The Human Medicines (Amendment) (No. 2) Regulations 2014
UK Statutory Instrument 2014 No. 1878 — creates 7 criminal offences.
- Made
- 16 July 2014
- In force from
- Not determined
- Extent
- Not stated
- Subject
- Drugs and medicines
- Made under
- European Communities Act 1972
Explanatory note
(This note is not part of the Regulations) — published with the instrument by the department that made it. © Crown copyright, reused under the Open Government Licence v3.0.
These Regulations amend the Human Medicines Regulations 2012 (“the 2012 Regulations”). In particular, regulations 3 to 21 and 26 set out how parallel import licences are granted. Regulations 22(a) and 23 amend provisions in the 2012 Regulations on the recognition of prescriptions issued by healthcare professionals in EEA States to make it clear that the rules also apply to prescriptions issued in Switzerland. Regulations 22(b) and 27 insert a definition of “school” and amend Schedule 17 of the 2012 Regulations so that inhalers containing salbutamol can be supplied in schools in an emergency by persons trained to administer them to pupils who are known to require such medication. Regulations 24 and 29 amend the requirements for advertisements for medicines that are aimed at persons qualified to prescribe or supply such products. Regulation 24 enables advertisements for medicines available without a prescription to contain a website address where information on adverse reactions, precautions, contra-indications and methods of use can be found as an alternative to providing that information on the face of the advertisement. Regulation 25 amends the 2012 Regulations to ensure that the new provisions on inhalers containing salbutamol are subject to review by the Secretary of State. Regulation 28 amends the information that must be contained in the package leaflet that accompanies a medicine. Paragraph (2) corrects an error and paragraph (3) substitutes a general requirement to include text on adverse event reporting in place of a requirement to include prescribed text. Regulation 29 enables advertisements to include relevant entries from the medicine’s summary of product characteristics as an alternative to a summary of those entries. A full impact assessment has not been produced for this instrument as no, or no significant, impact on private, public or voluntary sectors is foreseen.
Offences created by this instrument
- Urgent safety restrictions: parallel import licences 80A The holder of a parallel import licence is guilty of an… regulation 15 · Status not determined · Strict liability
- Offences in connection with parallel import licence application 95A A person is guilty of an offence if, in the course… regulation 16 · Status not determined · Strict liability
- Breach of pharmacovigilance condition 97 1 The holder of a marketing authorisation or a parallel import licence is… regulation 17 · Status not determined · Strict liability
- Urgent safety restrictions: parallel import licences regulation 80A · Status not determined · Strict liability
- A person is guilty of an offence if, in the course of an application for the grant, renewal or variation of a parallel… regulation 95A · Status not determined · Strict liability
- Breach of pharmacovigilance condition regulation 97(1) · Status not determined · Strict liability
- Breach of pharmacovigilance condition regulation 97(2) · Status not determined · Strict liability
What Parliament said about it
Hansard was searched for this instrument by name and returned nothing. That is the ordinary outcome: an instrument laid under the negative procedure is usually never debated, and becomes law without a word said about it in either House.
How Parliament handled it
Parliament's Statutory Instruments service records procedure from May 2017 onwards, and this instrument predates it. That is a limit of the source, not a statement that nothing happened.
Check the source
- This instrument on legislation.gov.uk The authoritative text, including amendments made since
- Other instruments from 2014