The European Medicines Agency (EMA) on Tuesday issued a new version of its questions and answers (Q&A) guide on Article 31 non-pharmacovigilance referrals.
In the EU, an Article 31 referral is a procedure in which member states or the European Commission may request that EMA conduct a scientific review of a medicine for quality, safety or efficacy reasons.
Unlike Article 20 referrals, Article 31 referrals may apply to any medicine or class of medicine authorized within the European Economic Area, regardless of whether it is authorized through a national procedure, mutual recognition procedure, decentralized procedure or centralized procedure.
EMA currently maintains two Q&A guides on Article 31 referrals, one for pharmacovigilance related referrals, which was last updated in May 2015, and one for non-pharmacovigilance related referrals.
While Article 31 pharmacovigilance referrals are made when the issue referred to EMA pertains to safety related issues, Article 31 non-pharmacovigilance referrals are made for quality and/or efficacy issues.
The updated document on Article 31 non-pharmacovigilance referrals includes seven revised sections.
The first four revised sections have to do with questions about the initiation of an Article 31 non-pharmacovigilance referral, such as how products are identified to be included in a referral, and what happens when a product is only authorized in a single member state.
Before a referral procedure is initiated, EMA says it will attempt to identify all authorized medicinal products that will be part of the procedure and publish them in a draft list of identified products. However, EMA notes that it can extend the scope of an Article 31 procedure if additional products are identified.
EMA also clarifies that member states should "take due consideration of the scientific conclusions of the procedure" and apply them to products that were not identified at the start of the procedure.
In cases where a product is only authorized in a single member state, EMA says it will not initiate a procedure, and that the concern should be handled by the member state where the product is authorized.
EMA says it intends to make an effort to contact drugmakers on the Wednesday its Committee for Medicinal Products for Human Use (CHMP) takes up the procedure. However, EMA notes that this notification may be dependent on whether the marketing authorization holder has identified a regulatory point of contact via the EudraVigilance system.
Once a referral has proceeded and CHMP has created a list of questions, EMA says that marketing authorization holders should submit "all available evidence to support the assessment of the impact of the concern being reviewed in the procedure."
Here, EMA says the quality of the documentation sent to the agency is "crucial to the overall assessment," and data "should be intended exclusively for the purposes of the concerned procedure."