[ Newsletter | November 2022 ] – The Process of Importing Oral Drop to Vietnam

An essential oil is a  liquid containing volatile aromatic chemical compounds, generally extracted by distillation or cold pressing from the leaves of plants; trunk; flower; phloem; roots; or other plant parts. Another method for essential oil extraction is solvent extraction.

They are used in perfumes, cosmetics, soaps, air fresheners and other products, for flavoring food and drink, and have also been used as a medicine. Medicinal applications range from skin beautification to cancer treatment and are often purely based on historical accounts of the use of essential oils for these purposes. Claims about the effectiveness of essential oil medical treatments, in particular as a cancer treatment, are currently subject to regulatory regulations in many countries.

In the following article, Noble Network will guide you through the process of importing essential oils/ oral drops to Vietnam.

 

Step 1. Determination of HS Code and Import Conditions

Time: 30 days

Authorities: General Department of Customs 

Businesses need to know and understand the actual imported goods, technical documents and records of the goods to determine and declare the appropriate code: for example, CBD essential oil is used as a nutritional supplement for the body, this product is classified as Food Supplement.

Businesses carry out the procedures for pre-determination of codes by sending a dossier of request for code predetermination to the customs office, according to Clause 11 Article 1 of Decree 59/2018 / ND-CP, Clause 3, Article 1 of Circular No. No. 39/2018 / TT-BTC.

Step 2. Declaration of conformity or registration for declaration of conformity 

Time: 20 – 25 days

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Authorities: Vietnam Food Administration 

As a Food Supplement product, there must be a declaration of compliance to food safety regulations and registration of declaration of compliance to food safety regulations at the Ministry of Health (Vietnam Food Administration) for imported and domestically produced functional foods that are not regulated by any technical regulations before they are put on the market. (43/2014/TT-BYT)

  1. Announcement on conformity with regulation on food safety: Decree No.38/2012/ND-CP.

First of all, imported essential oils need to be assessed for conformity with regulation on food safety: Organizations, individuals test products in appointed testing laboratory or recognized independent testing laboratory or accepted testing laboratory; assess conformity with regulation on food safety on based on results of testing and content

Registration of announcement in conformity with regulation on food safety: Organizations, individuals announcing products shall make and submit a dossier of announcement as prescribed in clause 2 this Article to agencies receiving registration.

  1. Dossier of announcement on conformity with regulation on food safety: 

Dossiers announcing conformity with food safety regulations according to Decree No. 38/2012/ND-CP include:

– Business registration certificate with the food business line or certificate of legal entity for organizations and individuals (copy certified by the organization or individual).

– Certificate of Free Sale – CFS

–  Documents proving uses; Certificate Of Analysis 

– The product testing results within 12 months, including the criteria of major quality, safety criteria granted by the following entities: the laboratories appointed by competent state agencies or the independent laboratories to be accredited (original or notarized copy); or the laboratories of the origin countries recognized  by the competent agencies in Vietnam (original or certified copy or consular legalized);

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– HACCP Certificate or ISO 22000/2005 Certificate (if any).

– Periodic monitoring plan (certified by the organization or individual); 

– Samples of product labels circulating in the country of origin and sub-labels in Vietnamese (certified by organizations or individuals);

– Product samples for products imported into Vietnam for the first time for comparison when submitting dossiers;

– A business registration certificate with a food business line or a certificate of legal entity for organizations or individuals importing food (a copy certified by the organization or individual);

– Certificate of establishment meeting food safety conditions, for importers subject to the issuance of certificates of establishments meeting food safety conditions as prescribed (a copy certified by the organization, individual);

 

Step 3. Application for the Certificate of Food hygiene and safety

Time: 3 – 7 days

Authority: Technical Center for Standards, Metrology and Quality 1 (Quatest 1, Hanoi), Technical Center for Standards, Metrology and Quality 3 (Quatest 3, HCMC); National Institute for Food Control (Hanoi)…

Dossiers: 

  • 04 Certificate of registration for inspection of imported food according to the form  15/2018/NĐ-CP;
  • Product self-declaration;
  • 03 (three) Satisfactory results of consecutive normal inspections under the tightened inspection method for shipments, which are subject to change from tightened inspection to normal inspection ( original);
  • A copy of the List of goods (Packing list);
  • Packing list; Bill of Lading; Invoice;
  • Authorized letter (LOA): the manufacturer or product owner authorizes the organization or individual to be responsible for bringing the product to the market to distribute products in Vietnam (if any).
  • Contract; CA; Free Sales; Health Certificate (if any)
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Fee: 

  • General inspection: Customers pay the registration fee and get the registration ( No. 117/2018/TT-BTC): 300,000 VND / shipment.
  • Strict inspection: Customers pay a registration fee of 1,000,000 VND/lot + (item number x100,000 VND, from item number 2). Maximum 10,000,000 VND/lot.

 

Step 4: Customs clearance to import goods

Step 5: Samples inspection

Step 6: After the customs authority checks and achieves standard results. Enterprises will have to submit additional results to the Customs office to clear the shipment. In case of failure, the enterprise must make payment.

 

If you are interested in importing oral drops, please don’t hesitate to contact us, Noble Network is delightful to support and guide you through every step of the process. 

We hope that the above article will bring many useful things to you! Join our network here

 

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