In accordance with the Law on Medicines and Law on Prevention of Drug Abuse the Institute is competent to:  


  • issue manufacturing and wholesale authorisations for medicines/medicines containing drugs for human use
  • issue certificates on Good Manufacturing Practice, Good Clinical Practice and other certificates in accordance with the Law
  • keep the registers stipulated by the Law
  • conduct inspection supervision – Inspection supervision is performed by competent inspectors for medicines for human use and veterinary use in accordance with the Law, as follows: pharmaceutical inspector in relation to medicines in the manufacturing, wholesale of medicines for human use, clinical trials of medicines, as well as application of guidelines of Good manufacturing practice, Good distribution practice, Good practice in pharmacovigilance and Good clinical practice, in accordance with this the Law and the law governing inspection supervision.

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