Taiwan FDA Drafted Administrative Measures for Cosmetics Certificate Issuance

Takehome:

On Sep 3, 2018, TFDA released a draft of Administrative Measures for Cosmetics Certificate Issuance.

The Measure includes the application requirements, review procedures and standards, validity period, cancellation of cosmetic certificates. Except for the regulations related to GMP certificate which will be effective on Jan 1, 2021, the implementation date of this Measure has not been determined yet. The main contents of Administrative Measures for Cosmetics Certificate Issuance include:

1. Legal basis
2. Certificate categories

• Cosmetics Production and Marketing Certificate I: Certificate that proves cosmetics manufactured in Taiwan are allowed to be sold in Taiwan;
• Cosmetics Production and Marketing Certificate II: Certificate that proves cosmetics manufactured in Taiwan have been sold in Taiwan;
• Cosmetics Manufacturing Factory Certificate: Certificate that proves the cosmetics manufacture at a Taiwan manufacturing plant;
• Cosmetics Sale Certificate: Certificate that proves imported cosmetics sell in Taiwan;
• Cosmetics Good Manufacturing Practice Certificate: Certificate that proves cosmetics manufacture meets GMP requirement.

3. Dossiers necessary for five kinds of cosmetics certificates application
4. Dossiers necessary for cosmetic GMP certificate

The central competent authority will conduct on-site inspections and issue the GMP certificate if the enterprise meets the requirement. The validity period is 3 years. Unqualified enterprises may submit a re-evaluation application within 2 months after receiving the rejection notice. Re-evaluation is limited to only 1 time.

Before the changes of Taiwan cosmetic overarching regulation, the GMP certificate is not mandatory for cosmetic enterprises. If the enterprise fails to pass the voluntary GMP on-site inspection, it can only reapply for GMP inspection three months after receiving the rejection notice. Now the new Measure gives an opportunity for re-evaluation within 2 months, which is more reasonable and convenient for enterprises.

The regulation related to GMP certificate will be effective on Jan 1, 2021. Prior to 2021, the GMP certificate is still issued by the Ministry of Economic Affairs in accordance with Key Points on the Implementation of Voluntary Cosmetics Good Manufacturing Practices.

5. Inadmissible conditions for certificate application

• Inconsistencies between dossiers and application contents;
• Fake dossiers;
• Other conditions do not comply with regulations.

6. Conditions for certificate cancellation.