Governmental Decree No. 736 validating the Regulation on state registration of medicines, including infant food, food for special dietary uses and food additives.

This Regulation establishes the procedure for state registration of medicines, including infant food, food for special dietary uses and food additives. The state registration shall be performed on the basis of the expertise of the documentation submitted for registration, with the consideration of efficiency, safety, quality of medicines and medical goods. The following commodities shall be subject to mandatory state registration: (a) infant food; (b) food for special dietary uses; and (c) food additives. In case of refusal of state registration the competent registration authority must inform the applicant of the grounds for refusal. Registration certificate shall be issued for each single registered commodity. Registration certificate shall be issued for the period of 5 years, upon expiry of this period the items must pass reregistration.