THE PRODUCT SUMMARY FILE (PSF) FOR A FOOT-AND-MOUTH DISEASE VACCINE
(x) symptoms of overdose and, where applicable, emergency procedures and antidotes in the event of overdose; (xi) withdrawal periods (also known as withholding times), even if such periods are zero; (d)
immunological information;
(e)
pharmaceutical particulars: (i) major incompatibilities; (ii) shelf life, where applicable after reconstitution of the medicinal product or after the immediate packaging has been opened for the first time; (iii) special precautions for storage; (iv) nature and composition of immediate packaging;
(f) name of the marketing authorisation holder; (g) marketing authorisation number or numbers; (h) date of the first marketing authorisation; (i) date of the last revision of the summary of the product characteristics.
1.C. Labelling and package leaflet For the final product, provide samples (or reproductions) of labels, boxes and package inserts to be used in English. 1.D. Lot summary protocol It is expected that a summary of all manufacturing steps, including in-process and finished product test results from each batch of vaccine, is captured and documented in a standard way and this is referred to as a lot/batch summary protocol, which is certified and signed by the responsible person of the manufacturing company. The vaccine manufacturer should provide a template of the lot/batch summary protocol outlining the information they capture routinely on vaccine batches.
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