Inspection Criteria for Internet Retailers

Transcription

1 Inspection Criteria for Internet Retailers (a) Introduction The inspection criteria set out below apply to internet retailers supplying veterinary medicinal products (VMPs) classified as: Prescription Only Medicine Veterinarian (POM-V) Prescription Only Medicine Veterinarian, Pharmacist, SQP* (POM-VPS) Non-Food Animal - Veterinarian, Pharmacist, SQP (NFA-VPS). *SQP refers to a Suitably Qualified Person who is registered with a body recognised under the Veterinary Medicines Regulations. The term must refers to legal requirements, whilst should refers to good practice or guidance. However, those internet retailers who wish to be accredited under the VMD s Accredited Internet Retailer Scheme ( accredited internet retailers ) to enable them to display the VMD s Internet Retailer Logo on their website, must comply with all of the following criteria. (b) Supply of POM-V, POM-VPS and NFA-VPS products Internet retailers supplying VMPs from registered veterinary practice premises (VPPs) and approved SQP Retailer premises must comply with the prescribing and supply procedures for VMPs set out in, respectively, Annexes B and C of Veterinary Medicines Guidance (VMG) Note 3 Guidance for Retailers, which is available on the VMD s website Pharmacists must comply with the requirements of the Veterinary Medicines Regulations and should observe any additional requirements of the General Pharmaceutical Council (GPhC) or the Pharmaceutical Society of Northern Ireland (PSNI). Internet retailers should have in place procedures to ensure that: before prescribing and supplying a POM-VPS product, a veterinary surgeon, pharmacist or SQP (collectively referred to as Responsible Qualified Persons - RQPs) assesses the details provided by the customer, and interacts with the customer as necessary, to ensure that sufficient information about the animal and the treatment for which the product is required is obtained and carefully considered, so that the most appropriate VMP is prescribed and supplied. A similar procedure should be followed before supplying an NFA-VPS product. Such interaction should take place even if a customer asks for a specific product; in addition to the above, when prescribing or supplying VMPs for horses, an RQP should inform the customer whether or not the product is suitable for use in food producing horses. This is to allow horse keepers to fulfil their obligations regarding the horse passport legislation; an RQP is available to advise the customer directly (e.g. by phone) if this is considered necessary to ensure the safe administration of the product; 1

2 orders for VMPs with the potential for abuse, e.g. products containing controlled drugs, are subject to particular scrutiny by the RQP. Retailers should be alert to prescriptions for large quantities of such products, or abnormally frequent repeat prescriptions, and refuse to make a supply where there are reasonable grounds for suspecting misuse and/or abuse customers are advised to consult a veterinary surgeon whenever information about the symptoms or condition described indicate that their best interests would be served by a face-to-face consultation with a veterinary surgeon. there is a system to record suspected forged or altered prescriptions and to report these to the VMD. (c) Additional requirements for the supply of POM-V medicines Veterinary medicinal products classified as POM-V may only be retail supplied by a veterinary surgeon from a registered veterinary practice premises (VPP); or by a pharmacist from a pharmacy registered with the GPhC or PSNI, or from a registered VPP, in accordance with a written prescription issued by a veterinary surgeon (Schedule 3 paras 3(2), 9 & 10). Internet retailers supplying POM-V products should clearly indicate to potential customers browsing the website that a valid written prescription is required before a POM-V product can be supplied, and provide information on how such orders will be processed. Internet retailers may also choose to indicate that POM-VPS products may also be supplied to a written prescription from a veterinary surgeon, pharmacist or SQP. Internet retailers of POM-V medicines should have in place systems to ensure that the correct POM-V medicine is supplied by a veterinary surgeon or pharmacist against a valid written prescription, and that the unlawful sale or supply of POM-V medicines is prevented. In particular: internet retailers should satisfy themselves that the prescriber and prescription are genuine and legally valid. This is particularly important where prescriptions are faxed or ed. Contacting the prescriber by phone and checking the prescriber s registration with the RCVS is considered a minimum step. It is also considered good practice for the retailer to request the hard copy of the prescription from the customer before any medicines are despatched. Controlled Drugs (CDs) may only be supplied against a hard copy written prescription but appropriate checks on the authenticity of the prescription must still be carried out; there should be a system for control for supplying POM-Vs against repeat prescriptions supply of POM-V products against prescriptions written by veterinary surgeons located in the European Economic Area (EEA) and Switzerland for use in the EEA or Switzerland must be recorded. The retailer should have systems to check that the prescription is legitimate, that the prescriber is a registered veterinary surgeon in the EEA or Switzerland and that the entry of the medicine into that country is legal. The retailer may refuse supply of the medicine if sufficient assurances cannot be provided by the buyer. 2

