Medicine and Healthcare Regulatory

Medicines and Healthcare Regulatory Agency (MHRA) Tel 00 44 20 7084 2000 www.mhra.gov.uk/home/groups/pla/documents/ websiteresources/con007552.pdf www.mhra.gov.uk/home/groups/comms-ic/documents/ publication/con007555.pdf... 

Committee on Safety of Medicines/Medicines and Healthcare Regulatory Authority. Kava-kava and hepatotoxicity. Current Problems (2003) 29,8. 

Drug analysis prints (Amoxicillin, claridiromycin, lansoprazole and metronidaa)le). Medicines and Healthcare Regulatory Agency, UK. Available at http //www.mhra.gov.uk/hcme/ idcplg IdcService=SS GET PAGE nodeId=742 (accessed 24/08/07). 

This section is designed to provide a short overview of the origins of current regulation in the UK. If a more detailed appreciation of the Medical Devices Directive and associated UK regulation is reqnired, the Medicines and Healthcare Regulatory Agency website (MHRA 2009) should be visited. 

MHRA (2006) EC medical devices directives guidance notes for manufacturers of class 1 medical devices. Medicines and Healthcare Regulatory Agency MHRA (2009) http //www.mhra.gov.uk/index.htm. Accessed 16 September 2009 MOD (1997) Defence Standard 00-55 Issue 2 Requirements for S ety Related Software in Defence Equipment. Ministry of Defence... 

Dayan AD Rifaximin (Normix ) Preclinical Expert Report. London, submitted to Medicines and Healthcare Products Regulatory Agency, 1997. 

Source Medicines and Healthcare Products Regulatory Agency. Clinical Final Report on rGM4i2.http //www.mhra.gov.uk/home/idcplg IdcService=SS GET PAGE useSecondary= true ssDocName=CON2023822 ssTargetNodeId=389 [accessed September 18,2007]. 

United Kingdom Medicines and Healthcare Products Regulatory Agency... 

In the United Kingdom, clinical trial applications are submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA). There are several schemes for clinical trial application the major two are the Clinical Trial Certificate (CTC) and Clinical Trial Exemption (CTX) schemes. 

The minimum standards for the facilities in which clinical pharmacology studies should be conducted are described in ABPl guidelines. Clearly, the same standards should apply to all organisations involved in conducting studies. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) has instituted inspection of facilities and procedures, and a system of certification is in place. 

The Leaflet MAE 30, issued by the Medicines and Healthcare Products Regulatory Agency to give guidance on the provisions of the legislation affecting doctors and dentists, states that ... 

In Guidance Note 14, the Medicines and Healthcare Products Regulatory Agency states that hospital trusts, health authorities and independent hospitals should have clear policies on the use of unlicensed medicines, explaining liability considerations and requiring all those involved in the supply chain to ensure that the unlicensed status of a product is commimicated and fully understood. 

In this, the fifth edition of this textbook, the title of the present chapter has been changed to The Safety of Medical Products in order to include devices which are now included in the remit of the Medicines and Healthcare Products Regulatory Agency (MHRA). It has also been decided to revise the chapter so as to reflect more closely the current needs of the pharmaceutical physician whose experience may have been entirely in the field of clinical medicine. 

The Medicines and Healthcare products Regulatory Agency (MHRA)... 

On the 12 September 2002, the Health Minister, Lord Philip Hunt announced that the MCA and the Medical Devices Agency (MDA) would merge with effect from 1 April 2003. The merged agency would be known as the Medicines and Healthcare products Regulatory Agency (MHRA). 

The applications for national authorisations are submitted to the national competent authority which, in the United Kingdom, is the Licensing Authority (LA), whose functions are discharged by the Medicines and Healthcare products Regulatory Agency (MHRA, previously Medicines Control Agency, MCA) of the Department of Health. The LA/MHRA are advised by the CSM, a multidisciplinary scientific body consisting of clinical, preclinical and pharmaceutical members well known for their expertise in their respective fields. Lay members are also included. 

Each Member State has designated a competent authority, which is the governmental authority responsible for implementing the Directive in that Member State. In the case of the United Kingdom, the competent authority is the Medicines and Healthcare Products Regulatory Agency (MHRA). The principal function of a competent authority in practice is to ensure the safety and health of patients and users of MDs. 

Promotional material must not include any reference to the Medicines Commission, the Committee on Safety of Medicines, the Medicines and Healthcare products Regulatory Agency, the Medicines Control Agency or the licensing authority, unless this is specifically required by the licensing authority. 

Companies shall preserve certificates and the relevant accompanying information for not less than three years after the final use of the promotional material or the date of the meeting and produce them on request from the Medicines and Healthcare products Regulatory Agency or the Prescription Medicines Code of Practice Authority. 

Companies should note that the Medicines and Healthcare products Regulatory Agency is entitled to request particulars of an advertisement, including particulars as to the content and form of the advertisement, the method of dissemination and the date of first dissemination, and such a request is not subject to any time limit. This does not apply to the certificates themselves in respect of which the three year limit in Clause 14.5 is applicable. 

Companies must prepare detailed briefing material for medical representatives on the technical aspects of each medicine which they will promote. A copy of such material must be made available to the Medicines and Healthcare products Regulatory Agency and the Prescription Medicines Code of Practice Authority on request. Briefing material must comply with the relevant requirements of the Code and, in particular, is subject to the certification requirements of Clause 14. 

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