About the Compendium
The NOAH Data Sheet Compendium is supplied as a voluntary service to prescribers by NOAH. There is no legal requirement to issue data sheets under the VMR (Veterinary Medicine Regulations) as the SPC (Summary of Product Characteristics) is now the full legally approved document for all authorised veterinary medicines under the VMR.
Full SPCs for all authorised veterinary medicines are made available by the VMD on their website.
The traditional Data Sheet is an abbreviated form of the SPC and contains all the essential information for the prescriber which is consistent with the SPC and are of course also available in this online version of the compendium in an easily searchable database. This compendium contains a mixture of SPCs and data sheets.
Data sheets are prepared by the individual companies concerned and as a result vary somewhat in style but they are to a consistent format in their principal headings.
Further information
Many data sheets include additional material under the heading 'Further information'. Manufacturers are always willing to provide additional information on their products upon request. Enquiries should be directed to the companies concerned.
An increasing number of authorised medicine packs now carry a Global Trade Item Number contained within a 2 dimensional data matrix bar code.
Description: GTIN
This enable users, with a special 2D Data Matrix bar code scanner, to identify the contents, expiry date and batch number of medicines. The relevant GTIN, where issued, is now included in the data sheet entry in this compendium under a separate heading called GTIN as a 13 or 14 digit number. This may be of assistance in stock control of medicines in practice management systems. For further details contact the NOAH office or your practice management system supplier.
Vm Symbol for Veterinary Medicines
Most marketing authorisation numbers in this compendium bear the designated Vm.
Products labelled with the Vm prefix indicate to users that their safety, quality and efficacy have been fully tested for use in the UK in the species in which use is recommended.
There will be products in the marketplace that were authorised through the European Medicines Agency, when the UK was a Member State of the European Union. These products will show marketing authorisation numbers prefixed EU. These have also been fully approved for safety, quality and efficacy, this time on an EU-wide basis and they remain authorised and available for us in the UK, following the UK's exit from the EU.
Products marketed under the Small Animal Exemption Scheme do not have a Marketing Authorisation number. A wholesaler dealer's authorisation number may be stated.
Geographical scope of Marketing Authorisations post EU exit
After the UK's exit from the European Union, the Northern Ireland Protocol requires veterinary medicines in Northern Ireland to be compliant with the requirements of the European veterinary medicines regulatory system. In practice this means that there could be a different range of authorised VMP's available for vets to consider when prescribing depending on whether a vet is in Northern Ireland or in Great Britain.
There are now 3 different types of Marketing Authorisations (MA) for veterinary medicines in the UK. This is important to note as the options that vets must consider under the prescribing cascade depending on whether they are working in Great Britain (GB) or Northern Ireland (NI). The 3 types of authorisations are as follows:
(1) UK MA
A product with a UK MA has been approved for marketing in England, Wales, Scotland and Northern Ireland.
(2) GB MA - national
A product with a GB MA has been approved for marketing in England, Wales and Scotland. These authorisations have been assessed and issued by the VMD against the requirements set out within the UK Veterinary Medicines Regulation 2013, as amended.
(3) NI MA - national
A product with an NI MA has been approved for marketing in Northern Ireland. These authorisations have been assessed against the requirements set out within the EU Regulations.
NB: Information about the geographical scope of products authorisations and whether they are authorised UK wide, GB wide or NI only, will be included in the product.
Trade marks
The ™ symbol by the name of a product indicates that the name is a trade mark: however, the absence of the symbol should not be considered confirmation that the name is not a trade mark. The company symbols which appear in certain participants' sections are also trade marks.
Withdrawal periods
It is the responsibility of the dispensing veterinarian to refer to the packaging and the online compendium and to also be aware of any announcements of withdrawal period changes for products.