Companies that are involved in the manufacture or supply of medicines in the UK need to have the relevant licence for the activity in question. Medicines regulation now extends to the entire supply chain for medicinal product, and imposes rigorous standards on medicines manufacturers and wholesale dealers who trade in them, as well as brokers who negotiate sales.
The regulation of licensing of medicines in the UK is undertaken by the Medicines and Healthcare Products Regulatory Agency (MHRA). The UK regulatory framework is set out in the Human Medicines Regulations 2012, which implement EU Directives 2001/83/EC and 2003/94/EC. The obligation for brokers to hold licences for their activities was introduced recently under Directive 2011/62/EU and Guidelines of 7 March 2013 (2103/C 68/01). The regulatory system is designed to safeguard public health, by ensuring that medicines are manufactured, stored and distributed in compliance with rigorous EU-wide regulatory standards.
Making, packaging (or 'assembling') and importing human medicines in or to the UK all require a site-specific manufacturer's licence. UK manufacturer's licences are issued by the Licensing Section in the Inspection, Enforcement and Standards Division of the MHRA. Different types of licence are required for the manufacturing of licensed, unlicensed and investigational medicinal products.
Applications for manufacturer licences are available on the gov.uk, and must be accompanied by supporting documentation giving further information about the operations to be carried out. The applicant must also designate at least one Qualified Person (QP), who will have a personal responsibility for ensuring that each batch is properly tested and complies with the requirements of the marketing authorisation. Submission of the application is followed by a site inspection, to verify that the information submitted is accurate and that the applicant complies with EU good manufacturing practice (GMP). Following the inspection, the Licensing Section will issue or refuse the licence, or in some cases it may notify the applicant of its proposals and provide it with a period in which to respond.
Once granted, any changes to the information shown on the licence must be notified and approved by the Licensing Authority through the submission of a variation application. The site will also be subject to regular routine inspections by the Licensing Authority, to confirm that the licence holder is complying with the conditions of their licence, and with the Human Medicines Regulation 2012 and GMP. Under the UK legislation, licence holders are obliged to give access to their premises to the Licensing Authority for inspections at any reasonable time.
Wholesaler licences are required for the sale or supply of medicine to anyone other than the patient using the medicine. Pharmacists are now also required to have a wholesaler licence if they supply medicines to anyone other than directly to the public. However, a holder of a manufacturer's licence may distribute medicine manufactured or assembled pursuant to their licence, without needing to obtain a separate wholesaler licence.
New application forms for wholesaler licences are now only accepted via the MHRA Process Licensing Portal. A site inspection will be carried out by the Licensing Authority after submission of the application, to verify the information and assess compliance with the EU Guidelines on Good Distribution Practice (GDP). The holder of the wholesaler licence is also required to designate a Responsible Person (RP) with responsibility for protecting against potential hazards arising from poor distribution practices. After grant of the licence, regular routine inspections will be carried out by the Licensing Authority.
Brokering is focused purely on negotiation for buying and selling product. The broker acts as an intermediary for another party in the supply chain, and does not pay for, own or physically handle the product. Wholesale dealing and brokering are different activities, and so companies which perform both activities are required to hold two separate licences.
In the UK, brokers are required to register their activities with the MHRA, as the national competent authority. Applicants for new broker registrations must apply via the Heads of Medicines Agencies (HMA) website. The MHRA will assess the application and supporting evidence, and may interview members of the applicant's staff and/or carry out a risk based inspection at the broker's registered premises. Following successful registration, the MHRA will enter the broker's registration on a publically accessible UK register, which will enable the broker to broker across the EEA.
Registered brokers are required to notify the MHRA by submitting a variation if the details of their original registration change. In some cases, the MHRA will carry out an inspection following submission of a variation. In addition, registered brokers must submit an annual compliance report to declare compliance with the requirements of the registration and provide details of the systems in place.