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The ISO recertification audit at the State Agency of Medicines has been successfully completed

04.01.2016.
 

The ISO recertification audit at the State Agency of Medicines has been successfully completed

At the end of 2015 the integrated management system of the State Agency of Medicines (SAM) has been recertified as in accordance with to the requirements of ISO 9001 and ISO 27001 standards.

The scope of certification:

  • Assessment in the field of human medicines and medical devices regarding marketing authorisation and post marketing procedures. Quality control of human medicines products. Pharmacovigilance and vigilance of medical devices.
  • Licensing and marketing authorisation in accordance with power of attorney. Assessment of relevant documentation.
  • Management and publishing of information in accordance with power of attorney.

The recertification audit was performed by Bureau Veritas Latvia.