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 Clause 13 - Non-Interventional Studies of Marketed Medicines

13.1 A non-interventional study of a marketed medicine is defined as a study where the medicine is prescribed in the usual manner in accordance with the terms of its marketing authorization. The assignment of the patient to a particular therapeutic strategy is not decided by a study protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures are applied to the patients and epidemiological methods are used for the analysis of collected data.

13.2 Companies must publish the summary details and results of non-interventional studies of marketed medicines in a manner consistent with their parallel obligations with respect to clinical trials.

13.3 Non-interventional studies that are prospective in nature and involve the collection of patient data must be conducted for a scientific purpose. They must comply with the following criteria:

  • there must be a written protocol and written contracts between the health professionals and/or the institutes at which the study will take place and the pharmaceutical company sponsoring the study, which specify the nature of the services to be provided and the payment for those services
  • any remuneration must be reasonable and reflect the fair market value of the work
  • in countries where ethics committees are prepared to review such studies, the study protocol must be submitted to the ethics committee for review
  • data protection legislation must be complied with
  • the study must not constitute an inducement to prescribe, supply, administer, recommend, buy or sell any medicine
  • the company’s scientific service must approve the protocol and must supervise the conduct of the study
  • the study results must be analysed and summaries must be made available within a reasonable period of time to the company’s scientific service, which service shall maintain records of such reports; the summary report should be sent to health professionals who participated in the study. If the study results are important for the assessment of benefit-risk, the summary report should be immediately forwarded to the relevant competent authority
  • sales representatives may only be involved in an administrative capacity and such involvement must be under the supervision of the company’s scientific service which will also ensure that the representatives are adequately trained for the role; such involvement must not be linked to the promotion of any medicine.

​Clause 13 Supplementary Information

Clause 13 EU Guidelines on Pharmacovigilance for Medicinal Products for Human Use

Attention is drawn to the EU Guidelines on Pharmacovigilance for Medicinal Products for Human Use.

Clause 13.2 Publication of Details and Results

This requirement applies to non-interventional studies completed on and after 1 May 2011 with which a UK company has had any involvement. Companies are, however, encouraged to publish details and results of such studies completed prior to that date.

Clause 13.3 Other Studies Covered by Clause 13.1

Companies are encouraged to comply with Clause 13.3 for all other types of studies covered by Clause 13.1, including epidemiological studies and registries and other studies that are retrospective in nature. In any case, such studies are subject to Clause 18.7.

Clause 13.3 Approval and Supervision

The approval and supervision of non-interventional studies are dealt with in Clause 21.2.

Clause 13.3 Date of Implementation

Companies must comply with Clause 13.3 in relation to noninterventional studies that are completed on or after 1 July 2008. Companies are encouraged to comply in relation to studies completed prior to that date.