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This annex applies to all veterinary medicinal products falling within the scope of Directive
2001/82/EC other than immunological veterinary medicinal products, which are the subject of a
Sterile veterinary medicinal products
Where this has been accepted by the competent authorities, terminally sterilised veterinary
medicinal products may be manufactured in a clean area of a lower grade than the grade
required in the annex on “Sterile preparations”, but at least in a grade D environment.
Continue at: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/pdfs-en/anx04en200408_en.pdf
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