Update of Annex 1: Requirements for Active Pharmaceutical Ingredient (API) Information during Section S Revision

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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