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Compliance with the principles of good manufacturing practice: certificate

The holder of a manufacturing licence shall, on request, issue a certificate of compliance with the principles of Good Manufacturing Practice ( GMP certificate) if the competent authority has the conditions for the manufacture, Testing and storage of agents or starting materials in accordance with the provisions of Sections 6 and 8 to 17 Ordinance on Sera, Vaccines and Antigens in accordance with the Animal Health Act (TierImpfStV) has been carried out by an inspection of the holding.

The inspection and issue of a GMP certificate may also take place in a third country which is not a contracting state to the Agreement on the European Economic Area, provided that the holder of the manufacturing licence is established in Lower Saxony.

Source: Serviceportal Niedersachsen (Portalverbund des Bundes und der Länder)

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