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AgVetLink for PAR Traders September 2004

Trading in prescription animal remedies: frequently asked questions

Part A: General

Can the approved trader be a company or does it have to be a specific person?

The ACVM Group will approve ‘trading entities’. These may be companies/organisations or individuals. See box on page 2.

Do all our factory workers and people in distribution depots have to be approved?

No. You need to specify the responsible person who will control the quality systems for recording and sales of PAR products. If you have several distribution centres, you need to advise us of the address and contact numbers for each site, but you might have only one person who is responsible for the quality systems for all the sites. This is the person who needs to be specified.

Do all our field reps have to be approved?

No. You need to specify the responsible person who will control the quality systems for recording and sales of PAR products. In most cases, field reps do not sell directly to end users anyway.

Does each staff member operating under the specified responsible person have to be confirmed as fit and proper?

No. It is expected that the specified person will take responsibility for confirming the appropriateness of staff to deal with PARs. Failure to take due care is a non-compliance issue for the specified responsible person and may result in loss of approval of the trading entity or even prosecution.

Is the approved trader responsible for goods while they are being transported by a courier or other company?

The trading entity is responsible for the product until the sales transaction has been completed. Consignment of the purchase to a transporter is the responsibility of the trader but the trading entity is not responsible for the actions of the courier or transport company.

Do we have to check that veterinarians buying our products are approved traders?

No. The ACVM Group has deemed veterinarians to be registered traders. However, you should sight the veterinary registration certificate if the veterinarian is unknown to you.

Do all product registrants have to be approved as traders and complete the fit and proper person part of the application?

No. If a registrant does not supply to end users, this is not needed. However, registrants who supply their products to end users must specify a person responsible for those transactions to be confirmed as a fit and proper person.

Does the responsible person have to be the person based on the site where we process orders?

No. The specified responsible person should be the person (or persons) operationally responsible for ensuring the quality system is implemented, particularly in regard to sales activities. This person may be responsible for several sites.

Will there be fees charged for notifying the ACVM Group of responsible persons and trading sites?

At this stage in the development of the approved trader programme, the ACVM Group is not charging any fees for processing notifications of specified responsible persons and/or trading sites, or for subsequently removing names from the list. The only fees will be for a verification visit (see page 3) if this is considered necessary.

Are traders allowed to hold stocks of specially compounded medicinal preparations and sell them to parties other than the veterinarian who placed the order?

The ACVM Group’s current expectations regarding compounding, which can be found in the draft ACVM Standard for Unregistered Veterinary Medicines Requiring Veterinary Overview, are that traders may not hold such stocks. However, consultation on the standard has brought up several issues relating to compounding that require further consideration. For this reason a working party has been set up to examine options. Developments will be advised on the website and in AgVetLink. In the meantime, the expectations stated in the standard apply.

Part B: Veterinarians

Do all veterinarians have to apply to become approved traders?

No. All veterinarians have already been deemed to be approved traders. They may hold PAR products under their own authority and enter into transactions to supply PAR products without a specific written prescription from themselves or any other veterinarian. The ACVM Group will use the list of registered veterinarians from the Veterinary Council of New Zealand (VCNZ) to identify all veterinarians who may be trading.

Are all veterinarians who write prescriptions for PAR products actually trading in PAR products?

No. Veterinarians who write prescriptions for PAR products but do not supply them directly from their own stocks (i.e. those who write prescriptions to be filled by some other trader) are not considered to be trading in PAR products. They are not directly involved in the supply transaction. They are deemed to be approved traders but that is irrelevant in this case.

Do all veterinarians in a practice have to be identified to the ACVM Group as a responsible person who manages the supply of PAR products?

No. It is assumed that all veterinarians may, under their own authority and based on their own instructions, enter into transactions to supply PAR products. All veterinarians are already known to the ACVM Group via their veterinary registration. It is assumed that almost all of these transactions relate to that veterinarian’s own veterinary consultations and treatment instructions rather than in association with the operation of a veterinary medicine trading outlet. Most practices have a senior veterinarian or office manager who should be specified as the responsible person.

Do individual veterinarians have to contact the ACVM Group and identify themselves as a principal responsible for the management and sale of PAR products?

No. The ACVM Group has sent letters to veterinary practices asking them to nominate the principal in the practice who is responsible for the management and sale of PAR products. These were sent to practices rather than to individual veterinarians on the assumption that practices are more likely to establish trading outlets specifically to sell veterinary medicines to the public and to fill prescriptions.

Even though the person who is responsible for the management of stock and for the staff who carry out the transactions is a veterinarian, the ACVM Group wants to know about the outlets and who is particularly responsible for the operation. Although more than one veterinarian in a practice will provide for a transaction through an outlet, they are often not equally responsible for the management and sale of the products. It is expected that one person would be responsible for the behaviour of non-veterinary sales staff and the management and security of stock.

Individual veterinarians would not have received the letter sent to practices unless they were identified in the VCNZ records as being the contact in a practice. This was intentional and, at this stage in the development of an approved trader programme, the ACVM Group is not expecting those veterinarians to provide any information. However, if a veterinarian who did not receive the letter considers that he/she is operating a veterinary medicine trading outlet, then he/she should contact the ACVM Group to discuss adding their name to the ACVM list of principals responsible for trading in PAR products.

How do non-veterinary members of staff involved in the management and sale of PAR products go about gaining fit and proper person status?

Only the responsible person in the practice must be confirmed as fit and proper, and that person becomes the approved trader in the practice who takes full responsibility for the trading. This confirmation is only an issue if the specified responsible person is not a registered veterinarian or registered pharmacist (both these groups have to notify convictions in order to be registered and this is considered sufficient). The ACVM Group requires all other responsible persons to be confirmed as fit and proper as per the application documentation (see page 3).

As for staff operating under the control of the specified responsible person, confirming the appropriateness of a person is the responsibility of the specified person. It is expected that the responsible person will be very careful (and have adequate checks in the trading system) to designate only persons who are appropriate to carry out the PAR trading activities in their job descriptions.

Failure to take due care is a non-compliance issue and is a responsibility of the specified responsible person in the practice and may result in loss of approval of the trading entity or even prosecution.