Revised Laws of Saint Lucia (2021)

Schedule 3

(Section 13(b)(i))

APPLICATION FOR AUTHORIZATION

1.     The name and address of —

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   (a)     the sponsor;

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   (b)     if any person has been authorized by the sponsor to make the application on his or her behalf, that person;

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   (c)     any other person to whom the sponsor has delegated any of his responsibilities in relation to the proposed clinical trial.

2.     The address of each trial site and the names and address of the investigator responsible for the conduct of the trial at each site.

3.     A copy of the opinion of the Ethics Committee opinion in relation to the clinical trial, if available.

4.     A description of any investigational medicinal product or investigational medical device to be used in the clinical trial.

5.     The name and address of the person responsible for the manufacture or importation of any finished investigational medicinal product or investigational medical device to be used in the clinical trial and the details of any authorization held by that person.

6.     A description of the proposed clinical trial.

7.     The protocol for the proposed clinical trial.

8.     (1)     Information on each investigational medicinal product or investigational medical device to be used in the clinical trial in sub-paragraphs (2) to (8).

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   (2)     A summary assessment of the potential risks and benefits of the use of the investigational medicinal product or investigational medical device in the proposed clinical trial.

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   (3)     In the case of an investigational medicinal product or investigational medical device, other than an investigational medicinal product or investigational medical device referred to in sub-paragraphs (4) to (7), the application must contain —

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      (a)     summaries of the chemical, pharmaceutical and biological data on the active substance and the finished product or device;

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      (b)     summaries of the non-clinical pharmacology and toxicology data on that product or device, if available; and

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      (c)     summaries of the available data from previous clinical trials of, and human experience with, that product or device.

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   (4)     In the case of an investigational medicinal product or investigational medical device which has a marketing approval, the application must contain —

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      (a)     a copy of the summary of product or device characteristics;

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      (b)     if there has been a change —

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         (i)     to the process of manufacture of the product or its active substance or device, or

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         (ii)     of manufacturer of that product or substance or device, the summaries referred to in sub-paragraph (3)(a);

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      (c)     if the product or device is to be used in the trial after it has been blinded, the summaries referred to in sub-paragraph (3)(a), in so far as they relate to the blinded product or device; and

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      (d)     if the product or device is to be used other than in accordance with the terms of the summary of product or device characteristics under that authorization, the summaries referred to in subparagraphs (3)(b) and (c), in so far as that data relates to such use.

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   (5)     In the case of an investigational medicinal product or investigational medical device which does not have a marketing approval, but where —

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      (a)     another pharmaceutical form or strength of that product or device has a marketing approval; and

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      (b)     the investigational medicinal product or investigational medical device is supplied by the holder of that approval, the application must contain the summaries referred to in sub-paragraph (3)(a), in so far as they relate to the finished product or device to be used in the clinical trial, and the summaries referred to in sub-paragraph (3)(b) and (c), in so far as they relate to the product or device to be used in the clinical trial.

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   (6)     In the case of an investigational medicinal product or investigational medical device which does not have a marketing approval, but where —

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      (a)     another medicinal product containing the same active substance or medical device has a marketing approval; and

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      (b)     the investigational medicinal product or investigational medical device is supplied by the manufacturer of that other product,

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        the application must contain the summaries referred to in sub-paragraph (3) (a), in so far as the summaries relate to that other product, and the summaries referred to in sub-paragraph (3)(b) and (c), in so far as they relate to the product or device to be used in the clinical trial.

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   (7)     Where the investigational medicinal product or investigational medical device is a placebo, the application must contain the summaries referred to in sub-paragraph (3)(a), in so far as they relate to that product or device.

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   (8)     An application relating to an investigational medicinal product is not required if —

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      (a)     the product has been used in a clinical trial that has been authorized, or is to be treated as having been authorized, by the National Competent Authority for the purposes of this Act; and

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      (b)     the sponsor of that clinical trial authorizes the National Competent Authority to refer to the application submitted in relation to that clinical trial.

9.     A description or sample of the labelling which is to appear on each investigational medicinal product or investigational medical device when supplied to a subject in the clinical trial.

CHAPTER 11.23
CLINICAL TRIALS ACT

SUBSIDIARY LEGISLATION

No Subsidiary Legislation