The European Medicines Agency (EMEA) has recently published on its website the procedure for classification of a veterinary medicinal product as intended for Minor Use Minor Species (MUMS)/Limited Markets (EMEA/429080/09). An additional guidance document (EMEA/CVMP/370663/09) addresses frequently asked questions.
With this policy EMEA and the CVMP (Committee for Medicinal Products for Veterinary Use) intend to stimulate new applications for veterinary medicinal products for minor species and for rare diseases in major species which may otherwise not be developed. On 20th October an info day on procedural advice for classification and incentives for veterinary medicinal products indicated as MUMS/limited markets will be organized in London. EMEA intends to offer financial and regulatory incentives to potential applicants, which may include free scientific advice, administrative assistance and assistance with fees for centralized submissions. Interested companies can register for the info day including a ‘surgery hours’ session during which they can book individual appointments with EMEA staff.