Contacting EMA: post-authorisation
Marketing authorisation holders may need to contact the European Medicines Agency (EMA) in a range of post-authorisation settings. During post-authorisation evaluation procedures, the Product Lead for the medicinal product is the primary contact point, but in certain circumstances there are different ways of contacting EMA.
EMA has a pre-submission queries service for questions about specific post-authorisation procedure types, and it may be necessary to contact EMA outside the scope of a particular evaluation procedure.
The EMA Product Lead assigned to your product is the marketing authorisation holder's (MAH) primary contact point. You should contact the Product Lead for any questions regarding the evaluation procedure.
Other members of the product team may be involved during the evaluation as needed, depending on the type, scope and complexity of the application. They may contact the MAH directly to facilitate discussion on specific aspects of the evaluation.
For specific procedures (post-authorisation safety studies (PASS) and periodic safety update single assessments (PSUSA) for nationally authorised products (NAPs), the MAH should contact the Risk Management Specialist who works in close collaboration with the Product Lead.
When the applicant corresponds with other members of the EMA product team, the Product Lead should always be copied on the correspondence.
For certain procedures (type IA and IB variations, type II variations, transfers of marketing authorisation and Article 61(3)notifications), EMA has a dedicated pre-submission queries service and will nominate a procedure manager upon receipt of those applications.
- EMA pre-authorisation guidance, section 5.1: 'What is the role of the EMA product team?' and 'Who is my contact at EMA during an application evaluation procedure?'
- Type-II variations: questions and answers: 'Who is my contact at the European Medicines Agency during a type II variation, including extension of indications?'
EMA has a pre-submission queries service to respond to questions about specific post-authorisation procedures.
Update: You need an EMA account to use EMA Service Desk. If you do not have one, you can create one via the EMA Account Management portal. For further information or guidance about how to create an EMA Account reference the guidance 'Create an EMA Account'.
Select tab 'Business Services', category 'Human Regulatory', subcategory 'Post-authorisation - Human' and sub-option 'Variation IA queries'
|Type-II variations (clinical, non-clinical and risk management plan variations)|
Please send us your query to IIquery@ema.europa.eu
|Transfer of marketing authorisation|
Select tab 'Business Services', category 'Human Regulatory', subcategory 'Post-authorisation - Human' and sub-option 'MAH transfer queries'
|Article 61(3) notifications (labelling and package leaflet)|
Select tab 'Business Services', category 'Human Regulatory', subcategory 'Post-authorisation - Human' and sub-option 'Article 61(3) Notification queries'
|Article 5 procedure: Regulatory and procedural guidance|
Select tab 'Business Services', category 'Human Regulatory', subcategory 'Post-authorisation - Human' and sub-option 'Article 5 procedure request'
|Periodic safety update reports (PSURs) for nationally authorised products||Send a question to EMA|
|Post-authorisation safety studies (PASS) for nationally authorised products||Send a question to EMA|
The service aims to provide timely pre-submission guidance 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 an EMA procedure manager before submitting an application.
To help the service deal with your query efficiently:
- please provide as much relevant information as possible, including the name of the product;
- if you are uncertain about the type of intended submission, raise your query using the option most likely related to your procedure;
- if the query is related to more than one procedure (e.g. both a type IA and type IB variation), please only raise a single query. EMA will provide a consolidated response.
The 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.
A team of EMA procedure managers with in-depth regulatory knowledge of procedures monitors all such queries. Your query will be assigned to a procedure manager specialising in the procedure concerned.
The procedure manager will endeavour to send a response within ten 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 ten 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.
The Product Lead can equally discuss a variety of other product-related issues during the post-authorisation phase that are not linked to a specific evaluation procedure (i.e. not related to a variation, extension, renewal, annual-reassessment, PSUR, referral, post-authorisation measure or an administrative procedure). For instance:
- upcoming shortages in supply of the medicinal product;
- information about emerging safety issues;
- provision of important late-breaking information that potentially impacts the product profile or the marketing authorisation;
- withdrawal of the marketing authorisation.
Communication through the Product Lead is supplementary to, not replacing, the formal reporting requirements and established reporting channels where they exist, e.g. for pharmacovigilance reporting. For more information, see Contacts at the European Medicines Agency.
For initial marketing authorisation applications, EMA assigns a Product Lead at the eligibility stage of the application and can be contacted for any pre-submission queries. For more information, see Pre-authorisation guidance.
Applicants and MAHs are required to notify the Agency of any upcoming changes to the following contact people as specified in the application form for initial marketing authorisation (sections 2.4.1-2.4.5 and 18.104.22.168), so that the EMA databases can be updated accordingly:
- contact person at the MAH address (referred to in section 2.4.1 of the application form). As this contact person is used by the European Commission for notification of Commission decisions to the MAH, this information should be kept up to date and any changes (including during the post-authorisation phase) notified to the Agency promptly;
- person or company authorised for communication between the MAH and the competent authorities (referred to in sections 2.4.2 and 2.4.3 of the application form). Section 2.4.2 refers to changes to the contact person during the initial application for marketing authorisation. After authorisation of the medicinal product, changes to the person or company authorised for communication with the Agency (referred to in section 2.4.3 of the application form) should be notified to the Agency promptly;
- qualified person in the European Economic Area (EEA) for pharmacovigilance (referred to in section 2.4.4 of the application form).
With regard to the qualified person in the EEA for pharmacovigilance (QPPV), please refer to question “How to inform the authorities of a change in the summary of the pharmacovigilance system?” in the Pharmacovigilance system section of the post-authorisation guidance.
- Scientific service of the MAH in the EEA as referred to in Article 98 of Directive 2001/83/EC (referred to in section 2.4.5 of the application form)
- Contact person in the EEA for product defects and recalls, as defined in Article 79 of Directive 2001/83/EC (referred to in section 22.214.171.124 of the application form)
Any of the above changes should be submitted via EMA Service desk, selecting the tab “Business Services”, category “Human Regulatory”. The subcategory to be selected is “Administrative Request - Human”, followed by the sub-option “Notification of changes to Contact Person(s)” and the filled-in template on company headed paper.
- If you are already registered for an EMA hosted system, your email enquiry will be logged in the new EMA Service Desk portal on your behalf. You will shortly receive an email confirmation with the assigned enquiry number.
- If you are not registered for an EMA hosted system,please register yourself with the EMA Service Desk portal (https://servicedesk.ema.europa.eu/jira/servicedesk/customer/portal/23/create/30). After you have activated your account, you will receive a login/password via email.
For more information, see: EU-CTD Module 1.2 Application Form.