The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2008 (revoked)

UK Statutory Instrument 2008 No. 3097 — creates 10 criminal offences.

10offences created

0recorded in force

0revoked

Made: 3 December 2008
In force from: 29 December 2008
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 provide for the enforcement in the United Kingdom of 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, as amended by Regulation (EC) No 1902/2006 of the European Parliament and of the Council amending Regulation 1901/2006 on medicinal products for paediatric use (the Paediatric Regulation). The Paediatric Regulation establishes a scheme of obligations and incentives to encourage the development of, and improve access to, medicines for children. The Paediatric Regulation is enforced through amendments to the Medicines for Human Use (Marketing Authorisation Etc.) Regulations (“the 1994 Regulations”). The 1994 Regulations are the primary piece of legislation through which Community obligations in relation to medicines are implemented. These Regulations also further amend the 1994 Regulations in connection with transposition of Directive 2001/83 of the European Parliament and Council on the Community Code relating to medicinal products for human use. Regulation 2 amends regulation 1 of the 1994 Regulations to update references to Community legislation amended by the Paediatric Regulation; and to identify the Paediatric Regulation as a “relevant Community Provision” for the purpose of the 1994 Regulations. Regulation 3 amends Schedule 3 to the 1994 Regulations by inserting various additional criminal offences through which provisions of the Paediatric Regulation can be enforced and by clarifying certain aspects of the information-reporting obligations in that Schedule. Regulation 4 updates references to Community legislation in the Medicines Act 1968 to include the Paediatric Regulation. Regulation 5 corrects a typographical error in the Medicines for Human Use (Prescribing by EEA Practitioners) Regulations 2008. A full impact assessment has not been produced for this instrument as no impact on the private and voluntary sectors is foreseen.

Offences created by this instrument

the following paragraphs— 6BA Where the holder of a United Kingdom marketing authorization (“H”) has benefited from… regulation 3(4) · Status not determined · Strict liability
the following paragraph— 6G Any person who— a is the holder of a United Kingdom marketing authorization; b obtains a… regulation 3(5) · Status not determined · Strict liability
the following paragraph— 13B 1 Any person established in the United Kingdom to whom a decision by the EMEA in respect… regulation 3(9) · Status not determined · Strict liability
Where the holder of a United Kingdom marketing authorization (“H”) instigates or conducts a paediatric clinical trial… regulation 3(9) · Status not determined · Strict liability
Where the holder of a United Kingdom marketing authorization (“H”) has instigated or conducted a paediatric clinical… regulation 3(9) · Status not determined · Strict liability
Any person who— a is the sponsor of a paediatric clinical trial in the United Kingdom in respect of a medicinal… regulation 3(9) · Status not determined · Strict liability
Any person who— a has sponsored a paediatric clinical trial in the United Kingdom in respect of a medicinal product— i… regulation 3(9) · Status not determined · Strict liability
Any holder of a United Kingdom marketing authorization who— a has knowledge of a paediatric study in respect of the… regulation 3(9) · Status not determined · Strict liability
Any holder of a United Kingdom marketing authorization who— a sponsors a paediatric study in respect of the product to… regulation 3(9) · Status not determined · Strict liability
Any holder of a United Kingdom marketing authorization who— a has sponsored a paediatric study in respect of the… regulation 3(9) · 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 2008