Parallel trade in veterinary medicinal products

A wholesale distributor can apply for a marketing authorisation for parallel trade in a veterinary medicinal product originating from another Member State of the European Economic Area (EEA) on the proviso that this veterinary medicinal product is identical to a veterinary medicinal product for which a marketing authorisation has been issued in the Netherlands. 

Article 102 of the Veterinary Medicinal Products Regulation describes parallel trade in veterinary medicinal products. Parallel trade is a new term in the Veterinary Medicinal Products Regulation. It was previously referred to as parallel import.

The pricing for a veterinary medicinal product could be lower in another Member State. Hence, it could be economically appealing to bring the product to market in the Netherlands through parallel trade.

What requirements are attached to the granting of marketing authorisations for parallel trade?

Any wholesale distributor wishing to engage in parallel trade in a veterinary medicinal product from another EEA Member State in the Netherlands or vice versa will have to satisfy the requirements set out in Article 102, paragraphs 1, 2, 5 and 6 of the Veterinary Medicinal Products Regulation. These are: 

A requirement of common origin applies to parallel trade in veterinary medicinal products. This means that, as a wholesale distributor, you are to ensure that the veterinary medicinal product that you are intending to import from one EEA Member State into another Member State is identical to the veterinary medicinal product already permitted in the Netherlands.

As a minimum, this means that the products should have the same: 

  • qualitative and quantitative composition in terms of active substances and excipients
  • pharmaceutical form
  • target animal species, withdrawal period and indication
  • manufacturer (or have a manufacturer working under licence according to the same formulation). 

Please note: you must provide the aforementioned information when applying. If the information is not included, we will not accept the application. 

In addition, the veterinary medicinal product must satisfy the labelling and language requirements set by the destination Member State. 

You will not be permitted to sell any veterinary medicinal product withdrawn from sale in the Netherlands or in the Member State of origin on the grounds of quality, safety or efficacy.

Step-by-step plan for applying for marketing authorisation for parallel trade

Any wholesale distributor wishing to engage in parallel trade in a veterinary medicinal product in another EEA Member State will have to run through the following steps: 

  • Inform the holder of the marketing authorisation for the veterinary medicinal product and the competent authority of the Member State of origin of your intention to engage in parallel trade in the veterinary medicinal product.
  • Declare to the competent authority in the destination Member State (this being the Veterinary Medicinal Products Unit in the Netherlands) that you have taken appropriate measures to ensure that you will keep the authorities in the Member State of origin informed of any issues pertaining to veterinary medicinal products monitoring.
  • Inform the holder of the marketing authorisation for the veterinary medicinal product in the destination Member State of your intention to apply to engage in parallel trade in the veterinary medicinal product at least one month prior to submitting the application.
  • Provide a written declaration to the competent authority in the destination Member State (this being the Veterinary Medicinal Products Unit in the Netherlands). This should state that you have informed the holder of the marketing authorisation in the destination Member State. Please include a copy of this statement.
  • Amass information on suspected adverse effects and report these to the holder of the marketing authorisation for the veterinary medicinal product being traded in parallel. 

How do I go about applying for a marketing authorisation for parallel trade?

If you as a wholesale distributor satisfy all of the above requirements, you will be able to apply for a marketing authorisation for parallel trade. Your chosen product name for the veterinary medicinal product may differ from the product name for the veterinary medicinal product in the country of origin and/or the destination country. 

In due course, further information on marketing authorisations for parallel trade will be published in the Best Practice Guide (BPG) on marketing authorisations for parallel trade. An application form will also be included in this BPG. It is expected that the CMDv finalises this BPG in July 2022, after processing the comments from the previous public consultation. The draft version of the BPG can be found on the CMDv website.

We advise you to wait with your application until this BPG has been finalised. In July 2022, a link to the application form and the BPG will be included on this page. If you have any questions, please contact the Veterinary Medicinal Products Unit.

A marketing authorisation for parallel trade in a veterinary medicinal product:

  • applies to a single veterinary medicinal product, but may cover multiple wholesale distributors in the country of origin
  • is not a trade licence
  • is subject to the provisions set out in the Summary of Product Characteristics (SPC) for the Dutch reference veterinary medicinal product. No separate SPC, label text and package leaflet text is stipulated for a marketing authorisation for parallel trade
  • contains information on what information deviating from the SPC may be given on the packaging and in the package leaflet once the veterinary medicinal product has been repackaged for the Dutch market. Consider in this regard:
    • the name and number of the veterinary medicinal product licence
    • the name of the holder of the marketing authorisation for parallel trade
    • the manufacturer release to market upon repackaging
    • the shelf life (if this differs from the Dutch reference)
  • contains information on the veterinary medicinal product’s country of origin
  • can be suspended if the marketing authorisation for the reference veterinary medicinal product is suspended
  • can be revoked if the marketing authorisation for the veterinary medicinal product in the country of origin or for the veterinary medicinal product already permitted in the destination Member State is revoked. Or if it no longer satisfies the requirements (is no longer identical) after a marketing authorisation has been amended
  • is included in the Veterinary Medicinal Products Information Bank and the UPD.

What responsibilities do I have as a holder of a marketing authorisation for parallel trade?

If you have been issued a marketing authorisation for parallel trade in a veterinary medicinal product, 

then the following applies: 

  • The texts on the label and in the package leaflet must be identical to the texts for the reference veterinary medicinal product. The text must satisfy the Dutch labelling and language requirements. To this end, you will have to repackage the veterinary medicinal product for the Dutch market.
  • You are required to monitor the situation with regard to the SPC in the destination country and, where applicable, in the country of origin to see whether any changes occur. If a change is made, you will have to amend the text on the packaging and in the package leaflet forthwith.
  • You can bring to market in the destination country a packaging size from the SPC for the Dutch reference veterinary medicinal product which does not feature in the SPC in the country of origin. To this end, you will have to repackage the veterinary medicinal product for the Dutch market. 

Which rules apply regarding marketing authorisation for parallel import?

Marketing authorisations for parallel import issued prior to 28 January 2022 were based on the old rules on parallel importation of veterinary medicinal products. Under the old rules, the veterinary medicinal product was allowed to be pretty much identical in terms of manufacturers and excipients to those of the veterinary medicinal product in the country of origin.

This means that, in order for you to be allowed to continue in the market: 

  • you will need to submit a new application for parallel trade in a veterinary medicinal product before 31 December 2022; and
  • your application must satisfy the aforementioned new requirements. 

Revocation of the marketing authorisation 

The marketing authorisation for parallel import will be revoked if: 

  • the application was not submitted on time;
  • the application is incomplete;
  • the application fails to demonstrate that the new preconditions for parallel trade are met;
  • the application process culminates in the issuance of a marketing authorisation for parallel trade in a veterinary medicinal product. 

Once a decision has been made to revoke a marketing authorisation, the delivery time frame agreements will apply.

Parallel trade does not apply to veterinary medicinal products for which a centralised marketing authorisation has been issued. Read more on parallel distribution