Import License needed from non EU country to Germany?

Anon
22/10/2020 15:11

Advice needed for transportation of products to and from non-EU country. As Sponsor (based in UK with manufacturing labs Spain and Germany) for a multi country Cell Therapy study involving the transport of Bone Marrow cells. We are in the process of setting up Georgia (Tibilisi) a non-EU country where it is required that bone marrow will be transferred from the sites in Tbilisi to our associated manufacturing lab in Frankfurt (Germany) for processing then back to the site for administration of the product. My question is; as the sponsor do WE need to apply to the Competent Authority for an Import or Export License for the manufacturing lab in Germany or does the lab have to apply for this themselves? Note: The product will be processed by the lab then sent back to the site in Tibilisi? I've had conflicting info! thanks

Juergen Kaetzler
22/10/2020 16:30

As far as I know the IMPORTER (the responsible party for IMP import, can be the sponsor or a pharmaceutical company or a lab) has to apply for the import licence; if not the sponsor, the importer has to provide that licence to the sponsor for submission of the trial to the National Competent Authority. The Paul-Ehrlich-Institute published a guideline concerning the electronic file structure: https://www.pei.de/SharedDocs/Downloads/EN/regulation-en/clinical-trials/specification-eletronic-submission.pdf?__blob=publicationFile&v=2 There it reads on page 4: "Copy of the import licence of the importer with office in the EU / EEA". So the sponsor can apply for the import licence with an office in the EU/EEA - so UK may not be the best option. >> If located in Germany, the application for an import licence shall be submitted to the local authorities (scroll down to chapter 15, only in German: https://www.zlg.de/arzneimittel/deutschland/qualitaetssystem/) >> To be safe: contact the Paul-Ehrlich-Institute and ask your question. You will find the contact details here: https://www.pei.de/EN/regulation/clinical-trials/clinical-trials-node.html >> It would be very interesting if you could also post the result of the discussion.

Anon
22/10/2020 17:43

Thanks for quick reply! Much appreciated, the lab are refusing to apply for the license citing it is the sponsor responsibility but the PEI confirmed that the lab has to apply for it! quite confusing, I will do some more digging and get back to you asap with feedback.

Juergen Kaetzler
23/10/2020 06:23

In my former job we had to apply for an import licence because we imported an active substance from outside the EU for manufacturing a tissue-engineered product. There was (for luck) no big discussion on the responsibities: the lab that manufactured the product also applied for the import licence. The application was sent to the "Regierungspräsidium Tübingen", the competent local authority for GMP in Baden-Würrtemberg in southern-east Germany. The Regierungspräsidium "cooperated" with the Paul-Ehrlich-Instutite, performed an inspection of the lab and then the import licence was issued. This is the way how it works in Germany. There is a checklist (again only in German): https://rp.baden-wuerttemberg.de/rpt/Abt2/Ref25/LeitstelleArznei/Documents/MerkblattEinfuhrerlaubnis.pdf >> If you - as a sponsor - do not have any adequate facilities (for example for storage of the imported product, documentation of quality checks, qualified personnel etc.) you cannot apply for an import licence. And as far as I understand now, this is the case for you? You are the sponsor, you have your office rooms but you are not involved in manufacturing a medicinal product? >> You wrote that you have a lab in Spain? Maybe this lab could apply for an import licence so you may import the product into the EU and then transfer it to Germany? https://www.pei.de/SharedDocs/Downloads/EN/regulation-en/clinical-trials/3rd-notification-clinical-trials-2006-08-10.pdf?__blob=publicationFile&v=2 (page 6, no. 11) (would be plan B because then you have to ensure that transportation from lab in Spain to the lab in Germany is done according to GMP, the "receiving" lab needs to check the incoming product etc.)

Anon
23/10/2020 09:11

Very useful info indeed! Yes, those were my thoughts too to maybe go via our lab in Spain; due to locations and timing to process the product we needed a lab closer to the Baltic states so we acquired the lab in Germany to help process some of the products on time within the 48hrs needed for the bone marrow. It has been working very well but now we have to set-up Georgia which is proving very challenging not least because of the distance.... Thanks for this I will look into the links more and feedback the outcome to the Forum.

RQA GLP Committee
20/11/2020 08:31

Dear Anon, Many thanks to Juergen for the comprehensive reply, unfortunately we can't add anything to this as it is outside of our GLP expertise.

Anon
16/12/2020 15:15

Hi again. I thought I'd update the Forum on the outcome of my query. Firstly special thanks to Jeurgen and other members for your support and advise in navigating through the minefield of information surrounding Import licenses. It has been a long journey but it turns out that it will not be pursuing an Import License for our lab in Germany for the following reasons; 1. The lab will need to apply for the license themselves because they do not have the capacity or expertise 2. Each site in Georgia will need to undergo a Regulatory Audit which could be at least three months AFTER the application submission (or longer if there are comments to address). This means that the license will not be granted until 4 or 5 months after the application 3. The cost of each site Audit could be at least 15, 000 Euros per site (this doesn't include extra expenses incurred by the inspectors on the day) per day. Each Audit expected to last 1.5 days. 4. The extra burden to sites is just too much to ask Fortunately we have a lab in Spain so we will be divert products there. These are all very useful lessons learned the main one being to ensure labs are in possession of relevant licenses and are able to accept products/samples from any country participating in the study. Just thought I'd share and close this query. Thank you all again and have a joyful festive season.

Juergen Kaetzler
22/12/2020 16:38

Dear Anon, thanks for coming back and sharing your experiences. Also very helpful for me/us to know about auditing requirements and also having a view on the costs. Fine holidays and happy new year - stay safe and healthy!

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