Regulatory Updates
Attention: – Manufacturers of Pharmaceuticals and Biologicals Drug
The Therapeutic Goods (Federal Inspectors, Laboratories and Federal Government Analysts) Rules, 2022 for comments
Draft Guidelines On Good Pharmacovigilance Practices For Registration Holders for view Comments to be Submitted to National PV Center DRAP till 15th January, 2022
User Guide For Online Import / Export Applications Software
Pre-Submission Screening Checklist for Biological Registration Dossier
Certificate Of Good Manufacturing Practices (GMP) For Establishment Units Manufacturing Medical Devices: Policy Board Decision.
Training: Implementation of online software for import export clearance
Deficiency letter of all deferred products in 93rd meeting of EEC held on 11-08-2021
Import of Short Shelf Life Material(s)/Product(s).
I am directed to refer to the subject cited above and to state that the “Recommendatory Committee to Recommend Import of Short Shelf-life Drugs” in its 50th Meeting held on 18th October, 2021 decided to issue the following Advisory: –
- The Manufacturers/Importers be advised to apply for pre-import permission for their import consignments with Short Shelf Life. Post import cases will be considered in very exceptional circumstances of Force Majeure.
- The Committee further advised to charge ‘Miscellaneous Fee’ (for each Batch of Short Shelf Life Material / Product being imported) for all cases recommended after May 2021.
2. The above recommendations of the committee have been approved by the Competent Authority i.e. CEO, DRAP and the same are being communicated for compliance in true letter and spirit. please.