BAKGRUNN (fra kommisjonsforordningen)

(1) The Union legal framework regarding variations to the terms of marketing authorisations is laid down in Commission Regulation (EC) No 1234/2008. In the light of practical experience in the application of that Regulation, it is appropriate to proceed to its review in order to establish a simpler, clearer and more flexible legal framework, while guaranteeing the same level of public health protection. 

(2) The procedures laid down in Regulation (EC) No 1234/2008 should therefore be adjusted, without departing from the general principles on which those procedures are based. 

(3) In order to achieve efficiency gains and to reduce the administrative burden for the pharmaceutical industry and to better use the resources of the competent authorities, the existing legal framework should be simplified and streamlined, ensuring the same standards for quality, efficacy and safety of medicines. 

(4) In order to constantly take account of scientific and technical progress and to ensure the streamlined procedures of variations, the classification guidelines may need to be updated more frequently on the basis of this knowledge. For this purpose, the Agency should provide annual recommendations on unforeseen variations and any updates to be integrated in the guidelines and published in the electronic version on the Commission website.

(5) Grouping of several variations in a single submission is already possible in certain cases. However, practical experience and knowledge acquired from the worksharing procedure have shown that the grouping of variations could be extended to enable more flexibility and to increase harmonisation. Therefore, the submission of a single submission of variations to the terms of more than one marketing authorisation (‘super-grouping of variations’) should be introduced in order to enable marketing authorisation holders to include their purely national marketing authorisation in the super-grouping of variations and to harmonise their purely national marketing authorisations in different Member States. 

(6) The variations worksharing procedure enables already today the single submission of variations to the terms of more than one marketing authorisation owned by the same marketing authorisation holder. In order to avoid duplication of work in the evaluation of variations, it should be possible for competent authorities to process all appropriate variations under the worksharing procedure. 

(7) Advances in science and technology and decades of experience in the manufacture of biological medicinal products enables the application of a risk-based approach for quality changes related to those biological medicinal products. Therefore, it is appropriate to adapt the approach of classifying some of the quality changes related to biological medicinal products as, by default, major variations. This will apply to all biological medicines including advanced therapy medicines. 

(8) Based on the experience gained from the COVID-19 pandemic and the adaptations to the variation systems that have been made to ensure the continued effectiveness of vaccines by changing their composition so as to protect against new or multiple variant strains in the context of that pandemic or otherwise, similar possibilities to change the composition should be introduced for other vaccines to address a public health emergency. 

(9) In line with the approach taken with human influenza vaccines, updates of human coronavirus vaccines should be streamlined outside a public health emergency. Thus, also the examination of variations concerning changes to the active substance for the purposes of the annual update of a human coronavirus vaccine should follow the same rules as influenza vaccines when the Agency considers it necessary from the public health perspective and takes into account global approaches to updates of human coronavirus vaccines. 

(10) It is necessary to take account of developments arising as a result of efforts to align at international level the life-cycle management of medicinal products, especially in the context of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. This may be supported by the use of additional regulatory tools, such as post-approval change management protocols. 

(11) Regulation (EU) 2019/5 of the European Parliament and of the Council4 moved certain core elements of the system for examination of applications for variations provided for in Regulation (EC) No 1234/2008 into Directive 2001/83/EC and Regulation (EC) No 726/2004. A delegation of powers is conferred on the Commission in Directive 2001/83/EC and Regulation (EC) No 726/2004 to complement those core elements by laying down further necessary elements and to adapt the system for examination of applications for variations to technical and scientific progress. In order to avoid any duplication, it is appropriate to delete those elements from Regulation (EC) No 1234/2008. In view of the changes introduced by Regulation (EU) 2019/6 of the European Parliament and of the Council5 , which provides that Regulation (EC) No 1234/2008 is to no longer apply to veterinary medicinal products, any references to veterinary medicinal products should be removed from Regulation (EC) No 1234/2008. 

(12) A transitional period should be established in order to give all interested parties, in particular competent authorities of the Member States and the pharmaceutical industry, time to adapt to the new legal framework. 

(13) Regulation (EC) No 1234/2008 should therefore be amended accordingly