Manufacturer’s and Wholesale Dealer’s licences

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/Importer's Licence application form (797Kb)
› Manufacturer's 'Specials' Licence application form (681Kb)
› Manufacturer investigational medicinal products (MIAIMP) (770Kb)
› Full Wholesale Dealer Licence application form (488Kb)
› Wholesale Dealer (GSL) Licence application form (462Kb)
› Additional requirements - Applicants for new Wholesale Dealer's licences for human use (130Kb)
› Additional requirements - Additional Responsible Persons (RPs) to be added to existing Wholesale Dealer's licences (127Kb)
› Application of a non-orthodox practitioner for authorisation to mix and assemble medicinal products (32Kb)
› Guidance notes on manufacturer’s licences authorising a non-orthodox practitioner to mix and assemble unlicensed medicinal products (72Kb)

Veterinary Products
› Manufacturer's/Importer's Authorisation application form (799Kb)
› Manufacturer's 'Specials' Authorisation application form (679Kb)
› Wholesale Dealer's Authorisation (481Kb)
› Additional requirements - Applicants for new Wholesale Dealer's authorisations (131Kb)
› Additional requirements - Additional Wholesale Dealer's Qualified Persons to be added to existing Wholesale Dealer's licences (128Kb)

Completed application forms should be sent to:

MHRA
PO Box 17
Mitcheldean
Gloucestershire
GL17 0WT

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, e-mail 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 guidancd 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 (33Kb).
  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 licensed Manufacturing and Wholesale Dealer's sites
› Department of Health and MHRA Register of Licensed Manufacturing Sites (Human Veterinary and Combined Sites) 2008 (1383Kb)
› Department of Health and MHRA Register of Licensed Wholesale Dealer Sites (Human Veterinary and Combined Sites) 2008 (2846Kb)
› Department of Health and MHRA Register of Manufacturer's Authorisations for Investigational Medicinal Products  (MIAIMP) 2008 (628Kb)
› Inspections against EU GMPs of Stand Alone Contract Laboratories, between April 2005 and March 2007 (111Kb)
› List of New Manufacturing and Wholesale Dealer Licences 2008 (95Kb)
› List of Terminated and Revoked Manufacturing and Wholesale Dealer Licences 2008 (139Kb)

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 the 16 July 2008.

Suspension of Wholesale Dealer’s licence - World Medical Ltd WL 25596
The Wholesale Dealer’s licence for World Medical Ltd WL 25596 was immediately suspended on the 14 July 2008 for a period of three months.

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 the 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 the 23 June 2008.

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

Suspension of Wholesale Dealer’s licence - Pharma Supplies LTD WL 24749
The Wholesale Dealer’s licence for Pharma Supplies LTD WL 24749 was immediately suspended on the 10 June 2008 for a period of three months.

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 the 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 the 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 the 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 the 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 the 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 the 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 Medical Ltd WL 30617
The Wholesale Dealer’s licence for Triple Two Medical Ltd WL 30617 was revoked with immediate effect on 17 March 2008.

Suspension of Wholesale Dealer’s licence - Triple Two Trading Ltd WL 30617
The Wholesale Dealer’s licence for Triple Two Trading Ltd WL 30617 was immediately suspended on 8 February 2008 for a period of three months.

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.

Immediate suspension of Wholesale Dealer's licence Ace 1 Technologies Limited WL 29976
The Wholesale Dealer's licence for Ace 1 Technologies Limited was immediately suspended on 9 January 2008 for a period of three months.

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 e-mail pcl@mhra.gsi.gov.uk or contact the PcL Enquiry Line on 020 7084 2844 or write to PcL Enquiries, 17-1, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.