In order to implement the Overall Plan for the Construction of Hainan Free Trade Port issued by the State Council, optimize the supervision measures for Hainan's offshore duty-free cosmetics, promote the return of overseas consumption, and help build Hainan into an international tourism consumption center, with the consent of NMPA, the following announcement is issued on the pilot implementation of electronic labels for offshore duty-free cosmetics:
I. Pilot Work Content
(I) From September 1, 2024, cosmetics sold through Hainan's offshore duty-free shopping channels (hereinafter referred to as offshore duty-free cosmetics) can use electronic labels to mark product Chinese labels. During the pilot period, offshore duty-free cosmetics can choose to use either electronic labels or traditional labels to mark product Chinese labels.
(II) The electronic label referred to in this announcement refers to the storage of the relevant content of the Chinese label of offshore duty-free cosmetics through a certain electronic storage mechanism and the generation of corresponding electronic codes. The electronic label should have a convenient reading function and can be directly read by consumers using common communication or payment software installed on their smartphones to obtain the Chinese label information of the product.
(III) The pilot period is tentatively set at 2 years. Before the expiration of the pilot period, the Hainan Provincial MPA will make corresponding adjustments to the management measures for electronic labels of off-island duty-free cosmetics in accordance with the deployment of the NMPA on the pilot work of electronic labels for cosmetics and according to the actual needs of the work.
II. Electronic Label Management
(I) If the offshore duty-free cosmetics intend to use electronic labels to mark the Chinese labels of the products, the cosmetics registrant, recorder or domestic responsible person shall fill in the product Chinese label information to be generated for the electronic label in accordance with the "Off-island Duty-free Cosmetics Electronic Label Pilot Work Requirements" attached to this announcement before the product is put on the market for sale or imported, and submit it online to the Hainan MPA.
(II) After receiving the product Chinese label information to be generated for the electronic label submitted by the offshore duty-free cosmetics registrant, recorder or domestic responsible person, the Hainan MPA shall encode the product Chinese label information that meets the requirements to generate an electronic label and publish it on the Hainan MPA government website.
(III) The offshore duty-free cosmetics registrant, recorder or domestic responsible person shall log in to the Hainan Provincial Medicine MPA government website, download the product electronic label by themselves, and print or affix the electronic label in a prominent position on the visible surface of the product sales packaging.
III. Requirements for the Pilot Work
(I) The content of the electronic label of offshore duty-free cosmetics shall comply with the provisions of the Regulations on the Supervision and Administration of Cosmetics, the Measures for the Administration of Cosmetics Registration and Filing, the Measures for the Supervision and Administration of Cosmetics Production and Operation, the Measures for the Administration of Cosmetics Labels and other laws and regulations. The registrant, registrant or domestic responsible person of cosmetics shall be responsible for the authenticity, accuracy, completeness and legality of the corresponding Chinese label information of the electronic label of offshore duty-free cosmetics.
(II) If offshore duty-free cosmetics use electronic labels to mark the Chinese labels of products, offshore duty-free operating enterprises shall cooperate in providing paper materials containing the Chinese label information of products according to consumer needs.
(III) Hainan Provincial MPA is responsible for the collection and collation of Chinese label information of offshore duty-free cosmetics, the management of electronic label coding, etc., and guides the drug supervision and administration departments of cities and counties where offshore duty-free cosmetics operating enterprises are located to strengthen the daily supervision and management of electronic labels in the product sales process.
IV. Supervision and Management
(I) Drug regulatory departments at all levels in Hainan Province shall strengthen supervision of electronic labels for duty-free cosmetics on offshore islands and strictly investigate and punish illegal and irregular behaviors of electronic labels. If violations of relevant provisions on cosmetic label management are found, they shall be handled in accordance with the relevant regulations such as the Regulations on the Supervision and Administration of Cosmetics. If counterfeiting and use of electronic labels for duty-free cosmetics on offshore islands is found, they shall be handled in accordance with Article 61, paragraph 1, item (5) of the Regulations on the Supervision and Administration of Cosmetics; if electronic labels are not clearly printed and difficult to scan and read, or are not firmly pasted, they shall be handled in accordance with Article 61, paragraph 2 of the Regulations on the Supervision and Administration of Cosmetics.
(II) Drug regulatory departments in Hainan Province shall strengthen coordination and cooperation with departments such as commerce and customs, and promptly report information on the management of the use of electronic labels for cosmetics and illegal and irregular behaviors, form a joint supervision force, and effectively protect the legitimate rights and interests of consumers and ensure public safety.
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