From 1 January 2024, the EC Decision Reliance Procedure (ECDRP) will be replaced by the new International Recognition procedure (IRP). The Mutual R...

Acceptable RRs are shown in the table below. Country or Jurisdiction Regulatory Authority Australia Therapeutic Goods Administration (TGA) Canada H...

There are two recognition timetables for initial MAAs: Recognition A: 60-day timetable Recognition B: 110-day timetable The timetables are calendar...

IRP can be used for line extensions, variations (Type 1B, Type II) and renewal applications (including annual renewal of conditional MAs and annual...

The ApplicantThe Applicant/MAH must be established in the UK (Great Britain or Northern Ireland) or in the EU/EEA. It is anticipated that the Appli...

The medicinal product must be classified as a medicinal product under the UK Human Medicines Regulations and the standard MHRA requirements for a U...

Fees for submission for international recognition applications will be included on MHRA fees - GOV.UK (www.gov.uk) in due course.

The lists below show the documents that comprise a complete assessment for each RR.The full set of documents must be submitted in your application....