Subject-matter and scope
Article 1
This Regulation lays down rules concerning the application of financial penalties to the holders of marketing authorisations, granted under Regulation (EC) No 726/2004, in respect of infringements of the following obligations, in cases where the infringement concerned may have significant public health implications in the Community, or where it has a Community dimension by taking place or having its effects in more than one Member State, or where interests of the Community are involved: 1. the completeness and the accuracy of the particulars and documents contained in an application for marketing authorisation under Regulation (EC) No 726/2004, or of any other documents and data submitted to the European Medicines Agency established by that Regulation, hereinafter ‘the Agency’, in response to obligations laid down in that Regulation; 2. conditions or restrictions included in the market authorisation and concerning the supply or use of the medicinal product, as referred to in Article 9(4)(b), the second subparagraph of Article 10(1), Article 34(4)(c) and the second subparagraph of Article 35(1) of Regulation (EC) No 726/2004; 3. conditions or restrictions included in the marketing authorisation with regard to the safe and effective use of the medicinal product, as referred to in Article 9(4)(c), Article 10(1), Article 34(4)(d) and Article 35(1) of Regulation (EC) No 726/2004; 4. the introduction of any necessary variations to the terms of the marketing authorisation to take account of technical and scientific progress and enable the medicinal products to be manufactured and checked by means of generally accepted scientific methods, as referred to in Article 16(1) and Article 41(1) of Regulation (EC) No 726/2004; 5. the supply of any new information which may entail a variation to the terms of the marketing authorisation, the notification of any prohibition or restriction imposed by the competent authorities of any country in which the medicinal product is marketed, or the supply of any information that may influence the evaluation of the risks and benefits of the product, as referred to in Article 16(2) and Article 41(4) of Regulation (EC) No 726/2004; 6. the supply at the request of the Agency of any data demonstrating that the risk-benefit balance remains favourable, as referred to in Article 16(2) and Article 41(4) of Regulation (EC) No 726/2004; 7. the detection of residues in the case of veterinary medicinal products, as referred to in Article 41(2) and (3) of Regulation (EC) No 726/2004; 8. placing on the market in accordance with the content of the summary of the product characteristics and the labelling and package leaflet as contained in the marketing authorisation; 9. the specific obligations referred to in Article 14(7) of Regulation (EC) No 726/2004 or in any other provisions adopted pursuant thereto; 10. the specific procedures referred to in Article 14(8) and Article 39(7) of Regulation (EC) No 726/2004; 11. notification to the Agency of the dates of actual marketing and of the date when the product ceases to be on the market, and provision to the Agency of data relating to the volume of sales and the volume of prescriptions of the product, as referred to in Article 13(4) and Article 38(4) of Regulation (EC) No 726/2004; 12. the appropriately qualified person responsible for pharmacovigilance, as referred to in Article 23 and Article 48 of Regulation (EC) No 726/2004; 13. recording and reporting of suspected serious adverse reactions and, in the case of veterinary medicinal products, human adverse reactions, as referred to in Article 24(1) and Article 49(1) of Regulation (EC) No 726/2004; 14. reporting of suspected serious unexpected adverse reactions, suspected transmission of infectious agents and, in the case of veterinary medicinal products, human adverse reactions, as referred to in Article 24(2) and Article 49(2) of Regulation (EC) No 726/2004; 15. detailed recording of all suspected adverse reactions and submission of such records in the form of periodic safety update reports, as referred to in Article 24(3) and Article 49(3) of Regulation (EC) No 726/2004; 16. communication of information relating to pharmacovigilance concerns to the general public, as referred to in Article 24(5) and Article 49(5) of Regulation (EC) No 726/2004; 17. collation and assessment of specific pharmacovigilance data, as referred to in the fourth paragraph of Article 26 and the fourth paragraph of Article 51 of Regulation (EC) No 726/2004.