The Medicines and Healthcare products Regulatory Agency (MHRA) has received five written inquiries and three telephone inquiries, one of which related directly to one of the written inquiries, concerning sublingual immunotherapy (SLIT) products used for desensitisation to allergies.
These products are unlicensed medicinal products and importation from elsewhere in the European Economic Area requires prior notification to the MHRA by a licensed importer. Notifications are assessed for regulatory compliance and for known issues with safety and quality and the MHRA may object to importation. In 2005 the Committee on Safety of Medicines (CSM, now the Commission on Human Medicines, (CHM) advised the MHRA that they should not object to the importation of unlicensed pollen based SLIT products, provided they were for use in non-asthmatic adults under the supervision of NHS specialists with access to resuscitation equipment. On this basis, the MHRA will object to importation of all non-pollen based SLIT products.
The MHRA has recently become aware that certain unlicensed SLIT products have been imported into the United Kingdom without prior notification to the Agency. The importer has been instructed to cease importation and distribution.
The MHRA is encouraging importers to make appropriate notifications. Some have been received and assessed in line with the CSM advice, with non-objections to import issued for pollen based SLIT products. Non-pollen based SLIT products continue to attract objections to import.