S.L. 35.38 Art. 4

Authorisations of activities related with the manufacturing and distribution of Veterinary Medicinal Products and active substances:

(a) for the issuance and as An renewal of the manufacturing determined annual authorisation requiring a GMP by the fee of inspection; Director 25% on following the total an payment inspection requested (maximum by the 3 years) contracto r carrying out the GMP inspectio n

(i) for changes in 60 manufacturing authorisations 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 issuance and as Small renewal of the manufacturing determined (less than authorisation not requiring a GMP by the 15 inspection; Director employee following s) - 980 an inspection Average (maximum (15 to 75 3 years) employee s) -1,500

Large (76 to 200 employee s) - 1,960

Super employee (more than 200 employee s) - 2,910

Partial manufact ure - 290 VETERINARY PHARMACIES (FEES)

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

(c) for the issuance and as renewal of wholesale distribution determined authorisation in an activity that may by the include an inspection in Malta or Director within the European Union or after European Economic Area, but does inspection not include the costs of travel and (maximum accommodation of inspectors, if 3 years) applicable;

(i) issuance of a new 465 for authorisation with an issuing a inspection; new authori-sation

(ii) renewal of an 700 authorisation;

(iii) to vary the 60 conditions of authorisation without inspection. Changes may be grouped if they are submitted at the same time and are related to each other;

(iv) to vary the 230 conditions of the authorisation by inspection.