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[DOCX File]Transition to new GMP requirements for medicinal products
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The TGA will adopt the current version of the . PIC/S Guide to Good Manufacturing Practice for Medicinal Products. PE009-14 (PIC/S Guide to GMP), excluding Annexes 4, 5 and 14, as the manufacturing principles for medicines and active pharmaceutical ingredients, with effect from 1 July 2020 as . communicated on 4 May 2020
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[DOC File]Form for submission of comments
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Clarify "equivalent" when the sites are located in third countries. 184-192 Clarification on the format to support the information shared between MAH and manufacturing site is welcome. Such information should be version controlled and handled as a current GMP relevant document at both, the MAH and Manufacturing site.
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[DOCX File]GMP clearance code tables guidance
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GMP clearance code tables guidanceV1.0 July 2020. Page 26 of 34. GMP clearance code tables guidanceV1.0 July 2020. Page 23 of 34. Document title. Page 2 of 3. V1.0 Month 2012. GMP clearance code tables guidance V1.0 July 2020. Page 33 of 34
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[DOC File]Rev - Heads of Medicines Agencies
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July 2020. Decentralised Procedure. RMS Day 120 Draft Assessment Report. ... the RMS has accepted copies of current manufacturer authorisations issued by inspection services of the competent authorities as certification that acceptable standards of GMP are in place at those sites.> ... the RMS has accepted copies of current GMP Certificates of ...
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[DOC File]REQUEST FOR PROPOSAL
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July 15, 2020 Workshop with national stakeholders, including MOH and relevant related documentation (e.g., the list of participants, agenda, plan, etc.) Organize and facilitate a meeting with MOH and other national GMP stakeholders to review and agree on the study plan.
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[DOCX File]Mutual Recognition Procedure
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< For manufacturing sites outside the Community, the RMS has accepted copies of current GMP Certificates or satisfactory inspection summary reports, 'close-out letters' or 'exchange of information' issued by the inspection services of the competent authorities (or those countries with which the EEA has a Mutual Recognition Agreement for their own territories) as certification that acceptable ...
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ANNEX A
The purpose of this meeting is to update the current Local Mitigation Strategy and seek public input for the it. This meeting will focus on Collier’s mitigation goals and review the draft project worksheet and changes to the working group’s voting membership requirements.
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[DOCX File]Kia
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2, 2020 — Hyundai Motor Group has unveiled its new Electric-Global Modular Platform (E-GMP), a dedicated battery electric vehicle (BEV) platform. Revealed online today during an ‘E-GMP Digital Discovery’ event, the platform will serve as the core technology for Hyundai Motor Group’s next-generation BEV line-up.
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[DOCX File]2. Review of Joint Owner Operating Committee Meeting ...
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As of April 30th, 2020, the Covid-19 dollars spent are $135,0000. These expenses will continue to be tracked. The accounting teams from GMP and VPPSA are aware of these expenses. The total budget, minus fuel, through April 30, 2020 was underspent by $795,585. We will continue to monitor the expenses against the budget.
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[DOCX File]Reforms to the generic medicine market authorisation process
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The current GMP clearance framework supports the process for evaluating applications for registration or listing of therapeutic goods on the ARTG. The framework is intended to inform the Secretary’s considerations under the Therapeutic Goods Act, in relation to an application for the registration or listing of goods that, where a step in the ...
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What are the current gmp 2020