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Detailed guide: Apply for a licence to market a medicine in the UK

Medicines Healthcare Products Regulatory Agency

December 13
11:37 2019

You can contact the Medicines and Health Products Regulatory Agency (MHRA) for advice before you make your application.

Email: RIS.NA@mhra.gov.uk
Telephone: 020 3080 7400

Which procedure to follow

Youll need to follow a specific application procedure depending on the licence you need. You need to use the:

You will usually need to submit a paediatric investigation plan (PIP) early in the development of your product. Proposals for PIPs must be submitted to the European Medicines Agency (EMA).

Decentralised procedure (DCP)

You should use the decentralised procedure if you want to market the medicine in the UK and other named EU countries.

One state will lead the assessment of the application as reference member state (RMS). The other member states you apply to are called the concerned member states (CMSs).

To start your application with MHRA as the reference member state (RMS), book a DCP submission date.

We will normally reply within 24 hours to confirm your booking and issue your product licence (PL) number and DCP number.

As the RMS, MHRA will lead the assessment of your application. The other member states you apply to are called the concerned member states (CMSs).

The procedure takes up to 210 days, excluding time taken to provide further information or data required.

If the application is approved, the MHRA and each CMS will issue a national licence for the product within 30 days of the approval being granted.

Find more information about the DCP on the Co-ordiniation Group for Mutual Recognition and Decentralised Procedures Human (CMDh) website.

Mutual recognition procedure (including repeat use)

Use the mutual recognition procedure when your product already has a national licence in at least 1 EU country, and you want to market it in more EU countries. The principle is that the countries you wish to add recognise the national licence(s) already granted.

To start your application with MHRA as the RMS, email MR-DCprocedures@mhra.gov.uk with the name of your product and the PL number.

We will confirm if the product can be accepted for a mutual recognition procedure and issue a mutual recognition procedure number to use on your application.

As the RMS, MHRA will lead the assessment of your application. The other member states you apply for are the concerned member states (CMSs).

The application process takes up to 90 days, excluding time taken to provide further information or data required.

If the application is approved, MHRA and each CMS will issue a national licence for the product within 30 days of the approval being granted.

Find more information about the mutual recognition procedure on the Heads of Medicines Agencies website.

Repeat use procedures

You can use the mutual recognition procedure more than once to add more member states to a mutually-recognised licence this is known as a repeat-use procedure. The process for repeat use is identical to the first mutual recognition procedure.

An expedited process may be available if you only want to add Iceland, Malta or Cyprus and your product has already been licensed through mutual recognition with UK as RMS. Email MR-DCprocedures@mhra.gov.uk giving your PL number and mutual recognition procedure number(s) for more information.

National procedure

You should use the national procedure if you want to market a medicine only in the UK.

If this is your first application, email Reference.Data@mhra.gov.uk and well issue a 5-digit company number.

Get a PL number from the MHRA Portal or by emailing PLNumberAllocation@mhra.gov.uk before you submit your application.

The application process takes up to 210 days, excluding time taken to provide further information or data required.

We can accept applications at any time.

If you are making a national application for an informed consent marketing authorisation and the licence you are using as a reference complies with current regulatory requirements then attach the informed consent checklist (MS Word Document, 350KB) to the covering letter of your MA application.

Centralised procedure

A centralised licence is mandatory for certain types of medicines, some new active substances and biotechnology products, and optional for others. Details of medicines that must have a centralised licence can be found in annex I of Regulation (EC) No 726/2004.

Use the centralised procedure to get a single licence that can be used to market a product in all EU member states as well as Iceland, Liechtenstein and Norway.

Centralised licences are granted by the EMA. Find more information on the EMA website.

Fast track your marketing authorisation

Applications can be fast tracked if there is compelling evidence to show that the product would provide a major breakthrough in the treatment of certain conditions. There is no additional fee for fast-tracking applications.

The disease categories for which fast tracking of applications may be applicable are:

  • chronic, debilitating diseases for which available treatments are ineffective or otherwise inadequate
  • severe or life-threatening diseases for which available treatments are ineffective or otherwise inadequate
  • the emergence of a disease with wide-spread resistance to treatment with currently available treatments
  • the emergence of a new disease entity which has severe or life-threatening effects and for which currently available treatments are ineffective or inadequate

To get your application fast tracked you should email a letter of no more than 3 pages to RIS.NA@mhra.gov.uk. The letter should include:

  • the disease category
  • a brief description of the major clinical properties of the product
  • evidence supporting the claimed benefits of the product for the proposed indication(s)

MHRA Corporate Executive Team will consider your request for a fast-tracked application and their decision will be communicated to you in confidence.

For more information about fast tracking your marketing authorisation email RIS.NA@mhra.gov.uk or call 020 3080 7400.

Applications can also be fast tracked if there is shortage of supply of essential medicines that has

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