News about GMP/cGMP

15.03.2019

MHRA: Six more documents on No-Deal Brexit

Brexit - and no end in sight. In preparation for a "No-Deal-Scenario", the British Medicines and Health Products Regulatory Authority (MHRA) published six new guidelines on a "No-Deal-Brexit" - five on the import and export of medicines and active ingredients and one on paediatric studies.

Central topic of the import/export documents is the process of batch release and the role of the Qualified Person (QP) or furthermore, the GDP requirements for air freight of medicines.

Some important facts in a nutshell:

  • The MHRA will allow the import of medicinal products for human use from EU countries, Iceland, Liechtenstein and Norway under a UK wholesale permit.
  • Batch releases of medicinal products for human use are accepted from all EU countries as well as Iceland, Liechtenstein and Norway, and in certain cases from Australia, Canada, Israel, Japan, New Zealand and Switzerland.
  • Since there is currently no MRA (Mutual Recognition Agreement) between the USA and England, the USA falls under the category "no batch testing is accepted".
  • The import of active ingredients to England from all EU countries as well as from Iceland, Liechtenstein and Norway, Australia, Brazil, Israel, Japan, Switzerland and the USA will continue to be accepted without a “Written Confirmation”.
  • For clinical trials conducted in England, in the case of imported investigational medicinal products (IMPs) from the EU or EEA, a UK Manufacturing and Import Authorisation (MIA(IMP)) holder is required to verify whether the IMPs have been certified by a qualified person from a listed country prior to import before they are released for study.

For more detailed information, please refer to the MHRA website.   


Source:

MHRA: Guidance and publications collection on a possible no deal scenario



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