- Latest available (Revised)
- Point in Time (09/02/2019)
- Original (As made)
Version Superseded: 31/12/2020
Point in time view as at 09/02/2019.
The Human Medicines Regulations 2012, CHAPTER 2 is up to date with all changes known to be in force on or before 26 August 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
Changes and effects yet to be applied by the editorial team are only applicable when viewing the latest version or prospective version of legislation. They are therefore not accessible when viewing legislation as at a specific point in time. To view the ‘Changes to Legislation’ information for this provision return to the latest version view using the options provided in the ‘What Version’ box above.
272. In this Chapter—
“appropriate practitioner” means any of the persons described as appropriate practitioners in relation to any prescription only medicine in regulation 214(3), (5) and (6);
“regulated medicinal product” means a medicinal product containing aspirin, paracetamol or more than 24mg of elemental iron, in the form of tablets, capsules, pills, lozenges, pastilles, suppositories or oral liquids, but does not include—
effervescent tablets containing not more than 25% of aspirin or paracetamol by weight;
medicinal products in sachets or other sealed containers which hold only one dose;
medicinal products which are not intended for retail sale or for supply in circumstances corresponding to retail sale; or
medicinal products which are for export only.
273.—(1) Regulated medicinal products sold or supplied otherwise than in accordance with regulation 274 may be sold only in containers which are—
(a)opaque or dark tinted; and
(b)child resistant.
(2) For the purposes of these Regulations, containers which are not reclosable are child resistant if they have been evaluated in accordance with, and comply with the requirements of—
(a)British Standard EN 14375:2003 published by the British Standards Institution on 18th April 2005; or
(b)any equivalent or higher technical specification for non-reclosable child resistant packaging recognised for use in the European Economic Area.
(3) For the purposes of these Regulations, containers which are reclosable are child resistant if they have been evaluated in accordance with, and comply with the requirements of—
(a)British Standard EN ISO 8317:2004 published by the British Standards Institution on 11th May 2005; or
(b)any equivalent or higher technical specification for reclosable child resistant packaging recognised for use in the European Economic Area.
274.—(1) Regulation 273 does not apply to the retail sale, or supply in circumstances corresponding to retail sale, of regulated medicinal products in accordance with paragraph (2).
(2) Sale or supply is in accordance with this paragraph if the sale or supply is carried out—
(a)by or under the supervision of a pharmacist;
(b)on premises which are a registered pharmacy; and
(c)either—
(i)in accordance with a prescription given by an appropriate practitioner where it is not reasonably practicable to provide the regulated medicinal products in containers that are both opaque or dark tinted and child resistant, or
(ii)at the request of a person who is aged 16 or over and specifically requests that the regulated medicinal products not be contained in a child resistant container.
(3) Regulation 273 also does not apply to the sale or supply of regulated medicinal products—
(a)by a doctor or dentist to a patient, or the patient's carer, for the patient's use;
(b)by a doctor or dentist to a person who is an appropriate practitioner, at the request of that person, for administration to a patient of that person; or
(c)in the course of the business of a hospital or health centre, where the sale or supply is for the purposes of administration, whether in the hospital or health centre or elsewhere, in accordance with the directions of an appropriate practitioner.
275. The sale or supply of a medicinal product containing aspirin or paracetamol of any colour other than white is prohibited if—
(a)it is a product for children aged 12 or under; and
(b)in the case of paracetamol, it is in a solid form (including tablets, capsules, pills, lozenges, pastilles or suppositories).
276.—(1) A person is guilty of an offence if, in the course of a business, the person sells or supplies, or possesses for the purposes of sale or supply—
(a)a regulated medicinal product in a container which does not comply with the requirements of regulation 273, unless the sale or supply is or would be exempt from those requirements under regulation 274; or
(b)a medicinal product containing aspirin or paracetamol the sale or supply of which is prohibited under regulation 275.
(2) A person guilty of an offence under this regulation is liable—
(a)on summary conviction to a fine not exceeding the statutory maximum; or
(b)on conviction on indictment to a fine, to imprisonment for a term not exceeding 2 years, or to both.
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Whole Instrument you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
The Whole Instrument without Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Whole Instrument without Schedules you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Whole Instrument without Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Point in Time: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:
This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: