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).
