Manufacturer's and Wholesale Dealer's licences

Latest news
Public consultation (MLX 365): Measures to strengthen the medicines’ supply chain and reduce the risk from counterfeit medicines - 18 December 2009
MLX 365 seeks your views on specific proposals designed to strengthen the medicines supply chain in the UK. It follows and builds on responses to ideas set out in an earlier consultation (MLX 357) undertaken from 18 December 2008 – 13 March 2009.
Public consultation (MLX 365): Consultation on measures to strengthen the medicines’ supply chain and reduce the risk from counterfeit medicines

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)

Changes to Manufacturer's and Wholesale Dealer's licences from August 2006
In August 2006, the MHRA changed the style of licences issued for manufacturers and wholesale dealers. For further information, please see the following section:
Changes to Manufacturer's and Wholesale Dealer's licences from August 2006

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 (17th Floor, Desk 148)
Market Towers
1 Nine Elms Lane
Vauxhall
London
SW8 5NQ

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 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 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 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, 16-150, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, telephone 020 7084 2442, fax 020 7084 2439, email info@mhra.gsi.gov.uk.


MHRA guidance
Manufacturers and wholesalers will find the following MHRA guidance useful:

• 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.
• 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 (86Kb).
  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
Department of Health and MHRA Register of Licensed Manufacturing Sites (Human Veterinary and Combined Sites) 2010 (957Kb)
Department of Health and MHRA Register of Licensed Wholesale Dealer Sites (Human Veterinary and Combined Sites) 2010 (4680Kb)
Department of Health and MHRA Register of Manufacturer's Authorisations for Investigational Medicinal Products  (MIAIMP) 2010 (753Kb)
Inspected UK Contract GMP Quality Control Laboratories (105Kb)

Monthly lists of new, terminated and revoked Manufacturing and Wholesale Dealer's Licences
List of New Manufacturing and Wholesale Dealer Licences - 2010 (138Kb)
List of Terminated and Revoked Manufacturing and Wholesale Dealer Licences - 2010  (72Kb)

Suspended, revoked and terminated licences
Further suspension of Manufacturer's Import Authorisation Licence - Karib Ltd MIA 20621 and Karib Kemi Pharm Ltd MIA 18224
The Manufacturer's Import Authorisation Licence for Karib Ltd (MIA 20621) and Karib Kemi Pharm (MIA 18224) was further suspended on 17 March 2010 for a period of three months until 17 June 2010.

Suspension of Wholesale Dealer's Licence - Waypharm LP WL 20732
The Wholesale Dealer's Licence for Waypharm LP was suspended on 12 March 2010 for a period of three months until 12 June 2010.

Revocation of Wholesale Dealer's Licence - eye to Eye Contactz WL 33068
The Wholesale Dealer's Licence for Medcare (EU) Limited WL 33068 was revoked on 4 March 2010.

Revocation of Wholesale Dealer's Licence - Medcare (EU)Limited WL 29867
The Wholesale Dealer's Licence for Medcare (EU) Limited WL 29867 was revoked on 4 March 2010.

Immediate suspension of Wholesale Dealer's Licence - Eye to Eye Contactz Limited WL 33068
The Wholesale Dealer's Licence for Eye to Eye Contactz WL 33068 was immediately suspended on 8 January 2010 for a period of three months.

Immediate suspension of Manufacturer's Import Authorisation Licence - Karib Ltd MIA 20621 and Karib Kemi Pharm Ltd MIA 18224
The Manufacturer's Import Authorisation Licence for Karib Ltd (MIA 20621) and Karib Kemi Pharm (MIA 18224) was immediately suspended on 17 December 2009 for a period of three months.

Termination of Manufacturer's 'Specials' Licence - Blackpool Fylde and Wyre Hospitals NHS Trust MS 21326
The Manufacturer's 'Specials' Licence for Blackpool Fylde and Wyre Hospitals NHS Trust MS 21326 was terminated on 9 October 2009.

