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Impacts of Good Manufacturing Practices (GMP)/ Quality System Requirements for Certain Excipients to be used in Medicinal Products for Human Use

In preparation of a Directive on GMP for certain excipients following Article 46 (f) of Directive 2001/83/EC, as amended by Directive 2004/27/EC, DG Enterprise and Industry asks excipient manufacturers and manufacturers/importers of medicinal products for human use (excipient users) to contribute to an online consultation on possible impacts of different policy options. Excipient distributors may also participate in this consultation.

Related topics

Industry Healthcare industries

Deadline:  30/07/2007

We publish the draft Specific Conditions of the Application of the Principles and Guidelines of GMP for Certain Excipients as a possible basis for a GMP Directive. Before responding, please carefully read the attached instruction note (DOC, webarchive). For separate comments to the draft specific GMP conditions please use the template for comments as attached to the instruction note.

Excipient manufacturers and excipient users are asked to respond by 30 July 2007. Small and medium size enterprises are specifically encouraged to contribute to this consultation.