Conditions for Cosmetics Production According to the New Regulations 2016

Adding to the list of business sectors subject to conditional investment, the Government has issued Decree 93/2016/ND-CP on July 01, 2016, stipulating the conditions for cosmetics production. The decree outlines the following salient points to note:

First, Article 3 of Decree 93/2016/ND-CP mandates that cosmetic manufacturing facilities must:

- Be legally established.- Have a certificate of eligibility for cosmetic production according to Form No. 01 specified in the Annex issued together with this Decree.

Second, in order to obtain a certificate of eligibility for cosmetic production under Article 4 of the Decree, the person in charge of the cosmetic manufacturing facility must have professional knowledge in one of the following fields: Chemistry, Biology, Pharmacy, or other related fields that meet the job requirements. Additionally,

The physical facilities as prescribed in this Decree must meet requirements on location, area, workshop, and equipment suitable for the production line and types of cosmetic products that the facility intends to produce as stated in the dossier requesting the Certificate of eligibility for cosmetic production. The storage for raw materials, packing materials, and finished products must ensure a separation between raw materials, packing materials, and finished products; there must be separate areas for the storage of flammable, explosive substances, highly toxic substances, raw materials, and products that are rejected, recalled, and returned.

Additionally, the quality management system must meet the following requirements:

- Raw materials and auxiliary materials used in cosmetic production must meet the quality standards of the manufacturer;- Water used in cosmetic production must at least meet the national technical regulations on drinking water set by the Minister of Health;- All semi-finished products used in production must have quality standards and meet the quality standards of the manufacturer;- There must be a production process for each product;- There must be a quality control department to check the quality of raw materials, semi-finished products, products waiting for packing, and finished products;- There must be a system for document retention.

Procedures for issuing a certificate of eligibility for cosmetic production are guided as follows:

| Procedure | Receiving and processing agency | Time limit | Content || :---: | :---: | :---: | :---: || Submit the dossier | Send by post to the Department of Health of the province where the manufacturing facility is located. | 02 working days from the date of receiving the application dossier |

  1. The dossier requesting a Certificate of eligibility for cosmetic production includes the following documents:
  • Application for a Certificate of eligibility for cosmetic production according to Form No. 02 specified in the Annex issued together with this Decree;
  • Factory layout and design of the manufacturing facility;
  • List of equipment available at the manufacturing facility;
  • List of products being produced or expected to be produced and quality standards of each product.
  1. Issuance of a dossier receipt certificate according to Form No. 05 specified in the Annex issued together with the Decree.

  2. Notification in writing of any incomplete or invalid contents.

|| **Eligible for certificate issuance** | Department of Health | 30 days from the date of receiving a valid dossier and appraisal fee as stipulated | The Department of Health inspects the manufacturing facility and issues a Certificate of eligibility for cosmetic production; in case of non-issuance or requirement for changes and remediation, a written notice indicating reasons must be provided. || **Procedure for changes and remediation** | Department of Health | | The cosmetic manufacturing facility carries out changes and remediation and submits a report || 15 days from the date of receiving the remediation report | The Department of Health reviews the report, inspects the dossier or re-inspects the cosmetic manufacturing facility (if necessary) and provides a written response on the inspection results; || 06 months from the date of issuing a written request for changes and remediation | If the Department of Health does not receive a remediation report from the facility, the dossier requesting a Certificate of eligibility for cosmetic production of the facility is no longer valid. |

Decree 93/2016/ND-CP regulating the conditions for cosmetic production takes effect from July 1, 2016.

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