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