REGJISTRI QËNDROR I
LEJEVE DHE LICENCAVE

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Galenic Laboratory License

Kosovo Medicines Agency

Qëllimi: The purpose of this procedure is to ensure the quality of this product. The manufacturing quality of galen products must conform to current EU pharmacopeia standards, USP and other pharmaceutical forms for the preparation of these products.

Përshkrimi: This procedure has not been applied so far since the sub-legal act for its application has not yet been approved. The galenic laboratory prepares galenic products under current EU official pharmacopoeia, US international pharmacopoeia, or in accordance with forms of magistral and galenic compounds. Magistral compounds are produced and dispensed only by pharmacies, for individual patients, based on the prescription of a licensed physician. The manufacturing quality of galen products must conform to current EU pharmacopeia standards, USP and other pharmaceutical forms for the preparation of these products and no Authorization of Marketing is required. The Operation Licence for Galen Laboratory is issued by KAMP.

Baza ligjore

Vlefshmeria e lejes: 5 years

Organi i ankimimit: Board of Appeals

Afati i ankimimit: 15 days

Informatat e kërkuara

  • Shall be determined by sub-legal act

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

Dokumentacioni i kërkuar

Lloji i pagesësShuma (në Euro)Mënyra e pagesësNumri i llogarisë
PaymentIt is not yet determinedBanking transfer

Formulari nuk është në dispozicion