You can use this notification form to submit various kinds of notifications. On this page you can find additional details and a clarification of the notification procedures.

General remarks

At the Medicine shortages and defects notification centre, marketing authorisation holders and manufacturers can submit the following notifications:

  • A medicinal product is placed on the market for the first time, or again following an interruption
  • The marketing of a medicinal product is being discontinued or interrupted (including a possible shortage). Please note: When you place a medicine on the market again, you must submit a new notification via the notification form. This applies to any period of a shortage.
  • A possible shortage because a medicinal product is being placed on the market in smaller quantities or to an insufficient degree 
  • A quality defect in relation to a medicinal product 

To submit the above notifications you must use the notification form.

Please note: You must complete a separate form for each medicinal product. A medicinal product is defined as all strengths and pharmaceutical forms of a medicinal product together.

If you need assistance with filling in the notification form, you can contact the Notification Centre.

A notification that a medicinal product is placed on the market for the first time, or again following an interruption

Clarification:

  • Here you can give notice that you are placing a medicinal product on the market.
  • This notification is obligatory for medicinal products which have a marketing authorisation.
  • This obligation does not apply to parallel import marketing authorisations.
  • Here you can also give notice that you are placing a medicinal product on the market again following a shortage. Please note: When submitting for the first time, you enter an indication of the date that the medicine will be on the market again. As soon as the medicine is on the market again, you submit a new notification stating the specific date.
  • You only have to submit this notification at the level of pharmaceutical form and strength, for products with a marketing authorisation granted via the national procedure as well as for products with a marketing authorisation granted via the centralised procedure. You do not have to submit a notification when it concerns only one (or a part) of the packaging forms/sizes from a group with the same pharmaceutical form and strength.

A notification that the marketing of a medicinal product is being discontinued or interrupted (including a possible shortage)

Clarification:

  • Such a notification can also be used to report the corresponding expected or unexpected shortages.
  • In accordance with Article 49.7 of the Medicines Act, this is an obligatory notification for medicinal products with a marketing authorisation. If you, as a marketing authorisation holder, temporarily suspend the marketing of a medicinal product and there is insufficient stock of your own medicinal product on the market, at wholesale suppliers and pharmacies to compensate for the temporary interruption, the situation will be one that must be reported to the Medicine shortages and defects notification centre.
  • This obligation does not apply to parallel import marketing authorisations.
  • You do not have to submit a notification if you, as a marketing authorisation holder, temporarily suspend the marketing of a medicinal product while there is still sufficient stock of your own product on the market, at wholesale suppliers and pharmacies to prevent the interruption leading to a shortage.
  • You only have to submit this notification at the level of pharmaceutical form and strength, for products with a marketing authorisation granted via the national procedure as well as for products with a marketing authorisation granted via the centralised procedure. You do not have to submit a notification when it concerns only one (or a part) of the packaging forms/sizes from a group with the same pharmaceutical form and strength.

A notification of a possible shortage because a medicinal product is being placed on the market in smaller quantities or to an insufficient degree

Clarification:

  • Such a notification can also be used to report the corresponding expected or unexpected shortages.
  • In accordance with Article 49.9 of the Medicines Act, this is a voluntary notification for medicinal products with a marketing authorisation. This article states that the marketing authorisation holder must ensure that sufficient quantities of the medicinal product to which the marketing authorisation relates are in stock for wholesale suppliers or pharmacies to fulfil patient requirements.
  • If a situation arises in which a marketing authorisation holder delivers less of a medicinal product, or cannot meet the increased demand, without suspending the marketing of the product, with this leading to a possible shortage, this situation can also be reported.
  • You only have to submit this notification at the level of pharmaceutical form and strength, for products with a marketing authorisation granted via the national procedure as well as for products with a marketing authorisation granted via the centralised procedure. You do not have to submit a notification when it concerns only one (or a part) of the packaging forms/sizes from a group with the same pharmaceutical form and strength.
  • You can also submit this notification to report (possible) shortages of medicine packages.

Notification of a quality defect in relation to a medicinal product

Clarification:

  • You can submit this notification for medicinal products with a marketing authorisation, parallel import marketing authorisations and medicinal products without a marketing authorisation.
  • In accordance with section 8 of the EU Good Manufacturing Practice (GMP), you must report a quality defect if it relates to batches of the medicinal product which are on the market and which can result in a recall or an abnormal supply restriction. If you are the manufacturer, you must also report batches which have been marketed elsewhere in the world.
  • Quality defects related to medicinal products with a marketing authorisation granted via the centralised procedure must be reported to the EMA and not to the Medicine shortages and defects notification centre. Please note: You can identify the authorisation by it having an EU number rather than an RVG number.
  • In the event of parallel distribution of medicinal products for which a marketing authorisation has been granted via the centralised procedure, quality defects must be reported to both the EMA and the Medicine shortages and defects notification centre.
  • You can also submit this notification to report instances of falsification or theft of a medicine.