- Latest available (Revised)
- Original (As made)
This is the original version (as it was originally made). This item of legislation is currently only available in its original format.
19.—(1) In any case where, prior to the coming into force of these Regulations, the licensing authority has issued an EAMS scientific opinion (under the pre-existing non-statutory arrangements) in respect of a medicinal product, the amendments to the Human Medicines Regulations 2012 made by these Regulations do not apply in respect of the sale or supply of, or the pharmacovigilance arrangements for, that product.
(2) Paragraph (1) ceases to apply in respect of the sale or supply of, or the pharmacovigilance arrangements for, that product once that EAMS scientific opinion is renewed (which the licensing authority may bring forward) or it ceases to have effect.
(3) Consent as mentioned in regulation 167H of the Human Medicines Regulations 2012 may be consent obtained prior to these Regulations coming into force.
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:
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: