- Latest available (Revised)
- Original (As made)
This is the original version (as it was originally made).
2. After paragraph 8 of Schedule 5 to the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994 (labels)(1) insert the following paragraph—
“9.—(1) In relation to a relevant medicinal product to which sub-paragraph (2) applies—
(a)paragraphs 1 to 7 do not apply; and
(b)the container of that product shall be labelled to show—
(i)the name of the person to whom the relevant medicinal product is to be administered,
(ii)the date on which the relevant medicinal product is dispensed, and
(iii)the necessary and usual instructions for proper use.
(2) This sub-paragraph applies to a relevant medicinal product which is—
(a)an antiviral medicine in the form of a solution which is to be used for the treatment of a child under the age of one year; and
(b)sold or supplied for the purpose of treating a disease which is—
(i)a serious risk to human health or potentially a serious risk to human health; and
(ii)which is pandemic or is imminently pandemic.”.
S.I. 1994/3144; Schedule 5 was amended by S.I. 1998/3105, S.I. 2000/292, S.I. 2002/236, S.I. 2002/542 and S.I. 2003/1618.
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: