- Latest available (Revised)
- Original (As made)
This is the original version (as it was originally made).
35.—(1) As soon as practicable after the end of the reporting year, a sponsor shall, in relation to each investigational medicinal product tested in clinical trials in the United Kingdom for which he is the sponsor furnish the licensing authority and the relevant ethics committees with—
(a)a list of all the suspected serious adverse reactions which have occurred during that year in relation to—
(i)those trials, whether at trial sites in the United Kingdom or elsewhere, or
(ii)any other trials relating to that product which are conducted outside the United Kingdom and for which he is the sponsor,
including those reactions relating to any investigational medicinal product used as a placebo or as a reference in those trials; and
(b)a report on the safety of the subjects of those trials.
(2) In paragraph (1), “reporting year”, in relation to an investigational medicinal product, means the year ending on the anniversary of—
(a)in the case of a product which has a marketing authorization, the earliest date on which any such authorization relating to that product was granted or issued; or
(b)in any other case, the earliest date on which any clinical trial—
(i)relating to that product, and
(ii)for which the person responsible for making the report was the sponsor,
was authorised in an EEA State.
(3) For the purposes of paragraph (2)(b), the date on which a clinical trial was authorised in an EEA State is—
(a)in the case of the United Kingdom, the date on which the trial was authorised by the licensing authority in accordance with these Regulations, or
(b)in the case of any other EEA State, the date on which the trial was authorised by the competent authority of that EEA State in accordance with the Directive.
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Whole Instrument you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
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.
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: