Manufacturer's and wholesale dealer's licences

Latest news

Best practice for ensuring the efficient supply and distribution of medicines to patients - February 2011

This guidance has been developed and is supported by eleven organisations, including the MHRA, following detailed consideration of the current problems with the supply chain, especially those caused by increased exports of medicines from the UK.

Best practice for ensuring the efficient supply and distribution of medicines to patients

Advertising of unlicensed medicines - 14 September 2010

On 19 August 2010 a change was made to the way in which appropriately authorised wholesale dealers and manufacturers can make healthcare professionals aware of the unlicensed medicines they have available. Holders of a licence permitting the manufacture, importation and/or distribution of unlicensed medicines can now issue a price list to healthcare professionals without first having received a bona fide unsolicited order.

Further information about the change in advertising of unlicensed medicines

Guidance for registered pharmacies that also hold wholesale dealer’s licences - 26 July 2010

In November 2009, the MHRA together with the Department of Health and eight other bodies, published guidance on “Trading medicines for Human Use: Shortages and Supply Chain Obligations". The MHRA would like to clarify that it considers the guidance to be best practice.

Further information on the guidance for registered pharmacies that also hold wholesale dealer’s licences

Guidance published on UK exporting of medicines - 13 November 2009

Guidance helping pharmaceutical manufacturers and distributors to meet their obligations regarding the supply of medicines has been jointly published by nine organisations including the MHRA. The new guidance aims to reduce future problems with the export of medicines for profit by setting out the key legal and ethical obligations for manufacturers, wholesalers, NHS trusts, registered pharmacies and dispensing doctors in relation to the supply and trading of medicines.

Trading medicines for human use: Shortages and supply chain obligations (32Kb)

Types of licence

Manufacturer's and wholesale dealer's licences

Application forms

Human products

Manufacturer's and wholesale dealer's licence forms - New applications and variations to existing licences

Veterinary products

Manufacturer's and wholesale dealer's licence forms - New applications and variations to existing licences

Completed application forms should be sent to:
Medicines and Healthcare products Regulatory Agency
Process Licensing
5th Floor, Y-363
151 Buckingham Palace Road
Victoria
London
SW1W 9SZ.

Or electronic submissions can be sent to:
pcl@mhra.gsi.gov.uk

Legislation

The Directive 2001/83/EC on the Community code relating to medicinal products for human use was amended on 30 October 2005, which  impacts on existing legislation (including the Medicines Act 1968 and Regulations/Orders made under that Act).  In relation to licences for manufacturers and distributors of medicinal products for human use, there is The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (SI 2005/2789).

The coming into force of The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (SI 2005/2789) means that the MHRA Guidance Notes  are currently under review:

• Guidance Note 5 - Notes for applicants and holders of a manufacturer’s licence
• Guidance Note 6 - Notes for applicants and holders of a wholesale dealer’s licence
• Guidance Note 8  - A guide to what is a medicinal product
• Guidance Note 13 - A guidance note on manufacturer’s licences authorising a non-orthodox practitioner to mix and assemble unlicensed medicinal products
• Guidance Note 14 - The supply of unlicensed relevant medicinal products for individual patients
  

Interpretation of legislation

The MHRA Inspection, Enforcement and Standards Division is responsible for ensuring compliance with the standards that apply to the manufacture and supply of medicines on the UK market. 

The Inspection, Enforcement and Standards Division’s Policy Unit advises on the interpretation of the law relevant to inspection and standards as well as developing policy on manufacturing and wholesaling of medicinal products.

The Inspection, Enforcement and Standards Division’s Policy Unit  are also a focus for contributions and comments on European legislative proposals concerning manufacturing and wholesale distribution of medicinal products for human use and their introduction when adopted into UK law.

For further information, please contact our Policy Section, MHRA, 5 Magenta, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ, telephone 020 3080 6442, fax 020 7084 2439, email info@mhra.gsi.gov.uk

MHRA guidance

Manufacturers and wholesalers will find the following MHRA guidance useful:

• Best practice for ensuring the efficient supply and distribution of medicines to patients
  (78Kb)This guidance has been developed and is supported by eleven organisations, including the MHRA, following detailed consideration of the current problems with the supply chain, especially those caused by increased exports of medicines from the UK.
• The MHRA Guidance Note 5, 'Notes for applicants and holders of a manufacturer's licence' (364Kb) provides guidance to manufacturers on the law covering the manufacture and/ or assembly of medicinal products.
• The MHRA Guidance Note 14, 'The supply of unlicensed relevant medicinal products for individual patients' (154Kb) provides guidance to manufacturers about the conditions under which they may manufacture and supply 'specials' and their legal obligations.
  (Please note: Changes have been made to the way in which appropriately authorised wholesale dealers and manufacturers can make healthcare professionals aware of the unlicensed medicines they have available - Advertising of unlicensed medicines.)
• The MHRA Guidance Note 6, 'Notes for applicants and holders of a wholesale dealer's licence' (279Kb)  provides guidance to manufacturers on the law covering the wholesale distribution of relevant medicinal products and wholesale dealing of medicinal products other than relevant medicinal products for example herbal remedies exempt under section 12(1) of the Medicines Act, for human use.
• The MHRA Guidance Note 27, 'Guidance notes for industry on the preparation of a Site Master File' (273Kb) provides guidance for manufacturers to prepare the Site Master File. A Site Master File is a document that the MHRA requests the licence holder or applicant to provide, that describes the structure of the organisation involved, the site, the manufacturing activities carried out, the facility and premises employed and also details of the quality management system in place.
• The MHRA Guidance Note 28, 'Guidance notes for industry on the preparation of a Site Master File for an overseas site subject to inspection by the UK regulatory authority' (279Kb) provides guidance for manufacturers to prepare the Site Master File for an overseas site.
• The MHRA Guidance Note 30, 'Site Master File model: For manufacturing 'specials'  licence holders or applicants for manufacturing authorisations relating to small-scale activities, including investigational medicinal products' (163Kb) describes the core components of a Site Master File suitable for units holding or applying for licences relating to small-scale manufacture, for example, 'specials' manufacture or Phase 1 and Phase 2 investigational medicinal products manufacture.
• Guidance for UK manufacturer’s licence and manufacturer’s authorisation holders on the use of stand alone contract laboratories (91Kb).
  This document:
• • Defines a stand alone contract laboratory in relation to quality control testing of medicinal products
  • Provides guidance as to when a contract laboratory must be named on a manufacturer’s licence (including import, export and specials) for relevant medicinal products for human use and/or a manufacturer’s authorisation (including import and export) for investigational medicinal products
  • Provides guidance as to when a contract laboratory is not required to be named on a manufacturer’s licence or authorisation
  • Outlines the MHRA’s criteria for inspection of contract laboratories

Registers of licences

Assembly only operations: manufacturing licences for assembly only (formerly AO) licences performing only primary or secondary packaging operations do not appear in this report. However, this information will, in due course, be available via the EUDRA GMP database which will display all Certificates of Good Manufacturing Practice. In the interim, if you have any queries regarding assembly only manufacturers please email pcl@mhra.gsi.gov.uk or telephone 020 3080 6844.

Department of Health and MHRA register of licensed manufacturing sites (human, veterinary and combined sites) 2011 (1008Kb)
Department of Health and MHRA register of licensed wholesale dealer sites (human, veterinary and combined sites) 2011 (6331Kb)
Department of Health and MHRA register of manufacturer's authorisations for investigational medicinal products  (MIAIMP) 2011 (714Kb)
Inspected UK contract GMP Quality Control laboratories (94Kb)

Monthly lists of new, terminated and revoked manufacturing and wholesale dealer's licences

List of new manufacturing and wholesale dealer licences - 2010/12  (1357Kb)
List of terminated, revoked and cancelled manufacturing and wholesale dealer licences - 2010/12  (1803Kb)
List of terminated and revoked manufacturing and wholesale dealer licences 2006-2009 (547Kb)

Suspended manufacturing and wholesale dealer's licences

Contact for further information

For further information please email pcl@mhra.gsi.gov.uk or contact the PcL enquiry line on 020 3080 6844 or write to PcL Enquiries, 5th Floor, 151 Buckingham Palace Road, Victoria, London SW1W 9SZ.