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Veterinary
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Schedule 1

Schedule 2

Schedule 3

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Schedule 1: GVP-requirements regarding the depot of veterinary medicines

Clause reference Requirement How
Sch. 1 Clause 1.1
1.1. Ordering medicines   
  • a pharmacist open to the public
  • Protocol, contract / statement
  • vaccines mentioned in the Ministerial Ruling of 10 July 1964
  • Protocol, ordered as appropriate
  • using the medicines ordering document
  • required format used
  • returned signed copy kept for a period of 10 years
  • protocol, procedure, file
  • the forms will be filed chronologically
  • protocol, procedure
  • all medicines present in the depot of GVP-veterinary practices shall be reconcilable with the order forms.
  • protocol, procedures
  • Computerised system: information is available on a printout upon request.
  • check with software-supplier
Sch 1, clause 1.2
1.2. Incoming medicines   
  • Checked for damaged packaging, delivered quantities, use-by date and identity of the pharmacist
  • protocol, procedure, checklist
  • Identification of GVP-veterinary practice put on the primary packaging
  • protocol, procedure
  • Documented procedure to return non-conforming products
  • protocol, procedure, agreement with pharmacist
  • Returned products stated on order forms, with the reason.
  • protocol, procedures, forms
  • Accepted products entered in incoming medicines logbook.
  • protocol, procedure, logbook
  • Register easily readable and accessible, if computerised printout possible at all times.
  • format, check with software-supplier
Sch 1, clause 1.3.1
1.3. Medicine depot   
1.3.1. General   
  • Associations have one central depot
  • protocol, procedure
Sch 1, clause 1.3.2
1.3.2. The depot   
  • Closed
  • lay-out
  • Easily cleanable
  • lay-out
  • Clean and orderly
  • cleaning protocol
  • Vermin- and dust-free
  • vermin control (baitstations) + checking regime, cleaning protocol
  • Categories of products stored physically separated
  • lay-out
  • Separate register for sedatives, anaesthetics and euthanasia drugs
  • lay-out, registers
  • Closed cabinet for narcotic drugs with a separate register
  • lay-out, register
  • medicines to be returned to pharmacist
  • lay-out
  • stored as required by producer
  • protocol, procedures, fridge, dark closet
  • min/max thermometer in all depot-rooms
  • thermometers
  • medicines in primary packaging
  • protocol, procedure, internal audit
  • stocked so they cannot contaminate other products or materials and vice versa
  • lay-out, regular checks: checklist, procedure
  • measures to prevent spillage, breakage and theft
  • lay-out, protocol, procedure, regular checks: checklist
  • classification orderly, hygienic and according to the keeping requirements, written down in a protocol
  • protocol, procedure, regular checks: checklist
  • lots with the nearest use-by-date are used first
  • protocol, procedure, regular checks: checklist
  • Documented procedures to ensure that products beyond their use-by date are removed from the depot and disposed of as appropriate
  • protocol, procedure, regular checks: checklist
  • Handling, storage, packaging, preservation and delivery procedures in accordance with section 6.10 of the Code of Good Veterinary Practices
  • protocol, procedure
Sch 1, clause 1.3.3
1.3.3. The surgery depot-extension   
  • Stock as small as possible
  • protocol, procedure, checklist
  • Stored as required by producer
  • protocol, procedure, checklist
  • Classification orderly, hygienic and according the keeping requirements
  • protocol, procedure, checklist
  • Date of first opening or first use of bottle written on the packaging
  • protocol, procedure, checklist
  • In use flacons or unsealed packages used maximum 3 months
  • protocol, procedure, checklist
  • Products beyond their use-by date or broken into more than 3 months removed from the depot and disposed of as appropriate
  • protocol, procedure, checklist
  • Medicines protected from spillage, breakage and theft
  • lay-out, protocol, procedure, checklist
Sch 1, clause 1.3.4
1.3.4. The car depot-extension   
  • Stock as small as possible
  • protocol, procedure, checklist
  • Medicines stored as required by producer
  • protocol, procedure, checklist, carfridge
  • Classification orderly, hygienic and according to the keeping requirements
  • protocol, procedure, checklist
  • in primary packaging
  • protocol, procedure, checklist
  • identifiable
  • protocol, procedure, checklist
  • cannot contaminate other products or materials or vice versa
  • lay-out, checklist
  • sufficient measures against spillage, breakage and theft
  • lay-out, protocol, procedure, checklist
  • date of first opening or first use of bottle written on the packaging
  • protocol, procedure, checklist
  • in use flacons or unsealed packages used for maximum 3 months
  • protocol, procedure, checklist
  • products beyond their use-by date or broken into over 3 months removed from depot and disposed of as appropriate
  • protocol, procedure, checklist
  • dustbin and a needle-container
  • equipment, checklist
Sch 1, clause 1.4 and subclauses
1.4. Outgoing medicines   
  • Outgoing medicines registered with relevant data
  • protocol, procedure, register
  • Registered per vet
  • protocol, procedure, register
1.4.1. Administering   
  • Relevant data are registered
  • protocol, procedures
1.4.2. Dispensing   
  • In primary packaging
  • protocol, procedure
  • Practice identification on primary packaging
  • protocol, procedure, labels
  • Any other required information on primary packaging
  • protocol, procedure
  • All relevant data registered
  • protocol, procedure
1.4.3. Medicines for destruction   
  • Documented procedures
  • protocol, procedure
  • All these medicines clearly and irreversibly marked that they are no longer to be used
  • protocol, procedure, label
  • Registered in logbook
  • protocol, procedure, register
Sch 1, clause 1.5
1.5. Stock controls   
  • At least once a year
  • protocol, procedure
  • Differences on a report
  • protocol, procedure, form
  • Kept for a period of 10 years
  • protocol, file
Sch 1, clause 1.6
1.6. Administration   
  • All administered/dispensed drugs specified on the outgoing bills
  • protocol, procedure, form
  • Recent veterinary medicines compendium present
  • compendium
  • Compendium on legislation on veterinary medicines present and kept up-to-date
  • compendium with contract or similar
  • Clear job descriptions
  • job descriptions, protocols, procedures adhered to
Sch 1, clause 1.7
1.7. Personnel requirements   
  • Continuous professional development
  • file
Sch 1, clause 1.8
1.8. Waste control procedures   
  • Documented procedures
  • protocol, procedures, records
  • Containers
  • materials
  • Room separated from living rooms, inaccessible for unauthorised persons and sign
  • lay-out
  • Removal company
  • contract, records

 

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