Open letter to Ms. Emer Cooke, Executive Director, European Medicines Agency (EMA)

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Open letter to Ms. Emer Cooke, Executive Director, European Medicines Agency (EMA)

and

This is the text:

Dear Ms. Cooke,

This is an open letter in relation to a question I submitted via EMAs: Send a question to the European Medicines Agency, on 20/12/2020. This is EMAs acknowledgement of the question:

“We received your question(s) on: 20/12/2020

Subject of your enquiry: GMDP in relation to COVID-19 vaccines that are delivered to vaccination centres bypassing the wholesaler networks

Your question(s):
Dear EMA,

I am an experienced consultant in biopharmaceutical supply- chains. I wish to enquire how the inspectorate with assure GMDP and appropriate quality systems will be maintained with regard to patient safety for the frozen and ultra cold vaccines being assessed for emergency approval? It appears to me that these vaccines are being despatched from manufactures part-finished ie not in the final dosage form for patient administration and there represents a potential risk if unt…