Manufacturer's and wholesale dealer's licences

 


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Medicinal products manufactured in the UK must be produced on a site that holds an appropriate manufacturer's licence (ML). Any company or individual wishing to wholesale deal (defined as selling, supplying or procuring to anyone other than the end-user) medicinal products within the EU must hold a wholesale dealer's licence (WL). The administrative activities for issuing and maintaining manufacturer's and wholesale dealer's licences are carried out by the Licensing Section in the Inspection, Enforcement and Standards Division and in fulfilling its role the Section works very closely with the Medicines Inspectorate.

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 obligationsPDF file (opens in new window) (32Kb)

Types of licence

Manufacturer's and wholesale dealer's licences

Licence type Licensed activity
Human products  
Manufacturer’s/importer’s licence (MIA)

Allows the holder to:

  • manufacture and/or assemble (package) medicinal products
  • wholesale deal licensed medicinal products imported from countries outside the EEA
 
Manufacturer 'specials' licence (MS)

Allows the holder to:

  • manufacture unlicensed medicinal products (commonly referred to as 'specials')
  • import unlicensed medicinal products from outside the EEA
Manufacturer investigational medicinal products (MIAIMP) Allows the holder to manufacture investigational medicinal products used in clinical trials
Hospital exemption licence:
Manufacturer’s Licence - Exempt Advanced Therapy Medicinal Products (MeAT)

Allows the holder to:

  • manufacture exempt Advanced Therapy Medicinal Products
  • on a non routine basis
  • for use in hospitals in the UK.
Full wholesale dealer licence (WL) Allows the holder to wholesale deal pharmacy (P), prescription only (POM) traditional herbal medicinal products (THMP) and General Sale List (GSL) medicines
Wholesale dealer (GSL) licence (WDL) Allows the holder to wholesale deal General Sale List (GSL) medicines only
Veterinary products  
Manufacturer’s/importer’s authorisation (ManA)

Allows the holder to:

  • manufacture and/or assemble (package) medicinal products
  • wholesale deal licensed medicinal products imported from countries outside the EEA
Manufacturer 'specials' authorisation (ManSA) Allows the holder to manufacture unlicensed medicinal products (commonly referred to as 'specials')
   
Wholesale dealer authorisation (WDA) Allows the holder to wholesale deal (POM-V), (POM-VPS), (NFA-VPS), (AVM-GSL) medicines

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 Medicines Act 1968 and its supporting regulations have been consolidated in The Human Medicines Regulations 2012 [SI 2012/1916]. The coming into force of this Regulation means that the following MHRA Guidance Notes are currently inaccurate concerning legislative references. The following Guidance Notes are under review:

  • Guidance Note 13 - A guidance note on manufacturer’s licences authorising a non-orthodox practitioner to mix and assemble unlicensed medicinal products


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 Regulatory Advice 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 Regulatory Advice 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 Regulatory Advice Unit, MHRA, 5 Magenta, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ, fax 020 7084 2439, email info@mhra.gsi.gov.uk

MHRA guidance

Manufacturers and wholesalers will find the following MHRA guidance useful:
 

 

Registers of licences

Suspended manufacturing and wholesale distribution authorisations

This list is updated on the same day that the suspension of the licence or authorisation takes place. Persons should use this list as part of due diligence to ensure they are dealing with a valid licence or authorisation holder.

Company name Licence suspended Date first suspended Suspended until
Nestor (UK) Limited MIA 31866 20 September 2013 Suspension has now been extended to 19 December 2014
Queen Elizabeth Hospital MS 12596 19 August 2014 18 February 2015
Moorfields Eye Hospital NHS Foundation Trust Partial suspension of
MS 11412
13 November 2014 12 February 2015
Acomed Limited WDA(H) 36824 19 November 2014 18 May 2015
Holburn Pharmacy Limited WDA(H) 40135 24 November 2014 23 February 2015

Revoked manufacturing and wholesale distribution authorisations

This list is updated on the same day that the revocation of the licence or authorisation takes place. Persons should use this list as part of due diligence to ensure they are dealing with a valid licence or authorisation holder.
 

