Thông tư 10/2013/TT-BYT sửa hướng dẫn điều kiện kinh doanh thuốc

THE MINISTRY OF HEALTH

Circular No. 10/2013/TT-BYT dated March 29, 2013 of the Ministry of Health amending and supplementing the number of Articles of the Circular No. 02/2007/TT-BYT dated January 24, 2007 of the Ministry of Health guiding in detail the implementation of a number of articles on drug-dealing conditions prescribed by the Pharmacy Law and the Government s Decree No. 79/2006/ND-CP dated August 9, 2006, detailing the implementation of a number of articles of the Pharmacy Law

Pursuant to Law No. 34/2005/QH11 on Pharmacy dated June 14, 2005 of the National Assembly;

Pursuant to the Decree No. 63/2012/ND-CP dated August 31, 2012 of the Government defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the Decree No. 89/2012/ND-CP dated October 24, 2012 of the Government amending and supplementing a number of articles of the Government s Decree No. 79/2006/ND-CP dated August 09, 2006 detailing the implementation of a number of articles of the Law on Pharmacy;

At the proposal of the Director of Drug administration of Vietnam,

The Minister of Health promulgates the Circular amending and supplementing the number of Articles of the Circular No. 02/2007/TT-BYT dated January 24, 2007 of the Ministry of Health guiding in detail the implementation of a number of articles on drug-dealing conditions prescribed by the Pharmacy Law and the Government s Decree No. 79/2006/ND-CP dated August 9, 2006, detailing the implementation of a number of articles of the Pharmacy Law.

Article 1. To amend and supplement a number of articles of the Circular No. 02/2007/TT-BYT dated January 24, 2007 of the Ministry of Health guiding in detail the implementation of a number of articles on drug-dealing conditions prescribed by the Pharmacy Law and the Government s Decree No. 79/2006/ND-CP dated August 9, 2006, detailing the implementation of a number of articles of the Pharmacy Law (hereinafter called the Circular No. 02/2007/TT-BYT) as follows:

1. To amend clause 9, section II as follows:

“9. Dossiers for grant or re-grant of pharmaceutical practice certificates

Dossiers for grant or re-grant of pharmaceutical practice certificates shall comply with clause 2 Article 1 of the Government’s Decree No. 89/2012/ND-CP, of October 24, 2012 amending and supplementing a number of articles of the Government’s Decree No. 79/2006/ND-CP, of August 09, 2006 detailing the implementation of a number of articles of the Pharmacy Law (hereinafter abbreviated to the Decree No. 89/2012/ND-CP).

2. To amend and supplement clause 10, section II as follows:

“10. Dossiers for grant, re-grant, extension, business scope supplementation of certificates of full satisfaction of drug-dealing conditions

a. Dossiers for grant, re-grant, extension, business scope supplementation of certificates of full satisfaction of drug-dealing conditions shall comply with clause 6 Article 1 of Decree No. 89/2012/ND-CP.

b. In case of grant, re-grant, extension, business scope supplementation of certificates of full satisfaction of drug-dealing conditions, if the drug-dealing facilities have been issued the certificate of well practicing (GMP, GSP, GLP, GDP, GPP) in conformity with business form and scope, the respective technical documents as prescribed in clause 6 Article 1 of the Decree No. 89/2012/ND-CP are required authenticated copy or copy of the well practicing certificate with signature of owner or head of facility and seal for confirmation (for enterprise).

c. In case of grant, re-grant, extension, business scope supplementation of certificates of full satisfaction of drug-dealing conditions (inter-issuance), if the drug-dealing facilities have not yet been issued the certificate of well practicing (GMP, GSP, GLP, GDP, GPP) in conformity with business form and scope, the technical documents as prescribed in clause 6 Article 1 of the Decree No. 89/2012/ND-CP shall perform as follows:

- For drug production facilities: Dossier of inspection on Good manufacturing practice (GMP) shall comply with guides in the Decision No. 3886/2004/QD-BYT, of November 13, 2004, of the Minister of Health on application of principle, standard on “Good manufacturing practice” according to the recommendations of the World Health organization and the relevant documents guiding, amending and supplementing.

- For facilities doing business on drug testing service: Dossier of inspection on Good laboratory practice (GLP) shall comply with guides in the Decision No. 1570/2000/QD-BYT, of May 22, 2000, of the Minister of Health on application of principle on “Good laboratory practice” and the relevant documents guiding, amending and supplementing.

- For facilities doing business on drug storage service: Dossier of inspection on Good storage practice (GSP) shall comply with guides in the Decision No. 2701/2001/QD-BYT, of June 29, 2001, of the Minister of Health on application of principle on “Good storage practice” and the relevant documents guiding, amending and supplementing.

