CFDA: Public Consultation on Supporting Document for Formula Registration Administrative Measures for Infant and Young Children Formula Milk Powder

by 范皓菲 | Source 未知 | Aug 18,2016

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On Aug 12, 2016, to carry out the formula registration of infant and young children formula milk powder, China Food and Drug Administration (CFDA) issued the following two support document for public consultation:


1. Application Materials and Requirements for Formula Registration of Infant and Young Children Milk Powder (Trial) (Draft for commons)

2. Key Points of On-site Verification and Inspection and Judging Principles for Formula Registration of Infant and Young Children Milk Powder (Trial) (Draft for commons)

 

According to the supporting document, milk powder enterprises shall register the formula of the milk powder. Ten materials shall be provided when make the application:

1. The application form for formula registration of infant and young children milk powder;

2. Documentary evidence for qualification of applicant body;

3. Quality and safety standard of raw materials;

4. Product formula;

5. The report of product formula development;

6. The statement of manufacturing technique;

7. Product test report;

8. Documentary evidence for development capacity, manufacture capacity and test capacity;

9. Other materials for the scientific and safety of the product;

10. Label and the sample of specification, and the statement of the claim with documentary evidence.

 

Enterprises shall provide the following document for import infant and young children formula milk powder:

1. Documentary evidence for registration of overseas production enterprise of imported infant and young children formula milk powder issued by national entry-exit inspection and quarantine departments

2. Registration through the representative offices of overseas applicants in China shall be provided the copy of Registration certificate for the representative offices of foreign enterprises in China

3. Overseas applicant entrusted China agency for registration shall provide the original letter of authorization with notarized and its translation, and the copy of business license for the entrusted agency.

 

Besides the provided materials, related departments shall conduct on-site audit. The key points include:

1. Production condition

2. Quality control

3. Test capacity

4. Development capacity

5. Sample trial

 

Source: CFDA

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