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Amended NHS Pharmacy Regulations

Posted: Thursday, May 8th, 2014

Regulations (The NHS (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Tranistional Provisions) Regulations 2014 SI No. 417) amending the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 No. 349 took effect from 1 April 2014. They contain a number of key changes to the content of the original regulations, principally affecting the pharmaceutical lists. (JW)

Consultation on European Professional card

Posted: Thursday, May 8th, 2014

The European Commission has opened a consultation as follows: The European Professional Card (EPC) is a key element of Directive 2005/36/EC on the recognition of professional qualifications, as amended by Directive 2013/55/EU. The amending directive took effect on 17 January 2014, and the EU countries are expected to implement it by 18 January 2016. The point of the EPC is to make it easier for professional qualifications to be recognised and for members of a regulated profession to practise elsewhere in the EU. This will be achieved by involving the relevant authorities in professionals’ home countries more, and through electronic procedures. Consultation closes on 2nd June 2014 (JW)

Removal of certain unlicensed medicines from the shelf

Posted: Thursday, May 8th, 2014

The MHRA issued a reminder in April that unlicensed herbal medicines without a traditional herbal registration or product licence must no longer be sold to consumers from 1 May 2014. For the MHRA’s press release, please see here (CC)

GPhC Corporate plan

Posted: Thursday, May 8th, 2014

The GPhC has published its corporate plan for 2014-2015 to accompany its strategic plan for 2014-2017. The second and third GPhC corporate plans for 2015-2016 and 2016-2017 will be published at a later date. The GPhC intends to focus on the following four theme over the next 3 years: (i) providing proactive, good-quality regulatory services; (ii) putting people at the heart of the GPhC's work; (iii) using the knowledge gained from the GPhC's regulatory services and other third parties to promote improvement in pharmacy care and services; and (iv) promoting a culture of patient-centered professionalism in pharmacy. (CC)

Early access to medicines scheme (EAMS)

Posted: Thursday, May 8th, 2014

The MHRA announced on 7 April 2014 that the EAMS is open for applications from the pharmaceutical industry and research organisations. The aim of the EAMS is to provide patients with life threatening or seriously debilitating conditions access to unlicensed medicines (i.e., those which do not yet have marketing authorisations). There are two parts to this scheme: (i) first, the "promising innovation medicine" designation will be granted with respect to products once there has been an assessment of clinical data and which show an early indication for potential for the EAMS scheme; and (ii) secondly, the MHRA will issue a scientific opinion based on the benefit risk profile of the medicine. Please see for the MHRA press release. (CC)

Evening Conference on Law Commission Proposals

Posted: Sunday, April 6th, 2014

Shoosmiths LLP, solicitors, will be hosting an evening conference at their Manchester offices on Wednesday 30th April 2014. Delegates will hear about the Law Commission's recent proposals and draft bill on reform of the regulation of healthcare professionals (and social workers in England)  - see news item below. Attendance is free and the event should run from 5.00pm to 7.30pm. See Shoosmiths-Regulation-of-health-social-care-flyer-April2014

EU will require transparent clinical trial data

Posted: Sunday, April 6th, 2014

Pharmaceutical companies and academic researchers will have to post the results of all their European clinical trials in a publicly-accessible database, under a draft law already informally agreed with EU ministers and passed by Parliament on Wednesday. The law also facilitates cross-border cooperation to make clinical trials larger, more viable and more reliable, which should in turn boost efforts to develop special treatments, e.g. for rare diseases. These requirements are expected to be implemented from 2016.

Law Commission: regulation of healthcare professionals

Posted: Friday, April 4th, 2014

The Law Commission published on 2nd April 2014 its report and recommendations following a review of the UK law relating to the regulation of healthcare professionals. The key proposal is for a single legal framework for the regulation of all healthcare professionals with the aim of achieving a clear and consistent framework to enable the regulator(s) to protect the public. The full report with draft bill is 465 pages; the summary is nine pages.

Assisted Suicide (Scotland) Bill

Posted: Wednesday, April 2nd, 2014

The Royal Pharmaceutical Society has been invited to give written evidence to the committee stage of the Assisted Suicide (Scotland) Bill which was lodged with the Scottish Parliament on 13th November 2013. This Bill differs from an earlier one in that it does not include provisions for those who are permanently physically incapacitated. The RPS already has a neutral policy (2012) towards this topic but its response will include: the need for an opt-out for pharmacists on the grounds of conscience, legal protection for dispensing any lethal prescription in accordance with the law and inclusion in advisory groups tasked with developing protocols for implementation.

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These news items are not exhaustive but are selected according to their relevance to pharmacy practice, NHS community pharmacy contracts and the regulation of the pharmacy profession. If you wish to add any items that you think we have missed, contact our news editor.