confirmation that no other aspect of the dossier has changed.When submitting a change of legal entity variation, you must provide: Include a clear, concise description of the variation under ‘scope of change’ in the application form. A change in legal entity will result in a change to the ‘company number’, which forms part of a product’s Vm number. To change the name and / or address of an existing MAH you will need to submit a national VRNA (Variation Not Requiring Assessment), (category A.1a).Ĭhanging the legal entity of the MAH is a VRA (Variation Requiring Assessment – Reduced, (category U.I.z.a) dealt with on national basis. Once your MA is authorised, you may wish to change the details of an MAH, such as your name and address, or transfer the MA from one company to another (change to legal entity). The authorisation number will be preceded with a Vm for veterinary medicines or Vh for registered veterinary homoeopathic remedies and will appear on the product’s labels.Ĭompany numbers are issued by the Medicines and Healthcare products Regulatory Agency ( MHRA), who keep and maintain the register of company numbers for MAHs of human and veterinary medicines. For partnerships and other bodies you must have a registered office in GB, NI or the EUĪn MAH will be given a unique 5-digit company number, which forms the first part of a product’s authorisation number. We will accept a letter on headed paper showing the address and registered charity number (or EU equivalent) as proof of establishment. The company personnel, such as Director or Secretary, don’t have to be based at the registered office and can live anywhereĪs a charity you must provide proof that you are registered as such with an address in GB, NI or the EU. When applying to be an MAH for the first time, as part of your MA application you must provide: PersonĪs a person wishing to be an MAH you must be a resident in GB, NI or the EU and provide proof of residencyĪs a Limited Company you must be registered with Companies’ House (or EU equivalent) and must have a physical address. MAH locationįor Centralised MAs, the MAH must be located in the EU for these products to be on the NI market.įor mutually recognised MAs, (in NI) or national MAs (in GB or NI), the MAH can be located in GB, NI or the EU to be on the market in GB and NI. The designation of a representative, such as a named distributor or local representative, does not relieve the MAH of their legal responsibility. The holder of the MA is responsible for the marketing of the product. The MAH can be a natural person, limited company, or other body such as a partnership or charity. The applicant will need to demonstrate that it can meet the obligations of a Marketing Authorisation Holder ( MAH) during the application process and before an MA is granted. Marketing Authorisation HoldersĪ veterinary medicine may not be placed on the UK market unless it is subject of a Marketing Authorisation ( MA) valid in the UK. The term Marketing Authorisation Holder includes holders of Veterinary Homeopathic Registrations ( VHR) and veterinary medicines include veterinary homeopathic remedies.
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