How to submit a scientific advice or protocol assistance request
- Complete a letter of intent using the 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 email@example.com. For submission deadlines, see Scientific advice and protocol assistance: Regulatory and procedural guidance.
- Attend a pre-submission meeting, if requested.
Full details on how to apply are available in the guidance for companies .
New: In the context of preparedness for the UK's withdrawal from the European Union (EU), EMA advises UK-based micro, small and medium-sized enterprises (SMEs) to note the deadlines below for applying for scientific advice and protocol assistance in order to be eligible for financial fee incentives:
|Start of procedure||Application deadline with pre-submission meeting||Application deadline without pre-submission meeting|
|11 – 14 February 2019||7 December 2018||18 January 2018|
12 – 15 March 2019
(Please note that this meeting will be held in Amsterdam, The Netherlands)
|18 January 2019||15 February 2019|
For applications after 29 March 2019, financial fee incentives for scientific advice will only be accessible through:
- an SME legal entity in the European Economic Area (EEA);
- indirectly through an SME regulatory consultancy established in the EEA;
For more information, see question 9 of Guidance related to the United Kingdom's withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the Centralised Procedure.
In addition, to be eligible for orphan fee incentives for protocol assistance, an SME needs to meet the following conditions at the start of the procedure:
- a decision by the European Commission on the orphan designation must be in place (product registered in the Community Register);
- the applicant for protocol assistance and the sponsor of the designation must be the same entity and qualified as an SME (companies are reminded that the transfer of orphan designation must be fully completed before 30 March 2019);
- the indication for which advice is sought must match the orphan designation indication.
The above advice is provided in view of the planned UK’s withdrawal from the EU as of 30 March 2019. Until ratification of the withdrawal agreement and the transitional arrangements contained therein, preparations should continue on the assumption that EU rules in the field of medicinal products no longer apply to the United Kingdom from 30 March 2019.
For more information, see Brexit-related guidance for companies.
New: EMA uses research product identifiers (RPIs) to track medicines through pre-authorisation procedures. The RPI replaces the previously-used unique product identifiers (UPIs). EMA has converted previously assigned UPIs into RPIs.
Applicants need to use this RPI every time they contact the Agency for any matter related to this specific medicine.
For guidance, including on obtaining any preliminary registration for the active substance(s) in the product, see:
The continuing assignment of RPIs contributes to the Agency's initiatives to improve the efficiency of its processes. It also helps create a unique platform for all pre-authorisation activities.
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 there is a need for additional expertise 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.
From September 2018, presubmission meetings for scientific advice will be held via teleconference only. Organising these meetings by teleconference is more practical during this period due to the relocation of EMA to Amsterdam. The majority of presubmission meetings are currently held by teleconference (70% of meetings in the last 12 months) and there is no difference in the quality of the meeting and in applicants’ satisfaction with the usefulness of the meeting.
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 firstname.lastname@example.org.