Changes in the registration processes connected to the amendment of the Act on Administrative Fees

On October 1, 2012 the amendment of the Act on Administrative fees No. 145 of 1995 as subsequently amended, which regulates payments for drug registration processes, will enter into force. The amendment changes the existing payments for the registration processes and introduces new fees.

According to the Legal Department of SIDC the administrative procedure of the drug registration process begins on the day the request is delivered to SIDC.

State Institute for Drug Control would, therefore, like to draw attention to the diagram of procedural possibilities for the drug registration until the amendment‘s entry into force:

1. The administration fee for the appropriate operation under the Act on Administrative Fees (hereinafter act) in force to September 30, 2012 applies to requests received by SIDC until September 30, 2012 (see No. 1 in the diagram).
    
2. If the administrative fee for the appropriate operation is carried out under the act in force to September 30, 2012 and the respective request is delivered to SIDC after October 1, 2012, administrative fees under the amended act in force as of October 10, 2012 will apply, i.e. the will be required to pay the difference in fees (see No. 2 in the diagram).
   
   In the time period until September 30, 2012, we do not recommend the aplicants for a new drug registration or changes in drug registration to enter the electronic system eŽiadosť and generate the variable symbol for payment under the previously applicable rates as long as the application is not going to be delivered to SIDC before September 30, 2012. Those applications would increase the administrative workload of SIDC employees as, if delivered after October 1, 2012, we would be forced to ask the applicant to pay the extra amount under the amended act with effect from October 1, 2012. If the applicant fails to make the supplementary payment under the amended act with effect from October 1, 2012 within 15 days of the delivery of the notice, we will be forced to stop the registration process in accordance with the law.
    
3. For applications submitted after October 1, 2012, administrative fees under the amended act with effect from October 1, 2012 will apply (see No. 3 in the diagram).

Diagram:

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