Institute for Medicines and Medical Devices has the authority to issue expert opinions within areas of its jurisdiction. For this purpose, Application form for the issuance of expert opinion within competences of the Institute for medicines and medical devices shall be submitted to the Institute.

Application for expert opinion may refer only to one of the areas listed on the form. In case that applicant intends to apply for expert opinion referring to more than one area, it is necessary to submit separate application form for each one. In case of more questions on a single application, only one of them will be answered.

Institute has the competence in issuing expert opinion on classification of a product into a medicine or group of medicines. For this purpose, it is necessary to submit documentation in line with the instruction – Documentation required for issuance of expert opinion on classification of a product into a medicine or group of medicines.

Documentation shall be submitted and expert opinion on classification shall be issued for each product separately.

Application for issuance of expert opinion on the exemption from approved packaging shall be submitted to the Institute in accordance with the instruction – Documentation required for issuing expert opinion on the exemption from approved packaging.

Application for issuance of the certificate for the purpose of export of medicines in line with WHO recommendations (Certificate of Pharmaceutical Product, CPP) shall be submitted on the Form for issuance of the Certificate of Pharmaceutical Product (CPP). This application shall be submitted to the Institute in accordance with the instruction – Manner of submitting application for issuance of the Certificate of Pharmaceutical Product (CPP certificate).

For the purpose of issuance of expert opinion on the classification of products as medical devices, it is necessary to submit an application in line with the instructions – Required documentation for issuance of expert opinion on classification of medical devices. One application for an expert opinion may be submitted for several medical devices if medical devices are manufactured by the same manufacturer and belong to the same class, or category.

Instructions and Forms