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MDR PROPOSAL

During the plenary session of the European Parliament of 22 October 2013,
the majority of the amendments proposed by the ENVI Committee of the
European Parliament, to the MDR Proposal and IVD MDR Proposal have
been adopted by the full European Parliament.

Click here to read the full text of the voted amendments to the ‘MDR Proposal’
and here for the voted amendments to the ‘IVD MDR Proposal’.

 

UDI GUIDANCE

Click here for the pdf.

 

GDP

On 23 November 2013, a new version of the Guidelines on good
distribution practice (GDP) of medicinal products was published in the
Official Journal of the European Union.

Click here (pdf file) to read the revised Guidelines.