New regulations manage pharmaceutical industry
New regulations manage pharmaceutical industry
On March 29, 2013, the Ministry of Health issued Circular No10/2013/TT-BYT amending and supplementing a number of articles of Circular No02/2007/TT-BYT on conditions for the drugs business.
Overall, the amendment circular aims to effectuate various new regulations on conditions for drug business under Decree No. 89/2012/ND-CP implementing the Law on Pharmacy 2005.
Among other things, the amendment circular clarifies documents called "technology documents" in the application for issuance/amendment of licences for drugs businesses under Decree No89/2012/ND-CP.
Accordingly, the technology document shall be the Good Practice Certificate corresponding to the drug business sector that the applicant applies for. If this Good Practice Certificate is not yet available, an application for such a Good Practice Certificate shall be submitted simultaneously along with an application for issuance/amendment of a licence for drugs business.
Under the Law on Pharmacy 2005, the licensing agency for pharmacy practices that are individual practitioners working for a foreign-owned enterprises shall be the health ministry.
The amendment circular now further provides that the health ministry shall authorise the Provincial Department of Health to grant these certificates in case foreign-owned enterprise's businesses are either drugs manufacturing, drugs maintenance, drug testing or import of drugs.
The amendment circular additionally issued the regulatory forms necessary for application for issuance/amendment of licenses for drugs business.
This amendment circular shall take effect from May 14, 2013.
Amending preferential import tax rates for some commodities
On April 4, 2013, the Ministry of Finance issued Circular No38/2013/TT-BTC amending and supplementing preferential import tax rates applicable to some commodities in the heading 39.03, 54.02, 59.02, 72.17 at the preferential import tariff ("Circular 38").
Accordingly, the preferential import tax rates applicable to some commodities in the heading 39.03; 54.02; 59.02; and 72.17 in the list of taxable products in Section I, Annex II attached with Circular No. 193/2012/TT-BTC dated 15 November 2012 ("Circular 193") of the Ministry of Finance are amended.
Under Circular 38, the preferential import tax rates applicable to the above-mentioned products shall be increased, as follows: (i) The preferential import tax rate applicable to the products with the codes of 3903.11.10; 3903.19.21; and 3903.19.29 shall be 5 per cent instead of 3 per cent as stipulated in Circular 193; (ii) The products with the codes 5402.44.00; 5902.20.99; and 7217.30.31 shall have the new tax rate at 3 per cent; and (iii) The preferential import tax rate applicable to the product with the code of 5902.10.91 shall be increased from 5 per cent to 7 per cent.
Circular 38 shall take effect from May 19, 2013
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