Please use this form to request the certificate required in respect of products being submitted to the Advisory Committee on Borderline Substances (ACBS). For further information see the ACBS section.
A copy of our letter and all the material you submit to the MHRA will be sent to ACBS for their information. If there are differences, the MHRA certificate is invalidated. If any discrepancies are found, the ACBS will advise the MHRA and we may then require a complete re-submission to confirm the original certification. In such cases we cannot guarantee the certificate will be issued to meet the ACBS deadline.
Please complete this form for pharma products only and email with any attachments to acbs@mhra.gov.uk
All fields and relevant attachments must be complete and must be received at least one calendar month prior to the ACBS deadline
*Company name
Company’s reference number (if any)
*Title
*First name
*Surname
*Phone number
*Email address
*Confirm email address
*Postal address
*City
*Post code
*Country
Note: Opinion will only be based on the information provided
Product name
Is this a Type 3 submission (Existing products to which minor changes are proposed)? YesNo
If this is a Type 3 Submission please specify the change to the current product. Please include all previous and present promotional materials
Product Form (eg tablet, capsule, oil, cream etc.)
Ingredients Please give details of all ingredients. If you would prefer, please email them separately to acbs@mhra.gsi.gov.uk
Dosage instructions
Product’s mode of action
Purpose of product including claims / wording used to promote the product
All promotional material relating to the product including the internet, SPC’s and datasheet/s must be attached and emailed to acbs@mhra.gsi.gov.uk
Note - Opinion will only be based on the information provided. ACBS will require additional information and documentation as set out in the information on the Commercial Medicines Unit Website.