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

• issue manufacturing authorisation for medicinal products/medicinal products containing drugs 
• issue wholesale authorisations for medicinal products/medicinal products containing drugs 
• performs control of the assessment of compliance with the guidelines of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP);
• keep the registers stipulated by the Law
• conduct inspection supervision – Inspection supervision is performed by competent inspectors for medicinal products for human and veterinary use in accordance with the Law, as follows: pharmaceutical inspector in relation to manufacturing of medicinal products, wholesale of medicinal products 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.