Examples of using Centralised authorisation in English and their translations into Italian
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Among other things, the centralised authorisation procedure is also to be introduced for veterinary medicines, although other authorisation procedures(national procedures,
the Commission recognises that the"centralised authorisation system was necessary
The harmonisation of the principles governing other modern biotechnological medicines currently covered by Community-level regulations involves a centralised authorisation procedure, i.e. a single scientific evaluation of the quality,
However, as I see it, extending the centralised authorisation procedure for medicinal products, as advocated by the Commission in committee,
With regard to the reasons"inherent" in the system, the emphasis is on the fact that"companies have used this centralised authorisation system not only to get legal security
If an assessment report or, in case of the centralised authorisation procedure, the opinion,
of the legislative proposals, the Parliament cleared the way for a new centralised authorisation procedure for medicines, to be administered by the European Medical Evaluations Agency EMEA.
payment of the fees payable to the European Agency for the Evaluation of Medicinal Products(EMEA) for carrying out the centralised authorisation procedure necessary to access the Community market;
inclusion of active substances used in biocidal products in Annex I of the Regulation and the centralised authorisation of certain biocidal products.
All other modern biotechnology medicinal products currently regulated at Community level are already subject to a centralised authorisation procedure, involving a single scientific evaluation of the quality,
ensure the widest possible availability of veterinary medicinal products in the Union, the centralised authorisation procedure should be extended to allow for applications for authorisations under that procedure to be submitted for any veterinary medicinal product, including for generics of nationally authorised veterinary medicinal products.
This centralised authorisation system was necessary
a mutual recognition procedure or a centralised authorisation.
particularly focusing on a centralised authorisation procedure for the placing on the market of GMOs within the Community.
the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of amending the list of groups of veterinary medicinal products for which the centralised authorisation procedure shall be compulsory.
thus establishing a centralised authorisation system for all restrictive practices requiring exemption.
to the Agency where the marketing authorisation was granted in accordance with the centralised authorisation procedure.
Regulation 17 thus established a highly centralised authorisation system for all agreements requiring exemption.
The proposed system is a compromise between the current situation and a fully centralised authorisation.
Zonal as well as centralised authorisation will by definition lead to more homogenous national markets.