European Commission updates list of European Harmonized Standards for the General Product Safety Directive (2001/95/EC)

On April 13, the European Commission published an updated list of the European harmonized standards that pertain to the General Product Safety Directive (2001/95/EC). The standards on this list may be used by manufacturers to prove that their products complies with the essential requirements of this directive.

This updated list is important to all manufacturers that have used European harmonized standards to prove compliance with the aforementioned directive. If you have done so, we recommend you to check the new list of standards to see if any of the standard you applied have been updated, or whether there are new standards available for your products. When standards have been updated by this list, you need to re-evaluate your products against the updated standard and update your documentation.

The updated list of standards can be found in our Library shortly

5 thoughts on “European Commission updates list of European Harmonized Standards for the General Product Safety Directive (2001/95/EC)”

  1. Can anyone update me about the requirement of raw material to be used for lubricating eye drops. it is necessary that the raw material be from a DMF grade vendor.

    Reply
  2. There is no such thing as “DMF grade”. APIs are manufactured to pharmacopoeia standards.

    DMF (Drug Master File) merely means that you have advised the health authority of the manufacturing and testing methodologies you have used – it is not an indication of pharmacopoeal specification or that you manufacture acccording to GMP.

    Reply

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