Marketing Authorisation Expenses for Veterinary Medicinal Products in Northern Europe

Result code in 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>

Result on the web

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DOI - Digital Object Identifier

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Result language

angličtina

Original language name

Marketing Authorisation Expenses for Veterinary Medicinal Products in Northern Europe

Original language description

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.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30104 - Pharmacology and pharmacy

Project

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Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2018

Confidentiality

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

Name of the periodical

Indian journal of pharmaceutical sciences

ISSN

0250-474X

e-ISSN

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Volume of the periodical

80

Issue of the periodical within the volume

3

Country of publishing house

IN - INDIA

Number of pages

8

Pages from-to

412-419

UT code for WoS article

000440512000002

EID of the result in the Scopus database

2-s2.0-85049670359