Termination of Manufacturer's/Importer's Authorisation Licence MIA 18632 and the Manufacturer's/Importer's Authorisation Licence for veterinary products ManA 18632 - ACS Dobfar UK Limited
The Manufacturer's/Importer's Licence in relation to medicinal products for human use for ACS Dobfar UK Limited MIA 18632 was terminated on 4 November 2009. The Manufacturer's Authorisation Licence in relation to medicinal products for veterinary use for ACS Dobfar UK Limited ManA 18632 terminated on 4 November 2009.

Further suspension of Wholesale Dealer's Licence - Pharmalogical Corporation Ltd WL 21031
The Wholesale Dealer's Licence for Pharmalogical Corporation Ltd WL 21031 has been revoked as of Thursday 19 November 2009.

Notice of revocation of Wholesale Dealer’s (General Sales List) Licence - Pharmalogic Europe WL 30609
The Wholesale Dealer’s (General Sales List) Licence for Pharmalogic Europe WL 30609 was revoked on the 16 September 2009.

Notice of revocation of Wholesale Dealer’s (General Sales List) Licence - BHM Health Group WDL 22360
The Wholesale Dealer’s (General Sales List) Licence for BHM Health Group WDL 22360 was revoked on 10 August 2009.

Licence revoked for Wholesale Dealer’s Licence - Ardana Bioscience Limited WL 20847
The Wholesale Dealer’s Licence for Ardana Bioscience Limited WL 20847 was revoked on 10 August 2009.

Termination of Wholesale Dealer’s Licence - Salford Royal NHS Foundation Trust WL 13904
The Wholesale Dealer’s Licence for Salford Royal NHS Foundation Trust WL 13904 was terminated on 26 January 2009.

Immediate suspension of Wholesale Dealer’s Licence - Ardana Bioscience Limited WL 20847
The Wholesale Dealer’s Licence for Ardana Bioscience Limited WL 20847 was immediately suspended on 11 June 2009 for a period of three months.

Immediate suspension of Wholesale Dealer’s (General Sales List) Licence - BHM Health Group WDL 22360
The Wholesale Dealer’s (General Sales List) Licence for BHM Health Group WDL 22360 was immediately suspended on 9 June 2009 for a period of three months. The Licence is suspended until Tuesday, 8 September 2009.

Immediate suspension of Wholesale Dealer's Licence - Blueridge (UK) Limited WL 32224
The Wholesale Dealer's Licence for Blueridge (UK) Limited WL 32224 was immediately suspended on 1 June 2009 for a period of three months.

Termination of Wholesale Dealer's Licence - Hopkins Chemist Limited WL 13351
The Wholesale Dealer's Licence for Hopkins Chemist Limited WL 13351 was terminated on 31 March 2009.

Revocation of Wholesale Dealer's Licence - Owl Ltd WL 20448
The Wholesale Dealer's Licence for Owl Ltd WL 20448 was revoked on 13 May 2009.

Revocation of Wholesale Dealer's Licence Arkeley Limited WL 23203
The Wholesale Dealer's Licence for Arkeley Limited WL 23203 was revoked on 7 May 2009.

Immediate suspension of Manufacturer's Authorisation for Investigational Medicinal Products Licence - University of Southampton MIA(IMP) 16730
The Manufacturer's Authorisation for Investigational Medicinal Products Licence for University of Southampton MIA(IMP) 16730 was immediately suspended on the 31 March 2009 for a period of three months. The Licence is suspended until Tuesday, 30 June 2009.

Further suspension of Wholesale Dealer's Licence - Pharmalogic-Europe Limited WL 30609
The Wholesale Dealer's Licence for Pharmalogic-Europe Limited WL 30609 was further suspended on 7 May 2009 for a period of three months. The Licence is suspended until Thursday, 6 August 2009.

Termination of Wholesale Dealer's Licence - Taurus Pharma Limited WL 32006
The Wholesale Dealer's Licence for Taurus Pharma Limited WL 32006 was terminated on 1 June 2009.

