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3rd Country Manufacturer

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GDP Compliance

Active substances and medicinal products shall be distributed in accordance with good distribution practices. Member States shall enter the certificates of good distribution practices which they issue into EudraGMDP in accordance with article 111(6) of the Directive 2001/83/EC as amended. On a voluntary basis, Member States can enter the certificates of good distribution practices following verification of compliance in accordance with article 95 (8) and article 99 (6) of Regulation (EC) 2019/6.

The Union formats for the GDP Certificate for Medical Products and for active substances are published in the Compilation of Union Procedures, which can be found at the following location:

Compilation of Union Procedures on Inspections and Exchange of Information revision 19.1 (europa.eu)

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