Lawyer in Vietnam Oliver Massmann - Legal Update - March 2016
1. Lawyer in Vietnam Oliver Massmann - Legal Update - March 2016
1. Circular No. 06/2016/TT-BYT issued by the Ministry of Health promulgating drugs
labelling (“Circular 06”)
Issuance date: 08 March 2016
Effective date: 01 July 2016
Circular 06 sets out labelling requirements for only drugs circulated in the market.
Those who are responsible for labelling drugs are registrants and producers of the drugs for
domestic circulation or export (for drugs produced in Vietnam); or registrants and producers of the
drugs (for imported drugs with registration numbers) or importers and producers of the drugs (for
imported drugs without registration numbers).
Compulsory contents of a drug label must be in Vietnamese, except drug names, common
international or scientific names, name and address of overseas registrants, producers, franchisees,
owners or processors of drugs. Drugs produced in Vietnam must be labelled in Vietnamese.
Imported drugs could be labelled in either of the following ways: (i) original labels with compulsory
contents in Vietnamese and other languages (if any); or (ii) supplementary labels with compulsory
contents in Vietnamese that are not yet included in the original labels but still keeping that original
ones. Circular 06 also includes guidance on contents of drug labels.
In addition, Circular 06 requires drugs circulated in the market must have at least one drug usage
guidance written in Vietnamese. Such guidance must specify drug name, warnings to be written right
after the drug name, ingredients and amount, product specifications, packaging, drugs used for
which purposes and how, side effects, etc.
Circular 06 encourages drug responsible individuals and organizations (producers, registrants,
importers, exporters, distributors, entrusted importers and exporters) to include the barcodes or
stamp the anti-counterfeiting signs or other confidential / anti-counterfeiting signs on the products
to prevent fake products or to easily identify products.
2. Decree No. 19/2016/ND-CP issued by the Government on 22 March 2016 on doing gas
business (“Decree 19”)
Issuance date: 22 March 2016
Effective date: 15 March 2016
One of the conditions for importing and exporting gases is a harbour lease contract of at least 5
years instead of enterprises having to own or co-own a harbour in the Vietnam’s harbour system.
In addition, enterprises importing and exporting gases must have a warehouse with tanks of total
capacity of at least 3,000 m3
; 60,000 m3
of LNG; 200,000 Sm3
for CNG owned or co-owned by
traders or leased by gas traders doing gas business for at least 01 (one) year for LPG and 05 (five)
years for LNG and CNG to receive gas from ship or other means of transport.
2. Additional conditions will be applied for enterprises importing and exporting LPG, LNG and CNG
respectively.
According to Decree 19, wholesale gas traders must buy product liability insurance for all types of
gas sold to customers; inform the competent authority when adjusting gas price; register price when
the State applies price stabilization and declaration measures; register the product circulation, verify
and re-verify LPG cylinders owned by the trader; pay taxes, management fees and manage LPG
bottles as prescribed.
Decree 19 also details conditions applicable for enterprises producing, processing, distributing,
transporting and mixing gas.
Enterprises being granted with certificate of qualifications with non-limited terms before the
effective date of Decree 19 are allowed to continue their business for an additional one year. After
that, they have to comply with all requirements prescribed in this Decree.
Enterprises being granted with certificate of qualifications with terms being before the effective date
of Decree 19 will continue to operate until the expiry of such certificate.
3. Decision No. 428/QD-TTg issued by the Prime Minister on 18 March 2016 on approving the
amended Plan on national development of electricity during 2011- 2020 with a vision to
2030 (“Amended Master Plan VII”)
Issuance date: 18 March 2016
Effective date: 18 March 2016
The Amended Master Plan VII aims at meeting the domestic electricity demand for economic and
social development of the country with average GDP growth of 7% during 2016 -2030. In particular
the commercial electricity output in 2020 would be 235 -245 billion kWh, 352 – 379 billion kWh in
2025 and 506 – 559 billion kWh in 2030. Development of renewable energy will be prioritized, with
electricity output from renewable sources accounting for 7% in 2020 and more than 10% in 2030 of
the total electricity output.
The Amended Master Plan VII further sets out the below target for each type of renewable power
projects:
- Wind power projects: total capacity from the current 140 MW to around 800 MW in 2020,
2,000 MW in 2025 and 6,000 MW in 2030.
- Biomass power projects: electricity generation from both sugar mills and food processing
factories; burning both biomass inputs and coal in coal fired plants; electricity generation
from hard waste; etc. Electricity output from biomass sources will account for 1% in 2020,
1.2% in 2025 and 2.1% in 2030 of the total electricity output.
- Solar power projects (both on ground and rooftop projects): bringing the total electricity
output from a negligible level to around 850 MW in 2020; 4,000 MW in 2025 and 12,000
MW in 2030.
In this amended Master Plan, in 2020, the targeted total capacity of power plants is 60,000 MW, in
which electricity output from renewable energy sources will account for 9.9%. These numbers in
3. 2025 will be 96,500 MW and 12.5% respectively. In 2030, a target of 129,500 MW being the total
capacity of power plants and 21% of electricity output generated from renewable energy sources is
also set.
To meet the above targets, the Prime Minister suggests solutions for grid improvement, electricity
price, environment protection, development of science and technology, human resources, and
economical and efficient use of electricity, etc.
This document also provides a list of project coming into operation during the period of 2016 -2030
and a plan for development of renewable energy plants for each year. This will replace the old
Master Plan VII (Decision No. 1208/QD-TTg of 21 July 2011.
4. Decree No. 06/2016/ND-CP issued by the Government on 18 January 2016 on managing,
providing and use of radio and television services (“Decree 06”)
Issuance date: 18 January 2016
Effective date: 15 March 2016
The number of foreign channels included in a pay radio or television service package will not account
for more than 30 percent of the total number of channels.
Under Decree 06, a foreign broadcasting channel in a pay radio or television system in Vietnam must
have healthy contents conformable with the Vietnamese culture and not violate the press law of
Vietnam; have met the requirement to own or use the copyrighted contents being aired or televised
in such system; and have obtained a certificate of registration of service provision on pay radio and
television.
Besides, the channel must be edited and translated into Vietnamese by a unit licensed to edit
foreign broadcasting channels and have an authorized agent in Vietnam to fulfill its financial
obligations under Vietnamese regulations.
The new regulation underlines that foreign channels must not broadcast advertisements from
abroad. Advertising contents, if any, must be prepared in Vietnam, edited by a responsible unit, and
comply with the advertising law of Vietnam.
The Decree also details the joint production of radio and television broadcasts. Specifically, a unit
licensed to produce broadcasts for domestic channels may select its partners that are legal entities
established under Vietnamese law to jointly produce part or whole of a program or channel and will
take responsibility for deciding on to-be-broadcast contents of jointly produced programs or
channels in accordance with the press law.
However, the joint production of radio and television news or political affairs broadcasts will not be
licensed.
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4. Please do not hesitate to contact Oliver Massmann under omassmann@duanemorris.com if you
have any questions or want to know more details on the above. Oliver Massmann is the General
Director of Duane Morris Vietnam LLC.
THANK YOU !