REGJISTRI QËNDROR I
LEJEVE DHE LICENCAVE

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Licensing for the first time as wholesale distributor of medicinal products and equipment

Kosovo Medicines Agency

Qëllimi: The purpose of this procedure is the Identification of wholesale distributors throughout the Republic of Kosovo in order to provide public health.

Përshkrimi: Initially, the applicant applies to the Kosovo Agency for Medicinal Products and Equipment. The Kosovo Agency for Medicinal Products and Equipment considers the application within 15 days for the applicant's licensing and the Kosovo Agency for Medicinal Products and Equipment submits the dossier to the Department of the Pharmaceutical Inspectorate for medicinal products and medical devices for the inspection of the pharmaceutical distributor within 7 days for the purpose of issuing the license. The department of the pharmaceutical inspectorate for medicinal products and equipment recommends to the licensing department the file. The licensing department issues the license within 5 days. Wholesale circulation of medicinal products and equipment means import, supply, storage and distribution.

Baza ligjore

Vlefshmeria e lejes: 5 years with annual renewal

Organi i ankimimit: Board of Appeals at KAMP

Afati i ankimimit: 15 days

Informatat e kërkuara

  • Name of the company
  • Adress of the company
  • Place
  • Telephone
  • E-mail
  • Owner's name
  • Business Registration Number
  • Supervising pharmacist
  • Number of pharmacists work license
  • Pharmacy Assistant
  • Number of pharmacy assistant's work license
  • Operations with narcotic drugs
  • Possession of a laboratory for magistral preparations
  • Applicant's statement
  • Documents on pharmacy licensing

Koha e parashikuar brenda së cilës duhet të jepet përgjigje për proceduren (në ditë): 15

Dokumentacioni i kërkuar

  • Business Certificate (Original)
  • Seal of pharmacy (Original)
  • Decision on the fulfillment of the hygiene and sanitation conditions (Original)
  • Report by the Pharmaceutical Inspectorate for Medicinal Products and Equipment (Verified copy)
  • Professional license of the pharmacist (Original)
  • Professional license of the technician (Original)
  • Employer and employee contract (Original)
  • Fiscal number (Original)
Lloji i pagesësShuma (në Euro)Mënyra e pagesësNumri i llogarisë
Tax150 EURBanking transfer 1000 4000 7000 2508
Payment5000 EUR divided into five annual installments; 150 EUR for application Banking transfer 1000 4000 7000 2508

Formulari nuk është në dispozicion