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L.S. 35.38 Regolamenti dwar Drittijiet dwar Prodotti Mediċinali Veterinarji u Spiżeriji Veterinarji

VETERINARY MEDICINAL PRODUCTS AND VETERINARY PHARMACIES (FEES) [ S.L. 35.38 SUBSIDIARY LEGISLATION 35.38 VETERINARY MEDICINAL PRODUCTS AND VETERINARY PHARMACIES (FEES) REGULATIONS 10th February, 2025 LEGAL NOTICE 336 of 2024. 1. The title of these regulations is the Veterinary Medicinal Products and Veterinary Pharmacies (Fees) Regulations. 2. In these regulations unless the context otherwise requires: Citation. Interpretation. "Director" means the Director for Veterinary Services; "GMP" means good manufacturing practice as defined in the Good Manufacturing Practice for Veterinary Medicinal Products Rules. 3. The fees specified in the Schedule shall be payable to the Director for services listed in the said Schedule. SCHEDULE (regulation 3) Service 1. Authorisation of Veterinary Medicinal Products: (

  1. a)for the issuance and renewal of an authorisation of exemption from a marketing authorisation; (
  2. b)for the issuance and renewal of an authorisation for research and development purposes; (
  3. c)for the issuance and renewal of an authorisation for cascade use; Validity € 5 years 300 3 years 180 1 year 60  S.L. 437.108. Fees. 1 2 [ S.L. 35.38 VETERINARY MEDICINAL PRODUCTS AND VETERINARY PHARMACIES (FEES) (
  4. d)for the issuance and renewal of a marketing authorisation of veterinary medicinal products authorised in accordance with the national procedure, decentralised procedure and mutual recognition procedure, but does not include the cost of assessment of the dossier; (
  5. e)for the issuance and renewal of a marketing authorisation of veterinary medicinal products in accordance with subsequent recognition procedure, but does not include the cost of assessment of the dossier. 2. Registration of Veterinary Medicinal Products: (
  6. a)for the registration of products in accordance with regulation 8

(1)of the Veterinary Medicinal Products Regulations (S.L. 437. 115); (
  1. b)for the registration of a homeopathic product; (
  2. c)for the registration of products for parallel trade; (
  3. d)for the registration of samples or demonstration packs. 3. For the notification of centrally authorised Veterinary Medicinal Products. 4. Authorisations of activities related with the manufacturing and distribution of Veterinary Medicinal Products and active substances: 5 years 1,000 5 years 150 3 years 180 5 years 300 5 years 300 1 year free 5 years 300 VETERINARY MEDICINAL PRODUCTS AND VETERINARY PHARMACIES (FEES) [ S.L. 35.38 (
  4. 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 (
  5. 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. (
  6. 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
  7. s)- 980 an inspection Average (maximum (15 to 75 3 years) employee
  8. s)-1,500 Large (76 to 200 employee
  9. s)- 1,960 Super employee (more than 200 employee
  10. s)- 2,910 Partial manufact ure - 290 3 4 [ S.L. 35.38 VETERINARY MEDICINAL PRODUCTS AND VETERINARY PHARMACIES (FEES) (
  11. 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. (
  12. 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 after within the European Union or European Economic Area, but does inspection not include the costs of travel and (maximum accommodation of inspectors, if 3 years) applicable; (
  13. i)issuance of a new 465 for authorisation with an issuing a inspection; new authorisation (
  14. 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; (
  15. iv)to vary the 230 conditions of the authorisation by inspection. 5. Registration of activities related with brokering of veterinary medicinal products and distribution of active substances: (
  16. a)for the registration for validity as the brokering of veterinary medicinal determined products which may or may not by the involve an inspection in Malta: Director (maximum 3 years) (
  17. i)initial registration 465 with or without an inspection; (
  18. ii)renewal of a 700 registration; VETERINARY MEDICINAL PRODUCTS AND VETERINARY PHARMACIES (FEES) [ S.L. 35.38 (
  19. b)for registration for as importation and distribution of active determined substances which may or may not by the involve an inspection in Malta; Director (maximum 3 years) (
  20. i)initial registration 465 with or without an inspection; (
  21. ii)renewal of a 700 registration. 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: (
  22. 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% administrative fee (
  23. 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; (
  24. 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% administrative fee 5 6 [ S.L. 35.38 VETERINARY MEDICINAL PRODUCTS AND VETERINARY PHARMACIES (FEES) (
  25. 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% administrative fee (
  26. 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. 7. Certifications related with the manufacture or marketing of veterinary medicinal products and active substances: (
  27. a)issuance and renewal of as as a GMP certificate after an inspection determined determine with or without the issuance of a by the d by the manufacturing authorisation; Director contracte following a d party GMP conductin inspection g the (maximum inspectio 3 years) n + 25% administrative fee (
  28. b)issuance and renewal of 3 years 180 a certificate of veterinary medicinal product, known as Free Sale Certificate. 8. Licensing of activities related with retail sale of Veterinary Medicinal Products and active substances: VETERINARY MEDICINAL PRODUCTS AND VETERINARY PHARMACIES (FEES) (
  29. a)for the issuance and as renewal of a veterinary pharmacy determined licence including an inspection in by the Malta; Director (maximum 5 years) (
  30. i)issuance of a new licence with an inspection; (
  31. ii)renewal of a licence. [ S.L. 35.38 350 325 9. Assessment of dossier for the as as Marketing Authorisation of Veterinary determined determine Medicinal Products with the scope of by the d by the granting any type of authorisation for Director contracte marketing. prior to the d party assessment conductin g the inspectio n + 25% administrative fee 10. For the testing (quality, safety, as as efficacy or environmental safety) of determined determine by the d by the veterinary medicinal products alone or in feed, active substances or other products intended to Director contracte d party be administered to or on animals or given as conductin feed or with feed or water for control purposes g the or enforcement. testing + administrative costs according to the case 7 8 [ S.L. 35.38 VETERINARY MEDICINAL PRODUCTS AND VETERINARY PHARMACIES (FEES) 11. For the destruction of veterinary not as medicinal products alone or in feed, active applicable determine substances or other products intended to be d by the administered to or on animals or given as feed contracte or with feed or water. d party carrying out the destructio n+ administrative costs according to the case

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AI explanation based on the official legal text. Indicative, not a substitute for legal advice.