Commission Delegated Regulation (EU) 2021/756 of 24 March 2021 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance)
Commission Delegated Regulation (EU) 2021/756of 24 March 2021amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products(Text with EEA relevance)THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human useOJ L 311, 28.11.2001, p. 67., and in particular Article 23b thereof,Having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines AgencyOJ L 136, 30.4.2004, p. 1., and in particular Article 16a(3) thereof,Whereas:(1)Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus (SARS-CoV-2). On 30 January 2020, the World Health Organization (WHO) declared the outbreak of COVID-19 a public health emergency of international concern. On 11 March 2020, it characterised COVID-19 as a pandemic.(2)The COVID-19 pandemic has given rise to an unprecedented public health emergency that has claimed hundred thousands of lives worldwide, affecting in particular older people and those with underlying or pre-existing health conditions.(3)COVID-19 is a complex disease that affects multiple physiological processes. COVID-19 vaccines are considered an efficient medical countermeasure during the ongoing pandemic, for the protection of particularly vulnerable groups and the population as a whole.(4)Based on the scientific assessment by the European Medicines Agency, the Commission has thus far authorised several COVID-19 vaccines.(5)Mutations of the SARS-CoV-2 virus are a natural phenomenon and to be expected. Authorised vaccines are not necessarily less effective against mutations, but there is a risk that they may be.(6)In order to ensure the continued effectiveness of authorised COVID-19 vaccines, it may be necessary to modify them in ways that involve changing their composition so as to protect against new or multiple variant strains in the context of the pandemic or otherwise. Such changes, which include the replacement or addition of a serotype, strain or antigen or a combination of serotypes, strains or antigens, should be considered as variations to the marketing authorisation in accordance with Commission Regulation (EC) No 1234/2008Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 334, 12.12.2008, p. 7).. Some vaccines are based on nucleic acid technology to produce an immune response. Modifications of those vaccines may include changes to the coding sequence.(7)The same approach should be followed for all human coronaviruses.(8)The provisions on such variations should be streamlined, especially during a pandemic. In line with the approach taken with human influenza vaccines, the procedures should apply to all human coronavirus vaccines and follow an accelerated timetable. However, where the competent authorities request additional data in the course of their assessment, they should not be required to take a decision until the assessment of that data has been finalised.(9)During a pandemic, it may be in the interest of public health to process variations on the basis of less comprehensive data than is normally the case. However, this approach should be subject to a requirement that the data be complemented subsequently, with a view to confirming that benefit-risk balance remains favourable.(10)Regulation (EC) No 1234/2008 should therefore be amended accordingly,HAS ADOPTED THIS REGULATION: