Draft for Comments of Implementing Guidelines for Imported Pharmaceutical Products from a Foreign Trader

All comments can be sent at [email protected]. Deadline of submission of comments shall be by 21 August 2020.

1. OBJECTIVES

This Circular aims to:

1. Provide guidelines to reflect the actual manufacturer of drug products;
2. Provide guidelines for all renewal, compliance, MR to Initial Applications which were disapproved due to non-submission of the Foreign current Good Manufacturing (cGMP) Clearance due to the reflected manufacturer is a loan license manufacturer; and
3. Provide guidelines to all pending and incoming registration of drug products having a foreign trader.

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