Notice

MAVIS edition 101

Published 27 January 2017

News

VMD re-certified to ISO 9001 and ISO 27001 Standards

We have been re-certified to the above international standards for quality management (ISO 9001) and information security management (ISO 27001) following external audits in September.

Professor Pete Borriello, the VMD’s Chief Executive, said:

Our re-certification against these exacting standards reflects the excellent systems and processes we have in place, the quality of our staff and our commitment to improve the efficiency and effectiveness of the services we provide to our customers.

In certifying the VMD against ISO 9001 and ISO 27001 the auditor found no non-conformities. We have not had a non-conformity raised against ISO 9001 since we were first certified against it in 2013 and have only had one minor non-conformity against ISO 27001 since we were first certified in 2005.

ISO 9001 and ISO 27001 are well-respected, international standards for business management which are used by health regulatory agencies across the world.

The certification assessment was carried out by SGS auditors and their assessment report was validated by UKAS – the accrediting body for all ISO certifying organisations. Certification lasts 3 years.

For further information contact Matthew Isted m.isted@vmd.defra.gsi.gov.uk

New version of the product literature standard is now on GOV.UK

Following a consultation period the Product Literature Standard has been updated.

A summary of the changes are:

  • a revised layout
  • formatting changes to make it easier to read
  • clearer guidance
  • general mock up procedure guidance moved to the general guidance detail

There are no changes to the regulatory requirements for producing mock ups for approval.

Licensing

Changes to publishing licensing information in MAVIS

Thank you to everyone who provided feedback on the proposed changes to the way we publish licensing information in MAVIS.

The following changes have now been agreed:

Marketing Authorisations

We will no longer publish information about varied Marketing Authorisations (MAs). Details of clinically significant variations will continue to be published in the Veterinary Record.

Information on newly authorised and expired MAs is available in the Product Information Database (PID). You can:

  • go to the homepage where you can select the Recently authorised MAs tab for a list of all MAs authorised in the previous 6 months

  • go to the Expired tab to see a list of all expired MAs

Quarterly reporting against VMD Published Standards for 2016-2017 licensing work

This report will now be published on a monthly basis under Our Statistics which can be found from the VMD home page.

For further information contact Natalie Shilling n.shilling@vmd.defra.gsi.gov.uk and put ‘Changes to MAVIS’ in the subject line.

Top Ten Imported Veterinary Medicines Quarterly Report from 1 July to 30 September 2016

The VMD provides a list on a quarterly basis of the ten products for which most Special Import and Special Treatment Certificates (SIC and STC) have been issued. This list contains details of the product, the active ingredient and the number of certificates. Where appropriate it will also indicate those imported products where a UK product is now authorised and available; no further imports of these products will be permitted.

We hope the pharmaceutical industry find this list helpful in considering where there might be a need for a UK authorised product.

Product Active Ingredient No. of Certificates Issued
Artuvetrin® Therapy, suspension for subcutaneous injection in dogs Allergens 2,715
Filavac VHD K C+V Rabbit Haemorrhagic Disease (Inactivated) 541
Vet-Goid Allergens 261
Spectrum Hyposensitisation Vaccine - Injectable Solution Allergen 245
Pneumabort-K +1b Equine Rhinopneumonitis Virus 156
Greer Allergenic Extract Patient Prescription Allergens 151
Gentaject 10% Solution for Injection Gentamicin sulphate 128
Artuvetrin® Test, injection fluid for intracutaneous use in dogs Allergens 125
ACTT Allergy Drops Allergens 81
Oncept (Canine Melanoma Vaccine) Canine Melanoma DNA 75

For further information contact Renee Sheehan r.sheehan@vmd.defra.gsi.gov.uk

Inspections and investigations

Overview of inspections and investigations

To ensure that veterinary medicines are appropriately manufactured and supplied we authorise and inspect manufacturers, wholesale dealers and retailers. We also approve and inspect manufacturers and distributors of animal feed containing veterinary medicines and/or coccidiostats; and conduct pharmacovigilance inspections of marketing authorisation holders. Our inspections are risk-based, which reflect the inherent risk (complexity) of an activity and a business’s compliance with the Veterinary Medicines Regulations (VMR). Breaches of the VMR are investigated in accordance with our published Enforcement Strategy.

