The Pharmaceutical Journal Vol 266 No 7151 p784-787
June 9, 2001

  Code of Ethics
  RPM
  Medicines promotion
  Parallel imports
  Patient packs
  Disillusioned youth
  Veterinary medicines
  Travel medicine
  Nurse prescribing
  Working conditions
  Mutual recognition
  Disinfection techniques

Mutual recognition

European Union deal with Japan clarified

From Mr J. Turner, MRPharmS

You correctly report that the European Union and Japan have signed a mutual recognition agreement (MRA) which will facilitate trade in several sectors between the two parties (PJ, May 26, p700). May I clarify a few points?

For medicines, it is the standard of manufacturing practice (GMP) and official inspections which it is intended will be mutually recognised as equivalent. Contrary to your report, the “technical standards” of a product will continue to be set, for Europe, by its European or UK marketing authorisation (product licence). The benefit will be that the European importer will be allowed to accept the Japanese manufacturer’s batch certification in place of retesting a sample of every batch in Europe, as is currently required, and the manufacturing site in Japan will normally not be inspected by a European authority. However this benefit comes into effect not now, as you suggest, but only after the successful completion of an evaluation exercise, it is hoped, by 2003. Importers, please do not jump the gun!

I also want to clarify the arrangements for medicines and for medical devices. It is only for the latter that third-party certification and conformity assessment bodies are used and will be mutually recognised.

John Turner
Policy and Standards Manager,
Inspection and Enforcement Division,
Medicines Control Agency

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