Legal status and reclassification

Legal status of medicines
The Medicines Act 1968 and Council Directive 2001/83/EEC 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 either on a prescription  (prescription only medicines (POMs)), or available in a pharmacy without prescription, under the supervision of a pharmacist (P) or on general sale (GSL). Prescriptions can be issued by doctors, dentists, nurse independent prescribers, pharmacist independent prescribers and supplementary prescribers. For further information, please see the section below:

› Availability, prescribing, selling and supplying of medicines: Exemptions from Medicines Act restrictions

Reclassification: the criteria

Criteria for switching from POM to P
Before a medicine can be switched 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 (Medicines Act 1968, section 58A) and 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; or
• 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; or
• contains substances or preparations of substances of which the activity requires, or the side effects require, further investigation; or
• is normally prescribed by a doctor for parenteral administration (that is, by injection).

Criterion for switching from P to GSL
Similarly, before a medicine can be switched 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' (Medicines Act 1968, section 51).  

Reclassification procedures
New medicines are usually authorised for use as prescription only medicines (POM). 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 substance 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.

The MHRA has introduced a new process by which medicines are reclassified from POM to P and P to GSL. Applications may be made at any time during the year with a target timescale for their determination.

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 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, wide public consultation, via the MHRA website takes place. Interested organisations will be notified when a new consultation has been added to the website. Responses to the consultation are evaluated by the MHRA and advice is sought from the CHM only 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 switching. All other products with the same active substance will need to make a separate application to follow suit.

The Government encourages wider availability of medicines as soon as there is adequate evidence of safety in use. The MHRA has published new guidance on how to make requests for reclassification and how these are processed. The MHRA Guidance Note 11, 'Changing the legal classification in the United Kingdom of a medicine for human use' covers reclassification from POM to P and P to GSL.

UK procedures have formed the model for new EC procedures for switching from prescription to non-prescription status 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 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:

› The Reclassification Strategy Group (8Kb)

Changes in licensing policy subsequent to implementation of the new reclassification
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 will no longer be possible to have more than one legal supply status on a single marketing authorisation. One effect of this change under current policy would be that POM, P, and GSL versions of the same product would require different brand names.

We have therefore decided that where a change in legal supply status 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 supply status, it will no longer be possible to grant a single authorisation and a separate authorisation for each legal supply status 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 status.

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 contact David Hook, telephone 020 7084 2037, (licensing issues), Dr Keith Pugh, telephone 020 7084 2427, (variation issues) or Mrs Amanda Williams, telephone 020 7084 2523, (reclassification issues) or e-mail our Central Enquiry Point.

Supplementary information

›  Article on new reclassification process in MAIL 130 (2441Kb) (March/April 2002)

› 'Changing the legal classification in the United Kingdom of a medicine for human' (163Kb) - guideline covering reclassification from POM to P and P to GSL.

›  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.

Contact for further information
For further information, please contact our Reclassification Unit, 14-1, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, telephone 020 7084 2523 (advice on applications) or 020 7084 2389 (on process), fax 020 7084 2293 or e-mail reclassification@mhra.gsi.gov.uk.