AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |
Back to Blog
Compendium of veterinary products1/9/2024 Unless the product/remedy has been recalled, those that were released by the Qualified Person on or before the date of suspension may continue to be supplied. Suspended products - Details about authorisations / registrations that have been temporarily suspended.Products and remedies that were released by the Qualified Person on or before the date of expiry may continue to be supplied. Expired products - Details of products and homeopathic remedies that are no longer subject of a valid authorisation / registration.To find out if a product is marketed please contact the MA holder. An authorised product may not necessarily be marketed. Currently authorised products - Details of products subject of a valid marketing authorisation (MA). ![]() If you are concerned about any differences seen, please contact the Authorisation / Registration holder or VMD for clarification by email you will see under the table headings: ![]() However, it may take up to 12 months for these changes to appear on marketed packaging. Once approved by the VMD, the updated Summary of Product Characteristics (SPCs) that supplies the label text will be available here almost immediately. In addition to the detail listed above, the information provided for each medicine includes the strength and the dosage form. To view a short tutorial on how to conduct an advanced search, click here.This website contains current information about veterinary medicines authorised in Great Britain and Northern Ireland. The advanced search function of the HPRA’s database of veterinary medicinal products that are authorised nationally allows users to search for medicines information using one or more of the following fields: The SPC is intended to be used by healthcare professionals, while the packaging information and package leaflet are intended for the product user. The SPC details the pertinent information regarding the safety, use, storage and disposal of the product. where the marketing authorisation supports the authorisation of the same medicine in a third country which requires that the medicine be authorised in an EU Member State).Ī Union Product Database of veterinary medicines that have been authorised in the European Union (including both centrally-authorised veterinary medicines as well as veterinary medicines authorised nationally in any EU Member State) is accessible here.Ī Summary of Product Characteristics document (known as an SPC) is provided for each medicine. Veterinary medicines that are not commercialised within 3 years must have their marketing authorisations withdrawn however, save for exceptional circumstances (e.g. Some products that have been newly authorised might not yet be manufactured with the mandatory nationally approved label, or might be temporarily out of stock. May also legally be supplied and used in accordance with national legislation.Įven if a veterinary medicine has been granted a marketing authorisation by the HPRA, this does not necessarily mean that the product concerned is available on the Irish market. That do not fall within the scope of the legislation on veterinary medicines (e.g.That are authorised by the Department of Agriculture, Food & the Marine under exceptional provisions of the national legislation,.That are authorised by the European Commission under the central-authorisation procedure,.You can use the search option on the HPRA’s veterinary medicines webpage to find information about veterinary medicines authorised by the HPRA. These changes are flagged in a monthly list of changes to the database, available here. ![]() addition of newly approved indications for use, changes to withdrawal periods, change of product name etc.) are implemented as soon as the changes are approved by the HPRA. Significant changes to existing marketing authorisations (e.g. Such medicines are no longer allowed to be marketed in Ireland (but existing products which have already been supplied may continue to be used once they are within the designated expiry date). Marketing authorisations for veterinary medicines that are withdrawn by the marketing authorisation holders are immediately removed from the HPRA’s database. The inventory of newly authorised veterinary medicinal products is updated on a weekly basis, as new medicines gain approval nationally. The HPRA’s database of veterinary medicinal products is a comprehensive and up-to-date listing of all veterinary medicines that have been assessed by the HPRA and granted a marketing authorisation so that they can be marketed in Ireland.
0 Comments
Read More
Leave a Reply. |