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Re: Tweedlede post# 57315

Wednesday, 06/21/2017 9:30:06 PM

Wednesday, June 21, 2017 9:30:06 PM

Post# of 128729
I believe its the EMA but inspections are coordinated with Canadian authorities (a member state with the EMA) via an MRA (Mutual Recognition Agreement). Its been a while since I reviewed all the specifics but here is the link that would be relevant and you can find some specifics in regards to Canada's association.

"Any manufacturer of medicines intended for the EU market, no matter where in the world it is located, must comply with GMP."


http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001205.jsp&mid=WC0b01ac0580027088