REGJISTRI QËNDROR I
LEJEVE DHE LICENCAVE

AL  SR  EN

Marketing authorization for sale of medicinal products in the Republic of Kosovo

Kosovo Medicines Agency

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.

Baza ligjore

Vlefshmeria e lejes: 5 years

Organi i ankimimit: Board of Appeals KAMP

Afati i ankimimit: 15 days

Informatat e kërkuara

  • Declaration and signature
  • Product name
  • Product Strength (s)
  • Pharmaceutical form
  • Active substance
  • Applicant
  • Authorized person
  • On behalf of the applicant
  • Signature
  • Name
  • Function
  • Place
  • Date

Koha e parashikuar brenda së cilës duhet të jepet përgjigje për proceduren (në ditë): 120-210 days

Dokumentacioni i kërkuar

  • Registration status of the legal entity (Original)
  • Authorization by the holder of the marketing authorization (Original)
  • Results of the pharmaceutical analyses (Original)
  • First clinical analyses results (For review)
  • Clinical research analyses results (Original)
  • A detailed description of pharmacovigilance (Copy)
  • Statement that the effects of clinical research done outside the European Union meet the ethical conditions (Original)
  • A summary of product characteristics (Copy)
  • Instructions for use of product packaging (Copy)
  • Evidence that the manufacturer is authorized in his country for the production of medicinal products (Original, Verified copy)
Lloji i pagesësShuma (në Euro)Mënyra e pagesësNumri i llogarisë
Payment1000 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