Translation of "Demande de désignation de périodes de déclaration " (French → English) :

Where an application for a marketing authorisation is submitted in respect of a medicinal product designated as an orphan medicinal product pursuant to Regulation (EC) No 141/2000 and that application includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, and the statement referred to in Article 28(3) of this Regulation is subsequently included in the marketing authorisation granted, the ten-year period referred to in Article 8(1) of Regulation (EC) No 141/2000 shall be extended to tw ...[+++]elve years.

is the total of all amounts, each of which is determined — for a selected motor vehicle that the financial institution, in the particular reporting period, either supplies by way of sale to a person that is not related to the financial institution or removes from Canada and registers in another country (other than, if the participating province is British Columbia, a selected motor vehicle that is supplied by way of sale or registered in another country on or after April 1, 2013) and in respect of the last acquisition or importation of which, in another reporting period of the financial institution, the financial institution included an ...[+++]amount under the description of G in determining its net tax for the other reporting period — by the formula

is the total of all amounts, each of which is determined — for a selected motor vehicle that the financial institution, in the particular reporting period, either supplies by way of sale to a person that is not related to the financial institution or removes from Canada and registers in another country (other than, if the participating province is British Columbia, a selected motor vehicle that is supplied by way of sale or registered in another country on or after April 1, 2013) and in respect of the last acquisition or importation of which, in another reporting period of the financial institution, the financial institution included an ...[+++]amount under the description of G in determining its net tax for the other reporting period — by the formula

3. As part of the scrutiny referred to in the second subparagraph of paragraph 2 of this Article, the Member State shall initiate a national opposition procedure that ensures adequate publication of the application and that provides for a reasonable period within which any natural or legal person having a legitimate interest and established or resident on its territory may lodge an opposition to the application.

4. Where the Commission requires further verifications due to incomplete or unclear information provided or disagreements, differences of interpretation or any other inconsistency relating to a declaration of expenditure for a reference period, resulting in particular from the failure to communicate the information required under Regulation (EU) No 1305/2013 and Commission acts adopted under that Regulation, or in view of serious indications that expenditure included in the declaration of expenditure may be affected by an irregularity ...[+++] or that there may be deficiencies in the functioning of the management and control system for rural development, the Member State concerned shall, upon request by the Commission, provide additional information within a period set in that request according to the seriousness of the problem.

The Member State shall carry out a national procedure ensuring adequate publication of the application and providing for a period of at least two months from the date of publication within which any natural or legal person having a legitimate interest and resident or established on its territory may object to the proposed protection by lodging a duly substantiated statement with the Member State.