Freedom of Information request (FOI 22/969)
Published 17 January 2024
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FOI 22/969
11th November 2022
Dear
Thank you for your correspondence dated 15 September, regarding the Manufacturer’s Authorization (MIA(IMP)) for Investigational Medicinal Products, number 19124, version 24 (24/08/2021), for Curia (Scotland) Limited (“Curia”), site 92248.
As stated in Annex 2 of the licence, ‘authorised manufacturing operations include total and partial manufacturing (including various processes of dividing up, packaging or presentation), batch release and certification, importation, storage and distribution of specified dosage forms unless informed to the contrary.’
This means that the approval of any dosage form in section 1.1-1.4 of the licence includes approval to package and certify that product. Activities in section 1.5 of the licence are intended to capture the packaging of bulk products (manufactured at another site) where the site is not authorised to perform manufacturing of that dosage form.
Quality control activities in section 1.6 can only be performed if explicitly authorised in this section. Therefore site 92248 may not currently conduct Microbiological: Sterility testing of Investigational Medicinal Products, and this activity would therefore be contracted out to another licenced site for IMPs manufactured at site 92248. A review of previous versions of MIA 19124 since 2015 indicates that this activity has not been authorised in that time.
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