License for import of medicinal products

Kosovo Medicines Agency

Qëllimi: The purpose of this procedure is to control the import of medicinal products. This procedure should exist for reasons of public health preservation.

Përshkrimi: Initially, applications from companies are accepted, then filed and reviewed in the licensing department. For applications that meet the requirements set forth in the applicable legislation, the authorization for import of medicinal products is prepared and issued. This authorization is signed by the Chief of the Import Division, the Director of the Department and the Chief Executive Officer.

Baza ligjore

Vlefshmeria e lejes: 3 months, with the possibility of maximum extension up to 6 months.

Organi i ankimimit: Board of Appeals at KAMP

Afati i ankimimit: 15 days

Informatat e kërkuara

  • Medical products (medicines)
  • KMA stamp / Signature of KMA officer/ Date
  • Customs seal / Signature of Customs officer / Date
  • Wholesale pharmaceutical trader
  • License number of pharmaceutical wholesaler L1 / Expiry date
  • Marketing Authorization Holder; Name; Address; Tel/Fax
  • Name transportation company Address / Telephone / Fax
  • Name of the border crossing point
  • Supporting documentation
  • Statement
  • Name and surname of the person making statement; Signature; Date
  • Company director; Supervising Pharmacist
  • To be completed by KMA officers
  • Date of receipt; Number of the Protocol; Signature of the officer receiving the file
  • Forms attached
  • The total number of medical products to be imported
  • Signature of the officer preparing the case for release
  • KMA stamp

Koha e parashikuar brenda së cilës duhet të jepet përgjigje për proceduren (në ditë): 30

Dokumentacioni i kërkuar

  • Application (Original)
  • Invoice (Copy)
  • Analysis Certificate (Copy)
  • Import Authorization (Copy)
Lloji i pagesësShuma (në Euro)Mënyra e pagesësNumri i llogarisë
Payment1% of the total valueBanking transfer 1000 4000 7000 2508

Formulari nuk është në dispozicion