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Established products to exit EU list of Black Triangle Products ?

The EMA Management Board discussed a report showing that many established products enter the list of medicines subject to additional monitoring.

As reported to our clients in September 2018 (Report NĀ°148), the EMA has published the minutes of the 100th Management Board meeting (1), which took place on 06 and 07-Jun-2018.

The Board discussed a great variety of topics, including Brexit and lessons learnt after the first EMA Public Hearing. It also included a discussion on a report exploring the experience made with the list of products subject to additional monitoring (2), also known as the list of Black Triangle Products.

As described in GVP Module X (3), all medicines on the list must be identified with an inverted Black Triangle, which is displayed in their package leaflet and in the SmPC. This system was derived from the Black Triangle scheme already in place in the UK to highlight the medicines under close scrutiny by the authorities, which was expanded throughout Europe with the implementation of the 2010 Pharmacovigilance Legislation. The EMA published the list for the first time in April 2013 and it is reviewed every month by the PRAC.

Photo by Danilo Alvesd on Unsplash

There are a few reasons that can make a medicine enter the list, knowing that it should remain on the list for 5 years unless the PRAC decides otherwise:

  • It contains a new active substance or a new biological/biosimilar product
  • It has been given a conditional approval, or approved under exceptional circumstances or with specific obligations on the recording of suspected ADRs
  • The company that markets the medicine is required to conduct a post-authorisation safety study (PASS)

One of the main conclusions of the report discussed by the Board is that the latter criterion has led to the inclusion of a large number of established products in the list (see item B.9 in the minutes). This is reportedly of limited value and the PRAC supports that this category of products should be removed from the scope of additional monitoring.

Based on the current list (4), i.e. Revision 58 dated 25-Jul-2018, there are 57 out of 346 active substances that are on the list only because of a required PASS. They are not all established products but those are easy to spot because the number of products and MAHs concerned is so large that they need to be presented in Annexes separate to the list. For example, the list of Domperidone-containing medicinal products (Annex X) is 6 pages long. Even though each formulation / MAH / Country is presented, it still concerns a large number of products indeed.

Based on the report and the opinion of the PRAC Committee, this may change in the future and these products would no longer qualify for the Black Triangle scheme in the EU. Following endorsement by the Heads of Medicines Agencies (HMA), the report will be sent to the European Commission for further consideration and decision by the European Parliament and Council.


(1) EMA – Minutes of the 100th meeting of the Management Board, 06 to 07-Jun-2018: Link here

(2) EMA webpage – Medicines under additional monitoring: Link here

(3) EMA Guideline on Good Pharmacovigilance Practices (GVP) Module X ā€“ Additional monitoring: Link here

(4) EMA webpage – List of medicines under additional monitoring: Link here

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