Tags
Exception
For products which their manufacturing sites are not registered at SFDA, does SFDA approve the product without site inspection? If the product manufacturing site is located in one of the countries mentioned in the Eligibility Criteria section, site inspection will not be a barrier for the product registration. SFDA will take the necessary actions to maintain the registration within the timeframe.
Specific Class of Exception
products which their manufacturing sites are not registered at SFDA
ELIGIBILITY CRITERIA
• The application must be submitted to the SFDA within two years from the date of
approval by the reference agency.
• The product does not need a more stringent assessment as a result of different
local disease patterns and/or medical practices.
• The product and its intended use (indications, dosage information, and patient
groups (for human product) or target animal species (for veterinary product)) has
not been rejected, withdrawn, suspended by any drug regulatory agency for
safety or efficacy reasons.
• The manufacturer should be located in one of the following countries:
USA, UK, Canada, Australia, Japan, Switzerland, Germany, France, Ireland,
Italy, Spain, Portugal, Finland, Sweden, Norway, Denmark, Belgium,
Netherlands, Austria or Singapore.
The level of manufacturing activity represents:
o For Biologicals: Biological Substance and Finished product.
o For Pharmaceuticals: Finished Product (bulk) and Primary Packaging.
ELIGIBILITY CRITERIA
• The application must be submitted to the SFDA within two years from the date of
approval by the reference agency.
• The product does not need a more stringent assessment as a result of different
local disease patterns and/or medical practices.
• The product and its intended use (indications, dosage information, and patient
groups (for human product) or target animal species (for veterinary product)) has
not been rejected, withdrawn, suspended by any drug regulatory agency for
safety or efficacy reasons.
• The manufacturer should be located in one of the following countries:
USA, UK, Canada, Australia, Japan, Switzerland, Germany, France, Ireland,
Italy, Spain, Portugal, Finland, Sweden, Norway, Denmark, Belgium,
Netherlands, Austria or Singapore.
The level of manufacturing activity represents:
o For Biologicals: Biological Substance and Finished product.
o For Pharmaceuticals: Finished Product (bulk) and Primary Packaging.
Regulation
Registration According to Verification and Abridged