S.L. 35.38 Art. 6

Inspections or supervision of activities related with veterinary medicinal products for which an authorisation, certificate, licence or registration is not issued, although existing ones may be varied:

(a) for inspections as as conducted outside the initial determined determine inspection to grant the first GMP by the d by the certificate and its subsequent Director contracte renewals, e.g. routine inspections and following a d party other necessary inspections, to GMP conductin investigate a complaint, following a inspection g the variation; (maximum inspectio 3 years) n + 25% adminis-trative fee

(i) for changes to the 60 GMP certificate that do not require any inspection. Changes may be grouped if they are submitted at the same time and are related to each other;

(b) for the as as pharmacovigilance inspection; determined determine by the d by the Director contracte following d party an conductin inspection g the (maximum inspectio 3 years) n + 25% adminis-trative fee VETERINARY PHARMACIES (FEES)

(c) pharmacovigilance as as inspection as a routine inspection or determined determine for other necessary inspections e.g. to by the d by the investigate a complaint, following a Director contracte variation; following d party an conductin inspection g the (maximum inspectio 3 years) n + 25% adminis-trative fee

(d) for the supervision of 50 destruction of veterinary medicinal products alone or in feed, active substances or other products intended to be administered to or on animals or given as feed or with feed or water but does not include the cost of destruction as determined by the entity which shall be carrying out the destruction. Covers all the period from the beginning until the end of the destruction.