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 Clause 21 - Scientific Services

​21.1 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.

21.2 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, where appropriate, a pharmacist, 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.

21.3 Companies must disclose details of clinical trials in accordance with the Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases and the Joint Position on the Publication of Clinical Trial Results in the Scientific Literature.

​Clause 21 Supplementary Information

Clauses 21.1 and 21.2 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.

Clause 21.3 Details of Clinical Trials

This clause requires the provision of details about ongoing clinical trials (which must be registered within 21 days of initiation of patients enrolment) and completed trials for medicines licensed for use in at least one country. Further information can be found in the Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases 2009 and the Joint Position on the Publication of Clinical Trial Results in the Scientific Literature 2010, bot at http://clinicaltrials.ifpma.org.

Details about clinical trials must be limited to factual and non-promotional information. Such information must not constitute promotion to health professionals, appropriate administrative staff or the public.