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SSL INTERNATIONAL
Private & Confidential
Project Meeting Minutes
Date: 23"“ February 2006 Venue CTC
Present: Stuart Pountney
Ian Love
Andrew Brownhill
By teleconference:
Wadee Kanphai
Surakait Kasemsuwan
Eric Folliot
Apologies: Suren Solanki
Date of Next Meeting: tbc
MINUTES
Introduction of ISO 4074:2002
The Thai FDA are introducing ISO4074: 2002 on March 21 2006 and after this date all new
and existing products will need to be tested against the new standard.
Currently ISO 4074:1996 is enforced by the ThaiFDA and this standard involves aged testing
for 7 days at 70°C. The new standard requires 90 days at 50°C data to be generated and
subsequent real time stability to 5 years.
It was stated that there are approximately 350 existing licences in Thailand, which will need
to be upgraded. 61 current products will require stability data to be generated. The ThaiFDA
have given SSL 1 year to undertake this testing.
The intention is to submit as many new products as possible for registration ahead of this
deadline. Asia Pacific Pleasuremax Warming (Chilli III), Chilli IV Asia Pacific Fetherlite
Warming (for Hong Kong) and Asia Pacific Extra Safe have all been submitted with
regulatory approve expected in March.
There was some discussion regarding which products will be moved to the Asia Pacific sized
condoms.
Action: Eric Folliot to confirm which sub-brands are to remain as parallel-sided. Any
products, which are not notified to the Thai FDA at this point, will cease to be
available.