- For drug import facilities: Dossier of inspection on Good storage practice (GSP) shall comply with guides in the Decision No. 2701/2001/QD-BYT, of June 29, 2001, of the Minister of Health on application of principle on “Good storage practice” and the relevant documents guiding, amending and supplementing (Facilities with foreign direct investment capital shall comply with the separate guiding documents).

- For drug wholesale facilities: Dossier of inspection on Good distribution practice (GDP) shall comply with guides in the Circular No. 48/2011/TT-BYT, of December 21, 2011, of the Minister of Health on promulgating principles of good distribution practice.

- For drug retail facilities: Dossier of inspection on Good pharmacy practice (GPP) shall comply with guides in the Circular No. 46/2011/TT-BYT, of December 21, 2011, of the Minister of Health on promulgating principles and standard of good pharmacy practice.

- For facilities producing medicines from pharmaceutical ingredients: Dossier of grant of certificate of eligibility for medicine production shall comply with guides in the Circular No. 16/2011/TT-BYT, of April 19, 2011, of the Minister of Health on the principles of producing medicines from pharmaceutical ingredients and the roadmap for application of principles, standards on the good manufacturing practice (GMP) to facilities producing medicines from pharmaceutical ingredients (hereinafter abbreviated to the Circular No. 16/2011/TT-BYT).

- For medicine retail facilities that have not yet performed GPP under the roadmap in application of principles, standards on Good pharmacy practice (GPP) provided by the Ministry of Health, the technical documents include: Declaration of locations and equipment of business facilities (Form No. 07/KKDD-TTB); declaration on list of personnel and professional degrees (Form No. 06/KKNS).”

3. To amend and supplement clause 11, section II as follows:

“11. Procedures and competence for grant, re-grant of pharmaceutical practice certificates

a. The procedures for grant, re-grant of pharmaceutical practice certificates shall comply with Clause 4, Article 1 of the Decree No. 89/2012/ND-CP.

b. The Ministry of Health shall authorize for the Provincial Health Departments to grant, re-grant or withdraw pharmaceutical practice certificates to individuals who register for pharmaceutical practice with foreign investment capital for business forms including: Medicine production, service of medicine storage, service of medicine testing, medicine import.

c. Provincial Health Departments shall set up advisory councils to consider and propose the Health Department directors to grant or re-grant pharmaceutical practice certificates for individuals as prescribed in Point b of this Clause and point b clause 3 Article 13 of the Pharmacy Law.”

4. To supplement Clause 11b, section II as follows:

“11b. Order of and procedures for returning the pharmaceutical practice certificates to individuals registering for pharmaceutical practice

The state management agencies competent to grant of certificate of drug business eligibility (hereinafter referred to as competent agencies) shall return the original of pharmaceutical practice certificates of the specialized manager of the drug-dealing facilities in the following cases:

a. When the drug-dealing facility changes the pharmaceutical manager:

- If the head of facility requests for re-grant of the certificate of drug business eligibility as prescribed in clause 6 Article 1 of the Decree No. 89/2012/ND-CP because change of the pharmaceutical manager, the competent agency shall return the original of pharmaceutical practice certificate of the old specialized manager for the facilities together with the new certificate of drug business eligibility that have been re-granted.

- If the pharmaceutical manager unilaterally files application for receiving back the original of pharmaceutical practice certificate, he/she must notify the request for change of professional manager for the head of drug-dealing facility. Within 05 working days after receiving the request of pharmaceutical manager, the competent agency shall notify for the head of drug-dealing facility to have to change professional manager. Within 30 working days after being notified by the competent agency, if the business facility fails to do procedures for change of the professional manager, the competent agency shall return the original of the practice certificate for the professional manager and carry out procedures for withdrawal of certificate of eligibility for medicine business.

b. When the drug-dealing facility terminates business operation:

Within 05 working days after receiving notice of operation termination of the drug-dealing facility or after the drug-dealing facility is withdrawn certificate of eligibility for drug business as prescribed in Article 31 of the Government’s Decree No. 79/2006/ND-CP, of August 09, 2006, detailing the implementation of a number of articles of the Pharmacy Law (hereinafter abbreviated to the Decree No. 79/2006/ND-CP), the competent agency shall withdraw certificate of eligibility for drug business and returning the original of pharmaceutical practice certificate for the professional manager (unless the professional manager is withdrawn pharmaceutical practice certificate under Article 19 of the Pharmacy Law).

c. When the facility submits dossier of grant of certificate of eligibility for drug business but receives reply in writing for grant refusal of the agency receiving dossier:

The competent agency shall return the original of pharmaceutical practice certificate, which has been filed in the dossier, for the facility, and enclose with reply official dispatch which clearly state reason thereof.

d. When individual apply for re-grant of pharmaceutical practice certificates

Not later than 60 days before the pharmaceutical practice certificate of the professional manager is expired, the drug-dealing facility must submit application for receipt of the original of pharmaceutical practice certificate (Form No. 03/DDN-NCC) to the competent agency.

