This page lists questions that marketing-authorisation holders (MAHs) may have on pre-submission queries service. It provides an overview of the European Medicines Agency's position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Revised topics are marked 'New' or 'Rev.' upon publication.
A PDF version of the entire post-authorisation guidance is available:
- European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.
MAHs must in all cases comply with the requirements of Community legislation. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text.
- 1. What is the pre-submission queries service? Rev. June 2016
The pre-submission queries service is a service set up to respond to pre-submission queries that marketing authorisation holders (MAHs) may have in relation to the following post authorisation procedures: types IA and IB variations, marketing authorisation transfers, Article 61(3) notifications, PSURs for Nationally Authorised Products (NAPs), and post-authorisation safety studies (under Article 107n/q) for Nationally Authorised Products.
The service aims to provide timely regulatory procedural pre-submission guidance to MAHs to facilitate the validation of these post-authorisation applications. It allows MAHs to receive specific regulatory guidance on planned applications and to discuss any pre-submission questions with a procedure manager before submitting an application.
This service does not address pre-submission queries for type II variations, renewal applications (including annual re-assessment and annual renewal procedures), extension applications, post-authorisation measures (PAMs) and PSUR for centrally authorised products, for these applications, please contact the procedure manager responsible for the product. For initial marketing authorisation application a PM is assigned at the eligibility stage of the application and can be contacted for any pre-submission queries.
- 2. How should I send queries to the pre-submission queries service? Rev. June 2016
You should send queries via email using one the following email addresses:
- Type IA variations: IAquery@ema.europa.eu
- Type IB variations: IBquery@ema.europa.eu
- PSURs for Nationally Authorised Products: firstname.lastname@example.org
- Marketing authorisation transfers: email@example.com
- Article 61(3) notifications: firstname.lastname@example.org
- Post-authorisation safety studies for Nationally Authorised Products: email@example.com
To help the service deal with your query, please provide as much relevant information as possible in your correspondence, not forgetting to include the name of the product.
If you are uncertain about the type of intended submission, send your query to the email address most likely related to your procedure. If the pre-submission query is related to more than one procedure (e.g. both a type IA and type IB variation), send the query to only one of the relevant email addresses. We will provide a consolidated response.
The pre-submission queries service should always be the first point of contact for the above mentioned procedures, including for products with a high number of upcoming post-authorisation procedures requiring detailed discussion where the product team would be involved.
- 3. How will my query be handled by the pre-submission queries service?
A team of procedure managers with in-depth regulatory knowledge of procedures monitors all queries we receive. Your query will be assigned to a procedure manager specialising in the procedure concerned by your query. An internal peer review process of the response is in place to ensure consistency in the advices provided.
Queries received & advice provided to the MAHs are also recorded to ensure consistency of the responses provided and identify areas for improvement of the existing post-authorisation guidance published on the Agency website.
- 4. When can I expect to receive a response to my query? NEW July 2015
The procedure manager will endeavour to send a response within 5 working days of the receipt of the query. You will receive along with your response the contact details of the procedure manager who handled your query in case you need further clarification, such as teleconference, related to the same query.
For complex queries where more internal consultation than usual is required, it may take more than 5 days to send a response. In those cases, you will be informed of the extra consultation and of the delay in sending you a response.
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