Effective from January 1, 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK's independent regulatory authority for medicines and medical devices, taking all decisions and performing all functions that have been taken or performed at the EU level, except for decisions on applications for marketing authorization submitted under the European procedures to market products in Northern Ireland.
Market authorisation holders may choose to opt-out of the conversion process for all or some of their CAPs by notifying the MHRA in writing, whereupon these UK market authorizations will be revoked. To opt out, you must notify the MHRA by the end of January 21, 2021. If the MAH decides to opt out, their products will no longer be licensed and may no longer be marketed in the United Kingdom.
Currently, the structure of Module 1 should use the EU Module 1 v3.0.2 and ICH v3.2.2 standards or, if they are superseded, by those standards applicable at the time of submission.
All existing centrally authorized MAs will automatically be converted to British MAs valid in the UK (only) and issued with a UK MA number on January 1, 2021. These UK MAs will be referred to in this guide as "converted EU MA". As a result of the implementation of the Northern Ireland Protocol, the existing centrally authorized products will continue to apply to the marketing of products in Northern Ireland.
Marketing authorizations for CAPs which are currently not marketed in the EU or UK can still be converted into UK marketing authorizations. For the purposes of the application of the sunset clause in accordance with Regulation 67 Human Medicines Regulations 2012 , the period of three years during which the product was not marketed in the UK will resume from the date of conversion to a UK marketing authorization.
To facilitate the “grandfathering” process, the MHRA will assign one or more Product License Numbers to CAPs based on existing practice in the UK to determine how many separate national licenses are required for a product line. In most cases this means that fewer UK marketing authorization numbers are required compared to the number of European Commission licences, as all pack sizes for a presentation are covered by a single marketing authorization number.