Marketing Authorisation Expenses for Veterinary Medicinal Products in Northern Europe
By: Černíčková, Z
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Contributor(s): Dohnal, J | Šaloun, J.
Publisher: Mumbai Indian Journal of Pharmaceutical Science 2018Edition: Vol. 80(03), September-October.Description: 412-419.Subject(s): PHARMACEUTICS | Member state | National procedure | MRP | DCPOnline resources: Click here
In:
Indian journal of pharmaceutical sciencesSummary: 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.
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Articles Abstract Database
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School of Pharmacy Archieval Section | Not for loan | 2018346 |
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.
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