With respect to the above matter,

Following the implementation of Regulatory control of API for registered products* with registration expiration starting 1 January 2020, product registration holders (PRH) must provide required API information via “Section S Revision” at least 12-15 months before the registration expiration date.

* Products containing scheduled poisons in Category of New Drug Product (NDP) or Prescription (Full)

National Pharmaceutical Regulatory Agency have recently revised the requirement of API information for "Section S Revision" for products containing Non Anti-infectives API. Hence, we are updating ANNEX 1 - ACTIVE PHARMACEUTICAL INGREDIENT (API) SUBMISSION CHECKLIST FOR UPDATING PART II S INFORMATION FOR PRODUCT REGISTERED BEFORE THE IMPLEMENTATION OF DIRECTIVE ON REGULATORY CONTROL OF API

Please find the updated Annex 1 here: Annex1_API-Requirement-for-Registered-Product-V2 (Version 2.0, May 2019).

Best Regards,

API Section