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The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2008
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- UK Statutory Instruments
- 2008 No. 3097
- Explanatory Note
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EXPLANATORY NOTE
(This note is not part of the Regulations)
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.
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