Within 05 working days after receiving request for receipt of pharmaceutical practice certificate from the drug-dealing facility, the competent agency shall return the original of pharmaceutical practice certificate for the drug-dealing facility, and notify the facility which has been issued certificate of eligibility for information, request the professional manager continue practice until past the time limit inscribed in the pharmaceutical practice certificate. Before the old pharmaceutical practice certificate is expired, the drug-dealing facility must resubmit the newly-issued pharmaceutical practice certificate. If the pharmaceutical practice certificate of the professional manager is expired but the facility fail to resubmit a new pharmaceutical practice certificate or do procedures for change of the professional manager, the competent agency shall withdraw certificate of business eligibility as prescribed in point b clause 1 Article 31 of the Decree No. 79/2006/ND-CP.

5. To amend and supplement clause 12, section II as follows:

“12. Procedures and competence for grant, re-grant, extension, business scope supplementation of certificates of full satisfaction of drug-dealing conditions

a. Procedures and competence for grant, re-grant, extension, business scope supplementation of certificates of full satisfaction of drug-dealing conditions shall comply with clause 8 Article 1 of the Decree No. 89/2012/ND-CP.

b. For drug-dealing facilities that have not yet issued the certificate of Good Practice (GMP, GSP, GLP, GDP, GPP) in conformity with business form and scope, they shall be entitled to apply the order of grant, re-grant, extension, business scope supplementation of certificates of full satisfaction of drug-dealing conditions as case of having to verify drug-dealing facilities (inter-issuance).

c. In case where dossier of grant, re-grant, extension, business scope supplementation of certificates of full satisfaction of drug-dealing conditions have had valid certificate of satisfying the Good practice standard (GMP, GSP, GLP, GDP, GPP) in conformity with business form and scope, the order of grant, re-grant, extension, business scope supplementation of certificates of full satisfaction of drug-dealing conditions without verification at business facilities as prescribed in clause 8 Article 1 of the Decree No. 89/2012/ND-CP shall be applied.

d. For re-grant of certificates of full satisfaction of drug-dealing conditions specified in point 4 clause 6 Article 1 of the Decree No. 89/2012/ND-CP, it shall apply the order which not require for verification at business facilities as prescribed in clause 8 of the Decree No. 89/2012/ND-CP.

dd. The order of and competence for grant, re-grant, extension, business scope supplementation of certificates of full satisfaction of drug-dealing conditions for facilities producing medicines from pharmaceutical ingredients according to the roadmap of carrying out application of principle and standard of “Good Manufacturing Practice – (GMP)” shall: comply with the Circular No. 16/2011/TT-BYT.

e. Case of verification at facilities, the Ministry of Health, the provincial Health Departments shall establish a delegation for verification at drug-dealing facilities. The verification result shall be submitted to leaders of the Ministry of Health or the provincial Health Departments to consider grant or refusal for certificate of eligibility for medicine business without facility of A Advisory Council.”

6. To supplement clause 13, section II as follows:

“13. To apply some content of principle, standard of “Good Pharmacy Practice” for retail facilities in roadmap of carrying out the Good practice (not yet compulsorily applied GPP)

The business conditions of agents, medicine cabinet of medical stations, facilities retailing traditional medicines, medicines from pharmaceutical ingredients shall comply with the Circular No. 46/2011/TT-BYT, of December 21, 2011, of the Minister of Health, on promulgating principles and standard of “good pharmacy practice” (hereinafter abbreviated to the Circular No. 46/2011/TT-BYT), other than point b, d clause 2; point b clause 3, point c clause 4 section II Chapter II and point b, dd clause 1 section III Chapter II of principles and standard of “good pharmacy practice” promulgated together with the Circular No. 46/2011/TT-BYT.

Members of inspection delegation: applying to Article 4 of the Circular No. 46/2011/TT-BYT.”

