The MHRA recently provided the following details - together with some helpful links (e.g. to companies’ GMP and GDP certificates via EudraGMDP) - for new licence applications and variations on the agency´s Inspectorate Blog.
The MHRA Licensing Office
According to the Blog, MHRA´s Licensing office typically deals with the manufacture, assembly and wholesale distribution of medicinal products under UK and EU legislation. These licences are often called process licences and include (amongst others):
Licenses for the manufacture/ importation of licensed medicinal products (MIA),
'Specials' licenses for the manufacture/ importation of unlicensed medicinal products (MS),
Authorizations for the manufacture/ importation of investigational medicinal products MIA(IMP),
Manufacturer's licenses for exempt advanced therapy medicinal products (MeAT),
Licenses for wholesalers (including those covering unlicensed medicines obtained from another EEA member state),
Active substance manufacturer, importer or distributor registrations,
Good Manufacturing Practice (GMP) certificates,
Good Distribution Practice (GDP) certificates.
The MHRA Licensing Portal
The MHRA Licensing Portal allows submitting new applications and variations to existing wholesale distribution authorizations electronically. According to the agency, the portal should be used for
wholesale distribution authorizations,
active substance manufacturers, importers and distributors, new & variation applications, and
annual compliance reports (active substance manufacturers, importers or distributors only).