Companies wishing to apply for scientific advice or protocol assistance from the European Medicines Agency should follow the procedure below.
- Complete a letter of intent using the template letter of intent and prepare a briefing document giving an introduction to the medicine under development, and the company's questions and positions. The Agency strongly recommends that companies use the briefing document template. Send these documents to the Agency via EudraLink. Note that the Agency only accepts electronic submissions.
- Send the letter to firstname.lastname@example.org. The letter should be sent approximately seven weeks in advance before the intended submission date if a pre-submission meeting is required. Otherwise, the letter should be sent three weeks in advance.
- Attend a pre-submission meeting, if requested.
Full details on how to apply are available in the guidance for companies.
Unique product identifier number (updated)
The Agency will automatically assign unique product identifier (UPI) numbers to medicines reaching the Agency for the first time through an application for scientific advice or protocol assistance.
Applicants will receive the UPI number by e-mail. They should quote this number every time they contact the Agency for any matter related to this specific medicine.
The Agency offers assistance to applicants in putting their scientific-advice or procedural-advice requests together through pre-submission meetings. These meetings are free of charge.
Pre-submission meetings are an opportunity for companies to:
- introduce their proposed development programme and receive feedback from Agency staff;
- receive feedback on the list of questions to be included in the request for scientific advice, with a view to obtaining satisfactory answers;
- identify additional issues to be included in the request for scientific advice;
- obtain more detailed information concerning the procedure for obtaining scientific advice or protocol assistance;
- ask regulatory questions that are outside the scope of scientific advice;
- establish contact with Agency staff involved with the application.
The meetings also allow the Agency to identify whether additional expertise needs to be be involved at an earlier stage in the procedure.
The Agency emphasises the importance of presubmission meetings, especially for first-time users of these procedures, for micro-, small- and medium-sized enterprises (SMEs), and for companies seeking general advice on specific types of medicinal products or therapies.
The discussion during the presubmission meeting is based on the information provided by the company. Scientific opinions expressed represent the personal views of the Agency participants and do not represent the final opinion of the Scientific Advice Working Party (SAWP) or Committee for Medicinal Products for Human Use (CHMP).
Applicants should submit a draft version of their request, such as a briefing document including questions or the company's position and a detailed table of contents in Microsoft Word format, at least five working days ahead of the presubmission meeting to email@example.com.
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- European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance (2014-10-14)
- Dates of 2016 Scientific Advice Working Party meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel European Medicines Agency-health-technology-assessment requests (2016-09-28)
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- Dates of 2015 Scientific Advice Working Party meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel European Medicines Agency / health-technology-assessment requests (2015-07-28)
- CHMP protocol assistance scientific advice briefing document template (2016-02-12)