Detailed guide: Apply for a Manufacturing authorisation for veterinary medicines

Updated: Updated register of specials manufacturing sites

Manufacturers are required to comply with the principles of Good Manufacturing Practice (GMP) where appropriate in relation to the following types of authorisation:

  • manufacturing authorisation (ManA)

  • manufacturing extemporaneous products (Specials) authorisation (ManSA)

  • autogenous vaccine authorisation (AVA-I/S)

  • non food animal blood banks authorisation (NFABBA)

  • equine stem cell centre authorisation (ESCCA)

  • exemptions for small pet animals (Schedule 6)

Guidance

For information about the requirements for veterinary only manufacturers.

Applications forms

An application for a ManA or ManSA should be accompanied by a Site Master File.

To help process your application more efficiently you should provide, in addition to paper copies, an electronic copy of the application or any parts of it. These should be in MS Word if possible, although other formats are acceptable.

You must submit your application to the Veterinary Medicines Directorate (VMD).

Timelines

The VMD will validate your application within 10 days of receipt although this time will be extended if the VMD has to ask you for further information.

After validation we will carry out the pre-approval inspection within 90 days.

Fees

The VMD charges a fee for:

  • a manufacturers authorisation
  • a manufacturers authorisation variation
  • the initial inspection of each site
  • duplicate or multiple GMP Certificates
  • on-going annual and inspection fees

The application and annual fees are not refundable or transferable.

Application refusal and appeals

We may refuse to grant an authorisation or may grant an authorisation that is different than that applied for. In such cases we will notify you.

Manufacturers of human and veterinary products

Where a site handles both human and veterinary medicines you should also refer to guidance published by the Medicines and Healthcare products Regulatory Agency (MHRA).

Any queries should be directed to the Regulatory Information Service on 020 3080 7400 or via their website.

Contact

You can contact the Inspections administration team by email at inspections@vmd.defra.gsi.gov.uk.or by phone on 01932 338426 or 338328.

EudraGMDP

Details of authorised manufacturing sites (ManA holders) and Good Manufacturing Practice (GMP) Certificates can be accessed by searching the European database, EudraGMDP. See
guide to using the EudraGMDP
(PDF, 87.4KB, 2 pages)

.

Registers

Approved Specific Manufacturing Authorisations – AVAS

Approved Specific Manufacturing Authorisations – Non-Food Animal Blood Banks, and Equine Stem Cell Centre Authorisations


Authorised specials manufacturing sites
(PDF, 130KB, 3 pages)

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Guidance: Vaccination of dogs

Updated: Vaccines table updated

The Veterinary Medicines Directorate’s (VMD) position on the authorised vaccination schedule for dogs has been published to help you make an informed decision on the vaccination schedule for your dog.

The table of vaccines lists vaccine products which have been authorised by the VMD.

Vets will use vaccination schedules that are based on the authorised summary of product characteristics (SPC).

However a vet may make the decision to use either a shorter or longer revaccination schedule based on the age, health, or vaccination history of the animal. This is considered to be off-label use of the product and the vet takes responsibility for the decision.

It is recommended that the course of action is agreed with the animal owner.




UK overseas intellectual property attaché network

Also referred to as Intellectual Property (IP) attachés, the IP liaison officers work with local UK Department for International Trade (DIT) and Foreign and Commonwealth Office (FCO) leads to provide support for UK businesses seeking advice on local IP matters.

They also:

  • raise awareness of IP through business outreach. This includes briefing business delegations, joint webinars with DIT and local trade associations

  • liaise with host governments and stakeholders about local and international IP frameworks / environment

Contact details

Kayleigh Nauman: Attaché North America

Career history: Before joining the Intellectual Property Office (IPO), Kayleigh worked for a Member of Congress in the US House of Representatives. There, she managed a diverse portfolio, working on intellectual property, trade, and telecommunications; developing and writing legislation; and supporting Congressional oversight of executive agencies. Previously, Kayleigh worked in local and state government in Wyoming, USA. She is a Fulbright Scholar and holds an MPhil from Emmanuel College at the University of Cambridge, UK.

Focus in North America: Supporting the IPO’s input into any Free Trade Agreement (FTA) with the United States and providing insight into US IP policies and IP discussions they may have with global trading partners. Kayleigh also focusses on building cooperation between the US and UK on IP matters such as global treaties, simplifying international patent procedures and approaches to IP enforcement. Finally, Kayleigh can provide IP advice and support to UK businesses operating or trading with the US, Canada and Mexico.

