Qëllimi: The purpose of this procedure is to certify the quality of medicinal products for human use, based on valid scientific evidence on the quality, safety and efficacy of medicinal products.
Përshkrimi: Initially, the applicant applies to the KAMPE, submits the dossier in English or the official languages of Kosovo, the KAMPE examines the application and submits it to the Kosovo Commission for Evaluation of Medicinal Equipment and Products for the purpose of scientific evaluation. The KAMPE reviews the application within 210 days after the issuance of the authorization then informs the competent authorities of the issuance of the marketing authorization. The medicinal product is traded in the Republic of Kosovo after obtaining Marketing Authorization from KAMPE. Any medicinal product for which a Marketing Authorization is issued shall have on the outside of the packing of the medicinal product included in the Brail alphabet as well as the instructions for use of the medicinal product in the official languages of the Republic of Kosovo.
Vlefshmeria e lejes: 5 years
Organi i ankimimit: Board of Appeals KAMP
Afati i ankimimit: 15 days
Informatat e kërkuara
Koha e parashikuar brenda së cilës duhet të jepet përgjigje për proceduren (në ditë): 120-210 days
Dokumentacioni i kërkuar
|Lloji i pagesës||Shuma (në Euro)||Mënyra e pagesës||Numri i llogarisë|
|Payment||1000 EUR for one product; 500 EUR for additional dose of the same product; 750 EUR for a different form of the same pharmaceutical product; 250 EUR for additional pack; Whereas extending the authorization: 500 EUR for one product; 250 EUR for additional dose of the same product; 375 EUR for a different form of the same pharmaceutical product; 125 EUR for additional pack;||Banking transfer||1000 4000 7000 2508|
Formulari nuk është në dispozicion