Request for scientific advice form

This form should be used to request a scientific advice meeting with the MHRA.

About you


Company name*
Contact name*
Contact address*
Telephone number*
Emergency contact number (mobile)
Fax number
Email address*
Confirm email address*

About the product


Name of the active substance* (if advice is not product specific please write ‘Broader Scope advice’)
Proposed indication(s)*
ATC code (if known)
Type of product	Chemical Biological Herbal Homoeopathic
Pharmaceutical form(s)
Proposed legal status (Please select)	Prescription Non-prescription
Is the advice solely connected with a future:	Clinical Trials Authorisation (CTA) Marketing Authorisation Application (MAA)
Or is advice on both CTA and MAA sought?

Regulatory procedure in the UK (Please select):*

Clinical Trial Authorisation
New Product Authorisation
Product maintenance and variation
Supply reclassification
Product advertising
Product and patient information
Medical device incorporating ancillary medicinal substance

Advice sought(Please select):*

Quality
Non-clinical
Clinical
Regulatory
Pharmacovigilance/Risk management plan
Paediatric development
National Institute of Biological Standards and Control

Please add any comments related to the advice sought (Please separately attach a draft of the proposed questions)



Attach file(click the icon to browse for a file)





Preferred dates
Unavailable dates


Is this product currently under assessment in any other Member State?*		Yes No


Has CHMP scientific advice been sought on this development programme		Yes No
If so please provide details and attach all advice received
Attach file(click the icon to browse for a file)





Has previous MHRA scientific advice been sought on this development programme		Yes No
If so please provide details and attach all advice received
Attach file(click the icon to browse for a file)





Has a previous MAA been made for this product for this indication		Yes No
If so, please give the PL number or European Procedure number


Actual/proposed procedure to be followed for this product (if known)		National MR Decentralised Centralised
For a centralised product is the UK rapporteur or co-rapporteur?		Yes No