§ 72(2a) AMG
Importing investigational medicinal products into Germany from outside the EU and EEA requires an import authorisation, granted under Article 61 of Regulation (EU) No 536/2014.
Case studies · Clinical trial sponsor, small biotech company
Non-EU active substance and investigational medicinal product released
The active substance and the investigational medicinal product are manufactured outside the EU. We oversaw GMP-compliant manufacture, audited the manufacturers and released the product after import into the EU.
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experts on the project
At a glance
How is an IMP manufactured outside the EU released after import?
- Client
- Clinical trial sponsor, small biotech company
- Task
- The active substance and the investigational medicinal product for the sponsor's clinical trial are manufactured in a non-EU country.
- Outcome
- The active substance and the investigational medicinal product were manufactured in compliance with GMP in the non-EU country.
- What A&O took on
- QP Batch Release
How it went
Starting point, approach, outcome.
Told plainly, in the order it actually happened.
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01
Starting point
What the client came to us with. The active substance and the investigational medicinal product for the sponsor's clinical trial are manufactured in a non-EU country. The sponsor needed an experienced partner to ensure that both are manufactured in compliance with GMP. In addition, the investigational medicinal product had to be released for use in the clinical trial following import into the EU.
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02
Approach
What we actually did. We oversaw the GMP-compliant manufacture of the active substance and the investigational medicinal product in the non-EU country and qualified the manufacturers through audits. Following import into the EU, we released the investigational medicinal product for use in the clinical trial.
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03
Outcome
The outcome. The active substance and the investigational medicinal product were manufactured in compliance with GMP in the non-EU country. GMP oversight of both manufacturing steps and batch release come from a single provider.
Terms used in this case
Anonymised. Confidentiality is part of our business; we only name clients with their consent.
The legal framework
What the rules required in this case.
Regulation (EU) No 536/2014, Art. 62
The Qualified Person must ensure and certify that each batch of investigational medicinal product manufactured in or imported into the EU meets the requirements of Article 63.
Delegated Regulation (EU) 2017/1569, Art. 12(1)(b)
Where manufacture takes place in a third country, the Qualified Person verifies that each batch was made and checked to at least equivalent GMP standards and in line with the trial dossier.
Commission Guidelines on GMP for investigational medicinal products, section 8
Without a mutual recognition agreement, the Qualified Person must establish that the third-country manufacturer applies equivalent GMP, normally by auditing its quality system.
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