Hello
The consolidated version is one with all the amendments and corrigenda incorporated into it. It's easier to read because you don't have to look at the original and the changes at the same time. The tags in the text show you which parts came from which amendment, like this:
Where, in the interests of public health, the laws of a Member State so provide, the competent authorities may require the marketing authorization holder for medicinal products derived from human blood or human plasma to submit samples from each batch of the bulk and/or the medicinal product for testing ►M4 by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose ◄ before being released into free circulation, unless the competent authorities of another Member State have previously examined the batch in question and declared it to be in conformity with the approved specifications. Member States shall ensure that any such examination is completed within 60 days of the receipt of the samples.
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Anne LeBlanc
United States
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Original Message:
Sent: 29-Nov-2021 13:07
From: Chi Bui
Subject: Directive 2001/83/EC consolidated
Hi everyone,
I am a beginner and I am reading Directive 2001/83/EC and in that consolidated document, it mentions some parts starting with►B, M1, M2, M4, M10... What does this mean? For example, M4 refers to M4 - Directive 2004/27/EC of European Parliament and of the Council of 31 March 2004. Do we need to refer to that Directive (M4) or the information has already been updated in the consolidated Directive? Please advise.
Thanks a lot.
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Chi Bui
United Kingdom
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