Is your product a medicinal product?
In the UK, as in the rest of the EC, medicinal products which are placed on the market, are required to have marketing authorisations (formerly product licences) in accordance with The Medicines for Human Use (Marketing Authorisations) Regulations 1994 (S.I.1994/3144). Amongst other things these provide that, unless exempt, no medicinal product shall be placed on the market unless a marketing authorisation has been granted in accordance with Community provisions by the licensing authority or the European Commission. It is an offence to sell or supply or to advertise a medicinal product which does not have a marketing authorisation.
Article 1 of Directive 2001/83/EC defines a 'medicinal product' as:
(a) 'any substance or combination of substances presented as having properties for treating or preventing disease in human beings
(b) any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis'.
In practice, in coming to a view about any product, the Agency considers all the characteristics of the individual product and any information which may have a bearing on the product's status. A product may be viewed as a medicinal product because of the way in which it is presented. The Agency also considers the effect the product has on human physiology. If it satisfies one or both of the criteria, it is classed as a medicine. A product presented as a nutritional substance or cosmetic may still be a medicinal product if it contains ingredients which have a significant pharmacological effect.
When considering the classification of products that are to be submitted to the Advisory Committee on Borderline Substances (ACBS) the MHRA applies the same criteria as it would to all products. For further information please refer to our Guidance Note 8 'A Guide to What is a Medicinal Product
(163Kb)', which I hope you will find helpful.
Information required by MHRA
To enable us to consider the classification for your product you will need to submit the information requested on our ACBS online request form.
- a cover letter stating the Type of application you will be submitting
- full details of the ingredients including quantities for each
- copies of the packaging, information leaflets and promotional material
- in respect of ACBS products we acknowledge that it may be appropriate to provide additional information to qualified healthcare professionals; if you need to include this for your product please confirm that this information will not be available direct to the public.
Please ensure that you finalise all decisions for your product(s) before submitting the information to MHRA. The information on the ingredients and the copies of the packaging, information leaflets and promotional material that you provide for MHRA must be identical to that which you provide for ACBS. ACBS will require additional information and documentation as set out in the information on their website at
The NHS Commercial Medicines Unit (external link).
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 you accordingly and it is likely that your application will need to be re-submitted to a future meeting.
Timescales
As we receive high volumes of requests in respect of ACBS, please ensure we receive details of your application no later than one month before the deadline for ACBS. This will allow time for you to make any necessary changes to meet requirements. Applications received after the closing date will be deferred until the following ACBS meeting. The deadlines for ACBS are shown on their website CMU (external link).
Type 3 applications will be considered as and when appropriate.
How to proceed
Requests for ACBS Certificates (including Type 3 applications) must be submitted using our online Advisory Committee on Borderline Substances Certificate Request Form.
We are unable to accept application received in any other format
ACBS decision
The issue of a letter from MHRA in respect of your application to ACBS does not mean that your product will be acceptable to the ACBS for reimbursement at NHS expense.
Information on ACBS, including the dates for this years scheduled meetings, is available at CMU (external link).
For further advice or assistance please contact Alexis Edwards on 020 3080 6361.
