L 159/46 Official Journal of the European Union 27.6.2003 COMMISSION DIRECTIVE 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Com- munity, Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating medicinal products for human use (1), as last amended by Directive 2002/98/EC (3), and in particular Article 120 thereof, Whereas: 1 () © 0] 0] Every medicinal product for human use that is to be placed on the European Community market must be granted a marketing authorisation delivered by a com- petent authority. With the view to obtaining a marketing authorisation, an application dossier containing particu- lars and documents relating to the results of tests and trials carried out on this medicinal product must be submitted. The detailed scientific and technical requirements of Annex I to Directive 2001/83/EC need to be adapted to take account of scientific and technical progress and in particular of a large set of new requirements resulting from recent legislation. The presentation and content of the marketing authorisation application dossier have to be improved in order to facilitate the assessment and the better use of certain parts of the dossier which are common to several medicinal products. Within the framework of the International Conference on Harmonisation (ICH) a consensus was reached in 2000 to provide a harmonised format and terminology for a Common Technical Document through which a homogeneous organisation and presentation of a marketing authorisation application dossier for human medicinal products could be achieved. Standardised marketing authorisation dossier requirements should therefore be introduced in order to implement the Common Technical Document without delay. L 311,28.11.2001, p. 67. L 33,8.2.2003, p. 30. ) The standardised marketing authorisation dossier requirements (harmonised format) should be applicable to any type of medicinal product for human use, regardless of the procedure for the granting of the marketing authorisation. Some medicinal products pre- sent, however, such specific features that all the require- ments cannot be fulfilled. To take account of these particular situations, a simplified dossier presentation should be provided for. The safety of biological medicinal products relies on rigorous control of their starting materials. Requirements for the suitability of human donors and the testing of donations of starting materials for plasma-derived medicinal products are laid down by Directive 2002/98/ EC setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC. Article 109 of Directive 2001/ 83/EC has been amended. Plasma-derived medicinal products per se are biological medicinal products, the manufacture of which is based on the careful handling of human plasma as a starting material. To take account of the fact that the same plasma material is used in most cases for several medicinal products and, as a result, that a substantial part of the marketing authorisation dossier may be common to a great number of other dossiers for totally different plasma-derived medicinal products, it is appropriate to establish a new system aimed at simplify- ing procedures for both the approval of and subsequent changes to human plasma-derived medicinal products. To this end the concept of a plasma master file (PMF) should be introduced, in particular in order to allow the pooling of national expertise and through the coordination by the EMEA of a single evaluation. A PMF should serve as a stand-alone document, which is separate from the marketing authorisation dossier and through which a harmonised control of the relevant information regarding starting material used for the manufacture of plasma-derived medicinal products could be achieved. The PMF system should consist of a two-step assessment: first, an assessment of the PMF carried out at Community level, the result of which, ie. a certificate of compliance with the Community legislation for each PMF, must be taken into account by any national competent authority, preventing them of any subsequent reassessment; second, an assessment of the finished plasma-derived medicinal product contain- ing the modified part of the PMF (the two essential parts of the content, plasma origin and plasma quality-safety).