Licence requirements for wholesale (G)

This part of our website is not up-to-date. The Veterinary Medicines Regulation has been in effect since 28 January 2022. The final national veterinary medicinal products legislation is not published yet. As soon as the final national veterinary medicinal products legislation is published, the Dutch web texts will be updated. Once these are ready, they will be translated into English. This will take some time. Therefore, check our website regularly for any updates.

You are a wholesaler

You are a wholesaler if you would like to supply veterinary medicinal products to other wholesalers or to retailers, veterinarians or pharmacists.

Licence requirements for the wholesaler

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 wholesale 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 wholesale channel, the quality of a veterinary medicinal product must continue to meet the requirements that were set when marketing authorisation was granted. Therefore, a supplier of veterinary medicinal products must meet a number of licence requirements. For the wholesale 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 wholesale licence holder, you ensure that the rooms where storage takes place (Article 5.2 of the Veterinary Medicinal Products Decree):

• are well-maintained, clean and tidy and are 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 medicinal products 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 wholesale 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 wholesale licence holder, you supply a veterinary medicinal product to another marketing authorisation holder for wholesale or retail trade. In doing so, you must ensure that the veterinary medicinal product complies with the applicable packaging and labelling requirements (Article 5.4 of the Veterinary Medicinal Products Regulations).

As a wholesale licence holder, you have an emergency plan for removing a veterinary medicine from the market (Article 5.6 of the Veterinary Medicinal Products Regulations). For more information, see Reporting a product defect and Recall of veterinary medicinal product.

Administration for wholesale licence (Article 5.15 of the Veterinary Medicinal Products Regulations)

The wholesale licence holder keeps records on every transaction involving veterinary medicinal products. 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 registration number of the veterinary medicinal product
• batch number
• expiry date
• quantity received
• name of the supplier.

Upon delivery of veterinary medicinal products to a wholesale licence holder, this administration contains the copies of invoices stating or 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 delivered
• name and address of the recipient
• proof of delivery with the information described above.

Wholesale authorisation for human medicinal products

If you have a wholesale authorisation for veterinary medicinal products and want to trade in human medicinal products as well, you must also apply for a wholesale authorisation for human medicinal products. This can be done at Farmatec.  

Because of the cascade scheme wholesalers are also allowed to supply medicinal products to veterinarians, provided the requirements are met.

In the context of the Falsified Medicines Directive (FMD), it is also necessary for wholesalers to have a human G authorisation to be affiliated to the Dutch Medicines Verification Organisation (NMVO) to keep the so-called human 'medicinal product chain' closed (zie: art.23 van de gedelegeerde verordening 2016/161).

This means that a wholesaler that physically has medicinal products must join the NMVO on the basis of the above-mentioned article. If a wholesaler (G authorisation holder) is a member of the NMVO, it will have access to the database in which these unique identification numbers are stored, except for medicinal products of which the safety characteristics are not mandatory. The wholesaler in question must be able to deactivate packages supplied to veterinarians in this database.

See also the information about this topic on the EMA and IGJ websites.

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

As a wholesale licence holder, you must perform an accurate audit of your records at least once per calendar year by comparing the veterinary medicinal products received and supplied 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 3 years.

Outsourcing the storage, transport and delivery of veterinary medicine

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

OMS

You must register in the Organisation Management Service (OMS)-database of the European Medicines Agency (EMA), otherwise we, as the Veterinary Medicinal Products Unit (BD), cannot process your manufacturing license or certificate (MIA), your wholesale license (WDA), or your registration for the veterinary raw materials register in this database. If you are not registered with the OMS, you will not be visible in the European database for manufacturers, importers and wholesalers (EudraGMDP). More information about OMS can be found on Organisation Management Service (OMS).