Introduction

Scope

Definitions

Veterinarians

Veterinary
Practice


Medicines
Control


Quality
Systems


Schedule 1

Schedule 2

Schedule 3

Appendices

Entire
Document

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

All GVP-veterinary practices with a medicines depot shall ensure they comply with the requirements of this schedule.

1.1. Ordering medicines
GVP Guide Entry

Medicines shall be ordered through a pharmacist open to the public 1; with the exception of the distribution of the vaccines mentioned in the Ministerial Ruling of 10 July 1964 regarding the control and distribution of certain medicines.
Orders of medicines shall be made using the medicines ordering document. This document shall have the following details pre-printed:

  • full name of the veterinary surgeon or the association of veterinary surgeons,
  • full address were the depot is kept and
  • a serial number in the following format: 0 (Flemish) or 1 (Walloon) / registration number with College of Veterinary surgeons / last two digits of the year the document was printed / continuous serial number.
This document is completed with the date, the order and is signed 1 by the depot manager or his deputy. The document is made in double 1 and sent to the pharmacist.
The pharmacist will deliver the medicines ordered, and return a signed copy of the order form. GVP-veterinary practices will keep this form for a period of 10 years 1. The forms will be filed chronologically. All medicines present in the depot of GVP-veterinary practices shall be reconcilable with the order forms 1. The ordering system can be replaced by a computerised system 1, provided the information is available on a printout upon request. 1.2. Incoming medicines
GVP Guide Entry

Incoming medicines shall be checked for damaged packaging, whether delivered quantities tally with ordered ones, use-by date and if the identity of the pharmacist is present.
The identification of the GVP-veterinary practice shall be put on the primary packaging 1 as well as a unique reference to the ordering document on which the medicines were ordered.
GVP-veterinary practices shall have a documented procedure to return non-conforming products to the pharmacist. Whenever products are returned, this is stated on the order forms, with the reason.
All accepted products will be entered in the incoming medicines logbook on the day of delivery. This logbook shall have at least the following details: date of delivery, identification of the medicines, lotnumber, quantity received, name and address of supplier. The register has to be easily readable and accessible 1. If it is computerised, a printout shall be possible at all times.
Any free samples shall be registered separate.
All medicines will then be stocked in the depot.

1.3. Medicine depot
1.3.1. General
GVP Guide Entry

The medicines depot will be seen as the total of the main depot and the extensions of the depots.
The main depot is where the stock of medicines is kept.
Extensions of the depots are:

  • the surgery stock
  • the car stock(s)
  • the bag(s) for housecalls
GVP-veterinary practices managed as an association of veterinary surgeons in whatever legal way, shall have one central depot. 1.3.2. The depot
GVP Guide Entry

The depot-room shall be a closed facility.
The reception area (de-boxing area) and administrative area shall be physically separated from the medicine-stock.
The depotroom shall be such that it is easily cleanable and shall always be clean and orderly. It shall be kept vermin- and dustfree at all times.
GVP-veterinary practices shall ensure that the following categories of products are stored physically separated from one another:

  • Medicines.
  • Feeds, feeds with a special purpose (e.g. diets) and feeds registered by the Ministry of Agriculture.
  • Pesticides/weed-killers for non-agricultural use.
  • Sedatives, anaesthetics and euthanasia drugs. These drugs shall have a separate register. A closed cabinet for narcotic drugs is present, with a separate register.
  • Medicines to be returned to the pharmacist.
Closed cabinets can be seen as rooms.
Medicines shall be stored as required by the producer.
A min/max thermometer shall be present in all depot-rooms.
All medicines shall be present in their primary packaging.
Medicines shall be stocked so that they cannot contaminate other products or materials and vice versa.
Sufficient measures shall be in place to prevent spillage, breakage and theft.
The classification shall be orderly, hygienic and according to the keeping requirements and shall be written down in a protocol.
There shall be an adequate product-flow, ensuring that first in - first out principles are followed.
Documented procedures shall be in place to ensure that products beyond their use-by date are removed from the depot and disposed of as appropriate.
Handling, storage, packaging, preservation and delivery procedures shall be in accordance with section 6.10 of the Code of Good Veterinary Practices. 1.3.3 The surgery depot-extension
GVP Guide Entry

The stock shall be kept as small as possible, in relation to the size and the throughput of the practice.
All medicines shall be stored as required by the producer. A fridge will be present for medicines that have to be stored under cooled conditions.
The classification shall be orderly, hygienic and according to the keeping requirements issued with the medicines.
Multi-dose packages shall have the date of first opening or first use of bottle written on the packaging.
In use flacons or unsealed packages shall be used for a period of maximum 2 months, unless otherwise stated on the requirements.
Documented procedures shall be in place to ensure that products beyond their use-by date or broken into more than 2 months are removed from the depot and disposed of as appropriate.
There shall be sufficient measures to protect the medicines from spillage, breakage and theft.

