Här hittar du alla produkter från levitra på nätet. Fri frakt, smidiga leveranser och trygga köp. Besök ditt närmaste apotek eller handla online idag.
Sildenafil spedra tadalafil kan denne direkt i Sverige och fortidsejakulering Viagra i Sverige. Erektil dysfunktion, Köpa Viagra i butik Göteborg.
Søger du et apotek hvor du kan købe Levitra online i Danmark? Køb levitra online i Danmark tryk venligst her! Køb Levitra uden recept.
Cialis kan købes via mange forskellige danske onlineapoteker som Cialis pris på apotek, Cialis kan købes i mængder fra 10 piller til 360 piller.
Якщо ви не хочете спілкуватись з менеджером МФО, тоді автоматичний кредит на карту онлайн те, що вам зара потрібно. Швидко і зручно.
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Written by DPR Biocides - Anses
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Regulations
Chapter VI of Regulation ( EU) No 528/2012
Timeframe
- Around 14 months with the possibility of a maximum 9-month suspension of the assessment if additional information is necessary.
- A synopsis of the information available via the link facilitates understanding of the overall procedure .
Validity of the MA
- 10 years as a general rule
- 4 or 5 years if the product contains an active substance meeting the criteria of Article 10(1) of the BPR and the comparative assessment provided for in Article 23(1) of the BPR enables the product to be authorised.
Fees payable to ANSES
- for one PT and one category of users: 40,000 euros
- Per additional PT, for one category of users: + 20,000 euros
- For one PT, per additional category of users: + 8000 euros
- product strictly identical to the reference product that enabled approval of the active substance: 12,000 euros
Composition of the dossier
Documents to be submitted on R4BP
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Language
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Draft SPC (xml format)
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EN
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Draft RCP (xml format)
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FR
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Completed technical IUCLID dossier. In section 13:
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FR or EN
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Table of intended uses in Word format
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FR or EN
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Detailed composition form in Excel or Word format
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FR or EN
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List of all trade names included in each meta-SPC of the product family – only for family
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FR
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Supporting document (see ECHA website): “Statement for national authorisation application”
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FR or EN
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Last Updated on Thursday, 07 July 2016 15:50 |