Suspension of Wholesale Dealer's Licence - Global Medical Healthcare Products Limited WL 30656
The Wholesale Dealer's Licence for Global Medical Healthcare Products Limited WL 30656 was immediately suspended on the 13 January 2009 for a period of three months. The Licence was further suspended on 14 April 2009 for a period of six months.

Revocation of Wholesale Dealer's Licence X2Y Limited WL 20457
The Wholesale Dealer's Licence for X2Y Limited WL 20457 was revoked on 7 April 2009.

Further suspension of Manufacturer's 'Specials' Licence Blackpool Fylde and Wyre Hospitals NHS Trust MS 21326
The Manufacturer's 'Specials' Licence for Blackpool Fylde and Wyre Hospitals NHS Trust MS 21326 was further suspended on 28 February 2009 for a period of nine months until Friday, 27 November 2009.

Revocation of Wholesale Dealer's Licence - Pharmacepta Limited WL 32517
The Wholesale Dealer's Licence for Pharmacepta Limited WL 32517 was revoked on 20 March 2009.

Further suspension of Wholesale Dealer's Licence - Pharmalogical Corporation Ltd WL 21031
The Wholesale Dealer's Licence for Pharmalogical Corporation Ltd WL 21031 which was immediately suspended on 20 November 2008, has been further suspended for an additional period of three months beginning Thursday, 21 May 2009.

Revocation of Wholesale Dealer's Licence Pharma Supplies Ltd WL 24749
The Wholesale Dealer's Licence for Pharma Supplies Ltd WL 24749 was revoked on 15 April 2009.

Suspension of Manufacturer's 'Specials' Licence - Wrightlington Wigan and Leigh Health Services NHS Trust MS. 12890
The Manufacturer's 'Specials' Licence for Wrightlington Wigan and Leigh Health Services NHS Trust MS 12890 was suspended on 7 October 2008. The Licence will remain suspended until the Trust recruits a new Aseptic Services Manager.

Termination of Wholesale Dealer’s licence - Cardinal Medical Limited- WL 17270
The Wholesale Dealer’s licence for Cardinal Medical Limited WL 17270 was terminated on 17 July 2008.

Termination of Wholesale Dealer’s licence - Essential Pharmaceuticals Ltd- WL 20866
The Wholesale Dealer’s licence for Essential Pharmaceuticals Ltd WL 20866 was terminated on 16 September 2008.

Revocation of Wholesale Dealer’s licence - Empire Wholesale Limited WL 29668
The Wholesale Dealer’s licence for Empire Wholesale Limited WL 29668 was revoked on 16 July 2008.

Termination of Wholesale Dealer’s Licence - World Medical Ltd WL 25596
The Wholesale Dealer’s licence for World Medical Ltd WL 25596 was terminated on 13 October 2008.

Revocation of Wholesale Dealer’s licence - Shafah Supplies Limited WL 30122
The Wholesale Dealer’s licence for Shafah Supplies Limited WL 30122 was revoked on 4 July 2008.

Revocation of Wholesale Dealer’s licence - Got-It Limited WL 30607
The Wholesale Dealer’s licence for Got-It Limited WL 30607 revoked on 23 June 2008.

Revocation of Wholesale Dealer’s licence - Elgin Investments Ltd WDL 30276
The Wholesale Dealer’s licence for Elgin Investments Ltd WDL 30276 was revoked on 23 June 2008.

Termination of Wholesale Dealer’s licence - Thurnby Rose Limited WL 18614
The Wholesale Dealer’s licence for Thurnby Rose Limited WL 18614 was terminated on 19 May 2008.

Revocation of Wholesale Dealer’s licence - Medical Healthcare Supplies Limited WL 30606
The Wholesale Dealer’s licence for Medical Healthcare Supplies Limited WL 30606 revoked on 16 May 2008.

Revocation of Wholesale Dealer’s licence - R&S Medical Suppliers Limited WL 30610
The Wholesale Dealer’s licence for R&S Medical Suppliers Limited WL 30610 was revoked on 16 May 2008.

