EMEA Plans Revision of the Note for Guidance on Plastic Primary Packaging Materials

GMP News No. 365

GMP News
14 November 2003

EMEA Plans Revision of the Note forGuidance
on Plastic Primary Packaging Materials

On 9 October 2003, EMEA (the European Agency for the Evaluation of MedicinalProducts) published a concept paper on the planned revision of the existingGuidance on Plastic Primary Packaging Materials.

The concept paper refers to the Note for Guidance on Plastic PrimaryPackaging Materials (3AQ10A). This guideline has to be revised in order tocomply with the new CTD (Common Technical Document)format for the procedure to obtain a marketing authorisation. At the sametime it has to be judged whether the requirements mentioned in the text arestill state of the art. After all, the guideline dates back to 1994 and isthus almost ten years old.

In this revision process, the following changes are to be made:

  • The new regulations are meant to apply also to plastic primarypackaging materials for APIs.
  • Requirements that are not specific to plastic packaging materials, butrefer to all sorts of packaging materials, are going to be omitted.
  • The references to pharmacopoeial monographs and requirements forfood-stuff are meant to be updated.

This guideline is planned to be released in December 2003 for a six-monthconsultation phase.

You will find the official concept paper on the EMEA website at:

Dr Günter Brendelberger


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