This section details the legal status and the reclassification procedures for medicines including lists of substances for prescription only, pharmacy and general sale supply and a list of authorised substances reclassified since April 2002.
In this section...
Legal status of medicines
The Medicines Act 1968 and Council Directive 2001/83/EC control the sale and supply of medicines. The legal status of medicinal products is part of the marketing authorisation (MA) and products may be available:
- on a prescription (referred to as Prescription Only Medicines (POMs))
- in a pharmacy without prescription, under the supervision of a pharmacist (P)
- on general sale (GSL) and can be sold in general retail outlets without the supervision of a pharmacist.
Prescriptions can be issued by doctors, dentists, nurse independent prescribers, pharmacist independent prescribers and supplementary prescribers. For further information, please see the section below:
Reclassification: the criteria
Criteria for reclassifying from POM to P
Before a medicine can be reclassified from POM to P, Ministers must be satisfied that it would be safe to allow it to be supplied without a prescription. This means that it is a medicine which no longer meets any of the following criteria (Human Medicines Regulations 2012, regulation 62(3)).
That it is a medicine which:
- is likely to present a direct or indirect danger to human health, even when used correctly, if used without the supervision of a doctor
- is frequently and to a very wide extent used incorrectly, and as a result is likely to present a direct or indirect danger to human health
- contains substances or preparations of substances of which the activity requires, or the side effects require, further investigation
- is normally prescribed by a doctor for parenteral administration (that is, by injection).
Criterion for reclassifying from P to GSL
Similarly, before a medicine can be reclassified from P to GSL, Ministers must be satisfied that it 'can with reasonable safety be sold or supplied otherwise than by or under the supervision of a pharmacist' (Human Medicines Regulations 2012, regulation 62(5)). 'Reasonable safety' may be usefully defined as “Where the hazard to health and the risk of misuse and the need for special precautions in handling are small, and where wider sale would be a convenience to the purchaser”.
New medicines are usually authorised for use as POMs. After some years' use, if adverse reactions to the medicine are few and minor, it is possible that the medicine may be safely used without a doctor's supervision. If there is sufficient evidence of safety, a medicine may be reclassified for sale or supply under the supervision of a pharmacist (P).
Pharmacy medicines which have been safely used for several years may be suitable for general sale and may be reclassified as GSL.
Reclassification of a product normally follows a request from the company which holds a marketing authorisation for it. However, requests can be made by any interested party, such as a professional body, or be initiated by the MHRA.
Less frequently, medicines which were previously classified as P are made POM if new risks are identified which require involvement of a doctor to ensure safe use of the medicine. In the same way a GSL medicine could be reclassified as P if new information showed that it was no longer safe to supply it without a pharmacist checking that it was suitable for the patient.
Applications to reclassify medicines are evaluated by the MHRA, with advice from a suitable expert committee (currently the Commission on Human Medicines (CHM)), as necessary. Where it is considered that the proposed reclassification may safely be made, public consultation, via the MHRA website can take place. Responses to the consultation are evaluated by the MHRA and advice is sought from the CHM if a new safety issue is raised during consultation. Following a successful reclassification proposal, the change of legal status will be conferred on the product that is the subject of the application for reclassification. The reclassification application is to a specific marketing authorisation and all other products with the same active substance will need to make a separate application to follow suit.
Following the announcement in the Chancellor’s Autumn Statement (November 2012), the MHRA has launched a new, streamlined procedure to speed the process of moving medicines from prescription-only to over-the-counter medicines.
Applicants are strongly encouraged to request a Scientific Advice Meeting via the MHRA website to discuss queries and strategies relating to a proposed reclassification, prior to submission of the application: For further information, please see the section below:
UK procedures have formed the model for new EC procedures for switching from prescription to non-prescription classification introduced in January 1999. The guideline is published in 'Notice to Applicants' Volume 2C. The full text is available on the European Commission Pharmaceuticals website (see 'Related information on the right of this page).
The legal classification of products is decided at national level, therefore the UK Licensing Authority makes decisions on legal classification for applications granted through National, Mutual Recognition (MR) and Decentralised (DC) Procedures. The European Commission (EC) makes decisions for products authorised through the Centralised Procedure.
Marketing authorisations (MAs) determined via the Mutual Recognition (MR) or Decentralised (DC) Procedures may require special consideration and applicants are advised to seek a Scientific Advice Meeting with the MHRA at an early stage. For further information, please see the section above on scientific advice for licence applications:
Reclassification applications for centralised Marketing Authorisations (MAs) are submitted to the European Medicines Agency (EMA). Applicants are advised to seek further information from the EMA.
Specific licensing policy issues related to reclassification
Legal classification and brand name
As a result of changes brought about by The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002 (SI 2002/542) it is no longer possible to have more than one legal classification on a single marketing authorisation.
One effect of this is that POM, P, and GSL versions of the same product require different brand names. Where a change in legal classification is due only to a difference in pack size of the medicinal product but all other aspects of the marketing authorisations are the same, the same brand name can be used for the products.
Applicants should note that it is expected that the two authorisations will be maintained such that no divergence between the authorisations will take place. If divergence takes place at a later date a new brand name will need to be used for the divergent authorisation. If applicants have any questions concerning these arrangements they should contact the MHRA prior to making applications.
Where other changes to a product result in a new marketing authorisation, a different brand name would have to be given to the different products as at present.
Change of ownership applications (COAs)
Where a COA is received by the MHRA involving a marketing authorisation currently containing more than one legal classification, it is no longer possible to grant a single authorisation and a separate authorisation for each legal classification must be granted.
Applicants are therefore advised to submit separate COA applications for each legal status which the applicant wishes to retain. It is recognised that these separate applications may have to be different, for example, different Summaries of Product Characteristics (SPCs) to reflect the requirement for each legal classification.
Each COA will attract a separate fee.
Incoming Mutual Recognition applications
The Mutual Recognition (MR) Procedure imposes the restriction on the marketing authorisation holder (MAH) of having to use the SPC agreed during the procedure and no local divergence is allowed.
The legal supply status to be granted in these cases is therefore dictated by the SPC agreed in the procedure. MAHs may make applications in the UK for a change in legal supply status of any product granted by MR but when the UK is the Concerned Member State (CMS), this can only be agreed where no change to the SPC is required.
Where the terms of a single SPC will allow multiple legal supply status, only one legal status will be allowed per MA and therefore duplicate authorisations will be required in the UK which should be made using duplicate applications in the Reference Member State (RMS).
Where the different legal status are defined by a common SPC but differences in pack size the UK will grant a separate authorisation for each legal status on the submission of a second application form reflecting the different pack size. A second fee will be required for this authorisation.
Contacts for further information
For further information please email our Central Enquiry Point.
Applications to reclassify medicines ARM's. Series of consultative letters issued when applications are made for change of legal status of products.
Exclusivity guidance (21Kb) - This document gives guidance on how Article 74a of Directive 2004/27/EC is to be applied in the UK by the MHRA during an application to reclassify a medicinal product from POM to P, or from P to GSL.
Article on reclassification process in MAIL 130 (2441Kb) (March/April 2002)
The Reclassification Strategy Group (RSG)
The establishment of the RSG was first announced at the launch of the new reclassification procedure on 1 May 2002. Further information about the Group is available in the document below:
Contact for further information
For further information, please contact the Self-medication Unit, 3.M, 151 Buckingham Palace Road, London SW1W 9SZ or email firstname.lastname@example.org