Apply for a BAN
Applying for a British Approved Name (BAN) involves submitting an application with scientific data as detailed below to the British Pharmacopoeia Secretariat for review and evaluation by expert committees. After approval, the assigned BAN is published in the British Pharmacopoeia, becoming the official name for the substance in the UK.
The main steps in the BAN application process are:
Step One: Submitting an Application
The first step is to submit an application to the British Pharmacopoeia Secretariat. The application should include comprehensive scientific data and documentation supporting the need for a new BAN. This information typically includes details about the substance's pharmacological properties, therapeutic uses, chemical structure, and existing nomenclature.
Step Two: Review and Evaluation
The application is reviewed by the British Pharmacopoeia Secretariat and relevant expert committees within the British Pharmacopoeia Commission (BPC). They assess the scientific validity, uniqueness, and suitability of the proposed name based on established criteria.
Step Three: Stakeholder Consultation
In certain cases, the BPC may seek external opinions and consult with relevant stakeholders, such as regulatory authorities, professional bodies, and industry representatives. This consultation helps ensure a comprehensive evaluation of the proposed BAN.
Step Four: Decision-making Process
Based on the application, review process, and stakeholder input, the BPC makes a decision regarding the suitability of the proposed BAN. If approved, the BAN is officially assigned and included in the British Pharmacopoeia.
Step Five: Publication
The assigned BAN, along with its relevant specifications and guidelines, is published in the British Pharmacopoeia. The BAN becomes the recognised and recommended name for that particular substance within the United Kingdom.
To apply for a BAN, fill out the BAN application form and send it to bpcom@mhra.gov.uk.