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Importing Non-Human Primate Samples into the European Union

A brief anecdote about the inconvenient import procedure for non-human primate specimen collected from non-European origins and covered by CITES regulations.

 

Introduction

Accelero Bioanalytics is a laboratory service provider: Good Laboratory Practice (GLP) certified; Good Clinical Practice (GCP) compliant; Biosafety level 3** for potentially infectious material; Genetic engineering safety level 2 approved;

From time to time Accelero finds itself in the situation to import biological samples from non-European origins. Even though the test facility is registered for the import (registration no. DE 11 009 00013 21) there is some paperwork to be done before the samples can be shipped.

The test facility manager can count himself lucky to import only specimen collected from species not falling under the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES). This procedure is well stablished and does not pose any problems at all.

In many cases non-human primates as the animal model of choice are still involved in regulatory drug development. Accelero is glad to recognize an increasing number of scientists dealing with the development of animal-free in vitro assays for both efficacy and toxicology. However, in some cases study sponsors are running in vivo experiments in non-European countries involving non-human primates as the toxicologically relevant species. In this case indeed the CITES regulations apply.

 

Animal By-Products Import Approval from the Local Authority

The import of animal by-products and derived products not intended for human consumption into the European Union is regulated in Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive.

According to Section 27 of the said EU regulation No 142/2011 the import is subject to approval by the authority where the airport is located. For example, if you plan to import your samples via Frankfurt International Airport, you should apply at the Ministry of Environment, Climate Protection, Agriculture and Consumer Protection of the Federal State of Hessen. In Germany, the EU regulation 142/2011 is reflected in the German “Regulation on intra-community movement and the importation and transit of animals and goods” (Binnenmarkt-Tierseuchenschutzverordnung - BmTierSSchV). Usually it only takes a few days until the approval is in your mailbox and should be valid for six months from the day of issue.

The import approval should indicate the exact number of samples, the exact volume or weight for each sample, and the total amount (volume, weight) of samples. The import approval may list the following additional requirements:

1. The samples must be sent by air.

2. The samples are subject to documentary, identity (The weird German word "Nämlichkeitskontrolle" is stated in the authority´s official letter, whatever that means, I have never come across this funny expression.), and physical examination at the border inspection post.

3. At the time of presentation or demonstration of the samples at the border inspection post, the following documents must be presented:

(a) The ORIGINAL import approval (or officially certified photocopy).

(b) The ORIGINAL of a health certificate from the official veterinarian responsible for the place of origin of the samples, proving that the samples originate from monkeys (species to be specified) ...

  • have been kept as experimental animals under veterinary supervision in the country of origin for at least three months at the time of sampling;
  • that have not been experimentally infected with animal disease agents;
  • have undergone veterinary examination prior to sampling and found to be clinically healthy in this study. The health certificate must be presented in ORIGINAL form and must consist of a single sheet. It is valid for ten days (!) from the day of issue.

6. The arrival of the material at the consignee must be reported to the competent veterinary authority without delay (Accelero has a good reputation at all local authorities involved in the import …).

7. The material may only be used for research or diagnostic purposes in premises that are suitable for use with these materials and that are technically equipped for the specified recipient. All necessary measures must be taken, in particular the application of the principles of good laboratory practice. A transfer is not allowed.

10. The recipient of the material must keep records of the type, quantity and origin of the licensed material received, its use and disposal. The records shall be submitted to the competent authority at their request.

 

CITES Import Certificate from the Federal Agency for Nature Conservation

Species listed in the annexes to Commission Regulation (EU) 2017/160 of 20 January 2017 (amending Council Regulation (EC) No 338/97) include species set out in the appendices to the Convention on International Trade in Endangered Species (CITES) of Wild Fauna and Flora as well as species whose conservation status requires that trade from, into and within the European Union be regulated or monitored.

Many non-human primates (e.g. like the crab-eating cynomolgus monkey Macaca fascicularis) are among this listed species, please visit www.cites.org to check the status of your species.

In Germany the Federal Agency for Nature Conservation (Bundesamt für Naturschutz, an English site is available) is the competent authority for CITES import/export. Applications can be filed online, and the CITES certificates will be sent only with a slight delay via regular mail. However, even though an email confirmation of receipt is sent after application, there is no separate email notification when the documents are issued and sent to the applicant.

Special care should be taken that all indicated information (e.g. the address of the exporter or the importer) are 100% identical among all documents provided to authorities or the border inspection post. As for the animal by-products import certificate, the CITES import certificate should indicate the identical information with regards to the importer, the exporter, and the total amount (volume, weight) of samples.

The CITES certificates are usually valid for six months from the day of issue.

Particular requirements:

(a) Two original CITES import certificates will be sent: the white issue will directly be returned to the authority after inspection at the border inspection post; the yellow issue will be shipped along with the samples to the final destination;

(b) Once the CITES certificates have become invalid (after six months) they should be returned to the competent authority (!). It is indeed a good idea to dog-ear your pocket calendar´s page as a little reminder;

 

Finding a Competent GxP Transport Service Provider

There are several transport service providers operating businesses on all relevant continents (e.g. like MARKEN or World Courier). All of these should be able to manage such shipments, and usually provide excellent support in assembling all required documentation.

Certainly a proforma invoice for the export should be issued by the exporter. The proforma invoice should provide identical information with a) the animal by-products import certificate, and b) the CITES import certificate (even the letters used should be the same).

 

Documents Required at the Customs Office

The following documents should be presented on the day of inspection at the border inspection post:

  • The ORIGINAL import approval from the authority where the airport used for the import is located (usually valid for six months from the date of issue);
  • The ORIGINAL health certificate from the official veterinarian responsible for the place of origin of the samples (not older than 10 days from the day of issue);
  • The ORIGINAL proforma invoice from the exporter;
  • The ORIGINAL CITES export certificate from the place of origin of the samples (usually valid for six months from the day of issue);
  • Both the white and the yellow ORIGINAL CITES import certificates (usually valid for six months from the day of issue); The white CITES import certificate will be sent to the Federal Agency for Nature Conservation. The yellow CITES import certificate will be shipped with the samples to the final destination (= importer).

 

Conclusion

The workload is extremely high. All documents must be in line with the regulations and should be consistent with one another. It requires good communication skills (with different authorities, with the exporter i.e. the place of origin of the samples, with the transport service provider, and with the study sponsor) and a good portion of patience. It can take up to two months from executing the sponsor´s contract to receiving the sample shipment at the final destination.

Given the fact that

  • one person will need at least 16 hours only for transport organization over a time period of at least 2 months,
  • all authorities charge fees for their approval/certificates,
  • and the transport service provider usually doesn´t provide services for free,

... the whole process can be expensive and time consuming. Costs can easily accumulate to reach 5000 euros for each shipment.

Accelero is familiar in handling such service requests. However, it could be worth thinking of contracting a research organization based in the European Union for your non-human primate toxicology study, couldn´t it?

 

This blog article is for information purposes only, and does not claim to provide full and complete information. If you would like to receive a checklist for organizing your sample import on your own, please feel free to send your request to service[at]accelero-bioanalytics.com.

 

Last update of this site: 12-FEB-2019 by CL