Reference translation notice: This English text is an operational reference translation prepared from the Vietnamese source text for website reading. It is not an official legal translation. Exact legal application must be checked against the Vietnamese original DOC/PDF and current amending/consolidated instruments.

Pursuant to the decrees and decisions on the functions of the Ministry of Health, product quality, advertising, labelling, international goods trading and certificates of free sale; and to implement the ASEAN Cosmetic Harmonization Agreement, the Ministry of Health provides the following regulations on cosmetic management:

CHAPTER I

GENERAL PROVISIONS

Article 1. Scope of regulation and subjects of application

Regulates domestic and imported cosmetic products circulated in Vietnam, including notification, Product Information File, safety, labelling, advertising, import/export, sampling, inspection, handling of violations, responsibilities of traders/importers and consumer rights.

Article 2. Interpretation of terms

Defines cosmetic product, cosmetic product announcement/notification, placing on the market, person responsible for placing the product on the market, Product Information File (PIF), product label, ASEAN Cosmetic Directive and related terms used for management.

CHAPTER II

COSMETIC PRODUCT NOTIFICATION

Article 3. Regulations on cosmetic product notification

Cosmetic products must be notified before being placed on the market. The organization or individual responsible for placing the product on the market is responsible for safety, efficacy and compliance with Vietnamese law.

Article 4. Cosmetic product notification dossier

Sets out the dossier components for cosmetic product notification, including notification form, business registration/investment certificate and power of attorney when applicable; dossiers must be prepared according to the prescribed form and data requirements.

Article 5. Preparation of the cosmetic product notification form and notification data

Guides how to prepare the notification form, product information, product name, form, intended use, composition, manufacturer, responsible entity and electronic/data requirements for submission.

Article 6. Power of attorney

Regulates form and validity of the power of attorney issued by manufacturer or product owner to the organization responsible for placing the cosmetic product on the Vietnamese market.

Article 7. Receipt and handling of notification dossiers

Provides the process for receiving, reviewing and issuing the receipt number for cosmetic product notification dossiers; also covers requests for amendment or supplement where the dossier is incomplete or not compliant.

Article 8. How to record the receipt number of the cosmetic product notification form

Regulates the structure and manner of recording notification receipt numbers to identify issuing authority, year and dossier sequence for management and traceability.

Article 9. Changes to notified contents

Sets out cases requiring notification or amendment when the product name, responsible organization, manufacturer, formula, product form or other notified information changes.

Article 10. Validity of the cosmetic product notification receipt number

Sets out the validity term of the notification receipt number and requirements for re-notification when the validity period expires or the notified information changes as prescribed.

CHAPTER III

PRODUCT INFORMATION FILE

Article 11. General provisions on the Product Information File

Requires the Product Information File to be kept by the organization responsible for placing the product on the market and to be made available to competent authorities for inspection.

Article 12. Contents of the Product Information File

Specifies key contents of the PIF, including product description, safety data, manufacturing method, product efficacy support and information required under ASEAN cosmetic management principles.

CHAPTER IV

COSMETIC PRODUCT SAFETY REQUIREMENTS

Article 13. Cosmetic product safety requirements

Organizations placing cosmetics on the market must ensure that products are safe for human health when used under normal or reasonably foreseeable conditions of use.

Article 14. Prohibited ingredients and ingredients subject to limits or conditions

Refers to prohibited substances, restricted substances, permitted colorants, preservatives and UV filters under ASEAN cosmetic annexes and applicable Vietnamese regulations.

Article 15. Products containing certain ingredients

Addresses transitional or specific cases for cosmetic products containing ingredients subject to ASEAN/Vietnamese control and the conditions for continued circulation where allowed.

CHAPTER V

COSMETIC LABELLING

Article 16. Position of the cosmetic label

Requires the label to be attached on the commercial package or container in a visible and legible manner suitable for circulation and inspection.

Article 17. Label size, form and contents

Provides requirements on label presentation, size, readability and the manner in which mandatory information must be displayed.

Article 18. Mandatory label contents

Requires mandatory label information such as product name/function, composition, net weight or volume, batch number, manufacturing/expiry information, use instructions, warnings and responsible organization details as applicable.

Article 19. Language used on cosmetic labels

Mandatory contents must be presented in Vietnamese, except for internationally accepted ingredient names or other terms allowed to remain in a foreign language under the regulation.

Article 20. Other contents shown on cosmetic labels

Allows other information to be displayed provided it is truthful, not misleading and compliant with laws on labelling, advertising and product safety.

CHAPTER VI

COSMETIC ADVERTISING

Article 21. Regulations on cosmetic advertising

Cosmetic advertising must be consistent with notified product functions and must not represent cosmetics as medicines or claim therapeutic effects.

Article 22. Contents of cosmetic advertisements, seminars and promotional events

Sets out information that may or must be included in cosmetic advertisements, seminars and events and prohibits misleading or non-compliant claims.

Article 23. Cosmetic advertising on television and radio

Provides rules for audio-visual advertising, including clear presentation of required information and compatibility with the approved advertising content.

Article 24. Advertising in newspapers and leaflets

Regulates advertising in printed press and leaflets, including required information, consistency with notified product contents and compliance with advertising law.

Article 25. Dossier for cosmetic advertising registration, seminars and events

Specifies dossier components for registering cosmetic advertising contents or organizing seminars/events introducing cosmetics.

Article 26. Authority receiving and handling advertising registration dossiers

Identifies competent health authorities that receive and handle cosmetic advertising, seminar and event registration dossiers.

