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The Human Medicines (Amendment) (No. 2) Regulations 2015
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- Northern Ireland Statutory Rules
- 2015 No. 259
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EXPLANATORY NOTE
(This note is not part of the Regulations)
These Regulations amend the Human Medicines Regulations 2012, which sets out the requirements in respect of the manufacture, distribution, sale and supply (amongst other things) of medicines for human use in the United Kingdom.
Regulation 4 amends regulation 219 of the 2012 Regulations in order to allow appropriate practitioners other than EEA health professionals to use electronic prescriptions for a product specified in Schedule 2 or 3 to the Misuse of Drugs Regulations 2001 or in Schedule 2 or 3 to the Misuse of Drugs Regulations (Northern Ireland) 2002, provided these are sent via the Electronic Prescription Service.
Regulations 3, 5 and 6 are required to preserve the current arrangements for electronic prescriptions given by an EEA health professional.
Regulation 7 corrects an error in regulation 269 of the 2012 Regulations by adding in words that were included in the equivalent provision of the Medicines Act 1968 (c. 67), which the 2012 Regulations replaced.
Regulation 8 amends regulation 346 of the 2012 Regulations to ensure that the new provisions relating to electronic prescriptions are subject to review by the Secretary of State.
A full impact assessment has not been produced for this instrument as no adverse impact on private, public or voluntary sectors is foreseen.
Amendments to the Human Medicines Regulations 2012 are subject to the requirements of the Statutory Rules (NI) Order 1979 and the corresponding SI in respect of this Statutory Rule is S.I.903/2015.
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