Post-registration: Response to pre-registration recommendation: Pharmaceutical and Analytical Pharmaceutical & Analytical Clinical Clinical Proprietary Name Proprietary Name Scheduling Scheduling Inspectorate Inspectorate e) Qualified person for Pharmacovigilance Name: Business address: 24 Hour Telephone no: Fax no: E-mail address: (Attach CV Annex 1.2.2.5) – f) Amendment history Date of letter of amendment Summarised details of Date of application amendment (include Type and Regulatory Authority response Category) UPDATE HISTORY Date Reason for update Version & publication Feb 2009 First publication released for comment Version 1, Feb 2009 Nov 2009 Finalised version released for implementation Version 2, Nov 2009 March 2011 Amendment of Sections b) re GMP certificates; c) re date of current amendment Amendment of introductory section to allow for submission Version 3, 2011 of different strengths in one dossier, and deletion of veterinary medicine. 1 June 2011 Implementation April 2014 Amendment of sections b) and d) to include Complementary Medicines Version 4, April 2014 With immediate Implementation effect
Post-registration: Response to pre-registration recommendation: Pharmaceutical and Analytical Pharmaceutical & Analytical Clinical Clinical Proprietary Name Proprietary Name Scheduling Scheduling Inspectorate Inspectorate e) Qualified person for Pharmacovigilance Name: Business address: 24 Hour Telephone no: Fax no: E-mail address: (Attach CV – Annex 1.2.2.5) f) Amendment history Date of letter of amendment application Summarised details of amendment (include Type and Category) Date of Regulatory Authority response UPDATE HISTORY Date Reason for update Version & publication Feb 2009 First publication released for comment Version 1, Feb 2009 Nov 2009 Finalised version released for implementation Version 2, Nov 2009 March 2011 Amendment of Sections b) re GMP certificates; c) re date of current amendment Version 3, 2011 Amendment of introductory section to allow for submission of different strengths in one dossier, and deletion of veterinary medicine. 1 June 2011 Implementation April 2014 Amendment of sections b) and d) to include Complementary Medicines Version 4, April 2014 With immediate effect Implementation
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