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Applicants/ PHCR

Communications to All Stakeholders

9.01_Antiretrovirals registered by the medicines control council for the period 1989-2004-Jul04v1 (MS-Word 117kb)

9.07_ADR terminology used in package inserts-Feb04_v1 (MS-Word 53kb)

9.08_Process for handling of Dear Healthcare Professional Letters and Medicine Safety Alerts Aug14_v3(PDF)

9.13_Package insert amendments concerning urgent safety restrictions: urgent safety restriction notice (USRN)-May06_v1(MS Word 64kb)

9.17_MCC and Expert Committees Meeting dates_2015_v1(PDF)

9.22_Scheduling matters – accessibility of malaria prophylaxis medicines-Mar09_v1 (MS Word 214kb)

9.24_Guidance to industry regarding submission of the screening copy of an application for registration of a medicine-Aug09_v1 (MS Word 71k)

9.25_Applications for registration of Medicines Containing Enoxaparin-Dec08_v1 (MS Word 65k)

9.26_Request for information on Non-finalized Applications-Sept09_v1 (MS Word 130kb)

9.28_Cancellation and withdrawal of applications or registered Medicines-Oct01_v1 (MS Word 49k)

9.33_Payments made to the Registrar of Medicines-Nov10_v1 (MS Word 88k)

9.40 Changes during the registration process_Jun11_v1(PDF)

9.41_Withdrawal of Dextropropoxyphene_Sept11_v1(PDF)

9.42_SR-PIN_Dates_Nov12_v1(pdf)

9.46_eCTD_pilot_phase_Feb13_v2

9.51_MCC-AAPS_Symposium_Jan14_v1(PDF)

9.52_Audit of clinical package insert amendments_Dec13_v1(PDF)

9.53_Clinical Trials Committee meeting and submission dates_2015_v1(PDF)

9.55_Scheduling of Codeine_Nov14_v2(PDF)

9.56_Correction notice to GG_38133 on vitamins and minerals_Nov14_v1(PDF)

9.57_Process for implementation of amended_Regulations 9 and 10_Nov14_v1(PDF)

GG36412 Callup_Notice-Red_Vine_Leaf-April2013(pdf)

Health Professionals

Manufacturers, Laboratories, Importers, Exporters