Archive for the ‘Law News’ Category


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.

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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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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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Regulations laid to establish NHS CB


Saturday, October 1st, 2011

Two statutory instruments, the NHS Commissioning Board Authority (Establishment and Constitution) Order 2011 SI No. 2237 and the NHS Commissioning Board Authority Regulations 2011 SI No. 2250, create the NHS Commissioning Board as a Special Health Authority and provide for its membership and procedures. Both come into force on 31st October 2011.

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NMS and new MUR Directions published


Thursday, September 29th, 2011

NHS Directions, the Pharmaceutical Services (Advanced and Enhanced Services) (England) Directions 2011 come into force on the 1st October 2011. They include provisions for the New Medicines Service (NMS) and modified provisions for Medication Use Reviews (MURs) to be targeted at specific groups of patients.

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Consultation on extended independent prescribing


Friday, September 16th, 2011

The DH has published consultations on extending independent prescribing to physiotherapists and podiatrists. A number of options are proposed, including extending authority to mix licensed medicines prior to administartion and prescribing independently from a limited list of controlled drugs. Both consultations close on 8th December 2011.

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Amended NHS contract regulations


Friday, September 16th, 2011

Coming into force on 1st October 2011, new NHS (Pharmaceutical Services) Amendment regulations 2011 SI no. 2136 add new definitions of “advanced services” and “registered pharmacy technician” both reflecting current practice; also add further obligations to reach an acceptable system of clinical governance. The regulations apply to England only.

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