Clause 25 - Scientific Services

Clause

  • Clauses 25.1 and 25.2 Scientific Services

    Companies are free to decide whether there is one scientific service in charge of both responsibilities  or separate services with clearly delineated duties. Clause 14 does not apply to the examination of non-interventional studies.

25.1 Companies must have a scientific service to compile and collate all information, whether received from medical representatives or from any other source, about the medicines which they market.

25.2 Companies must also have a scientific service to deal with the approval and supervision of non-interventional studies. This scientific service must include a registered medical practitioner or a pharmacist registered in the UK, who will be responsible for the oversight of non-interventional studies (including the review of any responsibilities relating to such studies, particularly those given to medical representatives). That person must state in writing that he or she has examined the protocol relating to the non-interventional study and that in his or her belief it is in accordance with the requirements of the Code.