Marketing Authorisation Expenses for Veterinary Medicinal Products in Northern Europe

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62157124%3A16370%2F18%3A43876835" target="_blank" >RIV/62157124:16370/18:43876835 - isvavai.cz</a>

Výsledek na webu

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DOI - Digital Object Identifier

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Jazyk výsledku

angličtina

Název v původním jazyce

Marketing Authorisation Expenses for Veterinary Medicinal Products in Northern Europe

Popis výsledku v původním jazyce

The marketing authorisation process is an integral part of the life cycle of a veterinary medicinal product, which the applicant wishes to market. The costs of the marketing authorisation of veterinary medicinal products are different from state to state. The differences in marketing authorisation fees are also between particular types of the marketing authorisation procedure such as the national procedure, mutual recognition procedure, decentralised procedure and centralised procedure and whether certain state is the reference member state or concerned member state particularly applicable in either a mutual recognition procedure or a decentralised procedure. The fees is also depended on the type of the marketing authorisation application, such as full, generic, hybrid, similar biological, well established use, fixed combination or informed consent and eventually whether a reference veterinary medicinal product is marketed in the state or not specifically for generic, hybrid and similar biological applications. If it is focused on the states in northern Europe, where Finland, Sweden, Norway, Iceland, Denmark and Baltic States Estonia, Latvia and Lithuania are included, it is a very varied group of states, where each competent authority has its own approach to the determination of marketing authorisation fees. It is important to mention that the marketing authorisation fees for veterinary medicinal products mostly are not the same as the fees for human medicinal products and also even this is paid attention.

Název v anglickém jazyce

Marketing Authorisation Expenses for Veterinary Medicinal Products in Northern Europe

Popis výsledku anglicky

The marketing authorisation process is an integral part of the life cycle of a veterinary medicinal product, which the applicant wishes to market. The costs of the marketing authorisation of veterinary medicinal products are different from state to state. The differences in marketing authorisation fees are also between particular types of the marketing authorisation procedure such as the national procedure, mutual recognition procedure, decentralised procedure and centralised procedure and whether certain state is the reference member state or concerned member state particularly applicable in either a mutual recognition procedure or a decentralised procedure. The fees is also depended on the type of the marketing authorisation application, such as full, generic, hybrid, similar biological, well established use, fixed combination or informed consent and eventually whether a reference veterinary medicinal product is marketed in the state or not specifically for generic, hybrid and similar biological applications. If it is focused on the states in northern Europe, where Finland, Sweden, Norway, Iceland, Denmark and Baltic States Estonia, Latvia and Lithuania are included, it is a very varied group of states, where each competent authority has its own approach to the determination of marketing authorisation fees. It is important to mention that the marketing authorisation fees for veterinary medicinal products mostly are not the same as the fees for human medicinal products and also even this is paid attention.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

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OECD FORD obor

30104 - Pharmacology and pharmacy

Projekt

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Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2018

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Indian journal of pharmaceutical sciences

ISSN

0250-474X

e-ISSN

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Svazek periodika

80

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

IN - Indická republika

Počet stran výsledku

8

Strana od-do

412-419

Kód UT WoS článku

000440512000002

EID výsledku v databázi Scopus

2-s2.0-85049670359