BREXIT: Procedural Updates for Type I EMA variations

The EMA is strongly encouraging MAHs to be prepared for Brexit to occur by the 12th of April 2019. In particular, the Agency is requesting that Type I variations are submitted ASAP in order to guarantee that they are validated on time, as the Agency has recently received a sharp increase in the number of these variations. 

Type IA variations cover administrative changes to a MA which are considered to have no impact on the efficacy and safety of a product. They are commonly referred to as ‘do and tell’, because the changes are implemented by the MAH and then subsequently submitted to the Agency. Type IA variations can be submitted up to a year later, or – in the case of Type IAIN - 14 days later, depending on specifications published in EC guideline 2013/C 223/01

Type IB variations cover changes which potentially impact the efficacy and safety of a product. They do, therefore, require Agency review prior to implementation, so are referred to as ‘tell and do’. The initial assessment period is one month, after which the applicant may be required to respond to questions; these will then need to undergo further assessment, resulting in an average implementation time of three months.

Pre-notification checklists for Type IA and Type IB variations provide the MAH with the required content and document structure for the different variations. The most common Type IA and Type IB variations related to BREXIT are:

  • Changes to participants involved in physical importation (Type IA)
  • Changes to sites responsible for batch release (Type IA)
  • Changes to CE marking documentation for medical devices co-packaged with medicinal products (Type IA)
  • Changes to batch control testing of the finished product (Type IA and IB)

Temporary Change to Type IA guidelines on Editorial Changes

Due to increasing numbers of variation-submissions resulting from Brexit preparations, the EMA has temporarily adapted its guidelines on editorial changes, in order to free up its assessment resources. For the next three months applicants are, therefore, urged not to include editorial changes within Type I variations. Editorial changes include, amongst others:

  • Addition of headers
  • Re-ordering of existing information without changing the meaning
  • Alignment of information within sections to a previously agreed reference
  • Punctuation changes or grammar corrections which do not change the meaning of the text

Other Enquiries on BREXIT

The EMA is also aware that many MAHs may have pressing questions regarding BREXIT which are not necessarily directly linked to their product dossiers. Herein, inquiries should be made using the online contact form.

More Information

For more information, please contact one of the EUDRAC offices.