Contact details: email: kayleigh.nauman@fco.gov.uk; tel: +44 202 588 1232; address: 3100 Massachusetts Ave NW, Washington, DC 20008, USA.

Christabel Koh: South East Asia

Joined IPO: August 2013

Career history: Prior to working for the UK Government, Christabel spent six years at the IP Office of Singapore and the IP Academy, last serving as an Assistant Director of Special Projects. In her roles she focused on international cooperation, IP capacity building and monitored IP developments. She also co-founded Just Tee It in 2007, an online golf portal. Her roles covered product development, marketing channel management and enhancing customers’ digital experience. She holds a MSc in Technopreneurship and Innovation from Nanyang Technological University in Singapore and University of Washington, Seattle, WA.

Contact details: email: christabel.koh2@fco.gov.uk; tel: +65 9619 1675; address: British High Commission Singapore, 100 Tanglin Road, Singapore 247919.

Desmond Tan: South East Asia

Joined IPO: April 2018

Career history: Prior to joining the Intellectual Property Office (IPO), Desmond was Senior Assistant Director with the Intellectual Property Office of Singapore (IPOS) for five years, covering various portfolios such as strategy and policy, industry development and planning, capacity building, as well as a stint in media engagement. Desmond holds a Degree in Aeronautical Engineering from the Nanyang Technological University, Singapore.

Focus in SE Asia: The IP landscape is SE Asia is diverse and evolving rapidly. Based in Singapore, the team provides regional IP support to UK businesses operating in or venturing to SE Asia. The team also works with the local governments and associations to develop a pro-business IP environment for the region.

Contact details: email: desmond.tan@fco.gov.uk; tel: +65 9088 4018; address: British High Commission Singapore, 100 Tanglin Road, Singapore 247919.

Cerian Foulkes: China

Joined IPO: April 2019

Career history: Prior to joining the Intellectual Property Office (IPO), Cerian was Senior Innovation Policy Officer for the UK government’s Science and Innovation Network in China. Previous to this, she worked in the China team of the UK’s Research Councils and in the auto industry. Cerian has lived and worked in China for over nine years and is fluent in Mandarin.

Focus in China: China’s IP framework is fast developing and the UK is a key international partner. Cerian and her team in Beijing and Shanghai, provide direct support to UK companies with concerns across the IP spectrum, particularly in supporting enforcement outcomes. The team also works closely with a number of Chinese government agencies on IP, to share UK expertise and best practice. This work is part of wider engagement by the UK IPO with China, including the annual UK-China IP Symposium and technical exchanges.

Contact details: email: cerian.foulkes@fco.gov.uk; address: British Embassy, 11 Guanghua Lu, Beijing 100200.

Angelica Garcia: Brazil

Joined IPO: August 2016

Career history: Lawyer with a LL.M in IP & International Trade from Queen Mary University, London. She was formerly Director of Marketing & Business Development for ACE Aceleratech start-up accelerator in Brazil and Latin America and worked on Deloitte’s German-Brazilian Desk. Most recently she worked for the Department for International Trade (formerly UKTI) of the British Government.

Focus in Brazil: Assisting UK companies that have IP issues in Brazil and working closely with Government to ensure that there is a strong IP framework. This includes outreach with both officials and business, highlighting the benefits of a strong IP system. Specific areas of interest include addressing backlogs in patents and trade marks, Geographical Indications (GIs), pharmaceuticals and IP enforcement.

Contact details: email: angelica.garcia@fco.gov.uk; tel: +55 11 3094 2729; address: British Consulate General, Rua Ferreira de Araújo, 741, São Paulo, Brazil – 05428-002.

India

Post currently vacant.

Useful guides




Guidance: IsItWaste tool: for advice on the by-products and end of waste tests

Updated: We’ve updated information on how to use our Definition of Waste Service to get an opinion on whether your waste derived material can be classed as non-waste.

Use the user guide to:

  • access the IsItWaste tool
  • do a self assessment to help you decide whether your material is likely to be waste
  • ask the Environment Agency Definition of Waste Service for an opinion

The IsItWaste tool is for England only. It’s based on English and Welsh case law. Northern Ireland and Wales may have similar tools.




Certification Officer: amendments to the lists

31 March 2022

The Certification Officer has carried out a review of the Trade Unions and Employers’ Associations on her lists to determine whether they still met the statutory definitions. This review resulted in some organisations being removed. The updated lists can be found on her website

22 September 2021

Equal Justice The Union has been entered on the list of trade unions held by the Certification Officer with effect from 22 September 2021.

