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Implementing Pharmacovigilance Directive

joywingfield — Thu, 15 Dec 2011 09:40:02 +0000

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

Consultation on second PNA regulations

joywingfield — Fri, 04 Nov 2011 13:00:38 +0000

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.

“3 year rule” is dropped

joywingfield — Thu, 03 Nov 2011 16:46:49 +0000

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.

Directions on Functions of NHS CB Published

joywingfield — Tue, 01 Nov 2011 16:06:48 +0000

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.

Consultation on medicines regulations

joywingfield — Tue, 25 Oct 2011 16:20:14 +0000

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

Commissioned evidence for off-label medicines

joywingfield — Thu, 13 Oct 2011 09:19:53 +0000

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.

Regulations laid to establish NHS CB

joywingfield — Sat, 01 Oct 2011 14:51:34 +0000

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.

NMS and new MUR Directions published

joywingfield — Thu, 29 Sep 2011 09:51:44 +0000

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.

Consultation on extended independent prescribing

joywingfield — Fri, 16 Sep 2011 10:32:15 +0000

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.

Amended NHS contract regulations

joywingfield — Fri, 16 Sep 2011 10:21:42 +0000

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.