Taiwan Abolished 16 Provisions Relating to Medicated Cosmetics

No.

Regulations/Provisions be Abolished

1

Official document: Instructions for modifying registered information of medicated cosmetics and colorants

2

Official document: Quality Control management provision for examination and registration and marketed sample inspection of manufactured/imported medicated cosmetics and colorants

3

Official document: Simplified procedures for the examination, registration and modification of registered information

4

Provision: Recognition rules for free sale certificate from overseas countries of imported medicated cosmetics

5

Official document: Administrative provision for standard usage of medical, poisonous or potent drugs in cosmetics

6

Provision: the enforcement method of priority examination plan for companies who comply with voluntary GMP and obtain official verified certificate. (Prescribed in the "Key Points on the Implementation of Voluntary Cosmetics Good Manufacturing Practices".)

7

Provision: Permission for medicated cosmetics with same functions, main ingredients(within the legal limits), forms and manufacturer/importers to register as one product and share only one certificate

8

Provision: No need to apply for modification of registered information when there is modification of excipients in medicated cosmetics

9

Provisions: For registered medicated cosmetic with manufacturing country change, if the product involves identical manufacturing procedures and formula, and the manufacturer complies with cosmetic GMP or standard of ISO 22716, this product can apply for modification with submission of actual certificate instead of application of new registration. The testing specification, method and testing report should be maintained with manufacturer for future reference

10

Provisions: No need to apply for review or future reference when there are modifications of label, prospectus and package of medicated cosmetics

11

Provision: To simplify the procedure for modifications of registered information (cosmetic label, prospectus and package), Ministry of Economic Affairs Intellectual Property Bureau should review and approve product's new trademark, and manufacturer can adjust trademark on label, prospectus and package in accordance with market demand themselves instead of applying for modification.

12

Official document: Simplified application procedure for medicated cosmetics re-applying for examination and registration when the former registration certificate is due without renewal

13

Provisions: In circumstance where drug factories, cosmetic factories and traders entrust Taiwanese manufacturer to manufacture medicated cosmetics, the license holder is the party to apply for examination and registration

14

Official documents: Procedures for application of modifying registered information on certificate of medicated cosmetic

15

Provision: When application dossiers submitted for examination and registration, renewal, modification and repackaging of medicated cosmetics are incomplete, applicants should supplement documents within 2 months (can apply for 1 month extension if necessary), or the TFDA will close the application

16

Provision: To apply for renewal of registration certificate, designated power of attorney or authorized distribution certificate issued by the original overseas manufacturers is changed to 2 years validity. (Prescribed in the "Requirements for applications for extension of period of validity of license for medicated cosmetics and colorants")