Email referrals are only accepted from a specific set of professionals where we have a prior agreement. If you are unsure whether your concerns are of a safeguarding nature, please ring and request a consultation with an Early Help advisor.
Help A referral is a procedure used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines.
In a referral, the European Medicines Agency is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the European Union EU.
There are a number of reasons why a referral may be started, ranging from concerns over the safety of a class of medicine to disagreements among Referral article States on the use of the medicine: Referrals can be started by the European Commission, any Member State or by the company that markets the medicine.
Types of referral All referrals are described in the legislative texts that govern how medicines are authorised and monitored in the EU. Safety issues Article i procedures This type of procedure is triggered when a Member State or the European Commission consider that urgent action is necessary because of a safety issue.
Situations that fall under this procedure include consideration for suspension or revocation Referral article the marketing authorisation for a medicine, the prohibition of supply of a medicine or major changes to the marketing authorisation such as deletion of indications, reduction of the recommended dose or new contraindications.
The procedure is also applicable in case of a safety issue with a class of medicines. Information for marketing-authorisation holders on this type of procedure is available under questions and answers: Urgent Union procedure Article i. Safety, quality, manufacturing or efficacy issues Article 20 procedures This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.
Article 20 pharmacovigilance procedures and questions and answers: Article 20 non-pharmacovigilance procedures Article 31 referrals This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.
Article 31 pharmacovigilance referral and questions and answers: Article 31 non-pharmacovigilance referral. Article 13 procedure referral. Article 29 4 referrals This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.
Article 29 4 referral. Article 30 referrals This type of referral is triggered when Member States have adopted different decisions over the years for some medicines e.
Article 30 procedure referral. For more information, see Article 5 3 opinions. Historical referral types A number of referral types are no longer applicable because of changes in European law. The outcomes of a number of these historical referral types are available on this website. Referral type Applicable prior to Article 5 11 referrals This type of referral was triggered for a medicine that had been authorised by mutual recognition or via the decentralised procedure when there was disagreement between Member States on a variation type IB.
January Article 6 12 referrals This type of referral was triggered for a medicine that had been authorised by mutual recognition or via the decentralised procedure when there was disagreement between Member States on a variation type II.
This referral has been replaced by Article 13 referrals. January Article 6 13 referrals This type of referral was triggered by the marketing-authorisation holder for a medicine that had been authorised by mutual recognition or via the decentralised procedure when Member States could not accept the variation type II.
January Article 36 referrals This type of referral applied for a marketing authorisation that were granted via the mutual-recognition or decentralised procedure. It was triggered when a Member State considered that action variation, suspension or withdrawal was needed on the grounds of the need to protect public health.
This referral has been replaced by Articles i and July Article procedures This type of procedure was triggered when a Member State varied, suspended or revoked the marketing authorisation for a medicine in its territory because of a safety issue.
This procedure has been replaced by Article i. July Publication of information on referrals Information on referrals for human medicines is published under referrals.
These pages include information on the referral written in public-friendly language in a question-and-answer format, key facts and all documents related to the referral. For safety-related referrals, it also includes information on how the public can submit data to be considered as part of the assessment and on whether a public hearing is taking place.
In addition, the Agency announces the key steps in referrals: Information on Article 20 procedures was previously published as part of the European public assessment report for the medicine concerned.Employee referral is an internal recruitment method employed by organizations to identify potential candidates from their existing employees' social regardbouddhiste.com employee referral scheme encourages a company's existing employees to select and recruit the suitable candidates from their social networks.
An Article 31 non-pharmacovigilance referral procedure can be initiated by the competent authorities in the Member States (MSs), the European Commission (EC) or by the marketing authorisation holder(s) (MAHs) and/or applicants. Free national musician referral system for musicians seeking bands, bands seeking musicians, music instructors seeking students, and .
Making a Safeguarding Referral. When making a safeguarding referral, it is advised to complete the safeguarding referral form via the link below PRIOR to ringing as it contains prompts for the level of information that will be asked when you make a safeguarding referral.
Sep 08, · A document used by schools detailing some form of a student's misbehavior and listing the actions taken before and after the student's receipt of the referral.
It determined that the affluent would prefer to meet you either 1) through a referral from a friend or colleague, or 2) through a referral from a CPA or other trusted advisor. This article will give you my proven strategy for asking for referrals from your affluent clients (all your clients for that matter).