7. To supplement clause 14, section II as follows:

“14. To promulgate together with this Circular the forms as follows:

a. Application of grant, re-grant of pharmaceutical practice certificates (Form No. 1a/DDN-CC, Form No. 1b/DDN-CLCC);

b. The request for receipt of pharmaceutical practice certificates (Form No. 2a/DDN-LCC; 02b/DDN-LCC);

c. Paper of confirmation on working time (Form No. 03/GXN);

d. Application of grant, supplementation, extension, re-grant of certificates of full satisfaction of drug-dealing conditions (Form No. 4a-4b-4c-4d/DDN-DDK);

dd. Form of recept for dossier of grant of pharmaceutical practice certificate/ certificate of full satisfaction of drug-dealing conditions (Form No. 5a/BNHS, 5b/BNHS);

e. Declaration of list of personnel and professional degrees (Form No. 6/KKNS); declaration of locations and equipment of business facilities (Form No. 7/KKDD-TTB)

g. List of individuals who are granted, re-granted, withdrawn pharmaceutical practice certificate within state management of the provincial Health Departments (Form No. 8a/BC-CCHN); List of drug-dealing facilities which are granted, re-granted, extended, supplied business scope of certificates of full satisfaction of drug-dealing conditions (Form 8b/BC-GCNDKKD).

h. The pharmaceutical practice certificate (Form No. 9a/CCHN, 9b/CCHN-CL);

i. The certificate of full satisfaction of drug-dealing conditions (Form No. 10a/GCN-DKKD, 10b/GCN-DKKD-CL, 10c/GCN-DKKD, 10d/GCN-DKKD-CL).”

Article 2. Transitional provisions

1. Transitional provisions shall comply with Article 2 of the Decree No. 89/2012/ND-CP.

2. The pharmaceutical practice certificates, certificates of full satisfaction of drug-dealing conditions which have been issued before the effective day of this Circular shall be valid untill past the time limit inscribed in the pharmaceutical practice certificates, certificates of full satisfaction of drug-dealing conditions.

3. The drug-dealing facilities which have been issued certificates of full satisfaction of drug-dealing conditions under wholesale form and certificates of Good Storage Practice and are operating in the medicine import further are entitled to import in accordance with scope and time limit inscribed in the certificates of Good Storage Practice. The drug-manufacturing facilities which have been issued certificates of full satisfaction of drug-dealing conditions and certificate of satisfying standard of “Good Manufacturing Practice” (GMP) are entitled to import raw materials for producing medicines for themselves and selling for other drug-manufacturing facilities as prescribed in point c clause 1 article 3 of the Circular No. 47/2010/TT-BYT, of December 29, 2010 of the Minister of Health, guiding the export, import of medicines and packaging in direct contact with medicines untill past time limit inscribed in the certificates of full satisfaction of drug-dealing conditions.

4. Individuals and facilities are entitled to submit dossier of grant, re-grant, extension, business scope supplementation of certificates of full satisfaction of drug-dealing conditions, grant, and re-grant of pharmaceutical practice certificate as soon as this Circular is promulgated.

The drug-dealing facilities and drug manufacturing facilities which are operating and of which pharmaceutical practice certificate, certificates of full satisfaction of drug-dealing conditions are expired after December 10, 2012 (as guided in clause 1 of the official dispatch No. 177/BYT-QLD, of January 09, 2013, of the Ministry of Health, on carrying out the Decree No. 89/2012/ND-CP) shall further operate 45 days after this Circular takes effect.

Article 3. Implementation organization and responsibilities

1. Drug administration of Vietnam, the provincial Health Departments shall guide and implement this Circular.

2. Drug administration of Vietnam shall summarize and announce information related to grant, re-grant, withdrawal of pharmaceutical practice certificates, list of facilities which are granted, re-granted, extended, supplied business scope in the certificates of full satisfaction of drug-dealing conditions, withdrawal of certificates of full satisfaction of drug-dealing conditions on its website in order to do as basis for units to perform grant, re-grant of pharmaceutical practice certificates; grant, re-grant, extension, business scope supplementation of certificates of full satisfaction of drug-dealing conditions.

3. Monthly, the provincial Health Departments shall summarize and announce list of individuals who are granted, re-granted, withdrawn pharmaceutical practice certificates, list of facilities which are granted, re-granted, extended, supplied business scope in the certificates of full satisfaction of drug-dealing conditions, cases of withdrawal and termination of business activities within their management scope on their websites and send data to Drug administration of Vietnam for updating in the database of pharmaceutical practice.

Article 4. Implementation provisions

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

2. The clause 9, clause 10, clause 11, clause 12 section II of the Circular No. 02/2007/TT-BYT and the Form of receipt of dossier, forms of pharmaceutical practice certificate, certificate of full satisfaction of drug-dealing conditions promulgated together with the Circular No. 02/2007/TT-BYT are repealed from the effective day of this Circular.

The Minister of Health

Nguyen Thi Kim Lien