How to get GMP Certificates, Importation Licenses & Broker Registrations in UK?

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),
• Broker registrations,
• 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).

A request for a new broker registration or a variation to an existing broker registration can be submitted via The Heads of Medicines Agencies (HMA) Portal.

Processing times

The Blog provides the following timelines:

• New applications typically take 90 working days,
• Variations where no inspection is required: 30 working days,
• Variations where an inspection is required: 90 working days,
• New applications for registration as Active Substance manufacturers, importers and distributors take 60 working days - if an inspection is required: 90 working days.

More information can be found in the new post, MHRA Process Licensing: useful information, which has just been published on the MHRA Inspectorate blog.