Attention

All market authorization Holders (MA)/Manufacturers/Distributors

NMRA announces the issuance of

1. 1.GL-017 – Guidelines on Recalls of medicines, medical devices and borderline products
2. 2.GL-003 – Guideline for safe disposal of expired and unwanted pharmaceuticals

These guidelines are effective from 01.02.2021.

Therefore all MA holders should adhere to these guidelines with immediate effect. As a result all MA holders are advised to send following information to NMRA promptly in the event of product/batch recall and disposal of recalled/expired/unwanted products

• -GL-017 -Annexure III – Summary report of product/batches recall Submit within one week of reconciliation of the defective product/batch.

• -GL-003- Annexure II – Application form for disposal of unusable and unwanted pharmaceuticals with the Annexure I –Register of unusable and unwanted pharmaceuticals

Above information should be sent to NMRA before disposal of the product/batch and should be reach NMRA at least 2 weeks prior to expected destruction date. Disposal should be carried out according to the NMRA guidelines.

(Date: 23 September 2021)