UK Offence Report

Offences in connection with application

regulation 95 of The Human Medicines Regulations 2012

The provision has been revoked, but a saving provision keeps it prosecutable for conduct before a stated date. A person can still be charged with something it is no longer an offence to do.

What the provision says

95 A person is guilty of an offence if, in the course of an application for the grant, renewal or variation of

a marketing authorisation for

a relevant medicinal product, the person—

a fails to provide the licensing authority with any information that is relevant to the evaluation of the safety, quality or efficacy of the product;

b provides to the licensing authority any information that is relevant to the evaluation of the safety, quality or efficacy of the product but that is false or misleading in

a material particular;

c fails to provide the EMA with any information that is relevant to the evaluation of the safety, quality or efficacy of the product as required by paragraph (7) or (11) in the “Introduction and general principles” of Annex

1 to the 2001 Directive as applied by Article 6(1) of Regulation (EC) No 726/2004; or

d provides to the EMA any information of the kind described in sub-paragraph (c) that is false or misleading in

a material particular.

Text as made, from legislation.gov.uk. © Crown copyright, reused under the Open Government Licence v3.0. This is the text as originally made; later amendments are not shown here.

Who it binds, and what has to be proved

Binds
a person
Conduct
making a false or misleading statement
Fault element
Strict liability
Burden of proof
Legal burden on the defendant

The prosecution must prove that the conduct happened. This is a strict liability offence as drafted: the provision uses no word of intention, knowledge, recklessness or negligence, so there is no need to show that a person meant to do it, knew about it, or was careless.

Intention, knowledge and carelessness are irrelevant to guilt. They may still matter a great deal to sentence.

The provision gives a defence the defendant must prove, on the balance of probabilities. A legal burden of that kind can be read down to a merely evidential one under section 3 of the Human Rights Act 1998 where placing it on the defendant would be disproportionate (R v Lambert [2001] UKHL 37; Sheldrake v DPP [2004] UKHL 43).

Classifier’s reasoning: no word of intention, knowledge, recklessness or negligence in the offence or its provision.

The defence, as drafted

contravention of a provision mentioned in paragraph (3). 2 It is a defence for the defendant to prove that— a the substance or article to which the contravention relates (the “relevant substance or article”) was sold to the defendant in the United Kingdom as— i a substance or article which could be lawfully sold, supplied or offered for sale or supply, or ii

What would breach regulation 95?

These are illustrations, not law. They are generated from the provision’s own words to show the shape of the offence. Whether any particular conduct is caught depends on the full text, on any amendment since, and on the facts.

  1. Entering a figure on a form or return that is known to be wrong under the Human Medicines Regulations 2012.
  2. Leaving out something the form asks for, where the omission is what makes the answer misleading.
  3. Producing a document to an official that has been altered since it was issued.

Penalty

Mode of trial
Either way — magistrates’ court or Crown Court
Maximum fine
£5,000
Maximum prison (summary)
Not determined
Maximum prison (on indictment)
2 years

expressed as the statutory maximum (the prescribed sum): the same words mean £5,000 in England and Wales and £10,000 in Scotland.

Sentencing

Offences of this kind are usually sentenced under the guidelines below. This is a mapping by subject, not a finding about this provision, and the links go to a search of the Sentencing Council’s own site.

Prosecution figures

The Ministry of Justice records offences under this instrument against offence code 8421 — 08421 - Triable either way offences under Human Medicines Regulations 2012. That code may cover several provisions of the instrument, so a count against it is not a count of prosecutions under this provision alone.

No published per-offence figure was found for this provision. Offences created by statutory instrument very largely do not have their own code in the MoJ’s Outcomes by Offence data tool. Absence of a figure is not evidence that the offence is unused.

Status and lifecycle

Current status
Revoked, but still prosecutable
Revoked by
The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
Made
19 July 2012
In force from
14 August 2012
Extent
Not stated

How this was established: revoked, but a saving provision keeps the offence prosecutable for conduct before the stated date.

What the instrument is for

(This note is not part of the Regulations) — the explanatory note published with the instrument, © Crown copyright.

