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In brief

The Ministry of Health (“MOH”) has published a draft circular dated December 2020, proposing the publication of lists of substances whose usage is banned in the production and trading of health supplements (“Draft Circular“).

This Draft Circular is expected to come into effect in 2021, with no indication of the specific date.1


Key takeaways

  • This alert provides the lists of substances proposed in the Draft Circular.

In more detail

1. Scope of applicability of the Draft Circular

The Draft Circular applies to:2

  • Vietnamese organizations and individuals
  • Foreign organizations and individuals in Vietnam participating in the production and trading of health supplements
  • Organizations and individuals conducting activities related to health supplements in Vietnam

2. Proposed lists of substances

  1. Lists of substances under Articles 2.1 to 2.5

Article 2, Clauses 1 to 5 provide the following lists of substances whose usage is banned in the production and trading of health supplements:

  • Annex V of Decree 54/2017/ND-CP dated 8 May 2017, providing a list of drugs and medicinal materials banned from importation and production
  • List No. I of Decree 73/2018/ND-CP dated 15 May 2018, providing a list of narcotic substances banned from healthcare used in social life and their use in scientific analysis, testing and research and criminal investigation, as regulated by competent authorities
  • List No. II of Decree 73/2018/ND-CP dated 15 May 2018, providing a list of narcotic substances with restricted use in scientific analysis, testing and research, criminal investigation or healthcare, as regulated by competent authorities
  • List No. III of Decree 73/2018/ND-CP dated 15 May 2018, providing a list of narcotic substances permitted in scientific analysis, testing and research, criminal investigation or healthcare and veterinary medicine, as regulated by competent authorities
  • List No. IVA of Decree 73/2018/ND-CP dated 15 May 2018, providing a list of essential precursors involved in the structure of narcotic substances
  • Annex I of Circular 20/2017/TT-BYT dated 10 May 2017, providing a list of narcotic active ingredients
  • Circular 06/2017/TT-BYT dated 3 May 2017, providing a list of toxic drugs and toxic medicinal materials
  • Annex I of Circular 42/2017/TT-BYT dated 13 November 2017, providing a list of medicinal materials with toxicity of plant origin
  • Annex II of Circular 42/2017/TT-BYT dated 13 November 2017, providing a list of medicinal materials with toxicity of animal origin
  • Annex III of Circular 42/2017/TT-BYT dated 13 November 2017, providing a list of medicinal materials with toxicity of mineral origin
  1. List of substances under Article 2.6

Article 2.6 proposes to ban the following list of substances, which is attached to the Draft Circular. This list may be amended, supplemented or updated according to “managerial demand,”3 subject to the approval of a Consulting Committee appointed by the MOH.4

No. International name
1 Beclomethasone
2 Betamethasone
3 Budesonide
4 Clobetasol propionate
5 Cortisone
6 Deflazacort
7 Deflazacort
8 Fludrocortisone
9 Fluocinolone
10 Flucinonide
11 Fluorometholone
12 Fluticasone
13 Hydrocortisone
14 Methylprednisolone
15 Mometasone
16 Prednisolone
17 Prednisone
18 Triamcinolone
19 Buformin
20 Metformin
21 Metformin
22 Cetilistat
23 Fluoxetine
24 Lorcaserin
25 Orlistat
26 Chlorzoxazone
27 Diclofenac
28 Doxepin
29 Ibuprofen
30 Indomethacin
31 Ketoprofen
32 Methocarbamol
33 Naproxen
34 Nefopam
35 Piroxicam
36 Aidenafil
37 Benzamidenafil
38 Dapoxetine
39 Desmethyl carbodenafil
40 Dithiodesmethyl carbodenafil
41 Flibanserin
42 Hydroxyhomosildenafil
43 Sildenafin
44 Sulfoaildenafil
45 Sulfohydroxyhomosildenafil
46 Tadalafil
47 Vardenafil
48 Chlorpromazine
49 Chlorpheniramine
50 Cyproheptadine
51 Furosemide
52 Hypothiazid
53 Aromatase inhibitor
54 Salbutamol
55 Terazosin hydrochloride

 


1 Article 3.1 of the Draft Circular

2 Article 1.2 of the Draft Circular
3 This is a direct translation of the phrase “nhu cầu quản lý” in the Vietnamese version of the Draft Circular.
4 Article 3.3 of the Draft Circular.

Author

Yee Chung Seck leads the Firm’s Mergers & Acquisitions, IT/C, Pharmaceutical and Healthcare Practices in Vietnam. Chambers Global (2014, 2013) and Chamber Asia (from 2010 to 2015) rank him as a leading lawyer in the field of Corporate M&A and TMT in Vietnam. He is a member of the Singapore Bar Association and serves as vice president of the Singapore Business Group. He also serves as AmCham's IT/C Sub-Committee Co-Chair. Mr. Seck is fluent in English and conversational in Mandarin.

Author

Minh Ha Vu is a Special Counsel in Baker McKenzie's Ho Chi Minh office.