Marketing and cessation notification: questions and answers

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This page lists questions that marketing-authorisation holders (MAHs) may have on marketing and cessation notification. 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.

The page only focuses on marketing and cessation information and does not address the requirements to provide in the context of pharmacovigilance, the volume of sales or the volume of prescriptions. For information on these processes, see Questions and answers on the application of the so-called ‘sunset clause’ to centrally authorised medicinal products.

The MAH's obligations for withdrawal of either a pharmaceutical form or strength of a medicinal product in at least one Member State are addressed in Withdrawals and cessation of centrally and nationally authorised medicines: questions and answers.

A PDF version of the entire post-authorisation guidance is available:

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.

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1. What is the meaning of “actual marketing” / “placing on the market”? Rev. October 2013

The definition hereafter is based on the general principles outlined in the Chapter 1 of volume 2A of the Notice to Applicants.

In this context, the terms “actual marketing” and “placing on the market” should be defined as when the medicinal product is “released into the distribution chain” i.e. out of the direct control of the Marketing Authorisation Holder.

References

2. What is the meaning of “cessation of placing on the market”? Rev. October 2013

The definition hereafter is based on the general principles outlined in the Chapter 1 of volume 2A of the Notice to Applicants.

The “cessation of placing on the market” shall be defined by analogy to the placing on the market, as the “cessation of release into the distribution chain” with the consequence that the concerned product may no longer be available for the supply to the patients.

It means that the date of cessation shall be the date of the last release into the distribution chain.

References

3. When to report/notify cessation to the Agency? Rev. August 2014

When the cessation affects a presentation of a centrally authorised product in at least one Member State, the MAH should report such action through the marketing status overview in the context of the “sunset clause monitoring” (see questions 1.4 “When and how to report the Agency with the marketing status overview?” and 1.6 “What information should be reported to the Agency on the medicinal product marketing status?”).

In addition when the cessation affects either a pharmaceutical form or strength of a medicinal product in at least one Member State, a notification should be made to the Agency according to the provisions laid down in article 23a and 123 (2) of Directive 2001/83/EC and article 13 and 14b of Regulation (EU) No 726/2004 via the dedicated mailbox withdrawnproducts@ema.europa.eu using the template cover letter and notification report table “Notification of withdrawn products” (see Questions and answers on the application of the so-called ‘sunset clause’ to centrally authorised medicinal products):

Please note that when the cessation concerns a presentation that may raise a public health concern. The MAH has to exercise his best judgement to determine when it is appropriate to notify such cessation.

References

4. When and how to report the marketing status overview to the Agency? Rev. Aug 2014

The so-called marketing status overview refers to the picture of the marketing situation of a specific product, at one time point of the product life-cycle, per presentation and per Member State.

MAHs should inform the Agency of the marketing status of their medicinal product(s) considering the different situations previously detailed, according to the timelines given hereafter and using the electronic tabular format that is provided.

The MAH should notify the Agency within 30 days of the initial placing on the market of the product within the Union. Thereafter, any subsequent placing on the market or change in the marketing status should be reported through updates provided following the PSUR-cycle timelines and after renewal, annually in accordance with the anniversary of the Commission Decision date. The reporting table should be attached to the cover letter (see also question 1.7 “What is the reporting format to the Agency and to whom to report?”).

An updated report should be provided on a regular basis according to the above mentioned timelines, even if there are no changes in the marketing status of the medicinal product over that period of time.

References

5. What is the intended use of the marketing status reporting for the purpose of the sunset clause monitoring? Rev. October 2013

The marketing status overview/reporting provides data that are the basis for the monitoring of the sunset clause (See also Sunset clause monitoring).

6. What information should be reported to the Agency on the medicinal product marketing status? Rev. August 2014

The actual marketing of a medicinal product shall be reported to the Agency per presentation and per Member State. For centrally authorised medicinal products, presentation corresponds to pack-size.

MAHs shall also report to the Agency any cessation (temporary/permanent) of marketing of their medicinal product per presentation and per Member State.

MAHs are advised that when cessation is due to efficacy, safety and/or quality related issues for which already particular procedures are established, reporting of such cessation is without prejudice to applying the other specific related procedures (e.g. quality defect, pharmacovigilance issues, etc.), as appropriate.

A date is to be reported for actual marketing which shall be defined as Day/Month/Year. By analogy, a cessation in placing on the market should also be defined as an exact date. If MAHs experience difficulties in identifying the exact date, the cessation date should still be defined as D/M/Y, mentioning the last day of the nearest week or month for the purpose of the sunset clause monitoring.

References

7. What is the reporting format to the Agency and to whom to report? Rev. August 2014

MAHs should inform the Agency of the marketing status of their medicinal product(s) using the electronic template provided in question 1.4 “When and how to report the Agency with the marketing status overview?”

Marketing status reports relating either to the first marketing or updates should be sent by the MAH to the mailbox marketingstatus@ema.europa.eu and copy the EMA Product Lead and the medicinal product mailbox. see Questions 1.3 “When to report / notify a cessation to the Agency?” and 1.4 “When and how to notify the Agency with the marketing overview?”).

References

8. Is there a database to collect the marketing status information? Rev. August 2014

To make the reporting for the MAH easier and to facilitate the tracking of this information by the Agency for the purpose of the sunset clause monitoring, the Agency intends to collect data electronically through the EudraVigilance Medicinal Product Dictionary (EVMPD). EVMPD extension will allow a direct and up-to-date reporting by the MAH to the Agency with the view to track a three-year period without marketing so-called “sunset period” and to make the marketing status information public (See also Sunset clause monitoring). This particular functionality within EVMPD is not available yet. The Agency will make a public announcement prior to the entry into force of this extension of the database.

9. Does the Agency intend to publish information about the marketing status of the medicinal products? Rev. August 2014

Currently the marketing status is not published. However, MAHs should be aware that when the particular reporting functionality within EVMPD is set up, the information on availability of the medicinal product and its various presentations per Member State will be made public by the Agency as “marketed”/ “not marketed” based on the data entered in EVMPD by the MAH.

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