These Regulations consolidate the law of the United Kingdom concerning medicinal products for human use (“products”) in respect of the topics described below. Parts 1 (general) and 2 (administration) consolidate, with only minor and drafting amendments, the administration provisions in Part 1 of the Medicines Act 1968 (“the 1968 Act”), including the definition of the licensing authority as the body responsible for regulating products. Part 1 also provides for interpretation, and for special provisions concerning the applicability of the Regulations to a number of activities by pharmacists and others. The latter provisions consolidate, with only minor and drafting amendments, provisions in Part 2 of the 1968 Act, except for the repeal of section 10(7) of the Act, which concerns wholesale dealing by pharmacists. Part 3 (manufacturing and wholesale dealing) of the Regulations governs the manufacture and importation of, and wholesale dealing in, products. It consolidates, with only minor and drafting amendments, the provisions of Part 2 of the 1968 Act, and statutory instruments made under powers in that Part, on these topics. In doing so the Regulations continue to implement the obligations of the United Kingdom under Titles IV and VII of Directive 2001/83/EC of the European Parliament and of the Council on the Community Code relating to medicinal products for human use (“the 2001 Directive”) (OJ No L 311, 28.11.2001, p.67, as amended most recently by Directive 2010/84/EU of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community Code relating to medicinal products for human use (OJ No L 348, 31.12.2010, p.74 ) (“the 2010 Directive”)). Part 4 (requirement for authorisation) of the Regulations establishes that products must not be sold, supplied, or offered for sale or supply in the United Kingdom unless authorised, either by the United Kingdom licensing authority under the Regulations, or by the European Commission under Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community Procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (“Regulation (EC) No 726/2004”) (OJ No L 136, 30.4.2004, p.1, as amended most recently by Regulation (EU) No 1235/2010, OJ No L 348, 31.12.2010, p.1). Parts 5 to 8 (marketing authorisations, certification of homoeopathic medicinal products, traditional herbal registrations and Article 126a authorisations) provide for the procedures for authorisation by the United Kingdom licensing authority of medicinal products in various categories. Part 5 (marketing authorisations) also provides for offences in the case of breach of the corresponding requirements in the procedures under Regulation (EC) No 726/2004, and for the breach of certain obligations under Regulation (EC) No 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ No L 378, 27.12.2006, p.1, as amended by Regulation (EC) No 1902/2006 (OJ No L 378, 27.12.2006, p.20). In respect of United Kingdom authorisation, Parts 4 to 8 of the Regulations consolidate, with only minor and drafting amendments, the following principal statutory instruments: the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144, as amended, most recently by S.I. 2010/1882) (“the marketing authorisations regulations”), the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (S.I. 1994/105, as amended, most recently by S.I. 2006/2407) (“the homoeopathic regulations”), except in respect of fees provisions that are not being revoked, and the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 (S.I. 2005/2750, as amended, most recently by S.I. 2010/1621) (“the traditional herbal regulations”). In doing so, the Regulations continue to implement Titles III and VI of the 2001 Directive. At the same time the Regulations repeal the parallel national scheme for the licensing of the sale and supply of products, found in Part 2 of the 1968 Act, but now almost entirely superseded by EU provision in this field. Part 9 (borderline products) of the Regulations consolidates, with only minor and drafting amendments, provision in the marketing authorisations regulations for the licensing authority to determine whether products that are supplied without authorisation are medicinal products and thus subject to the Regulations. Part 10 (exceptions) consolidates, with only minor and drafting amendments, provisions in the marketing authorisations regulations, the homoeopathic regulations and the traditional herbal regulations concerning exemptions from the requirement for authorisation. Part 11 (pharmacovigilance) consolidates provisions in the marketing authorisations regulations and the traditional herbal regulations concerning the monitoring of the safety of medicines in clinical use. This Part also implements the amendments to Title IX of the 2001 Directive made by the 2010 Directive. Part 11 also provides for offences in the case of breach of the corresponding requirements under Regulation (EC) No 726/2004. Part 12 (dealings with medicinal products) governs the circumstances in which products may be sold, supplied and administered, and consolidates, with only minor and drafting amendments, the greater part of Part 3 of the 1968 Act, certain provisions of the latter which are outside the scope of the 2001 Directive being left unrepealed. Parts 1, 3, 5, 10 and 12 contain provisions consolidating the effect of the Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (S.I. 2010/1882). In so doing, the Regulations continue to make provision necessary for the operation of Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ No L324, 10.12.2007, p.21). Part 13 (packaging and leaflets) Chapter 1 consolidates, with only minor and drafting amendments, provisions in the marketing authorisations regulations, the homoeopathic regulations and the traditional herbal registrations in respect of the information to be supplied with products, continuing to implement Title V of the 2001 Directive. Chapter 2 consolidates certain United Kingdom provisions on child safety in the presentation of products. Part 5 of the 1968 Act, which made parallel provision, is repealed, and the instruments made under it revoked, except in respect of certain powers outside the scope of the 2001 Directive. Part 14 (advertising) consolidates, with only minor and drafting amendments, the Medicines (Advertising) Regulations 1994 (S.I. 1994/1932, as amended, most recently by S.I. 2006/2407) and the Medicines (Monitoring of Advertising) Regulations 1994 (S.I. 1994/1933, as amended, most recently by S.I. 2006/2407). In doing so, it continues to implement Titles VIII and VIIIa of the 2001 Directive. Part 6 of the 1968 Act, which made parallel provision, is repealed, and the instruments made under it revoked. Part 15 (British Pharmacopoeia) consolidates, with only minor and drafting amendments, Part 7 of the 1968 Act. Parts 16 (enforcement) and Part 17 (miscellaneous and general) consolidate, with only minor and drafting amendments, Part 8 (miscellaneous and supplementary provisions) of the 1968 Act as it concerns the topics in the Regulations. That Part remains in force, in amended form, in relation primarily to Part 4 (pharmacies) of the 1968 Act, which remains in force, and to certain other matters outside the scope of the 2001 Directive. Impact assessments for these Regulations have been prepared and are available from the Medicines and Healthcare Products Regulatory Agency (“MHRA”), 151 Buckingham Palace Road, London SW1W 9SZ, and published with the explanatory memorandum alongside the Regulations on www.legislation.gov.uk. A transposition note for the 2010 Directive has been prepared, and is also available from MHRA.

Read the full note and every offence in this instrument

What Parliament said

Mentions of this instrument in Hansard. Parliamentary material is reused under the Open Parliament Licence v3.0.

Other offences in the same instrument

How this was identified as an offence

Everything above rests on the judgement that this provision creates a criminal offence, rather than mentioning one. That judgement is made by rule, from the words of the provision, and this is the rule that made it — with a confidence of 0.92.

Basis
the provision says a person is “guilty of an offence”
Confidence
0.92 of 1.00

A provision that states a penalty for an offence created elsewhere can read very like one that creates an offence, and the rules can mistake the one for the other. If the text quoted above sets a penalty for something made an offence by another provision, treat the classification on this page with that in mind, and read the instrument.

Check the source