for their own drug production and sell them to other drug manufacturing establishments in accordance with Point c Clause 1 of Article 3 of Circular No. 47/2010/TT-BYT dated December 29, 2010 issued by the Minister of Health guiding export and import activities of drugs and direct packaging until the expiration date indicated on the Certificate of Eligibility for Drug Production.

4. Individuals and entities permitted to submit applications for issuance, reissuance, extension, and supplementation of the scope of business in the Certificate of Eligibility for Drug Business, issuance, and reissuance of the Pharmaceutical Practice Certificate may do so immediately upon issuance of this Circular.

Drug manufacturing and trading establishments currently operating whose Pharmaceutical Practice Certificates and Certificates of Eligibility for Drug Business expire after December 10, 2012 (as guided in Clause 1 of Circular No. 177/BYT-QLD dated January 9, 2013 of the Ministry of Health on the implementation of Decree No. 89/2012/NĐ-CP) may continue operations for 45 days after the effective date of this Circular.

Article 3. Responsibility for implementation

1. The Department of Medicine Management, Provincial Health Departments, and Municipal Health Departments under the Central Government shall be responsible for guiding and implementing this Circular.

2. The Department of Medicine Management shall be responsible for compiling and publishing information related to issuance, reissuance, revocation of Pharmaceutical Practice Certificates, lists of establishments granted, reissued, extended, or supplemented scope of business in the Certificate of Eligibility for Drug Business, and revocation of Certificates of Eligibility for Drug Business on the Department of Medicine Management’s electronic information website to serve as a basis for units to implement issuance, reissuance of Pharmaceutical Practice Certificates; issuance, reissuance, extension, and supplementation of the scope of business in the Certificate of Eligibility for Drug Business.

3. Monthly, Provincial Health Departments shall compile and publish lists of individuals granted, reissued, or revoked Pharmaceutical Practice Certificates, lists of establishments granted, reissued, extended, or supplemented scope of business in the Certificate of Eligibility for Drug Business, and cases of revocation or suspension of business operations within their management scope on the Provincial Health Department’s electronic information website and send data to the Department of Medicine Management for updating into the database on pharmaceutical practice.

Article 4. Implementation provisions

1. This Circular takes effect from May 14, 2013.

2. Repeal Clause 9, Clause 10, Clause 11, Clause 12 Section II of Circular No. 02/2007/TT-BYT and the Sample Receipt Form, Sample Pharmaceutical Practice Certificate, and Sample Certificate of Eligibility for Drug Business issued together with Circular No. 02/2007/TT-BYT from the effective date of this Circular./.