7.

However, in the cover letter it is not necessary to reproduce information already contained in the EU application form, with the following exceptions: specific features of the clinical trial population, such as subjects not able to give informed consent, minors and pregnant or breastfeeding women; whether the clinical trial involves the first administration of a new active substance to humans; whether scientific advice relating to the clinical trial or the investigational medicinal product has been given by the Agency, a Member State or a third country; whether the clinical trial is part or is intended to be part of a Paediatric Investigation Plan (PIP) as referred to in Title II, Chapter 3, of Regulation (EC) No 1901/2006 (if the Agency has already issued a decision on the PIP, the cover letter contains the link to the decision of the Agency on its website); whether investigational medicinal products or auxiliary medicinal products are a narcotic, psychotropic or radiopharmaceutical; whether the investigational medicinal products consist of or contain a genetically-modified organism or organisms; whether the sponsor has obtained an orphan designation for the investigational medicinal product for an orphan condition; a comprehensive list, including the regulatory status, of all investigational medicinal products and a list of all auxiliary medicinal products; and a list of medical devices which are to be investigated in the clinical trial but which are not part of the investigational medicinal product or products, together with a statement as to whether the medical devices are CE-marked for the intended use.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.