| Title: | MANUFACTURER (MID) MISMATCHES IN FDA PRIOR NOTICE |
|---|---|
| Date: | 2005-08-17 |
| To: | abi |
| Links: | previous, next |
TO: ALL ABI FILERS
FROM: CLIENT REPRESENTATIVE BRANCH
FOOD & DRUG ADMINISTRATION
SUBJECT: MANUFACTURER (MID) MISMATCHES IN FDA PRIOR NOTICE ENTRIES
REFERENCE: ADMINISTRATIVE MESSAGE 05-0810, JULY 19, 2005
THE REFERENCED ADMINISTRATIVE MESSAGE ADDRESSED THE ISSUE OF
FDA PRIOR NOTICE REJECTS DUE TO INACCURATE CREATION AND USE OF
MANUFACTURER IDENTIFICATIONS (MID'S) BY ABI FILERS. THESE REJECTS
ARE TIME-CONSUMING TO CORRECT AND RESULT IN SIGNIFICANT DELAYS IN
RELEASE OF FDA ENTRIES AND COMPLAINTS FROM IMPORTERS. EVERY FILER
EMPLOYEE WHO IS INVOLVED IN PREPARING FDA ENTRIES SHOULD RE-READ
ADMINISTRATIVE MESSAGE 05-0810. REJECTS BASED ON COUNTRY CODE PROBLEMS
CONTINUE AT THE SAME LEVEL. IN ADDITION TO THE COUNTRY CODE PROBLEM
EXAMPLES CITED IN THAT MESSAGE THE FOLLOWING PROBLEM AREAS HAVE
ALSO CAUSED REJECTS:
THE COUNTRY AND CITY OF HONG KONG (AND KOWLOON) STILL HAVE THE ISO
CODE OF 'HK' NOT 'CN' (CHINA). A RECENT QUERY FOUND OVER 15,000
MID'S,WHERE THE CITY IS EITHER "HONG KONG" OR "KOWLOON",HAVE BEEN
CREATED WITH AN ISO CODE OF 'CN'.
THE COUNTRY OF BULGARIA IS 'BG'. THE COUNTRY OF BELGIUM IS 'BE'.
BANGLADESH IS 'BD'. GREAT BRITAIN IS 'GB'. HUNDREDS OF RECORDS FOR
C,TIES IN GREAT BRITAIN HAVE BEEN CREATED WITH THE REVERSED ISO OF 'BG'.
THE COUNTRY CODE OF 'GB' INCLUDES SCOTLAND, WALES AND NORTHERN IRELAND.
'SC' (SEYCHELLES) HAS BEEN USED FOR SCOTLAND, 'WE' (WEST BANK) FOR
WALES AND 'IE' (IRELAND) FOR CITIES IN NORTHERN IRELAND.
'MA' IS FOR MOROCCO, 'MK' FOR MACEDONIA, 'MN' FOR MONGOLIA AND
'MY' FOR MALAYSIA.
THE ISO CODE FOR NETHERLANDS IS 'NL', 'NE' IS FOR NIGER, 'NG' FOR
NIGERIA.
THE COUNTRY OF GERMANY IS 'DE' NOT 'GE' (REPUBLIC OF GEORGIA). THE
COUNTRY OF EAST GERMANY, ISO = 'DD',NO LONGER EXISTS. DENMARK'S ISO
CODE IS 'DK' NOT 'DE' (GERMANY).
THE COUNTRY CODE OF 'CS' IS NOT VALID. THE CORRECT ISO CODE FOR
THE CZECH REPUBLIC IS 'CZ'. 'CS' IS NOT TO BE USED FOR CITIES LIKE
"BELGRADE" THAT ARE IN SERBIA. THE CORRECT ISO CODE IS 'YU'.
PLEASE CONTACT YOUR ASSIGNED CLIENT REPRESENTATIVE IF YOU HAVE
ANY QUESTIONS.
CLIENT REPRESENTATIVE BRANCH
FOOD & DRUG ADMINISTRATION