It is the responsibility of Competent Authorities (CA) to give the industry advice by answering questions connected with the development of medicinal products. LINK may assist you in the preparation for and execution of Scientific Advice procedures.

• Scientific Advice is limited to scientific issues.
• Scientific Advice may be requested for all medicinal products, irrespective of the subsequent choice of procedure for approval.
• Scientific Advice is prospective in nature. It focuses on development strategies rather than pre-evaluation of data to support a MA application.
• Scientific Advice or Protocol Assistance can be requested during the initial development of the medicinal product but also during the post authorisation phase, and may relate to questions concerning issues on quality, non-clinical and clinical aspects, including pharmacovigilance plans and risk-management programmes.