Medicinal Products

Complaint against the Agency external documents could be lodged a in written form solely by the
clients of the Medicines and Medical Devices Agency of Serbia or in electronic form – LEK ePortal.

Medicines and Medical devices Agency of Serbia made a great effort to ensure continuousdevelopment of regulatory performance, in order to assure that only quality, efficacious and safemedicines and medical devices are available to patients in Serbia.One of the main goals of certified quality management system is continuous improvement ofservice quality. Also, intensive cooperation with all stake holders contributes to this improvement.For that purpose we have prepared a questionnaire to determine if all customer requirements aremet, as well as how customers are satisfied with the quality of service.We think that the opinions of our clients, as well as the comments and suggestions may contributeto the improvement of the quality management system, and overall efficiency of the Agency.

An appeal, as an ordinary legal remedy, and the procedure upon appeal are regulated by Articles151 to 174 of the Law on General Administrative Procedure.
A party has the right to file an appeal:

1. against a first-instance decision of the Agency, and
2. if a decision has not been issued within the time limit prescribed by law (“administrativesilence”).

An appeal shall be submitted within 15 days from the date on which the party was notified of thedecision, unless otherwise prescribed by law. Every decision contains instructions on legalremedy, indicating the name of the authority to which the appeal is submitted, the time limit forsubmission, and the authority to which the appeal must be filed.

When the Agency fails to issue a decision within the legally prescribed time limit, an appeal maybe filed after the expiration of that time limit, but no later than one year from the date of itsexpiration.

The appeal must specify the decision being challenged and indicate the name of the authoritythat issued it, as well as the number and date of the decision and the signature of the appellant.It is sufficient for the appellant to state in which respect he or she is dissatisfied with thedecision; the appeal does not need to be specifically elaborated.

New facts and new evidence may be presented in the appeal, but the appellant must explain whythey were not presented in the first-instance procedure. A first-instance decision cannot bechallenged on the basis of facts arising after the decision was issued.

Even if the submission is not designated as an appeal, it shall be considered an appeal if itscontent clearly indicates the party’s intent to challenge the decision.

An appeal is submitted to the Agency as the first-instance authority.

If the appeal is submitted to the second-instance authority (the Ministry of Health / Ministry ofAgriculture, Forestry and Water Management), that authority shall immediately forward it to thefirst-instance authority.

An appeal that is submitted to the second-instance authority within the prescribed time limit isconsidered timely.

An appeal due to administrative silence is submitted directly to the second-instance authority.

Procedure of the Agency as First-Instance Authority Upon Appeal

The first-instance authority shall, by a decision, dismiss an appeal that is: not timely, notpermitted, filed by an unauthorized person, or not completed within the time limit set by the authority

A party may file an appeal against the decision dismissing the appeal within eight days from thedate of notification. The appeal is filed with the second-instance authority which, if it finds theappeal well-founded, shall simultaneously decide on the merits of the appeal that was previously dismissed.

If the appeal is timely, permitted, and filed by an authorized person, the Agency shall assess themerits of the appeal. If it finds the appeal fully well-founded, it may replace the contesteddecision in order to satisfy the appellant’s request. The new decision shall annul the contesteddecision, unless otherwise prescribed by law.

If the Agency neither dismisses the appeal nor grants the appellant’s request, it shall forward theappeal to the second-instance authority within 15 days from the date of its receipt.The case file and the first-instance authority’s reply to the appeal must be attached

Procedure of the Second-Instance Authority Upon Appeal

The competent Ministry shall, by a decision, dismiss an appeal that is: not timely, not permitted,submitted by an unauthorized person, or not completed within the time limit set by the authority.

If the appeal is not dismissed, the second-instance authority may: reject the appeal, annul thedecision in whole or in part and decide on the administrative matter itself, annul the decision andreturn the case to the first-instance authority for a repeated procedure, or modify the decision.

The decision of the second-instance authority on the appeal shall be issued without delay, and nolater than 60 days from the date a proper appeal was submitted.