Pharmacy Order 2010
What this means for your business
- Enforced by
- MHRA
- Applies to
- United Kingdom
- On this page
- 16 compliance obligations, 1 practical guide
What you must do
16 compliance obligations under this legislation.
Risk assessment 1
Provide English evidence for pharmacist or tech registration
When you or a pharmacist staff member apply for entry or renewal, you must prove you have enough English to keep patients safe. The regulator will tell you what paperwork it needs and will ask for more or for you to sit a test if their evidence is not clear enough. Make sure you submit the required documents and be ready for an assessment if requested.
Insurance 1
Maintain appropriate indemnity insurance while practising
If you are a registered pharmacist or pharmacy technician, you must have valid indemnity insurance that covers any liabilities arising from your practice. The cover must be suitable for the level of risk in your work and must be kept in force at all times. You also need to inform the pharmacy regulator if the insurance stops or if you rely on employer‑provided cover.
Management duties 1
Comply with directions from the Fitness to Practise Committee
If the Pharmacy Order’s Fitness to Practise Committee decides that a pharmacist’s fitness is impaired, you must follow their instructions – a warning may be issued, parts of your registration could be removed or suspended, or you may be required to meet certain conditions. The committee’s decisions are binding, so you need to act immediately to keep your registration in good standing.
Offences and prohibitions 3
Fail to comply with improvement notice
Unlimited fineIf your pharmacy does not follow the terms of an improvement notice served by the regulator, you commit a criminal offence. On conviction in the magistrates' court you can be fined up to the maximum level 5 amount (which is now unlimited). There is no custodial sentence attached to this specific offence.
Misrepresent pharmacy registration or use unregistered titles
Unlimited fineIf you claim that someone is listed on the pharmacy register as a pharmacist, pharmacy technician or holds a specialist annotation when they are not, or you use those titles without a proper entry, you are committing an offence. It also covers practising as a pharmacist or pharmacy technician without being on the register and displaying false entry notices or certificates. Conviction is dealt with in the magistrates' court and can lead to a fine – up to an unlimited amount for false representations or up to £1,000 for false documents.
Obstruct inspector or withhold/falsify information
Fine up to £1,000If you deliberately block a MHRA or CQC inspector, refuse to give the help or information they reasonably need, give false or misleading information, or refuse to produce documents they ask for, you commit a criminal offence. On conviction in the Magistrates' Court you can be fined up to £1,000. No prison term is prescribed for this offence.
Record keeping 1
Provide records for professional performance assessments
If the pharmacy regulator asks for records as part of a professional performance assessment of a pharmacist, you must supply the requested documents within 14 days. Failure to do so can lead to a court order forcing you to produce the records. This applies whether the pharmacist works for you or runs their own business.
Registration and licensing 3
Apply to restore your pharmacy registration after removal
If your name has been taken off the pharmacy register, you can ask for it to be put back, but only after five years have passed and you must wait at least 12 months between applications for the same entry. You need to submit a formal application with the details the Council requires, provide evidence you are fit to practise, and may have to meet any conditions they set.
Register as a pharmacist or pharmacy technician and keep the registration current
If you want to work as a pharmacist or pharmacy technician in Great Britain, the Channel Islands or the Isle of Man you must be entered on the professional Register. You can only be entered or have your entry renewed if you have the right qualifications, are fit to practise, can speak English, intend to work in the area and have paid the required fee. This duty applies each time you apply for a new entry or for renewal.
Submit a complete application and answer Registrar requests quickly
If you want to become a registered pharmacist or pharmacy technician – or renew your registration – you must send the Registrar a fully completed application, all supporting documents and any required fees. If the Registrar finds a missing piece, you have to supply it within the time they give you. Failure to do so may lead to the Registrar refusing your entry.
Reporting and filing 6
Maintain and report CPD as a registered pharmacist
If you’re a registered pharmacist, you have to keep up-to-date skills and knowledge and show proof of it. Each year you must complete a declaration that you’ve met the CPD requirement and hand in records of your training to the Registrar. Failure to do so can lead to your registration being removed.
Provide employment and service‑arrangement details when requested
If a pharmacy regulator receives an allegation or concerning information about your fitness to practise, you must give the Registrar details of any employer or anyone you have arrangements with to provide pharmacy services. You have to supply this information within 14 days (or any longer period the Registrar allows). Failing to do so can be treated as misconduct and may lead to further regulatory action.