3 (d) Record keeping: Internet retailers must comply with the record keeping requirements set out in the current Veterinary Medicines Regulations, and repeated in the main inspection criteria for VPPs and SQP Retailer premises. Further information can also be found in VMG Note 14 Record- Keeping requirements for Veterinary Medicinal Products, which is available on the VMD s website. Internet retailers should: have an online registration system to record the details of customers who wish to order POM-VPS or NFA-VPS products over the internet, and record relevant information about the animal for which the treatment is required, such as the species/breed, number, age, weight, sex, and previous treatments given. Such records should be kept up to date. If returning customers are permitted to log-in without having to provide the information again there should be a confirmatory declaration that the details are unchanged with each order. An RQP should then make the necessary checks on the suitability of the product ordered before any products are prescribed and/or supplied; prepare an online questionnaire for completion by customers to confirm whether they have administered the product previously, that they are aware of the relevant safety precautions relating to the product, and that they will read the packaging and product literature (e.g. the SPC) before using the product. Customers should be required to complete the questionnaire before they proceed to payment; ideally have in place a procedure that, following the placing of an order for a POM-V product, the veterinary surgeon or pharmacist contacts the customer by or telephone to enable the veterinary surgeon or pharmacist to discuss any issues before fulfilling the prescription. This procedure must be followed if there is any missing or conflicting information. The veterinary surgeon or pharmacist should also be prepared to follow this procedure if he/she is not completely satisfied that the medicine to be supplied is appropriate for the animal or the condition to be treated, or if there is any safety concern regarding the product; and make and retain appropriate records of all interchanges, e.g. phone calls and s, with customers. (e) Delivery & Returns: Internet retailers should be aware that some carriers have restrictions on the transporting of veterinary medicines and retailers should check the terms and conditions before despatching VMPs by post. Internet retailers should take all reasonable measures to ensure that: the integrity of VMPs that are subject to special storage conditions is not compromised during delivery to the customer. All products, particularly cold chain products such as vaccines, should be transported in such a 3

4 way so that they are maintained within the temperature range specified on their SPC/label; delivery agents, including their own staff, are aware of any special handling and storage requirements for the VMPs, and are aware of what action to take in the event of such incidents as accidents, spillages and non-delivery. Whilst not a legal requirement, it is recommended that special/recorded delivery is used for POM-V and POM-VPS products. Internet retailers should have a procedure for quarantining and ultimately appropriately disposing of returned VMPs. (f) Other Legislative Requirements Internet retailers should be aware that other legislative requirements may apply to the sale/supply of VMPs over the internet e.g. the Distance Selling Regulations (please see: The Data Protection Act 1998 (please see: ) (g) Requirements for Registration under the VMD s Accredited Internet Retailer Scheme Internet retailers of veterinary medicinal products classified as POM-V, POM- VPS and NFA-VPS who wish to be accredited under the VMD s Internet Retailer Scheme must apply to the VMD for accreditation of their website and use of the VMD logo. All website addresses used to retail supply VMPs, including any forwarding addresses, must be listed on the application form. Application forms for accreditation as an internet retailer can be downloaded from the VMD s website. Hard copies can be requested from the VMD s Inspection Administration Team by phoning or by ing inspections@vmd.defra.gsi.gov.uk Website identification Accredited internet retailers must display on their website: the name of the owner of the business and a correspondence address a postal address for the premises where the internet retailing business is carried out the name of the RQP responsible for the internet retailing business and information about how to confirm the registration status of that person e.g. links to their professional membership Registers the VMD logo which gives details of how to access the VMD s Register of Internet Retailers which is published on the VMD s website, to enable the registration status of the internet retailer to be confirmed 4

5 details about how to make a complaint to the business about their website s services and, in the event of an unsatisfactory response from the business, to the VMD. The website should give instant access ( address, phone number, fax number) to qualified personnel to answer questions about the products ordered. Accredited internet retailers must notify the VMD if they open or acquire a new website, shutdown a website or move their website to another address; and notify the VMD of a change of ownership of the business. Security of the website and the VMD logo Accredited internet retailers issued with the VMD logo must not: transfer, replicate or duplicate the logo for use by non-accredited internet retailers websites modify or have additional information or logos superimposed on it use the logo to mislead or misinform website users. Website design Accredited internet retailers must offer a link in their website to the VMD s Product Information Database and explain that the Summary of Product Characteristics (SPCs) for the product purchased may be found there. They must also offer a link to the VMD s Report an Adverse Event (yellow form) (Suspected Adverse Reaction Surveillance Scheme) page. Accredited internet retailers must comply with the advertising requirements of the current Veterinary Medicines Regulations. 5