MUTUAL RECOGNITION PROCEDURE | PROCESS FLOW CHART

The mutual recognition procedure and decentralised procedure must be used for applications for marketing authorisation for medicinal products in more than one Member State. The requirements of submitting an application are described in section 3 and 4. Once the procedure has been used, all variations to these medicinal products must use the procedure foreseen in the Variations Regulation.

The mutual recognition procedure and decentralised procedure must be used for applications for marketing authorisation for medicinal products in more than one Member State. The requirements of submitting an application are described in section 3 and 4. Once the procedure has been used, all variations to these medicinal products must use the procedure foreseen in the Variations Regulation.

June 13, 2023

| EU, Procedures

The mutual recognition procedure (MRP) is the European Union-wide procedure through which a granted marketing authorisation of a medicine in one European Union Member State is recognised in other EU countries.

The legal provisions covering the mutual recognition procedure for human medicinal products are contained in Directive 2001/83/EC.

The process of a MRP is quite challenging and there are a lot of timelines to be kept.

We have summarized all MRP steps in this flow chart for you to download and keep always at hand. You can view it here:

Infografia MRP ASPHALION.

For further information, you can contact us at: info@asphalion.com

Search News & Events

EVENT | Symposium AEFI 2024

May 7, 2024

¡Mañana arranca el 42º Symposium de AEFI! No olvidéis visitarnos en la mesa 6 para conocer de todos los servicios que ofrecemos. Os recordamos los

EVENT | RAPS Euroconvergence

May 6, 2024

Dates: May 6-8 | Berlin Congress Centre Day 1 at RAPS! ASPHALION’s team is in Berlin!! Come by booth B2 to get to know us

NEWS | María Jesús Lamas, Director of the Spanish Agency for Medicines, on HTA and its Impact

April 26, 2024

The director of the Spanish Agency for Medicines (AEMPS), María Jesús Lamas, gave an interview where she discusses HTA and its impact. Here are the

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.

Necessary

Always Enabled

Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.

Cookie	Duration	Description
cookielawinfo-checkbox-advertisement	1 year	Set by the GDPR Cookie Consent plugin, this cookie records the user consent for the cookies in the "Advertisement" category.
cookielawinfo-checkbox-analytics	1 year	Set by the GDPR Cookie Consent plugin, this cookie records the user consent for the cookies in the "Analytics" category.
cookielawinfo-checkbox-necessary	1 year	Set by the GDPR Cookie Consent plugin, this cookie records the user consent for the cookies in the "Necessary" category.
cookielawinfo-checkbox-others	1 year	Set by the GDPR Cookie Consent plugin, this cookie stores user consent for cookies in the category "Others".
CookieLawInfoConsent	1 year	CookieYes sets this cookie to record the default button state of the corresponding category and the status of CCPA. It works only in coordination with the primary cookie.
elementor	never	The website's WordPress theme uses this cookie. It allows the website owner to implement or change the website's content in real-time.
viewed_cookie_policy	1 year	The GDPR Cookie Consent plugin sets the cookie to store whether or not the user has consented to use cookies. It does not store any personal data.
wpEmojiSettingsSupports	session	WordPress sets this cookie when a user interacts with emojis on a WordPress site. It helps determine if the user's browser can display emojis properly.

Analytics

Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.

Cookie	Duration	Description
_ga	1 year 1 month 4 days	Google Analytics sets this cookie to calculate visitor, session and campaign data and track site usage for the site's analytics report. The cookie stores information anonymously and assigns a randomly generated number to recognise unique visitors.
_ga_*	1 year 1 month 4 days	Google Analytics sets this cookie to store and count page views.
_gat_gtag_UA_*	1 minute	Google Analytics sets this cookie to store a unique user ID.
_gid	1 day	Google Analytics sets this cookie to store information on how visitors use a website while also creating an analytics report of the website's performance. Some of the collected data includes the number of visitors, their source, and the pages they visit anonymously.

Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.

Cookie	Duration	Description
VISITOR_INFO1_LIVE	6 months	YouTube sets this cookie to measure bandwidth, determining whether the user gets the new or old player interface.
VISITOR_PRIVACY_METADATA	6 months	YouTube sets this cookie to store the user's cookie consent state for the current domain.
YSC	session	Youtube sets this cookie to track the views of embedded videos on Youtube pages.
yt-remote-connected-devices	never	YouTube sets this cookie to store the user's video preferences using embedded YouTube videos.
yt-remote-device-id	never	YouTube sets this cookie to store the user's video preferences using embedded YouTube videos.
yt.innertube::nextId	never	YouTube sets this cookie to register a unique ID to store data on what videos from YouTube the user has seen.
yt.innertube::requests	never	YouTube sets this cookie to register a unique ID to store data on what videos from YouTube the user has seen.

Others

Functional

About

Team

Partners

CSR

Careers

MUTUAL RECOGNITION PROCEDURE | PROCESS FLOW CHART

Search

Filter by category

Related news and events

EVENT | Symposium AEFI 2024

EVENT | RAPS Euroconvergence

NEWS | María Jesús Lamas, Director of the Spanish Agency for Medicines, on HTA and its Impact

About

Team

Partners

CSR

Careers

MUTUAL RECOGNITION PROCEDURE | PROCESS FLOW CHART

Search

Filter by category

Related news and events

EVENT | Symposium AEFI 2024

EVENT | RAPS Euroconvergence

NEWS | María Jesús Lamas, Director of the Spanish Agency for Medicines, on HTA and its Impact

Schedule a Free Meeting