(NAR) VOL. II NO. 3 / JULY - SEPTEMBER 1991
"Action on registration application shall be based on the complete set of specifications of the drug product proposed to appear in the label, i. e. formulation, dosage form, strength, therapeutic indication and manufacturer. Any change in any of the above specifications will require a new registration."2. This Circular clarifies the requirements for a new registration of a drug product with a valid registration when there is a change of manufacturer without any change in other specifications covered by Section 2.2 above.
3.1 | Upon determination by BFAD that the new manufacturer meets the above criteria and upon submission of the complete requirements for product registration including the old original CPR, conditional CPR shall immediately be issued. | |
3.2 | The CPR of the product with the old manufacturer shall automatically be cancelled with the issuance of the conditional CPR with the new manufacturer. The products produced by the old manufacturer before the new conditional CPR is issued will be allowed in the market until expiration date of the product. | |
3.3 | The conditional CPR shall be effective for a period of one (1) year subject to the results of the BFAD Laboratory Tests and Stability Studies on the product of the new manufacturer. Unsatisfactory results will mean the immediate cancellation of the conditional CPR. |