Good Manufacturing Practice Inspection Team (GMPIT)

The GMPIT is headed by Dr Jason Todd and currently comprises two inspectors. The team will be back to full strength by the end of March 2017 with the appointment of a third inspector.

The team authorises and inspects sites on which the following products are manufactured:

  • authorised veterinary medicines-only [footnote 1]
  • products marketed under the exemption for small pet animals
  • extemporaneous products (also known as ‘Specials’)
  • equine stem cell products
  • non-food animal blood products
  • autogenous vaccines

The GMPIT also inspects veterinary-only [footnote 1] wholesale dealers to assess compliance against good distribution practice (GDP).

Manufacturing sites must comply with Good Manufacturing Practice (GMP) standards. Eudralex Volume 4 provides guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use.

Guidance is available on obtaining a UK manufacturing authorisation (ManA) for an authorised veterinary medicine or an authorisation for an extemporaneous product (special) (ManSA).

Guidance is also available on obtaining a manufacturing authorisation for an equine stem cell centre (ESCCA), a non-food animal blood bank (NFABBA) or an autogenous vaccine (AVA).

The Inspections and Investigations Team (IIT)

The IIT comprises eight regionally-based inspectors, headed by Christine Paine. The IIT authorises/approves and inspects the following premises to assess compliance against the requirements of the VMR:

They also conduct investigations of alleged breaches of the VMR.

The Pharmacovigilance Team

The Pharmacovigilance team, headed by Dr Gillian Diesel, has one inspector who conducts pharmacovigilance inspections of marketing authorisation holders to assess compliance against Eudralex Volume 9B guidelines.

For further information contact inspections@vmd.defra.gsi.gov.uk or phv.inspections@vmd.defra.gsi.gov.uk

Pharmacovigilance Reports

Quarterly Report

During the period 1 October to 30 November 2016, the VMD received 1,232 animal suspected adverse event reports. Of the 1,674 products involved in these reports, 1,592 were authorised veterinary medicines, which belong to the following distribution categories:

Amount Legal Category
1,452 Prescription Only Medicine Veterinarian (POM V)
92 Prescription Only Medicine Veterinarian, Pharmacist, SQP (POM VPS)
29 Non Food Animal Veterinarian, Pharmacist, SQP (NFA VPS)
19 Authorised Veterinary Medicine General Sales List (AVM GSL)

The remaining 82 products were:

Amount Type
25 authorised human medicines
16 authorised medicines imported from other countries
5 medicines sold under the exemption for small pet animals
3 specially formulated veterinary medicines
3 veterinary products without any medicinal claim
2 biocides
1 medicine used in a trial under an Animal Test Certificate
27 incompletely identified products

During this period 28 reports of human suspected adverse reactions were received. Of the 34[footnote 2] products included in the human reports, 31 belong to the POM-V distribution category and 3 to POM-VPS. No environmental incident reports were received during this period.

For further information contact Roy Savory r.savory@vmd.defra.gsi.gov.uk

Enforcement

A list of prosecutions and notices involving illegal activity with veterinary medicines in the last year can be found on GOV.UK.

You can report information about suspected illegal medicines or breaches of the Veterinary Medicines Regulations to enforcement@vmd.defra.gsi.gov.uk. Details of how to report and how we will deal with the reports can be found in the guidance Report illegal animal medicines.

If you have concerns about a non medicinal product (product making unauthorised claims etc.) you can submit them using the Unauthorised Product Complaint Reporting Form.

All information will be treated confidentially.