1.3.4. The car depot-extension
GVP Guide Entry

The car depot-extension will be defined as the medicines permanently kept in the car(s) and the medicines in the bag(s) used by the GVP-practitioner on house-calls.
The stock shall be kept as small as possible, in relation to the size and throughput of the practice.
All medicines shall be stored as required by the producer. A fridge will be present for medicines that have to be stored under cooled conditions.
The classification shall be orderly, hygienic and according to the keeping requirements issued with the medicines.
Medicines shall be transported in such a way that:

  • they are kept in their primary packaging
  • they are identifiable
  • they cannot contaminate other products or materials or vice versa
  • there are sufficient measures against spillage, breakage and theft.
Multi-dose packages shall have the date of first opening or first use of bottle written on the packaging.
In use flacons or unsealed packages shall be used for a period of maximum 2 months, unless otherwise stated on the requirements.
Documented procedures shall be in place to ensure that products beyond their use-by date or broken into over 2 months are removed from the depot and disposed of as appropriate.
A dustbin and a needle-container shall be present in the car.
1.4. Outgoing medicines
GVP Guide Entry

All outgoing medicines shall be registered in the relevant logbook, stating date 1, identification of the medicines 1, lotnumber 1, quantity 1, number of the administration or dispensing document if required 1, client and patient details if required or reason for removal out of depot.
In multivet GVP-veterinary practices, outgoing medicines shall be registered per vet.

1.4.1. Administering
GVP Guide Entry

GVP-veterinary practices shall ensure that all relevant data are registered 1. See the relevant schedules to the type of veterinary services offered.

1.4.2. Dispensing
GVP Guide Entry

GVP-veterinary practices shall ensure that:

  • Medicines are dispensed in their primary packaging 2.
  • The practice identification is put onto the primary packaging of any dispensed medicines 1.
  • Any other required information is put onto the primary packaging of the medicines dispensed: see the relevant schedules to the type of veterinary services offered.
  • All relevant data are registered as required.
1.4.3. Medicines for destruction
GVP Guide Entry

Documented procedures shall be in place for the destruction of any medicines that no longer can be used.
These include:

  • Medicines beyond their use-by date.
  • Medicines of which the primary packaging was opened over 2 months.
  • Returned medicines from clients.
  • Medicines that were contaminated in any way.
  • Medicines that should no longer be used for any reason.
All these medicines will be clearly and irreversibly marked that they are no longer to be used.
All these shall be registered in the outgoing logbook, with lotnumber, stating the reason why they were removed. 1.5. Stock controls
GVP Guide Entry

At least once a year the total medicines stock shall be reconciled with the register data 1. Any differences shall be reasoned on a report 1. The reports shall be kept 1 for a period of 10 years.

1.6. Administration
GVP Guide Entry

All administered/dispensed drugs shall be specified on the outgoing bills.
A recent veterinary medicines compendium shall be present.
A compendium on the legislation on veterinary medicines and the instructions of the competent authorities shall be present and kept up-to-date.
Clear job descriptions shall be available for all personnel involved in the ordering, receiving, stocking or use of veterinary medicines.

1.7. Personnel requirements
GVP Guide Entry

The depot manager and the deputy shall dedicate an appropriate proportion of their continuous professional development to the developments in the depot and the use of veterinary medicines.

1.8. Waste control procedures
GVP Guide Entry

There shall be documented procedures to ensure that empty medicine bottles and medicines removed out of the depot for whatever reason are removed and siposed of in the correct manner.
All bottles shall be kept in rigid impervious containers, shock, cut and tear-resistant, stating hazardous clinical waste 3. All containers awaiting removal for destruction shall be stored in a room, separate from the living rooms, inaccessible for unauthorised persons 3, which shall be incorporated in the cleaning and disinfection schedule. On the door to the room shall be a sign stating "CLINICAL WASTE - NO ENTRY".
Records of the removal shall be kept. They shall be dated, signed by the removal and/or destruction company and kept for a period of 5 years.

KB 23-05-2000 on the special conditions on the buying, the depot, the prescribing, the dispensing and the administration of medicines for animals by veterinary surgeons and on the possession and the administration of medicines for animals by the person responsible for the animals
KB 29-06-1999 on the requirements on dispensing veterinary medicines
Decreet 02-07-1981 on the prevention and the management of waste materials (as amended by the decreet of 20-04-1994), Vlarea and Arrete du Gouvernement wallon 30-06-1994 on clinical waste

 

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