19 August 2021

National Union of Professional Foster Carers (NUPFC) has been entered on the list of trade unions held by the Certification Officer with effect from 19 August 2021.

12 August 2021

UK Private Hire Drivers Union has been entered on the list of trade unions held by the Certification Officer with effect from 12 August 2021.

10 August 2021

CWOATA Trade Union has been removed from the list of trade unions maintained by the Certification Officer, because it dissolved.

Incorporated Guild of Hairdressers, Wigmakers and Perfumers was removed from the schedule of employers’ associations held by the Certification Officer because it ceased to meet the definition of an employers’ association under the TULRC 1992 Act.

9 July 2021

Change of Name: The College of Podiatry

The Certification Officer has approved an application from The College of Podiatry to change its name to The Royal College of Podiatry with effect from 9 July 2021..

28 June 2021

Association of Trade Union Political and Public Sector Staff has been removed from the list of trade unions held by the Certification Officer with effect from 28 June 2021 because it has ceased to exist from 31 December 2018

UK Cinema Association Ltd was removed from the List of Employers’ Associations with effect from 28 June 2021 because it ceased to meet the definition of an employers’ association under the TULRC 1992 Act.

7 June 2021

Association of Local Council Clerks has been removed from the schedule of trade unions and has been entered on the Official list of trade unions held by the Certification Officer with effect from 7 June 2021.

15 March 2021

PPU has been removed from the list of trade unions maintained by the Certification Officer because it dissolved on 2 February 2021.

9 March 2021

Autonomous Workers’ Union (AW Union) has been entered on the list of trade unions held by the Certification Officer with effect from 9 March 2021.

5 March 2021

Trade Union for Ethnic Minority Social Workers (TUEMSW) has been entered on the list of trade unions held by the Certification Officer with effect from 5 March 2021.

06 November 2020

British Lace Federation was removed from the List of Employers’ Associations with effect from 05 November 2020 as it ceased to be an Employers’ Association

13 July 2020

App Drivers and Couriers Union has been entered on the list of trade unions held by the Certification Officer with effect from 13 July 2020.

29 June 2020

Criminal Justice Workers Union (CJWU) has been entered on the list of trade unions held by the Certification Officer with effect from 29 June 2020.

27 March 2020

Change of Name: National Hairdressers’ Federation Limited to National Hair and Beauty Federation Limited

The Certification Officer has approved an application from National Hairdressers’ Federation Limited to change its name to National Hair and Beauty Federation Limited with effect from 27 March 2020.

18 March 2020

Union Workers’ Union has been entered on the list of trade unions held by the Certification Officer with effect from 18 March 2020.

20 February 2020

The City Screen Staff Forum has been removed from the list of trade unions held by the Certification Officer with effect from 20 February 2020 because it has ceased to exist.

22 January 2020

Leicestershire Overmen Deputies and Shotfirers Association has been removed from the list of trade unions held by the Certification Officer with effect from 08 January 2020 because it has ceased to exist.

11 November 2019

CU Staff Consultative Group has been removed from the list of trade unions held by the Certification Officer with effect from 11 November 2019 because it has ceased to exist.

25 October 2019

Scottish Building Federation has been removed from the schedule of employers’ associations held by the Certification Officer because it ceased to meet the definition of an employers’ association under the TULRC 1992 Act.

22 October 2019

WALGAS TU has been entered on the list of trade unions held by the Certification Officer with effect from 21 October 2019.

22 October 2019

Radio, Electrical and Television Retailers’ Association (RETRA) Limited has been removed from the schedule of employers’ associations held by the Certification Officer because it ceased to meet the definition of an employers’ association under the TULRC 1992 Act.

10 October 2019

Mastic Asphalt Council has been removed from the list of employers’ associations held by the Certification Officer because it ceased to meet the definition of an employers’ association under the TULRC 1992 Act.

20 September 2019

British Allied Trade Federation has been removed from the schedule of employers’ associations held by the Certification Officer with effect from 20 September 2019 because it ceased to meet the definition of an employers’ association under the TULRC 1992 Act.

31 August 2019

R&C Trade Unionhas been removed from the list of trade unions held by the Certification Officer with effect from 31 August 2019 because it has ceased to exist.

07 June 2019

CWOATA Trade Union has been entered on the list of trade unions held by the Certification Officer with effect from 07 June 2019.

01 April 2019

Perth and District Master Plumbers Association has been removed from the schedule of employers’ associations held by the Certification Officer because it dissolved on 31 December 2018.

