Skip to main content

Chemicals

Question for Department of Health

UIN HL5128, tabled on 23 February 2015

To ask Her Majesty’s Government further to the Written Answer by the Parliamentary Under-Secretary of State for Business, Innovation and Skills, Mr George Freeman, on 14 January (HC220047), what are the necessary steps that would be required for laboratory reagents to be licensed for use as medicinal products.

Answered on

5 March 2015

A laboratory reagent that does not make medicinal claims is not a medicinal product per se ; however, if a company wishes to apply for a licence to use a laboratory reagent - as a medicinal product as defined in Directive 2001/83 EC they would need to submit an application for a marketing authorisation to the Licensing Authority, supported by the appropriate safety, efficacy and quality data set out in that Directive.

CE marking applies to medical devices. Products meeting the definition of a medicinal product are required to obtain a marketing authorisation before they can be placed on the market. In order to obtain a marketing authorisation, all data related to quality, safety and efficacy of the product, including prior use in the relevant population should be submitted and will be evaluated by the Medicines and Healthcare products Regulatory Agency (MHRA) on behalf of the Licensing Authority. If a product already has a marketing authorisation and is in clinical use in another EU member state, the licence holder is eligible to apply for an authorisation in the United Kingdom through a Mutual Recognition procedure where the data supporting the product’s use and the evaluation report of the Member State that has approved the product will be submitted to the MHRA for a decision on approval of a UK marketing authorisation to be reached within the defined timelines of the procedure.

Medicines legislation contains a provision for the use of an unlicensed medicinal product which is provided for by way of an exemption from the requirement for a marketing authorisation. In the interests of public health this exemption is narrowly drawn because these products, unlike products holding a marketing authorisation, will not have been assessed and approved against the criteria of safety, quality and efficacy. Under their terms of service, general practitioners and hospital doctors are allowed to prescribe any medicinal product, including any unlicensed medicinal product which they consider necessary to meet the clinical needs of their patients and under their clinical responsibility. They should always satisfy themselves that the medicinal products or other substances they consider appropriate for their patients can be safely prescribed, that patients are adequately monitored and that, where necessary, expert hospital supervision is available.