Antimicrobial Resistance

World Antibiotic Awareness Week (WAAW) and European Antibiotic Awareness Day (EAAD) Activities

European Antibiotic Awareness Day is an annual European public health initiative developed by the European Centre for Disease Prevention and Control (ECDC) that occurs on 18 November, with the aim to raise awareness about the threat to public health of antibiotic resistance and prudent antibiotic use.

2016 also marked the second World Antibiotic Awareness Week, a World Health Organisation (WHO) led initiative that took place on 14-20 November 2016. The UK’s activities for EAAD and WAAW represented one aspect of our delivery of the UK 5 Year Antimicrobial Resistance Strategy 2013 to 2018, which sets out actions to slow the development and spread of antimicrobial resistance.

In 2016, to support both initiatives, the VMD developed six infographics and one animation focussing on common misconceptions of antibiotic use in farming. These were uploaded on to the Defra Twitter account where they gained excellent government and stakeholder support. The VMD also collaborated with the British Veterinary Association (BVA) to produce a One Health poster for Veterinary Practices and GP surgeries and to launch the annual UK Veterinary Antibiotic Resistance and Sales Surveillance Report (UK-VARSS) 2015 at the London Vet Show on 17 November 2016.

The Chief Veterinary Officer, Nigel Gibbens, led the launch, providing headline figures from the UK-VARSS report during the BVA congress. Lord Gardiner also visited the London Vet Show to highlight the report, attracting coverage on social media from Defra, BVA and APHA.

More information about EAAD and WAAW can be found on their respective websites.

Sales Data Report and Antibiotic Resistance Surveillance Report

The UK Veterinary Antibiotic Resistance and Sales Surveillance Report (UK-VARSS) 2015 was published on 17 November 2016. This report compiles data on 2015 UK antimicrobial sales and antibiotic susceptibility data for veterinary and foodborne pathogens to form a joint UK report.

The full 2015 report, highlights and previous years’ reports can be found on GOV.UK.

For further information contact Stacey Brown s.brown@vmd.defra.gsi.gov.uk

Veterinary Products Committee

Meetings of the VPC

The VPC met in September 2016. Summary minutes of the meetings held from October 2014 are available on GOV.UK.

Minutes of meetings held between 2009 and May 2014 are available on the National Archives.

For further information contact Lea Stott l.stott@vmd.defra.gsi.gov.uk

Residues Controls and Monitoring

Results of Statutory Surveillance

Sampling commenced in January 2016 and full details of UK results, together with information on any action taken, can be found on GOV.UK.

For further information contact Sandra Russell s.russell@vmd.defra.gsi.gov.uk

Staff Changes

The following staff changes took place during this quarter:

New Staff

  • Julia Pearce joined the Inspections and Investigations team
  • Raffaella Focosi-Snyman and Lee Smith joined the Pharmacovigilance team

Departing Staff

  • Nicky Connors and Katherine Grace transferred to the Animal and Plant Health Agency (APHA)
  • Steve Eldridge transferred to Core Defra
  • John Hall retired

Movements within the VMD

  • Nina Dorian and Bijal Mistry were promoted and moved to the Legislation team
  • Caroline Millward was temporarily promoted and moved to the IT team
  • Anna Tout was promoted and moved to the Pharmacovigilance team
  • Abi Seager has become the EU Exit Co-ordinator
  • Gavin Hall was temporarily promoted to the Head of General Assessment and Licensing Administration team
  • Ines Morreale was promoted within the Licensing Administration team
  • Kitty Healey and Stacey Brown were temporarily promoted within the Antimicrobial Resistance Control and Surveillance team
  • Sandra Russell returned to the Residues team
  • Alison Jones returned to the Enforcement team

VMD Organogram

VMD Organogram as at 1 January 2017

VMD Organogram as at 1 January 2017

  1. Those sites that manufacture/wholesale both human and veterinary medicines are authorised and inspected by the Medicines and Healthcare products Regulatory Agency (MHRA) 2

  2. Individual reports may involve more than one product