15 January 2019

Lanarkshire Master Plumbers’ Association has been removed from the schedule of employers’ associations held by the Certification Officer because it dissolved on 31 December 2017.

31 October 2018

Psychotherapy and Counselling Union has been entered on the list of trade unions held by the Certification Officer with effect from 31 October 2018.

2 October 2018

Poole Greyhound Trainers Union has been entered on the list of trade unions held by the Certification Officer with effect from 2 October 2018.

14 August 2018

Change of Name: The Society of Chiropodists and Podiatrists to The College of Podiatry

The Certification Officer has approved an application from The Society of Chiropodists and Podiatrists to change its name to The College of Podiatry with effect from 13 August 2018.

9 August 2018

ASPSU has been removed from the list of trade unions maintained by the Certification Officer because it ceased to be a trade union on 31 July 2017.

5 July 2018

National Union of Mineworkers (North East Area) and National Union of Mineworkers (Scotland Area) have been removed from the schedule of trade unions on the grounds that neither of them meet the statutory definition of a trade union.

2 July 2018

Britannia Staff Union has been removed from the list of trade unions maintained by the Certification Officer because it ceased to exist on 1 July 2018.

7 June 2018

Scottish Colliery Enginemen Boilermen and Tradesmens Association has been removed from the schedule of trade unions as it ceased to be a trade union on 1 March 2018.

9 May 2018

Change of Name: Retained Firefighters Union to Fire and Rescue Services Association.

The Certification Officer has approved an application from Retained Firefighters Union to change its name to Fire and Rescue Services Association with effect from 9 May 2018.

7 February 2018

Change of Name: Leeds Building Society Staff Association to Leeds Building Society Colleague Association.

The Certification Officer has approved an application from Leeds Building Society Staff Association to change its name to Leeds Building Society Colleague Association with effect from 7 February 2018.

5 February 2018

Association of Somerset Inseminators has been removed from the list of trade unions maintained by the Certification Officer because it ceased to exist on 1 September 2017.

9 January 2018

National Union of Mineworkers (Northumberland Area) has been removed from the list of trade unions maintained by the Certification Officer because it ceased to exist on 30 November 2017.

3 November 2017

Confederation of British Surgery has been entered on the list of trade unions held by the Certification Officer with effect from 3 November 2017.

21 September 2017

CU Staff Consultative Group has been entered on the list of trade unions held by the Certification Officer with effect from 21 September 2017.

4 September 2017

Welsh Local Government Association was added to the list on 12 June 2017.

1 September 2017

As a result of an amalgamation between the two unions, Association of Teachers and Lecturers and National Union of Teachers have been removed from the list of trade unions maintained by the Certification Officer. The new, amalgamated, union, National Education Union, has been added to the list.

21 August 2017

Change of Name: Graphic Enterprise Scotland to Print Scotland

The Certification Officer has approved an application from “Graphic Enterprise Scotland” to change its name to “Print Scotland” with effect from 21 August 2017.

21 August 2017

Ellington Branch of the North East Area of the National Union of Mineworkers has been removed from the list of trade unions maintained by the Certification Officer because it ceased to exist on 21 August 2017

2 August 2017

Change of Name: National Association of Stable Staff to National Association of Racing Staff

An application to change the name of National Association of Stable Staff to National Association of Racing Staff was approved on 2 August 2017.

22 May 2017

National Union of Mineworkers (Scottish Area) has been removed from the schedule of trade unions as it ceased to be a trade union on 22 May 2017

24 April 2017

Fencing Contractors Association has been removed from the schedule of employers’ associations maintained by the Certification Officer because it dissolved on 31 December 2016

20 March 2017

Lancaster Morecambe and South Lakeland Master Plumbers Association was removed from the List of Employers’ Associations with effect from 17 March 2017 as it ceased to be an Employers’ Association

15 September 2016

Pursuant to section 4 of the Trade Union and Labour (Relations) Consolidation Act 1992 (“the 1992 Act”), the Certification Officer removed the National Association of Colliery Overmen, Deputies and Shotfirers from the list of trade unions on the grounds that it is no longer a trade union within the meaning of the 1992 Act (Listings Decision: National Association of Colliery Officials Deputies and Shotfirers (CO/L/2/16-17)).

24 August 2016

Society of Local Council Clerks has been removed from the schedule of trade unions as it ceased to be a trade union on 17 August 2016.

18 August 2016

The Certification Officer has approved an application from “Cinema Exhibitors Association Ltd” to change its name to “UK Cinema Association Ltd” with effect from 18 August 2016.

