Snapshot

The Lot Release of Biological Products in Egypt pathway has been developed by the of Egypt.

This pathway can be used where biological products.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

The lot release for biological products in Egypt will follow one of the following pathways: a) Normal release pathway: in which all biological products will be categorized into three risk groups (low, moderate and high-risk groups). b) Expedited release pathway: Expedited release may be granted in exceptional cases and upon appropriate justification such as: • Product shortage in Egypt • Public health emergency • Biological products donated from international organizations. Batches will be released after evaluation of relevant documents and performing the minimum test items that assure product safety & quality. For other situations in which a product is needed to be released immediately, it will be handled on a case-by-case basis. c) Recognition of Lot Release by Other NRAs/NCLs pathway: Lot release (LR) administration shall accept a batch for release based on the existing release certificate from one of the reference regulatory authorities listed, through a unilateral recognition process. In this case, the batch release process is performed on the basis of the existing NRA/NCL release certificate and laboratory testing is minimized to visual inspection test. LOT RELEASE TIMELINES. The timelines for each activity in the lot release process are as follow: (i) Submission of batch data form and required relevant documents =10 working days before product arrival at warehouse. (ii) Issuance of lot documents review report = Within a duration range from 7-10 working days according to product type. (iii) Submission of samples of lots inspected to LR for testing = Within 2 working days from cold chain inspection for warehouses. (iv) Issuance of lot release certificate = Within 5 working days from receiving all lot testing results. (v) Submission of non-conformity appeal by the applicant = Within 10 working days from the date that it was informed of the non-conformity.