Licence requirements for retail (D)

The quality of a veterinary medicinal product must always be guaranteed in order to prevent any danger to the health of humans, animals or the environment. The quality must also be guaranteed after the veterinary medicinal product has left the factory. Therefore, licence requirements have been drawn up for the storage, transport and delivery of veterinary medicinal products. The licence requirements for the retailer are described below.

You are a retailer

You are a retailer if you would like to supply veterinary medicinal products to end users (keepers of animals). If you also want to deliver to other retailers, veterinarians or pharmacists, a wholesale licence is required.

Licence requirements for the retailer

The licensing requirements pertain to the organisation and use of the premises for the storage and/or delivery of veterinary medicinal products, the technical equipment and the administration systems in place.

Prior to issuing or changing a licence (only with a change of address or location), an on-site inspection is performed. This is not applicable when a retail licence for (veterinary) medicinal products has already been issued for the applying location (provided that the address or location does not change). After an appointment for an on-site inspection has been made, it will be confirmed in writing. The licensing requirements will be enclosed with the letter.

In the retail channel, the quality of a veterinary medicinal product must continue to meet the requirements that were set when the marketing authorisation was granted. Therefore, a supplier of veterinary medicinal products must meet a number of licence requirements. For the retail trade in veterinary medicinal products, the following requirements apply with respect to:

  • the location where storage and delivery takes place
  • the business administration.

Requirements regarding the location where storage and delivery takes place

As a retail licence holder, you ensure that the rooms where storage takes place (Article 5.2 of the Veterinary Medicinal Products Regulations):

  • are well-maintained, clean and tidy and well lit
  • are equipped with climate control to ensure that the temperature, humidity and ventilation do not have any undesirable effects on the veterinary medicinal products contained in the room and the temperature is monitored and recorded by you
  • are fitted with floors, walls and ceilings that are constructed so that they do not impede cleaning
  • are designed so that pipes, fans and other facilities do not create spaces that are inaccessible for cleaning
  • offer optimal protection against intrusion by vermin, partly through design and equipment of the building;
  • have sufficient capacity for the orderly storage of veterinary medicinal products
  • are designed so that the storage rooms for veterinary medicines with the designation ‘UDA’ or ‘UDD’ are not accessible to the general public. Veterinary medicines with the designation ‘URA’ must be stored out of direct reach of the general public
  • are fitted with a separate storage room for veterinary medicinal products that have been rejected, recalled or returned;
  • are designed so that veterinary medicinal products that are placed on loading and unloading bays are protected against certain weather effects
  • prevent employees from being exposed to the hazards of active ingredients stored in the room through the design, layout and equipment
  • offer suitable accommodation to animals where animals are present, which is properly separated from the other rooms.

As a retail licence holder, you ensure that (Article 5.3 of the Veterinary Medicinal Products Regulations):

  • the equipment can be easily and thoroughly cleaned due to its design
  • the equipment cannot be used incorrectly due to an error in the installation
  • repair and maintenance work in the rooms and of the equipment are performed in such a way that they do not pose any risk to the quality of the veterinary medicinal products
  • maintenance work for measurement and monitoring equipment is performed regularly. This maintenance must be carried out in accordance with appropriate methods, so that this equipment is calibrated and checked.

As a retail licence holder, you supply a veterinary medicinal product in accordance with the applicable packaging and labelling requirements (Article 5.4 of the Veterinary Medicinal Products Regulations).

As a retail licence holder, you only supply a veterinary medicinal product to a keeper of animals (Article 5.7 of the Veterinary Medicinal Products Regulations).

  • if the shelf life of the veterinary medicinal product has not expired
  • with an unbroken, original closure of the primary packaging and, if applicable, the outer packaging
  • if the veterinary medicinal product is supplied on prescription, it must contain a clearly visible, legible and indelible indication with the following information:
    • the words ‘licence holder’
    • the name and address of the retail licence holder concerned
    • the delivery date of the veterinary medicinal product.

A retail licence holder will only keep prescription medicinal products (URA) with the purpose of delivery in stock or ready for delivery in a room (that meets the requirements in Article 5.2 as stated above) and will only deliver them (Article 5.8 of the Veterinary Medicinal Products Regulations):

  • in a room to a keeper of an animal
  • from a room to the business of the keeper of the animal that is being treated, using a mode of transport suitable for the veterinary medicinal product, or
  • from a room to the home of the keeper of the animal if the animal is not kept for production, using a mode of transport suitable for the veterinary medicinal product.

Administration for retail licence (Article 5.16 of the Veterinary Medicinal Products Regulations)

As a retail licence holder, you keep administrative records on every transaction involving veterinary medicinal products of the URA category, which are only delivered after being prescribed.

When purchasing veterinary medicinal products, this administration contains the invoices relating to the receipt and states or is accompanied by at least the following details:

  • date of the transaction
  • name and, if applicable, the REG NL number of the veterinary medicinal product
  • batch number
  • expiry date
  • quantity received
  • name of the supplier.

Upon delivery of veterinary medicinal products to a retail licence holder, this administration contains copies of invoices stating or accompanied by at least the following details:

  • date of the transaction
  • name and, if applicable, the registration number of the veterinary medicinal product
  • batch number
  • expiry date
  • quantity delivered, and
  • name and address of the recipient.

Upon delivery of a veterinary medicinal product, this administration shall contain:

  • the prescription, (with the exception of URA products), if applicable, and
  • copies of invoices with or at least the following details:
    • date of the transaction
    • name and, if applicable, the registration number of the veterinary medicinal product
    • batch number;
    • quantity delivered
    • name and address of the recipient or unique company number of the location where the animals are kept.

Audit of administration and storage period (Article 5.17 of the Veterinary Medicinal Products Regulations)

As a retail licence holder, you must perform an accurate audit at least once per calendar year by comparing the veterinary medicinal products received and delivered to the stock inventory. A report must be drafted as proof of this check and must contain in any case the differences that were observed. You must keep this administration and report for at least 5 years.

Outsourcing the storage, transport and delivery of veterinary medicinal products

Outsourcing the storage, transport and delivery of veterinary medicines is allowed under certain conditions.