Article 27. Procedures for issuing the receipt for cosmetic advertising registration dossiers

Provides the sequence and timing for receiving, reviewing and issuing receipts for cosmetic advertising registration dossiers.

Article 28. Appraisal fee for information and advertising contents

Provides that appraisal fees for cosmetic information and advertising contents are implemented under applicable fee regulations.

Article 29. Cosmetic advertising in other localities

Regulates the use of advertising contents in localities other than the locality where the receipt was issued, subject to required notification/coordination.

Article 30. Changes or supplements to advertising contents, seminars and events

Requires registration or supplementation when advertising contents, seminar/event information or relevant materials are changed.

Article 31. Cases where cosmetic advertising or seminar/event contents cease to be valid

Lists cases where advertising or event registration contents no longer remain valid, such as changes to product notification, safety issues or regulatory violations.

CHAPTER VII

COSMETIC EXPORT AND IMPORT

Article 32. Cosmetic export

Regulates export of cosmetics and issuance/use of supporting documents where required by importing markets or competent authorities.

Article 33. Dossier and procedure for issuing Certificates of Free Sale (CFS) for exported cosmetics

Provides dossier and procedure for issuing CFS for cosmetics exported from Vietnam.

Article 34. Dossier and procedure for issuing certificates of compliance with cosmetic GMP principles

Provides dossier and procedure for certifying manufacturing establishments that satisfy cosmetic good manufacturing practice principles.

Article 35. Cosmetic import

Regulates import of cosmetics, including requirement for product notification receipt numbers prior to customs clearance/circulation, except where specific exceptions apply.

CHAPTER VIII

SAMPLING FOR COSMETIC QUALITY INSPECTION

Article 36. Sampling principles

Provides principles for taking cosmetic samples for quality inspection in a representative, lawful and traceable manner.

Article 37. Rights and responsibilities of the sampler

Sets out authority, documentation, sample sealing and responsibilities of persons taking samples.

Article 38. Transport and handover of samples

Regulates sample preservation, transport and handover to testing or inspection units to ensure sample integrity.

Article 39. Conclusion on quality inspection results of cosmetic samples

Regulates how quality inspection results are concluded and used as a basis for handling non-conforming products.

Article 40. Funding for sampling and testing to determine cosmetic quality

Provides rules on funding for sampling and testing activities according to applicable law and responsibility of relevant parties.

CHAPTER IX

STATE INSPECTION, EXAMINATION AND HANDLING OF VIOLATIONS

Article 41. State inspection of cosmetic quality

Regulates state quality inspection of cosmetics circulating on the market, imported cosmetics and products subject to safety or quality concerns.

Article 42. Forms of inspection and examination

Provides forms of inspection and examination, including planned, periodic, ad hoc or risk-based inspections.

Article 43. Inspection and examination contents

Sets out contents to be checked, such as notification, PIF, labels, advertising, import documents, quality, safety and compliance with responsibilities.

Article 44. Priority order in post-market surveillance

Sets the priority order for post-market surveillance based on risk, complaints, previous violations, product type, origin or other management information.

Article 45. Suspension of circulation and recall of cosmetics

Regulates cases and measures for suspending circulation and recalling cosmetic products that are unsafe, non-compliant or otherwise violate regulations.

Article 46. Withdrawal of the cosmetic product notification receipt number

Provides cases where notification receipt numbers may be withdrawn, including false dossiers, serious violations, safety issues or non-compliance with notified contents.

Article 47. Cases of temporary suspension from receiving cosmetic product notification dossiers

Provides cases where authorities may temporarily suspend receiving notification dossiers from violating organizations or individuals.

CHAPTER X

RESPONSIBILITIES AND CONSUMER RIGHTS

Article 48. Responsibilities of organizations and individuals manufacturing, trading and importing cosmetics

Sets out responsibilities for legal compliance, product safety, notification, PIF retention, labelling, advertising, recall, reporting and cooperation with authorities.

Article 49. Rights of cosmetic consumers

Recognizes consumer rights to information, product safety, complaints and protection under consumer and product quality laws.

CHAPTER XI

IMPLEMENTATION PROVISIONS

Article 50. Information and reporting regime

Requires information exchange and reporting by competent authorities and relevant organizations on cosmetic management activities.

Article 51. Forms and annexes attached to the Circular

Lists forms and annexes attached to the Circular, which are part of the legal dossier framework for notification, advertising, PIF, sampling, inspection and related procedures.

Article 52. Transitional provisions

Regulates transitional handling of dossiers, receipt numbers, advertisements and other management matters arising before or around the effective date of the Circular.

Article 53. Effect

Specifies the effective date of the Circular and responsibilities for implementation by relevant authorities, organizations and individuals.

Annexes and forms attached to the Circular

Annex 01-MP – Guidelines on classifying cosmetic products and non-cosmetic products.

Annex 02-MP – Cosmetic product notification form.

Annex 03-MP – Guidance on Product Information File and related technical information.

Annex 04-MP – Cosmetic product notification and management forms.

Annex 06-MP – Cosmetic import/export and CFS-related forms.

Annex 07-MP – Product Information File content requirements.

Annex 08-MP – Cosmetic sampling record/form.

Annex 09-MP – Sample handover and storage-related form.

Annex 10-MP – Quality inspection and reporting form.

Annex 11-MP – Suspension/recall and handling form.

Annex 12-MP – Reporting form for cosmetic management.

Annex 13-MP – List/reporting template attached to management dossiers.

Annex 14-MP – Other implementation forms attached to the Circular.

FOR THE MINISTER
DEPUTY MINISTER
Cao Minh Quang