Polish Health Ministry unveils changes to GMP ordinance
2010-08-24
The Health Ministry has published for consultation a draft amendment to the ordinance on Good Manufacturing Practice. The deadline for the submission of comments has been set at 20 August.
The amendment concerns Part II, Annex 6 and Annex 13 of the ordinance. The need to amend the regulation follows from changes to relevant annexes of EU guidelines concerning Good Manufacturing Practice in respect of medicinal products for human and veterinary use.
In a statement accompanying the document, the ministry admitted that for some manufacturers and importers, the amendment might require changes to documentation and might create extra costs, depending on their sphere of activity.
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