UK MCA On Changes To US Export Law

The UK Medicines Control Agency reports that the advice in Section 6 of its newly-published Guidance Notes on Applications for Clinical Trial Exemptions and Clinical Trial Certificates (MAL 4) is no longer valid, following recent changes to US law.

Under the new law (Bill HR 3019) companies need no longer submit permission letters to the Food and Drug Administration on behalf of US drugmakers when wishing to import unlicensed medicinal products from the USA to the UK for use in clinical trials in the UK, or for transhipment to other countries for clinical trials.

Prior FDA approval is no longer required for exports of these products for clinical trials in the UK or for transhipment to countries in the European Union and the European Free Trade Area, or to Switzerland, Australia, Canada, Israel, Japan, New Zealand or South Africa.