Medicines and Healthcare Products

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. 

It should be noted that the Medicines and Healthcare products Regulatory Agency s guidance notes on advertising and promotion state that each page of an advertisement for a prescription only medicine should be clearly labelled as intended for health professionals. 

The Code of Practice Appeal Board and its Chairman are appointed by the Board of Management of the ABPI. The appointment of independent members to the Appeal Board is made following consultation with the Medicines and Healthcare products Regulatory Agency. 

In the event of the Medicines and Healthcare products Regulatory Agency making a complaint which relates to the safety or proper use of a medicine, and requesting that an advertisement be withdrawn, the respondent company has five working days to respond with its comments. 

Where a company not in membership of the ABPl fails to comply with the procedures set out in Paragraphs 5, 6, 7 or 10 and indicates that it no longer wishes to accept the jurisdiction of the Authority, the Appeal Board may decide that the company should be removed from the list of non member companies which have agreed to abide by the Code and the Medicines and Healthcare products Regulatory Agency advised that responsibility for that company under the Code can no longer continue to be accepted. 

Copies of the published reports are sent to the Medicines and Healthcare products Regulatory Agency, the Office of Fair Trading, the British Medical Association, the Royal Pharmaceutical Society of Great Britain and the Editors of the BMJ and The Pharmaceutical Journal. Copies of the published reports are also available to anyone on request. 

The views of the Prescription Medicines Code of Practice Authority and the Code of Practice Appeal Board must be sought on any proposal to amend the Code or this Constitution and Procedure. The views of the Medicines and Healthcare products Regulatory Agency, the British Medical Association and the Royal Pharmaceutical... 

Advertising and Promotion of Medicines in the UK (Medicines and Healthcare producte Regulatory Agency Guidance Note No. 23)... 

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