Article 1
Regulation (EC) No 340/2008 is amended as follows: (1) In Article 3, paragraph 7 is replaced by the following: ‘7. Where the registration has been rejected due to the failure of the registrant to submit missing information or due to his failure to pay the fee before expiry of the deadlines, the fees paid in relation to that registration before its rejection shall not be refunded or otherwise credited to the registrant.’ (2) In Article 4, paragraph 7 is replaced by the following: ‘7. Where the registration has been rejected due to the failure of the registrant to submit missing information or due to his failure to pay the fee before expiry of the deadlines, the fees paid in relation to that registration before its rejection shall not be refunded or otherwise credited to the registrant.’ (3) Article 5 is amended as follows: (a) In paragraph 2, the following subparagraphs are inserted after the second subparagraph: ‘For change in the access granted to information in the registration, the Agency shall levy a fee per item for which an update is made, as set out in Tables 3 and 4 of Annex III. In the case of an update concerning study summaries or robust study summaries, the Agency shall levy a fee for each study summary or robust study summary for which the update is made.’ (b) In paragraph 6, the third subparagraph is replaced by the following: ‘Where the payment is not made before the expiry of the second deadline, in the case of other updates, the Agency shall reject the update. Where the applicant so requests, the Agency shall extend the second deadline provided that the request for extension has been submitted before the expiry of the second deadline. Where the payment is not made before the expiry of the extended deadline, the Agency shall reject the update’. (c) Paragraph 7 is replaced by the following: ‘7. Where the update has been rejected due to the failure of the registrant to submit missing information or due to his failure to pay the fee before expiry of the deadlines, the fees paid in relation to that update before its rejection shall not be refunded or otherwise credited to the registrant.’ (4) In Article 6, paragraph 3 is replaced by the following: ‘3. In the case of a request that refers to a joint submission, the Agency shall levy a reduced fee, as set out in Annex IV. In the case of a request by the lead registrant, the Agency shall levy a reduced fee to the lead registrant only, as set out in Annex IV.’ (5) In Article 7, paragraph 5 is replaced by the following: ‘5. Where a notification or the request for an extension has been rejected due to the failure of the manufacturer, importer, or producer of articles to submit missing information or due to his failure to pay the fee or charges before expiry of the deadlines, the fees or charges paid in relation to that notification or that request for an extension before their respective rejection shall not be refunded or otherwise credited to the person making the notification or the request.’ (6) In Article 8, the third subparagraph of paragraph 2 is replaced by the following: ‘The Agency shall issue one invoice covering the base fee and any applicable additional fees, including in the case of a joint authorisation application.’ (7) In Article 9, the third subparagraph of paragraph 2 is replaced by the following: ‘The Agency shall issue one invoice covering the base charge and any applicable additional charges, including in the case of a joint review report.’ (8) In Article 13(3), the following subparagraph is inserted after the first subparagraph: ‘Where the evidence to be submitted to the Agency is not in one of the official languages of the Union, it shall be accompanied with a certified translation into any of those official languages.’ (9) In Article 22, paragraph 2 is replaced by the following: ‘2. The Commission shall also keep this Regulation under continual review in the light of significant information becoming available in relation to underlying assumptions for anticipated income and expenditure of the Agency. By 31 January 2015, the Commission shall review this Regulation with a view to amend it, if appropriate, taking into account in particular the costs of the Agency and the related costs of the services provided by the competent authorities of the Member States.’ (10) Annexes I to VIII to Regulation (EC) No 340/2008 are replaced by the text set out in the Annex to this Regulation.