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MHRA - Process for approving Manufacturing Authorisations or API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal Use

16th November 2022

Several companies have contacted the MHRA regarding cannabis-based products for medicinal use. This blog provides information on what authorisations are required in order to MHRA Manufacturing Licence Application manufacture within this sector of the pharmaceutical industry.

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WHO - WHO releases first data on global vaccine market since COVID-19

16th November 2022

This is the first report to capture the implications of COVID-19 for vaccine markets.

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Access Consortium Good Manufacturing Practice (GMP) Statement

15th November 2022

MHRA Notice Access Consortium Good Manufacturing Practice (GMP) Statement Published 15 November 2022

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EMA - Human Medicines Highlights Newsletter

15th November 2022

EMA - Human Medicines Highlights Newsletter, Issue 163 (Nov 22) released.

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EMA - ICH Guideline and Template for Consultation

15th November 2022

ICH M11 guideline (Step 2b), ICH M11 technical specification (Step 2b) and ICH M11 template (Step 2b) - open for consultation.

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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022

15th November 2022

EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022

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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 November 2022

15th November 2022

EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 November 2022

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MHRA - Information about procurement at the Agency

15th November 2022

Procurement at MHRA - Information about procurement at the Agency and how they are improving procurement opportunities for small and medium-sized enterprises.

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MHRA - Return to International GMP Inspections

15th November 2022

MHRA - Return to International GMP Inspections

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EDQM - All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 34.4 is 31 December 2022.

19th October 2022

All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 34.4 is 31 December 2022.

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