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Changes to CD legislation

Posted: Saturday, May 24th, 2014

Regulations (The Misuse of Drugs and Misuse of Drugs (Safe Custody) (Amendment) (England Wales and Scotland) Regulations 2014 SI No 1275) making many amendments to the detail of previous regulations will come into force on 10th June 2014. Principally, tramadol will become a Sch. 3 CD; lisdexamfetamine becomes a Sch. 2 CD and Zopiclone and Zalpion becomes Sch. 4 Part 1. Detailed guidance on the implications of these changes is available from the RPS - support alerts.

GPhC memoranda on all pharmacy inspections

Posted: Thursday, May 22nd, 2014

The GPhC has agreed Memoranda of Understandings (MoUs) with the Care Quality Commission, the Medicines and Healthcare products Regulatory Agency, NHS England and NHS Protect to improve inspection and sharing of information on inspection of registered pharmacies. The aim is to reduce unnecessary burdens on the businesses and to avoid duplication of inspection and enforcement. The GPhC is also working on MoUs with the Home Office regarding controlled drugs inspections and with the relevant stakeholders in Wales and Scotland. Details of the MoUs are on the GPhC website.

Consultation on Animal Scientific Procedures Act

Posted: Wednesday, May 14th, 2014

The Home Office has launched a consultation on changes to the Animals (Scientific Procedures) Act 1986. The principal proposal is to amend section 24 of the Act which currently prevents the Home Office from releasing any information received in confidence under the Act, even when the provider has no objection to its disclosure. The preferred amendments are to create a criminal offence of malicious disclosure and to exclude release of information about people, places or intellectual property concerned with the use of animals in scientific research. Consultation closes on 13th June 2014. (JW)

MHRA’s leaflet on developing innovative medicines

Posted: Tuesday, May 13th, 2014

The MHRA has published a leaflet which provides advice to parties involved in the development of new products, including ATMPs and products which require novel means of manufacturing, to name a few. The MHRA points such parties to sources of information and to processes in place to provide assistance (including the recently implemented “Early Access to Medicines Scheme”), as well as to the support offered by the EMA (including with respect to its adaptive licensing pilot launched in March 2014). (CC)

Law to allow salbutamol inhalers in schools

Posted: Thursday, May 8th, 2014

MHRA is consulting (MLX 385) on changes to the 2012 Medicines Regulations to allow the supply of salbutamol inhalers to schools to be kept for emergency use in asthma management. The consultation closes at the end of May 2014. (JW)

New law requires indemnity insurance

Posted: Thursday, May 8th, 2014

The Department of Health has published its response to the consultation on the need for all health professionals to hold indemnity or insurance to cover their professional activities. The response accepts that there is such a need and legislation (Healthcare and Associated Professions (Indemnity Arrangements) Order 2014 which accompanied the consultation itself) will be laid before Parliament this month with a view to enforcement from July 2014. (JW)

Updated MHRA guidance on "specials"

Posted: Thursday, May 8th, 2014

The MHRA has updated its - official - guidance note 14 on the supply of unlicensed medicines or "specials". This guidance now takes account of the recent consolidation (2012) of most of the UK Medicines Regulations and recent EU court cases. (JW)

First report on EU pharmacovigilance

Posted: Thursday, May 8th, 2014

The European Medicines Agency (EMA) has produced its first report after the first year of implementing the new EU legislation on pharmacovigilance. Among other benefits, it claims better collection of key information on medicines, improved analysis and understanding of data and information, improved timeliness of procedures and greater transparency (JW)

Changes to FOIA publications scheme for pharmacy contract holders

Posted: Thursday, May 8th, 2014

The RPS advises that the Information Commissioner's Office is consulting on changes to the publication scheme for holders of community pharmacy contracts. However, the consultation does not appear to be publicly available on the ICO website

The Freedom of Information Act 2000 (FOIA) requires all public authorities to adopt and maintain a publication scheme. In 2008 the Information Commissioner’s Office (ICO) introduced a single generic model publication scheme, for adoption by all public authorities that are subject to FOIA. Those providing pharmaceutical services under contract to the NHS in England, Wales and Northern Ireland are public authorities in respect of information relating to those services. The consultation closes on 16th May 2014 and comments should be passed to the RPS. (JW)

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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.