18 August 2016

Shield Guarding Staff Association has been removed from the list of trade unions maintained by the Certification Officer because it dissolved on 21 May 2016.

17 August 2016

Association of Local Council Clerks has been entered on the schedule of trade unions held by the Certification Officer with effect from 16 August 2016.

24 June 2016

National Union of Mineworkers (Leicester Area) removed from the list of trade unions maintained by the Certification Officer following a decision by the Certification Officer that it was no longer a trade union within the meaning of the Trade Union and Labour Relations (Consolidation) Act 1992 (Listings Decision: National Union of Mineworkers (Leicester Area) (CO/L/16-17)).

11 May 2016

Whatman International Staff Association has been removed from the list of trade unions maintained by the Certification Officer because it dissolved on 9 October 2015.

30 March 2016

Cleaners and Allied Independent Workers Union (CAIWU) has been entered on the list of trade unions held by the Certification Officer with effect from 16 March 2016.

16 March 2016

The Association of Professional Ambulance Personnel has been removed from the list of trade unions maintained by the Certification Officer because it dissolved on 31 December 2015.

18 November 2015

The Union of Country Sports Workers has been removed from the list of trade unions maintained by the Certification Officer because it dissolved on 30 June 2015.

1 October 2015

The Bus Workers Alliance has been removed from the list of trade unions maintained by the Certification Officer because it dissolved on 29 May 2015.

3 September 2015

The Certification Officer refused the application by Equal Justice to be entered in the list of trade unions (Listings decision: Equal Justice).

11 August 2015

The Federation of Professional Railway Staff has been removed from the list of trade unions maintained by the Certification Officer because it dissolved on 30 June 2015.

11 August 2015

The Pop-Up Union has been removed from the list of trade unions maintained by the Certification Officer. The Certification Office last had contact with the Pop-Up Union in May 2013, when it was entered on the list of trade unions. Since then all attempts at contacting the organisation have been unsuccessful. It appears that the Pop-Up Union had ceased to exist by the end of 2013. In the circumstances it never came under a duty to supply this office with an annual return.

30 July 2015

British Ceramic Confederation has been removed from the schedule of employers’ associations held by the Certification Officer with effect from 30 July 2015 because it is no longer an employers’ association.

25 June 2015

The Certification Officer has approved an application from “Local Government Yorkshire and Humber” to change its name to “Yorkshire and Humber (Local Authorities) Employers’ Association” with effect from 25 June 2015.

22 May 2015

National Association of Colliery Overmen, Deputies and Shotfirers (South Wales Area) has been removed from the schedule of trade unions maintained by the Certification Officer because it dissolved on 22 May 2015.

6 May 2015

The Certification Officer has approved an application from “Whatman Staff Association” to change its name to “Whatman International Staff Association” with effect from 6 May 2015.

16 April 2015

European SOS Trade Union has been entered on the list of trade unions held by the Certification Officer with effect from 13 April 2015.

26 February 2015

Newspaper Society has been removed from the list of employers’ associations maintained by the Certification Officer because it ceased to exist on 16 June 2014.

9 February 2015

Equality For Workers Union (EFWU) has been entered on the list of trade unions held by the Certification Officer with effect from 09 February 2015.

20 January 2015

R&C Trade Union has been entered on the list of trade unions held by the Certification Officer with effect from 20 January 2015.

19 November 2014

Driver and General Union has been entered on the list of trade unions held by the Certification Officer with effect from 18 November 2014.

3 November 2014

Artists’ Union England has been entered on the list of trade unions held by the Certification Officer with effect from 3 November 2014.

29 October 2014

Driver and General Union has been entered on the schedule of trade unions held by the Certification Officer with effect from 29 October 2014.

22 October 2014

Aberdeen Fish Curers & Merchants Association Ltd has been removed from the schedule of employers’ associations maintained by the Certification Officer because it dissolved on 19 September 2014.

13 August 2014

Artists’ Union England has been entered in the schedule of trade unions held by the Certification Officer with effect from 1 August 2014.

29 July 2014

PTSC has been entered on the list of trade unions held by the Certification Officer with effect from 29 July 2014.

22 July 2014

London Fish Merchant Association (Billingsgate) Limited has been removed from the schedule of employers’ associations held by the Certification Officer with effect from 22 July 2014 because it is no longer an employers’ association.

4 July 2014

Covent Garden Tenants Association Ltd has been removed from the schedule of employers’ associations held by the Certification Officer with effect from 2 July 2014 because it is no longer an employers’ association