AMENDMENT AND SUPPLEMENT AFTER PRODUCT DECLARATION

From February 2, 2018 when Decree 15/2018/ND-CP takes effect, the certificate for product announcement registration is valid indefinitely (This means that businesses only need to register a product once). Therefore, The precision of the information in the product registration dossier when submitting it to the website of the Food Safety Department is crucial.

However, during the validity period of the product declaration registration certificate, if a business wishes to make any changes, it must consider whether the information can be supplemented after the announcement or if it requires re-registering the product declaration. Contact Medgate – a company providing product announcement registration consulting services for advice and guidance when businesses have changed arising, avoiding risks after the test later.

Changes that can be made after receiving the product declaration registration certificate

*When changes are related to the following information, businesses can proceed with the amendment and supplement procedures after the announcement:

– Change of company name

– Change of head office address

– Change of legal representative as stated in the business registration certificate

– Correction of errors made during the dossier preparation, such as spelling mistakes

Documentation for amending and supplementing (Health Supplement) on the website for the changed content

– Official dispatch and explanation about the changes of published content

– Updated relevant documents reflecting the changes

Penalties for organizations do not register the product declaration with the changes that need to be announced

A fine ranging from 20 million VND to 30 million VND for any of the following behaviors:

a) Failure to re-register the product announcement as required by law in cases where there are changes to the product’s name, origin, or composition.

b) Failure to provide written notification of changes after product announcement registration to the state authority as required by law, or providing notification but with inappropriate content that does not match the product’s changes, or lacking proper documentation according to legal regulations to prove those changes.

Contents not allowed to be changed after receiving  the product declaration registration certificate

*The changes related to the following contents, businesses must re-register the product:

– Change of product name

– Change in composition

– Change in the function, target users, and precautions of the product

– Change in the origin of the product

Medgate’s tasks for amending and supplementing with the changed content

– Verify the legal validity of the documents provided by customers.

– Determine if the requested changes fall within the permissible scope of modifications

– Complete the documentation: draft letter, Update relevant documents reflecting the changes

– Represent the customer in submitting the documents on the Food Safety Department’s website.

Reasons to choose Medgate’s services

– Providing a variety of services to help customers save time in finding reputable and reasonably priced service providers.

– A team of professional experts with extensive experience

– Regular updates on new regulations and guidelines.

– Enthusiastic consultation and customer support.

Customers can also refer to other services provided by Medgate, such as

– Domestic Health Supplement Declaration Registration Service

– Import Health Supplement Declaration Registration Service

– Advertising Services for Cosmetics, Drugs, and Medical Devices, Health Supplement.

– Cosmetic Declaration Registration Service

– Classification and Declaration of Standards for Class A and B Medical Devices

– Classification and Registration for Circulation of Class C and D Medical Devices

– Announcement of Eligibility for Trading of Class BCD Medical Devices

– Announcement of Eligibility for Production of Medical Devices

– Training Services for Product Registration Announcement, Cosmetics, Drugs, and Medical Device

For consultation on MEDGATE’s registration and import-export services, please contact us at the hotline 098.546.1894 or send a message via our fan page for immediate assistance.

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