Medicines (Licensing, Standard Provisions and Fees) Regulations, 2010

These Regulations, made under section 81(1) of the Medicines Order 2007, establish standard provisions applicable to product licences, import licences, wholesale dealer's licences and manufacturer's licences for medicinal products. They regulate licensing requirements concerning the importation, manufacture, assembly, handling, storage and distribution of medicinal products, and prescribe fees for applications, licences, amendments, certificates and related documents. Import licences granted to persons not authorised by the holder of a product licence are issued on a per-consignment basis. The Regulations also provide for the costs of assessments or evaluations of medicinal products undertaken by the Authority in connection with applications for the grant or amendment of product licences.
The standard provisions for product and import licences require licence holders to notify the Authority of specified changes concerning medicinal products, including changes to specifications, composition, manufacturing methods, storage arrangements, indications for use and, where applicable, labelling and package information. Licence holders must report specified adverse effects associated with medicinal products in human beings or animals, maintain records available for inspection, and undertake testing or submit samples when required. The Regulations also provide for the withholding and withdrawal of medicinal products found to be harmful, unsafe or not in conformity with applicable requirements concerning strength, quality or purity.
Wholesale dealers are required to maintain appropriate staff, premises, equipment and facilities for the handling, storage and distribution of medicinal products and to retain records for inspection and product withdrawal or recall. Manufacturers must maintain appropriate premises, equipment, plant and personnel for manufacturing and assembly operations, ensure conformity with applicable standards of identity, strength, quality and purity, and comply with the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practice for Medicinal Products. Manufacturers are also required to conduct or arrange product testing, maintain manufacturing and testing records, and facilitate the withdrawal or recall of defective medicinal products.
The Regulations establish fees for product, import, wholesale dealer's and manufacturer's licences, amendments, inspections and specified certificates and documents. Failure by a licence holder to comply with an applicable standard provision constitutes an offence punishable by a fine, imprisonment, or both.