Revocation of Wholesale Dealer’s licence - AHZ Pharmaceuticals Limited WL 22770
The Wholesale Dealer’s licence for AHZ Pharmaceuticals Limited WL 22770 was revoked on 16 May 2008.

Revocation of Wholesale Dealer’s licence - DNDR Limited WL 30349
The Wholesale Dealer’s licence for DNDR Limited WL 30349 was revoked on 7 May 2008.

Termination of Wholesale Dealer's licence - Jakmans Europe Limited WL 27725
The Wholesale Dealer's licence for Jakmans Europe Limited WL 27725 was terminated on 21 April 2008.

Termination of Wholesale Dealer's licence - Primary Care Pharmaceuticals Ltd WL 18074
The Wholesale Dealer's licence for Primary Care Pharmaceuticals Ltd WL 18074 was terminated on 27 March 2008.

Revocation of Wholesale Dealer’s licence - Triple Two Trading Limited WL 30617
The Wholesale Dealer’s licence for Triple Two Trading Limited WL 30617 was revoked on 17 March 2008.

Revocation of Wholesale Dealer’s licence - Allerayde (UK) Ltd WL 18618
The Wholesale Dealer’s licence for Allerayde (UK) Ltd WL 18618 was revoked with immediate effect on 28 January 2008.

Termination of Wholesale Dealer's licence - Jakman (UK) Ltd WL18029
The Wholesale Dealer's licence for Jakman (UK) Ltd WL18029 was terminated on 10 January 2008.

Revocation of Wholesale Dealer's licence Ace 1 Technologies Limited WL 29976
The Wholesale Dealer's licence for Ace 1 Technologies Limited WL 29976 was revoked on 18 June 2009.

Revocation of Wholesale Dealer’s licence - Consolidated Medical Supplies Limited WL 24900
The Wholesale Dealer’s licence for Consolidated Medical Supplies Limited WL 24900 was revoked with immediate effect on 8 January 2008.

Suspension of Wholesale Dealer’s licence - Richard Kemp T/A KEMCO, WL8496
The Wholesale Dealer’s licence for Richard Kemp T/A KEMCO WL8496 was suspended on 24 November 2007.

Revocation of Wholesale Dealer’s licence - Alzur Trading Ltd,  WL 29499
The Wholesale Dealer’s licence for Alzur Trading Ltd WL 29499 was revoked with immediate effect on 16 November 2007.

Revocation of Wholesale Dealer’s licence - Advanta Associates WL20669
The Wholesale Dealer’s licence for Advanta Associates WL20669 was revoked with immediate effect on 28 September 2007.

Suspension of Manufacturer’s ‘Specials’ Licence No. 13904 - Salford Royal NHS Foundation Trust
The Manufacturer’s ‘Specials’ Licence for Salford Royal NHS Foundation Trust Licence No. 13904 was suspended on 1 August 2007.

Revocation of Wholesale Dealer’s licence - Q Pharma, WL 25609
The Wholesale Dealer’s licence for Q Pharma, WL 25609, was suspended on 25 July 2006 for three months and again on 25 October 2006 for a further three months. The reason for the suspension was that the licensed premises were no longer being used by the company.  On 17 November 2006 the Wholesale Dealer’s licence for Q Pharma, WL 25609, was revoked.  The reason for the revocation was that the licensed premises were no longer being used by the company.

Revocation of Wholesale Dealer’s licence - Medline Clinics, WL 20754
The Wholesale Dealer’s licence for Medline Clinics WL 20754, was suspended on 25 July 2006 for three months and again on 25 October 2006 for a further three months. The reason for the suspension was that the licensed premises were no longer being used by the company.  On 9 February 2007 the Wholesale Dealer’s licence for Medline Clinics WL 20754, was revoked.  The reason for the revocation was that the licensed premises were no longer being used by the company.

Contact for further information
For further information please email pcl@mhra.gsi.gov.uk or contact the PcL Enquiry Line on 020 7084 2844 or write to PcL Enquiries, 17-148, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.