Provide information to the Council on request
If you run an institution or other provider that offers pharmacy‑related courses or competence tests, you must give the Council any information and assistance it reasonably asks for. Failure to comply can lead to the Council withdrawing approval for your courses or qualifications.
Provide required information to the Pharmacy Council
If you run a retail pharmacy, you must give certain details to the Pharmacy Council whenever it is requested or when a rule sets a specific time. This includes who owns or runs the pharmacy, where it is located, who the superintendent pharmacist is, what activities take place, and any relevant offences or investigations. Keep clear records and submit them on time to avoid penalties.
Respond to Council inspection reports within one month
If your company runs a pharmacy training course, the Pharmacy Council can appoint inspectors to review your courses. After they send you the report, you must give your feedback within at least one month. This keeps the Council informed and allows your course to be kept up to standard.
Respond to Council’s notice on approval concerns
If the pharmacy regulator (the Council) tells you it thinks your course, qualification, test or institution does not meet the required standards, you must reply with your comments within the period they set – which must be at least one month. Your response is needed before the Council can decide to refuse or withdraw approval.
Penalties for non-compliance
3 penalties under this legislation. 2 carry an unlimited fine.
Fail to comply with improvement notice
Unlimited fine
Misrepresent pharmacy registration or use unregistered titles
Unlimited fine
Obstruct inspector or withhold/falsify information
Fine up to £1,000
Practical guidance
Our guides explain how to comply with the requirements above.
Sections and provisions
80 classified provisions from this legislation.
Duties 24
- s.7 Standards: general
- s.8 The Inspectorate
- s.9 Inspection and enforcement
- s.20 Entitlement to entry in Part 1 or 2 of the Register: pharmacists and pharmacy technicians
- s.24 Notification by the Registrar: entry and renewal
- s.26 Notice of entry in the Register
- s.29 Corrections to the Register
- s.32 Indemnity arrangements person seeking
- s.43 Continuing professional development
- s.44 Specific obligations and powers of the Council in respect of education and training
- s.45 Visitors
- s.46 Information to be given by institutions or other providers institution or other provider
- s.47 Refusal or withdrawal of approval of courses, qualifications and institutions
- s.48 Standards of conduct and performance
- s.52 Initial action in respect of allegations
- s.53 Consideration by the Investigating Committee
- s.54 Consideration by the Fitness to Practise Committee
- s.55 Professional performance assessments
- s.57 Restoration of names to the Register: fitness to practise
- s.61 Rules in respect of proceedings person
- ... and 4 more duties
Offences and penalties 4
Powers 25
- s.4 The Council and its Committees
- s.10 Power of entry
- s.11 Powers of an inspector
- s.13 Improvement notices
- s.16 Appeals against improvement notices
- s.17 Powers of a court on appeal
- s.18 The Registrar
- s.19 Establishment, maintenance of and access to the Register
- s.23 Form, manner and content of applications for entry or for renewal of an entry in the Register: pharmacists and pharmacy technicians
- s.27 Specialisations: registrants and registered pharmacies
- s.28 Registrants’ duties with regard to their entries
- s.30 Fitness to practise matters before entry or renewal of an entry
- s.31 Voluntary removal from the Register
- s.35 Temporary annotations with regard to emergencies involving loss of human life or human illness etc.
- s.36 Fees in connection with entry
- s.37 Restoration to the Register of persons or premises removed from the Register
- s.49 Disclosure of information: general
- s.50 Disclosure of fitness to practise matters in the public interest
- s.60 Interim measures pending a direction taking effect
- s.62 Procedure for the Fitness to Practise Committee and the Appeals Committee
- ... and 5 more powers
Definitions 8
- s.3 Interpretation the 2007 Order adaptation period annotation
- Schedule 5 Transitional Provisions the 1968 Act the 2007 registers the premises register
- s.21 Pre-entry requirements in respect of qualifications and additional education, training or experience: pharmacists relevant European qualification
- s.22 Pre-entry requirements in respect of qualifications and additional education, training or experience: pharmacy technicians
- s.42 Education, training and acquisition of experience
- s.51 Impairment of fitness to practise
- European qualifications: pharmacists European qualifications: pharmacists reference date
- Schedule 2A Directive 2005/36/EC: European professional card