The Human Medicines (Amendment) Regulations 2019

UK Statutory Instrument 2019 No. 62 — creates 7 criminal offences.

Made

14 January 2019

In force from

9 February 2019

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 order to implement— points 8, 9, 11 and 12 of Article 1 of Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (“Directive 2011/62/EU”); Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (“the Delegated Regulation”). These regulations further amend the 2012 Regulations in order to widen the type of products containing naloxone hydrochloride that drug treatment services are able to supply for the purpose of saving life in an emergency and to introduce serious shortage protocols. Regulations 3 to 8, 10 and 12 to 15 amend the 2012 Regulations in order to ensure that the provisions of the Delegated Regulation are enforceable in the United Kingdom. Regulations 11, 17 and 19 amend the 2012 Regulations in order to transpose the changes made to Directive 2001/83 by points 8, 9, 11 and 12 of Article 1 of Directive 2011/62/EU. Regulation 9 amends the 2012 Regulations in order to provide for the sale or supply of prescription only medicines by retail pharmacy businesses under a severe shortage protocol issued by the Ministers. The Ministers will have powers to issue such protocols where, in their opinion, the United Kingdom or part of the United Kingdom is experiencing or may experience a severe shortage of particular prescription only medicines. The protocols will allow for substitution, in restricted circumstances, of a different quantity of a prescription only medicine, or a different prescription only medicine, to that ordered by the prescriber. Regulation 16 amends regulation 346 of the 2012 Regulations so that the new provisions are subject to review by the Secretary of State. Regulation 18 amends Schedule 17 of the 2012 Regulations in order to allow naloxone hydrochloride that is for non-parenteral administration to be supplied by drug treatment services for the purpose of saving life in an emergency. A transposition note is published with the Explanatory Memorandum alongside the instrument on www.legislation.gov.uk. Copies may also be obtained from the Department of Health and Social Care, 2E14 Quarry House, Leeds, LS2 7UE.

Offences created by this instrument

• Offences relating to Commission Regulation 2016/161: management of the repository system 255C 1 A legal entity… regulation 10 · Status not determined · Strict liability
• If an enforcement authority has objective grounds for considering that a person to whom this regulation applies has… regulation 255A(2) · Status not determined · Strict liability
• e warning the person that that a failure to comply with the enforcement notice constitutes an offence under paragraph… regulation 255A(2)(e) · Status not determined · Strict liability
• A person is guilty of an offence if, without reasonable excuse, the person fails to comply with an enforcement notice… regulation 255A(5) · Status not determined · Strict liability
• A legal entity established to set up and manage the repositories system pursuant to Article 31 of Commission… regulation 255C(1) · Status not determined · Strict liability
• Offences relating to the safety features appearing on the packaging of medicinal products Offences relating to… regulation 8 · Status not determined · Strict liability
• The holder of a marketing authorisation or parallel import licence, or a parallel distributor, is guilty of an offence… regulation 94A(1) · Status not determined · Strict liability

What Parliament said about it

Contributions, debates and written statements mentioning this instrument by name. Parliamentary material is reused under the Open Parliament Licence v3.0.

• Human Medicines (Amendment) Regulations Commons · Commons Chamber · 18 March 2019 · Jonathan Ashworth (Leicester South) (Lab/Co-op)

  I beg to move, That the Human Medicines (Amendment) Regulations 2019 (S.I., 2019, No. 62), dated 14 January 2019, a copy of which was laid before this House on 18 January, be revoked. This motion concerns the serious shortage protocol. I thank the business managers for allowing time for this debate, but it really should not have come about as a result of the Official Opposition tabling a prayer against the regulations. The Government should have brought these proposals to the House for full debate and scrutiny, because the serious shortage protocol is perhaps one of the most far-reaching and…

• Interserve Commons · Commons Chamber · 18 March 2019 · Mr Deputy Speaker (Sir Lindsay Hoyle)

  The hon. Gentleman has resolved the matter by putting it on the record. I know that through his good offices, and given his background, he will not let the issue drop today. I am sure that he will find other methods to ensure that he continues to support the employees whose jobs may be at risk. Business of the House (Today) Ordered, That, at this day’s sitting, proceedings on the Motion in the name of Jeremy Corbyn relating to the Human Medicines (Amendment) Regulations 2019 (S.I., 2019, No. 62) may continue, though opposed, for 90 minutes after the commencement of proceedings on the motion…

• Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 Lords · Lords Chamber · 30 September 2019 · Baroness Thornton (Lab)

  I thank the Minister and welcome him to the world of EU health statutory instruments and their amendments—whether it is just for today or for a longer period. I also thank him for his explanation. I really hope that the Government have managed to get it right this time—I am not quite sure whether I have visited this twice or three times in the last year or so. This statutory instrument comes into force immediately before exit day to correct the defects and omissions in the Human Medicines (Amendment) Regulations 2019 and the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019. They…

• Community Pharmacies Commons · Westminster Hall · 2 October 2019 · Holly Lynch (Halifax) (Lab)

  I beg to move, That this House has considered the role of community pharmacies. May I say what a pleasure it is, Sir David, to serve under your chairship this morning, and to have you join us for this important debate? Between the ages of 14 and 18 I worked in a local chemist shop two evenings a week and some Saturday mornings. There were the usual first job responsibilities: restocking shelves, cleaning, and meeting and greeting customers and patients who were not always well, for a variety of reasons. I loved it, because there is never a dull moment in a pharmacy. I remember a frantic…

How Parliament handled it

This instrument became law without a vote to approve it. A motion to stop it being law was tabled.

Procedure

Made negative — law unless a motion to stop it succeeded

Could either House amend it?

No. A statutory instrument is put to each House as a whole thing, to be approved or not. Neither House can change a word of it.

Motion to stop it

Tabled

Objection motion

A non-fatal motion to object was tabled — it records disapproval without stopping the instrument

Procedural history

• Instrument created 14 January 2019
• Instrument made (signed into law) 14 January 2019
• Laid before the House of Commons 18 January 2019 · Commons
• Laid before the House of Lords 18 January 2019 · Lords
• Motion (prayer) to stop the instrument being law tabled 5 February 2019 · Commons
• Considered by the Joint Committee on Statutory Instruments (JCSI) 6 February 2019 · Commons, Lords
• Not drawn to the special attention of the Houses by the Joint Committee on Statutory Instruments (JCSI) 6 February 2019 · Commons, Lords
• Instrument comes into force as law 9 February 2019
• Considered by the Secondary Legislation Scrutiny Committee (SLSC) 12 February 2019 · Lords
• Information paragraph provided by the Secondary Legislation Scrutiny Committee (SLSC) 12 February 2019 · Lords
• Objection period ends 26 February 2019
• Instrument remains law 26 February 2019
• Procedure concluded in the House of Commons and the House of Lords 26 February 2019 · Commons, Lords
• Non-fatal motion (prayer) to object to the instrument tabled 14 March 2019 · Commons
• Chamber debate 18 March 2019 · Commons
• Question on non-fatal motion (prayer) to object to the instrument put 18 March 2019 · Commons
• Non-fatal motion (prayer) to object to the instrument rejected 18 March 2019 · Commons

From Parliament's Statutory Instruments service. Parliamentary material is reused under the Open Parliament Licence v3.0.

Check the source

• This instrument on legislation.gov.uk The authoritative text, including amendments made since
• Other instruments from 2019