https://mhrainspectorate.blog.gov.uk/2019/10/04/mhra-process-licensing-useful-information/

MHRA Process Licensing: useful information

decorative image: human head, cogs and binary code, representing information processing

The Process Licensing Office sits within the Inspectorate and Process Licensing Group of the Inspection, Enforcement and Standards division. It 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:

  • licences for the manufacture/importation of licensed medicinal products for human use, commonly abbreviated to MIA
  • 'specials' licences for the manufacture/importation of unlicensed medicinal products for human use, commonly abbreviated to MS
  • authorisations for the manufacture/importation of investigational medicinal products for human use, commonly abbreviated to MIA(IMP)
  • authorisations for the manufacture/importation of licensed medicinal products for veterinary use (ManA)
  • 'specials' licences for the manufacture of unlicensed medicinal products for veterinary use, (ManSA)
  • manufacturer's licences for exempt advanced therapy medicinal products (MeAT)
  • licences for the wholesale distribution of medicinal products for human use, commonly abbreviated to WDA (H) (including those covering unlicensed medicines obtained from another EEA member state)
  • licences for the wholesale distribution/importation of medicinal products for veterinary use - WDA (V)
  • blood establishment authorisations (BEA)
  • non-orthodox practitioners (NOP)
  • broker registrations
  • active substance manufacturer, importer or distributor registrations
  • certificates of Good Manufacturing Practice (GMP)
  • certificates of Good Distribution Practice (GDP)

The MHRA Process Licensing Portal

The MHRA Process Licensing Portal is part of the government's Digital by Default agenda and is a web application which provides a secure environment and an easy to use platform which allows customers to submit new applications and variations to existing wholesale distribution authorisations electronically via https://pclportal.mhra.gov.uk/

The portal should be used for wholesale distribution authorisations [WDA(H)] and active substance manufacturers, importers and distributors – new applications, variation applications and annual compliance reports (active substance manufacturers, importers or distributors only).

The Heads of Medicines Agencies (HMA) Portal

Apply for new broker registrations and to vary existing broker registrations via https://fmdbroker.hma.eu/

Application forms for manufacturer licences:

Processing times:

  • new applications typically take 90 working days to process
  • 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

Fees

Using link to MHRA fees:  https://www.gov.uk/government/publications/mhra-fees

Please note that companies are not required to make payment on submission of both initial and variation application for all wholesale dealer and manufacturing licences – invoices are sent via email once the company’s application has been processed by the process licensing team.

Submissions or queries

All applications or queries regarding applications can be sent to the PCL team via email: pcl@mhra.gov.uk  - stating in the subject box:

Initial/Variation/Query – type of licence held - company name/number (for example: ‘Initial MIA 12345’).

We aim to respond to queries within 18 working days, however, where expert advice is required from other parties this may take longer.

Contact us: 

Helpline: 0203 080 6844

Opening hours 9:30-4:30

For all inspectorate queries:

Wholesale dealer licences/API/broker licences: GDP.Inspectorate@mhra.gov.uk

Manufacturing licences:  gmpinspectorate@mhra.gov.uk

Please note, you are required as a company to ensure that all personal details provided to the MHRA are up to date and the MHRA needs to be notified within any application if any changes in personal details need to be updated, including email addresses and telephone numbers.

Some helpful links

List of new manufacturing licences and wholesale distribution authorisations 2015: https://www.gov.uk/government/publications/medicines-new-manufacturing-and-wholesale-dealer-licences

List of manufacturers licences MIA and MANA, MIA(IMP) – on EUDRAGMDP link below: http://eudragmdp.ema.europa.eu/inspections/displayHome.do

List of API manufacturers, importers and distributors, see EUDRAGMDP link above.

Link to companies’ GMP and GDP certificates, see EUDRAGMDP link above.

List of manufacturer specials (human) (MS) and manufacturer specials authorisation (veterinary): https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-manufacturing-sites

List of licensed wholesale distribution sites (human and veterinary): https://www.gov.uk/government/publications/human-and-veterinary-medicines-register-of-licensed-wholesale-distribution-sites

List of brokers: https://www.gov.uk/government/publications/register-of-brokers-authorised-to-deal-in-human-medicines

List of suspended and revoked licences and authorisations: https://www.gov.uk/government/publications/suspended-licences-for-manufacturers-and-wholesalers-of-medicines

Export certificates: https://www.gov.uk/export-a-human-medicine

Terminated and cancelled manufacturing and wholesale dealer licences: https://www.gov.uk/government/publications/medicines-terminated-and-cancelled-manufacturing-and-wholesale-dealer-licences

All other specific services or enquiries contact can be found via the following link:

https://www.gov.uk/guidance/contact-mhra#contents

 

Medicines and Healthcare products Regulatory Agency

Inspection, Enforcement & Standards Division – Inspectorate and Process licensing

10 South Colonnade, Canary Wharf, London E14 4PU

Direct line: 020 3080 6844

 

Don’t miss the next post,  sign up to be notified by email when a new post comes out

Sharing and comments

Share this page

2 comments

  1. Comment by Ilyas ali posted on

    Is there any portal where we can check the list of MIA holders?
    Also is there any process to verify that MIA licence is still valid?

    Reply

Leave a comment

We only ask for your email address so we know you're a real person

By submitting a comment you understand it may be published on this public website. Please read our privacy notice to see how the GOV.UK blogging platform handles your information.