1-9 of 9 results for subject:Laboratories
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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.
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.
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.
To ask Her Majesty’s Government what progress has been made in setting up a laboratory in the United Kingdom able to conduct blood folate status analysis.
To ask Her Majesty’s Government what progress has been made in setting up a laboratory in the United Kingdom able to conduct blood folate status analysis.
The Medical Research Council Human Nutrition Research are in the process of setting up the new method for serum folate in their laboratories in Cambridge, working closely with scientists at the Centre for Disease Control in the United States, who are the leading international experts on this analysis. Work is well advanced and it is hoped that the method will be ready to use to analyse blood samples collected in the National Diet and Nutrition Survey later this year.
Agreed to on question.
Agreed to on question.
May I say what a pleasure it is to serve under your chairmanship for the first time, Mr Robertson?
I have called this debate on the back of two similar debates in June 2010 and September 2013, several questions in the House, the lobbying of Ministers and meetings with officials over...
May I say what a pleasure it is to serve under your chairmanship for the first time, Mr Robertson?
I have called this debate on the back of two similar debates in June 2010 and September 2013, several questions in the House, the lobbying of Ministers and meetings with officials over...
It is a pleasure to serve under your chairmanship, Mr Robertson. I congratulate my hon. Friend the Member for Salisbury (John Glen) on securing this important debate. We are in the strange position of being good friends in the House but having completely different perspectives on this issue. I am...
It is a pleasure to serve under your chairmanship, Mr Robertson. I congratulate my hon. Friend the Member for Salisbury (John Glen) on securing this important debate. We are in the strange position of being good friends in the House but having completely different perspectives on this issue. I am...
It is a pleasure to serve under your chairmanship, Mr Robertson. I congratulate my hon.
Friend the Member for Salisbury (John Glen) on securing this debate. It is not his first on this subject, but he is right to use his opportunities to highlight such important topics. I also thank...
It is a pleasure to serve under your chairmanship, Mr Robertson. I congratulate my hon.
Friend the Member for Salisbury (John Glen) on securing this debate. It is not his first on this subject, but he is right to use his opportunities to highlight such important topics. I also thank...
I congratulate my hon. Friend the Member for Salisbury (John Glen) on securing the debate. We have focused on the business side, which is very important when we introduce a national hub, but I am concerned that my constituents’ views about what will happen to them and their extended families...
I congratulate my hon. Friend the Member for Salisbury (John Glen) on securing the debate. We have focused on the business side, which is very important when we introduce a national hub, but I am concerned that my constituents’ views about what will happen to them and their extended families...
I would be disappointed if that issue had not been considered. There have already been some meetings with staff, but this is an ongoing process. My understanding is that at the point at which any firm decisions are made there will be an extensive consultation process. I have time set...
I would be disappointed if that issue had not been considered. There have already been some meetings with staff, but this is an ongoing process. My understanding is that at the point at which any firm decisions are made there will be an extensive consultation process. I have time set...