Certain women may start treatment with Esmya once the new measures are implemented. In addition, use of the medicine for more than one treatment course has been restricted to women who are not eligible for surgery. Esmya is used to treat moderate to severe symptoms of uterine fibroids benign tumours of the womb. The medicine has been shown to be effective at reducing bleeding and anaemia associated with the condition, as well as the size of the fibroids.
It provides an overview of the European medicines Agency's practical and operational aspects with regards to handling of Article 31 non- pharmacovigilance referral procedure.
Revised topics are marked 'New' or 'Rev. A PDF version of these questions and answers is available: These questions and answers are for guidance only, and should be read in conjunction with the rules governing medicinal products in the European Union, Volume 2A, chapter 3, notice to applicants.
Initiation of an Article 31 non-pharmacovigilance referral Expand all 1. What is the legal basis of an Article 31 non-pharmacovigilance referral?
It applies where the interests of the European Union are involved, and when the procedure is initiated as a result of the evaluation of data other than data relating to the pharmacovigilance 1 of authorised medicinal product s or application s.
Notice to applicants, volume 2A Procedures for marketing authorisation, Chapter 3 Union Referral Procedures 1 When the procedure is initiated as a result of the evaluation of data relating to the pharmacovigilance activities of authorised medicinal product sthe procedure for an Article 31 pharmacovigilance referral will apply, and in such cases the matter should be referred to the Pharmacovigilance Risk Assessment Committee PRAC.
In which situations can an Article 31 non-pharmacovigilance referral be initiated? In such cases the matter will be referred to the Committee for Medicinal Products.
The term 'interest of the Union' refers particularly to the interests of public health related to medicinal products in the Union for example in light of concerns related to the quality and efficacy of a medicinal product and to the free movement of products within the Union.
Who can initiate an Article 31 non-pharmacovigilance referral?
The notification will identify the concern and question s referred to the CHMP for consideration. The notification will also include a detailed explanation of the issue raised, and should address how the Union interests are involved. Only the MS concerned or the EC can identify the question. The notification will be publicly available at the start of the procedure please refer to Question 8.
Can a Member State take regulatory action during an Article 31 non-pharmacovigilance referral? A Member State MS may, where urgent action is necessary to protect public health, suspend the marketing authorisation at any stage of the procedure, and prohibit the use of the medicinal product concerned on its territory until a definitive decision is adopted.
Which medicinal products can be involved in an Article 31 non-pharmacovigilance referral? All medicinal products affected by the concern and with a valid marketing authorisation MA in the European Economic Area EEA will be included in the Article 31 non- pharmacovigilance referral.
This includes all medicinal products affected by the concern, regardless of whether the MA was granted nationally including via the mutual recognition and decentralised procedures or via the centralised procedure.
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