26.1. Order Line Ltd trading as Church Pharmacy, WDA(H) 24695 are authorised to supply medicinal products on a wholesale basis under the Human Medicines Regulation (2012) and MHRA regulations.
26.2. Wholesale Orders Can be received and supplied on the following basis:
26.2.1. A signed order from a doctor, dentist or HIS registered Nurse.
26.2.2. An order received from a WDA(H) holder (wholesale distribution authorisation (for human medicines)).
26.2.3. A Pharmacy Order received from a GPhC registered Pharmacy.
26.3. Prior to supply various customer verification and bona fide checks must be carried out including but not limited to:
26.3.1. Delivery address checks to ensure the delivery address is compliant for the delivery and storage of medicinal product including checking the CQC, RQIA and HIS database.
26.3.2. Where a delivery address is not CQC, RQIA or HIS registered, a risk assessment will be carried out on the delivery address which will involve requesting an in-date proof of ID and a utility bill (dated within 6 months) from the customer to verify the customer is associated with the requested delivery address. A risk assessment is valid for one year at which point, an updated in-date utility bill will be requested and a proof if ID, if the ID has expired at the point of the annual review.
26.3.3. Wholesale Customer Registration checks i.e. WDA(H) and GDP certificate checks and may involve requesting and reviewing original copies of licenses. Other checks that may be carried out are company registration and VAT registration checks.
26.3.4. Personal individual checks to confirm the registration number of the signee and verify their registration status via the relevant registration body website e.g. GMC, GDC, NMC or GPhC.
26.4. Signed Orders:
26.4.1. It is the customers (referenced in clause 26.2.1) full responsibility to ensure that the item(s) ordered on signed order are received, handled, stored and administered in line with the legislations and regulations outlined in the Medicines Act 1968, Prescription Only Medicine (Human Use) Order 1997, The Human Medicines Regulation 2012, MHRA guidelines and the manufacturer's product guidelines.
26.4.2. By accepting these terms and conditions throughout the order process and at the time of order confirmation/dispatch, the customer (referenced in clause 26.2.1) accepts:
a) Full responsibility for the products on the signed order.
b) In the instance of a Doctor or Dentist delegating the administration of the products ordered to a trained individual under their supervision, that the Doctor or Dentist takes full responsibility for the clinical oversight of the patient, administration and after care.
c) Where the products ordered are to be administered, that these products are only administered following a face-to-face consultation with the patient.
d) The products that have been ordered on Signed Order cannot be re-sold and are for clinical use only.
e) It is the customers responsibility to inform Order Line Ltd if their circumstances have changed whereby they can no longer order, receive, handle or administer the products ordered.
26.4.3. Unlicensed medicines can be ordered and supplied on Signed Order, provided the below conditions are met as listed under this clause. These conditions have also been listed in the Signed Order Declaration, which must be completed and signed by the Customer, per Signed Order of Unlicensed Medicines. By ordering an Unlicensed Medicines on Signed Order, the customer understands:
a) That the order is for an unlicensed product and is supplied to meet an individual patient’s special needs and that the patient’s details, quantity supplied, batch number supplied and details of any adverse events will be kept on record at the delivery address detailed on this form.
b) That the order is for an unlicensed medicinal product for use by a patient for whose treatment they are directly responsible for, as a healthcare professional and that this order is to fulfil the special needs of that patient.
c) As a healthcare professional they are responsible for deciding whether an individual patient has “special needs” which a licensed product cannot meet.
d) The patient will be counselled accordingly.
e) That Unlicensed products must only be ordered and supplied in accordance with the guidance set out in ‘The Supply of Unlicensed Medicinal Products (“specials”)’ MHRA Guidance Note 14.
f) Unless exempt, a medicinal product must be the subject of a marketing authorisation or product license before being placed on the market. Regulation 167 of the Human Medicines Regulations 2012 provides an exemption from the need for a marketing authorisation for a medicinal product.
26.4.4. Order Line Ltd reserves the right to refuse supply of products or services to any person and/or company it sees fit, this may be due to public safety risks and/or other technical, investigative or commercial reasons. Order Line Ltd are not obliged to disclose the reasons for refusal of supply. If supply of products or services are withheld for any reason(s), Order Line ltd take no responsibility in any consequential impacts including costs/losses incurred by the customer(s) by withholding of our supplies/services.
26.5. Wholesale Orders
26.5.1. Order Line Ltd T/A Church Pharmacy WDA(H) 24695 is authorised to supply medicinal products on a wholesale basis to other Wholesale Dealers Authorisation Holders (for human medicines), WDA(H).
26.5.2. Prior to a WDA(H) holder being authorised to receive medicinal products and prior to supply, Order Line Ltd will carry out verification and bona fide checks on the WDA(H) holder in line with The Human Medicines Regulation 2012, including but not limited to, WDA(H) and GDP certificate verification checks, companies house and VAT registration checks, verifying company contact details and delivery addresses.
26.5.3. Following the checks completed in clause 26.5.2, if Order Line Ltd believe that the WDA(H) holder is not authorised to receive medicinal products and/or the company, personnel, premises, processes, Quality Management System is GDP compliant, Order Line Ltd reserves the right to refuse supply. If supply has been refused, clause 26.4.4 applies and Order Line Ltd will not be responsible for any consequential impacts including costs/losses incurred by the customer(s).
26.6. Pharmacy Orders
26.6.1. Order Line Ltd T/A Church Pharmacy WDA(H) 24695 is authorised to supply medicinal products on a wholesale basis to GPhC registered Pharmacies.
26.6.2. Prior to a WDA(H) holder being authorised to receive medicinal products and prior to supply, Order Line Ltd will carry out verification and bona fide checks on the Pharmacy in line with The Human Medicines Regulation, including but not limited to, verifying the Pharmacy and Responsible Pharmacist GPhC details on the GPhC database and companies house and VAT registration checks.
26.6.3. Following the checks completed in clause 26.6.2, if Order Line Ltd believe that the GPhC registered Pharmacy is not authorised to receive medicinal products and/or the company, personnel, premises, processes are GDP compliant, Order Line Ltd reserves the right to refuse supply. If supply has been refused, clause 26.4.4 applies and Order Line Ltd will not be responsible for any consequential impacts including costs/losses incurred by the customer(s).
26.6.4. By placing and receiving a Pharmacy order, the Responsible Pharmacist listed on the order form and/or the account holder understand that supply of medicinal products to a GPhC registered Pharmacy is for the dispensing and fulfilling of named patient prescriptions and/or retail sale to the general public.
26.6.5. By placing and receiving a Pharmacy order, the Responsible Pharmacist listed on the order form and/or the account holder understand that supply of medicinal products to a GPhC registered Pharmacy is not for onward wholesale supply. If the Pharmacy holds a valid WDA(H) authorisation and intends to wholesale the received medicinal products, this order should be submitted to Order Line Ltd as a Wholesale Order, failure to do so or comply with these terms and conditions may result in suspension of the Pharmacy account and refusal of further supply.