Company name Licence revoked Date of revocation Reason
Vinayak Pharma Limited WDA(H) 42580 15 November 2014 Regulatory Action
Life Pharmaceuticals WDA(H) 32124 26 January 2014 Regulatory Action
Pharma Cure Health Care Limited WDA(H) 34535 07 May 2014 Regulatory Action
Overdrake Limited WDA(H) 33449 20 May 2014 Regulatory Action
Laudon Dispensing Chemist Limited WDA(H) 32450 23 July 2014 Regulatory Action
Euro Trade (Wholesale) Limited WDA(H) 40708 20 September 2014 Regulatory Action

 

Revocation:
The MHRA, acting as the licensing authority, may in accordance with the provisions of the Human Medicines Regulations 2012 [SI 2012/1916]:

  •  revoke a manufacturer’s licence;
  •  revoke a wholesale dealer’s licence;
  •  remove a person from the broker register or active substance register.

The MHRA, acting as the licensing authority may also in accordance with the provisions of the Medicines for Human Use (Clinical Trials) Regulations 2004 [SI 2004/1031] revoke a manufacturing authorisation for investigational products.
Revocation of a licence and authorisation or the removal of a person from a register may take place as a result of regulatory action where the MHRA considers it necessary to safeguard public health.

 

Registers of manufacturing and wholesale distribution authorisations

 

List of Manufacturers (MIA, MANA, MIA(IMP)

This information is now available on the EUDRAGMDP database and is updated on a daily basis. Use the database to verify:

  • Manufacturing sites (MIA, MANA and MIA(IMP) licences)
  • Certificates of Good Manufacturing Practice (GMP)

The website address is: http://eudragmp.ema.europa.eu

Persons should use this database as part of due diligence to ensure they are dealing with valid licence or authorisation holders.

Brief Guide to using EudraGMDP for GMP Word file (opens in new window) (988Kb)

 

List of Manufacturers (MS and MANSA)

This information forms part of national legislation and does not appear on EudraGMDP, the information is updated on a monthly basis and should be used by persons as part of due diligence to ensure they are dealing with valid licence or authorisation holders.

Department of Health and MHRA register of licensed manufacturing sites (MS and MANSA Only)PDF file (opens in new window) (1063Kb)

 

List of Wholesale Distribution Authorisations

This information is now available on the EudraGMDP database and is updated on a daily basis. Use the database to verify:

• Wholesale Distribution Authorisations

• Certificates of Good Distribution Practice (GDP)

The website address is: http://eudragmp.ema.europa.eu

Brief Guide to using EudraGMDP for GDP Word file (opens in new window) (929Kb)

The information included in Annex 5 of the Wholesale Distribution Authorisations forms part of national legislation and does not appear on EudraGMDP, persons wishing to check this information should make use of the list below which is updated on a monthly basis.

Department of Health and MHRA register of licensed wholesale dealer sites (human, veterinary) 2014PDF file (opens in new window) (12857Kb)

Not all sites will have Certificates of Good Distribution Practice as these only became a requirement as a result of the Falsified Medicines Directive in 2013. Certificates are only issued after a successful inspection and as such it will be necessary for the three year inspection period to conclude before all GDP certificates are listed.

 

List of UK Contract GMP Quality Control laboratories

Inspected UK contract GMP Quality Control laboratoriesPDF file (opens in new window) (124Kb)

Queries

If you have any queries please email pcl@mhra.gsi.gov.uk

 

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

List of new manufacturing and wholesale dealer licences - 2014PDF file (opens in new window) (371Kb)
List of terminated and cancelled manufacturing and wholesale dealer licences - 2014PDF file (opens in new window) (350Kb)
List of new manufacturing and wholesale dealer licences - 2010/13PDF file (opens in new window) (1377Kb)
List of terminated, revoked and cancelled manufacturing and wholesale dealer licences - 2010/13PDF file (opens in new window) (968Kb)
List of terminated and revoked manufacturing and wholesale dealer licences 2006-2009 PDF file (opens in new window) (547Kb)

 

Register of brokers

This publicly available UK register is required to enable National Competent Authorities in other EEA Member States to establish the bona fides and compliance of brokers established in the UK where they are involved in the sale or purchase of medicines on their territories. Reciprocal arrangements apply for brokers established in other member States involved in the sale or purchase of medicines to and from the UK.

Broker Registration (2014)PDF file (opens in new window) (89Kb)

Active substance manufacturers, importers and distributors registration

Active Substance Manufacturers, Importers and Distributors Registration (17 March 2014)

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.


Page last modified: 08 December 2014