After biologics being imported or manufactured, pharmaceutical firms shall fill out an application form for lot release procedures of Biologics (as per attachment 1), and submit the application along with the following to the central competent health authority, and pay the assessment fee upon notice (including testing fee, lot release fee, travel and delivery fee):
1. Importing packing list
2. Drug approval license or a copy of the approval document from the central competent health authority
3. Lot release certificate issued by the health authority of country of origin may be replaced by reviewing summary protocol and certificate of analysis from the manufacturer where the original health authority allows self-release
4. Literatures regarding the manufacturing process, testing method, specifications, and standards of the biologics
5. Standard operating procedures (SOP) of source management on animal raw materials and proof of source of raw material
6. Summary protocol of biologics during manufacturing process, and testing records and the certificate of analysis of finished products
Domestic manufacturer shall apply for lot release referred in the preceding Paragraph after the product being tested by the manufacturer and complied with the specification, and is exempt from providing information in the preceding first and third Subparagraph.
Biologics for epidemic controlor exportation use, submission of documents mentioned in Paragraph1, Subparagraph 6 can be postponed until the date before the release of the product upon permission of the central competent authority.
Pharmaceutical firms failure to pay the assessment fee, fill out the application, submit all necessary document or comply with Paragraph 1 shall complete all process upon notice of the central competent health authority within two months.
Pharmaceutical firms failure to complete the process within the deadline, shall file an extension with written reasons before the deadline; the period of extension, if permitted, is one month after the date of the deadline, and such extension will be granted only once.
Pharmaceutical firms failure to complete the process before the deadline, or before the expiration of the one-month extension period, the central competent health authority may perform review on the basis of existing information and accept or reject the application.