REGJISTRI QËNDROR I
LEJEVE DHE LICENCAVE

AL  SR  EN

License for import of drugs

Kosovo Medicines Agency

Qëllimi: The purpose of this procedure is to put under control the import of narcotic drugs and psychotropic substances in order to preserve public health.

Përshkrimi: Initially, applications from companies are accepted, then processed and reviewed by the Head of Division. For regular applications that meet the criteria required by the applicable legislation, the authorization for import of narcotics is prepared and issued.

Baza ligjore

Vlefshmeria e lejes: 3 months

Organi i ankimimit: The Board of Appeals at KAMP

Afati i ankimimit: 15 days

Informatat e kërkuara

  • Narcotics
  • KMA stamp / Signature of KMA officer/ Date
  • Customs seal / Signature of Customs officer / Date
  • Name of the importer of narcotics
  • Number of license for operations with narcotics L1 / Expiry date
  • Manufacturer; Importer
  • Marketing Authorization Holder; Name; Address; Tel/Fax
  • Name of the transportation company
  • Supporting documentation
  • Statement
  • Name and surname of person making the statement; Signature; Date
  • Company director Supervising Pharmacist
  • To be completed by KMA officers
  • Receipt date; 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 release file
  • KMA stamp

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

Dokumentacioni i kërkuar

  • Application (Original)
  • Analysis Certificate for each batch (Copy)
  • Invoice / proforma (Copy)
Lloji i pagesësShuma (në Euro)Mënyra e pagesësNumri i llogarisë
Payment1% of the total value of the billBanking transfer 1000 4000 7000 2508

Formulari nuk është në dispozicion