Taiwan Proposes Amendments to Medicated Cosmetics and Colorants Test Registration

FDA attempts to amend Test Registration Notices for Medicated Cosmetics and Colorants, in order to consolidate requirements listed in numerous separate announcements. Test Registration Notice for Medicated Cosmetics and Colorants was issued during a cosmetic communication and discussion conference held by TFDA in December 2016...

Takehome:

TFDA attempts to amend Test Registration Notices for Medicated Cosmetics and Colorants, in order to consolidate requirements listed in numerous separate announcements.

Test Registration Notice for Medicated Cosmetics and Colorants was issued during a cosmetic communication and discussion conference held by TFDA in December 2016. Compared with current requirements, three new regulations have been proposed. The new notice allows the addition of secondary manufacturers to the registration application; simplifies change of manufacturing country application procedures and exempts applications for the addition or deletion of promotional terminology.

Detailed modifications are below:

Clause	Current provision	modification
Add registration of secondary manufacturers	Only singular manufacturer can be registered.	Agree to add registration of secondary manufacturers: Head office should provide documents about entrust manufacturing relationships; Certificate of free sale can be replaced by head office’s documents, which need be signed by local competent authorities, public committee and foreign embassy; Modifying registration of secondary manufacturers, procedures will be the same.
Modification of manufacturing country	Original manufacturer shall submit the supporting document proving compliance with ISO22716 issued by competent authority of the new manufacturing country. Or original manufacturer can apply for a new registration.	Companies can choose to submit either documents below: Certificate of free sale of original countries; Or supporting document proving compliance with ISO22716 issued by competent authority.
Exempting examinations of adding or deleting promotion words	In 1987, it was announced that modifications of medicated cosmetics' labels, instructions and packages can be free from examination.	No need to apply for examination of adding or deleting promotional words such as "buy one get one free", "buy to get one free", "buy big get small", "limited time promotion" and so on.

All information above is under discussion on internal conference, which cannot be treated as official release.