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Covering Letter

Primary and Community Care Directorate
Pharmacy Division
T: 0131-244 2870
F: 0131-244 2375
E: mary.waugh@scotland.gsi.gov.uk

25 October 2007

Dear Colleague

Health Act 2006: Consultation on Regulations Relating to the Responsible Pharmacist

I am writing to invite your views on the attached consultation document, which sets out proposals for developing pharmacy services throughout the UK. The results of this consultation will be considered along with the results of separate consultations to be carried out in England, Wales and Northern Ireland and will inform regulations to be made under the UK Health Act 2006.

The Health Act amends the Medicines Act 1968 and related NHS legislation in a number of important respects. It replaces personal control with a requirement that each registered pharmacy is to have a responsible pharmacist with a statutory duty to secure the safe and effective running of the pharmacy. Together with existing provisions in the Medicines Act, the Health Act also provides for changes in the pharmacist supervision requirements.

These are complex changes. Therefore, it has been agreed to begin the regulation-making process by consulting on the responsible pharmacist provisions, which are mandatory. Consultation on the pharmacist supervision regulations will follow later.

The regulations under the Health Act 2006 will set out how the responsible pharmacist is to exercise the statutory duty, which will be underpinned by a quality systems approach. To inform the regulations, the attached consultation letter is seeking views on:

• proposals on the content of the responsible pharmacist regulations;
• the timing of introduction of the responsible pharmacist regulations and the time needed to prepare for change;
• the need for guidance to support introduction of the regulations.

Responses are invited by 20 January 2008 by email to Mary.waugh@scotland.gsi.gov.uk or to:

Mary Waugh

The Responsible Pharmacist Consultation
The Scottish Government
Primary & Community Care Directorate, Pharmacy Division

This consultation and all other Scottish Government consultation exercises can be viewed online at http://www.scotland.gov.uk/consultations/current You can telephone Freephone 0800 77 1234 to find out where your nearest public internet access point is.

The Scottish Government now has an email alert system for consultations (SEconsult: http://www.scotland.gov.uk/consultations ). This system allows stakeholder individuals and organisations to register and receive a weekly email containing details of all new consultations (including web links). SEconsult complements, but in no way replaces Scottish Government distribution lists, and is designed to allow stakeholders to keep up to date with all consultation activity, and therefore be alerted at the earliest opportunity to those of most interest. We would encourage you to register.

Handling your response

We need to know how you wish your response to be handled and, in particular, whether you are happy for your response to be made public. Please complete and return the Respondent Information Form enclosed with this consultation paper as this will ensure that we treat your response appropriately. If you ask for your response not to be published we will regard it as confidential and treat it accordingly.

All respondents should be aware that the Scottish Government are subject to the provisions of the Freedom of Information (Scotland) Act 2002 and would therefore have to consider any request made to it under the Act for information relating to responses made to this consultation exercise.

Where respondents have given permission for their response to be made public, these will be made available to the public in the Scottish Government Library and on the Scottish Government web pages by the end of February 2008. All responses not marked confidential will be checked for any potentially defamatory material before logging them in the Library or placing them on the website. You can make arrangements to view responses by contacting the Library on 0131 244 4565. Responses can be copied and sent to you, but a charge may be made for this service.

Next steps

Following the closing date, all responses will be analysed and the results of this consultation together with the results of the England, Wales and Northern Ireland consultations will inform UK regulations on the responsible pharmacist provisions.

Comments and complaints

If you have any comments or queries about how this consultation exercise has been conducted please send them to the address above.

Thank you for your help.

Yours sincerely

Bill Scott

Professor Bill Scott
Chief Pharmaceutical Officer

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