一系列EU与变更相关的法规（Regulation (EC) No 1234/2008)的修订，将于2012年11月2日周五正式实施。修订内容参见于2012年8月24日生效的欧盟法规Commission Regulation (EU) No 712/2012。尽管这些修订的主要目的是为了统一各国审评和集中审评的上市授权要求，但一系列的变化也将影响到集中审评产品。关于通过集中审评申请的产品上市后变更文件将在今后几周内进行修订。
A number of amendments to the Variations Regulation (Regulation (EC) No 1234/2008) that affect the provisions governing centrally authorised medicines will start to apply from Friday 2 November 2012.
The amendments are described in Commission Regulation (EU) No 712/2012, which entered into force on 24 August 2012. Although their main purpose was to extend the application of the Variations Regulation to marketing authorisations granted at national level so that all marketing authorisations granted in the European Union (EU) are subject to the same rules, a number of changes affect centrally authorised medicines. These include:
changes to the decision-making process for variation procedures, so that changes that are critical for public health are reflected in marketing authorisations within two months, while other changes are reflected in periodic updates (within one year);
Information on transitional arrangements explaining how the new rules will affect pending variation procedures and applications submitted following a worksharing procedure is available.
Provisions governing purely nationally authorised medicines and applications submitted following a worksharing procedure start to apply on 4 August 2013.
The Variations Regulation, which has applied since 1 January 2010, describes how applications from marketing-authorisation holders for changes to existing marketing authorisations are handled, including the introduction of grouped applications and worksharing procedures. It applies to human and veterinary medicines
