Status Video Download Market
Glenda Cavicchia
This page lists questions relating to the notification of marketing and cessation, suspension, withdrawal of a medicinal product from the market and withdrawal of a marketing authorisation. It also covers 'sunset-clause' monitoring.
The monitoring of marketing status of medicinal products aims to increase communication and transparency on availability of medicinal products across the Union and potential safety issues and to allow consideration on the need for action in different Member States or at EU level.
In accordance with Article 13(4) of Regulation (EC) No 726/2004, Marketing Authorisation Holders are required to inform EMA if their centrally-authorised product ceases to be placed on the market of a Member State, either temporarily or permanently.
This marketing status reporting also aims to increase transparency on availability of medicinal products across the Union and to enable EMA and National Competent Authorities to consider the need for action in different Member States or at EU level to protect Public Health.
The so-called marketing status overview refers to the picture of the marketing situation of a specific medicinal product, at one time point of the product life-cycle, per presentation and per Member State. As of July 2021, the EMA is using the IRIS database to collect the marketing status notifications for centrally-authorised products and to provide an up-to-date overview to the EU Member States. (see question How to report marketing status updates to the Agency for CAPs?)
MAHs should inform the Agency of the marketing status of their centrally authorised medicinal product(s), at the time of the initial placing on the market and for any subsequent changes in marketing status (i.e. temporary marketing cessation, reintroduction on the EU market or permanent cessation), for each presentation and in each Member State, according to the timelines given hereafter:
Since the IRIS database is intended to be kept up-to-date with the marketing status of centrally authorised medicinal products, it is no longer needed to provide an annual update to the Agency at the time of anniversary of the Commission Decision on the central marketing authorisation. However an overview of the marketing status of medicinal products is still expected to be provided within PSUR and renewal applications.
- For authorised CAPs not yet marketed in any EU/EEA MS, MAHs should report the initial placing on the market of relevant presentations and any subsequent marketing status updates directly via the IRIS platform.
- For authorised CAPS already marketed in at least one EU/EEA MS, MAHs will progressively upload the marketing status of their CAPs in IRIS during a 9-months transition period (baseline data). Whilst it is allowed to report changes to the marketing status of their CAPs via the existing process (emails) during the transition period, once the baseline data have been submitted in IRIS, reporting of changes to the marketing status should continue in IRIS.
For CAPS already marketed in at least one EU/EEA MS, MAHs should progressively upload the marketing status of their CAPs in IRIS during a 9-months transition period (baseline data). To upload the baseline data, the same options available to report marketing status updates can be used, i.e. single or bulk upload. For detailed information on how to perform the submission, see IRIS technical guidance (sections 6.1 and 6.2).
During the 6-month transition period where IRIS is progressively being populated with marketing status data of CAPs, MAHs can continue to report the marketing status updates of their already marketed CAP via emails as per the existing process until the baseline data are submitted into IRIS:
In case of an emerging safety issue (ESI), should the MAH decide to take any action with regards to the marketing of the medicinal product or to the marketing authorisation of this medicinal product, the notification of such action to the Agency should be done in parallel to the notification to the ESI mailbox (P-PV-emerging...@ema.europa.eu).
As of end of July 2021, EMA uses the IRIS database to collect marketing status updates in the different EU/EEA Member States including withdrawn product notifications for centrally-authorised products and this information will be accessible to the National Competent Authorities and the European Commission. Notifications of withdrawn products received by email for NAPs will continue to be forwarded to EEA Competent Authorities as per the existing process.
The MAH should send by email a request for withdrawal of the marketing authorisation to the European Commission (SANTE-PHA...@ec.europa.eu and SANTE-PHARMA...@ec.europa.eu) keeping in copy the EMA Product Lead, the CHMP/PRAC/CAT Rapporteurs (as applicable), Chairs and Vice chairs of relevant committees and the EMA withdrawn products mailbox (withdraw...@ema.europa.eu).
- The proposed effective date for the withdrawal of the MA. The withdrawal of the MA will become effective on the EC notification date by default (e.g. usually within two months of the MAH request), or by any date agreed with the European Commission and specified in the Commission decision withdrawing the marketing authorisation. The MAH is therefore invited to clarify in their request if they would like to suggest a withdrawal date more than the two-month after their request to withdraw the marketing authorisation.
- How the MAH will approach the continued use of any remaining product, as they will continue to be responsible for any remaining product on the market(s); The MAH should therefore ensure that any product remaining on the market has been produced according to current GMP standards and that the QP responsible for batch release remains fully responsible for any remaining product that may still be in the market, including continuous monitoring of any product defects. Further, the MAH should ensure that the Pharmacovigilance System is still fully active in monitoring any safety signals that may arise from the usage of the withdrawn product and that the QP responsible for Pharmacovigilance is still maintaining all responsibilities for the product (whilst stock remains).
Provided that the withdrawal is solely based on commercial reasons (i.e. the withdrawal of the marketing authorisation is not linked to underlying quality, safety, efficacy or benefit/risk issues), it is agreed at EU level that there is no need for batch recalls for CAPs, the medicinal product can remain on the EU market until expiry date. The MAH remains responsible for the batches on the market and for pharmacovigilance activities.
MAHs are also required to notify the EMA of any action taken outside the EEA to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market, to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation, when such action is based on any of the grounds set out in Article 116 or Article 117(1) (e.g. quality, safety or efficacy issue).
As of July 2021, EMA uses the IRIS database to collect an overview of the marketing status of centrally authorised products in the EU/EEA/UK(Northern Ireland) (at presentation level) Currently these marketing status data are only shared with the National Competent Authorities and the European Commission.
Therefore, for centrally-authorised medicinal products for which a MA has been granted before 20 November 2005 and for which no presentation are marketed in the Union at this date, the three-year period which leads to cessation of the MA will start as of 20 November 2005.
The marketing authorisation of a centrally authorised medicinal product includes the initial marketing authorisation and all variations (e.g. additional presentations) and extensions (e.g. new strengths, new pharmaceutical forms) authorised for this specific medicinal product. This notion has been applied since the beginning of the centralised procedure and is reflected in the way the EU numbers are allocated to a specific centrally authorised medicinal product and all its presentations.
A three-year period without marketing of a medicinal product in the EEA can be encountered further to the granting of the marketing authorisation: when a medicinal product has never been marketed or, after marketing of a medicinal product has been completely stopped.
As of end of July 2021, the EMA uses the IRIS database to collect marketing status updates and monitor the sunset clause provision for centrally authorised medicinal products. This is done in view to notify the Commission when a three consecutive year period without marketing has elapsed and that the sunset clause provision should take effect.
The determination of the start of the 3-year period from granting of the marketing authorisation should be the date when the medicinal product can be marketed by the marketing authorisation holder, taking into account, e.g. marketing protection and other protection rules which have to be respected.
However, where data protection rules applies to reference products, the 3-year period for generic, hybrids and similar biological medicinal products will start as of the end of the 10 or 11-year of marketing protection period of the concerned reference medicinal product.
At the time of the granting of the marketing authorisation, the medicinal product may not be immediately placed on the Community market. As a consequence, the sunset timer will start running from the granting of the marketing authorisation by the Commission or when the MAH can legally place the medicinal product on the market. (see also question 5 of this Q&A listing: "In case of a protection period to be respected before placing the medicinal product on the market, when will the sunset clause period start counting?")
The MAH is obliged to inform the Agency of any product cessation (see question 1 of the Marketing and cessation notification Q&A listing). When there is no longer any presentation of the medicinal product placed on the Community market, the sunset timer will start running from the last date of release into the distribution chain of the medicinal product.
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