Archive for 2011


CHRE consultation on efficient regulation


Saturday, December 31st, 2011

The Council for Healthcare Regulatory Excellence (CHRE) has issued a “call for ideas” on cost effectiveness and efficiency in health professional regulation. This is prompted by the Government white paper of February 2011 “Enabling Excellence: autonomy and accountability for health care workers, etc…”. Consultation closes on 19th January 2012.

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Implementing Pharmacovigilance Directive


Thursday, December 15th, 2011

The MHRA has published a consultation (MLX 374) on draft regulations to implement Directive 2010/84/EU on pharmacovigilance. These regulations will form part 11 of the current draft consolidated medicines regulations (MLX 375 below) to be enacted under the European Communities Act 1972. Consultation closes 28th February 2012

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Consultation on second PNA regulations


Friday, November 4th, 2011

The DH has issued a consultation on a further set of regulations to implement the Health Act 2009 provisions regarding Pharmaceutical Needs Assessments (PNAs). These include removal of three (not “distance selling”) of the current exemptions to control of entry, notably the “100 hour exemption”. The consultation also covers powers to take remedial action over breach of terms of service and poor performance. Consultation closes 25th January 2012.

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“3 year rule” is dropped


Thursday, November 3rd, 2011

Since 1985 and mutual recognition of EU pharmacists, the UK took advantage of a derogation to prohibit EU pharmacists from becoming the pharmacist “in personal control”, later replaced with the Responsible Pharmacist, for a pharmacy which had been established for less than three years. An Order , the Medicines Act 1968 (Pharmacy) Order 2011 SI No 2647 has removed this prohibition from 3rd November 2011.

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Directions on Functions of NHS CB Published


Tuesday, November 1st, 2011

The DH has published directions setting out the functions of the proposed NHS Commissioning Board allowing it be established in “shadow form”. Subject to the passage of the Health and Social Care Bill, the NHS CB is expected to be fully operational from April 2013.

Posted in Law News |

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Consultation on medicines regulations


Tuesday, October 25th, 2011

MHRA has issued a consultation (MLX 375) on draft consolidated medicines regulations and proposed policy changes. Consultation closes 17th January 2012

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Consultation on GPhC Guidance


Saturday, October 15th, 2011

The GPhC has issued draft guidance for consultation on four topics: consent, confidentiality, raising concerns and maintaining proper professional boundaries. Consultation closes on 15th December 2011.

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Commissioned evidence for off-label medicines


Thursday, October 13th, 2011

The DH has announced plans to commission expert assessments of the evidence on the use of off-label medicines, including in rare conditions. These assessments will be designed to inform doctors’ decision-making and patients’ choices, not to provide a yes or no recommendation.

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CQC registration of GP practices delayed


Thursday, October 13th, 2011

The DH has published its response to their consultation on delaying registration of GP practices by the CQC. Their response says the date will now be April 2013 (rather than April 2012)

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Consultation on NHS Duty of Candour


Thursday, October 13th, 2011

The DH has announced a consultation on a “duty of candour” (a duty to be open with patients when things go wrong with their healthcare) on NHS providers. The document covers providers in the managed service; further consultation may follow on amending standard contracts for family health care providers. Consultation closes 2nd January 2012

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