1. Is there a list of medicines that are available as Prescription Only Medicines (POM)?
2. Is there a list of medicines that are available as General Sale List (GSL) medicines?
3. Is there a list of medicines that are available as Pharmacy (P) medicines?
4. How do I submit a 'me-too' reclassification application?
5. What is an analogous product?
6. Is it possible to apply for two different legal statuses (eg POM and P or P and GSL) on a single marketing authorisation?
7. Is it necessary to submit a risk-management plan?
8. Is it possible to submit a national reclassification application for a marketing authorisation that has been approved via the Decentralised Procedure (DCP) or the Mutual Recognition Procedure (MRP)?
1. Is there a list of medicines that are available as Prescription Only Medicines (POM)?
The MHRA maintains lists relating to the conditions for POM supply. The lists that include circumstances under which substances are included in POM products are List A and List C.
2. Is there a list of medicines that are available as General Sale List (GSL) medicines?
If a drug is available GSL, it will be listed in List B with details of the conditions for GSL supply. For recently reclassified drugs (since 2002), additional information may also be contained in the (List C).
3. Is there a list of medicines that are available as Pharmacy (P) medicines?
No, there is no definitive list of Pharmacy medicines as a Pharmacy medicine is defined as a medicine that is not a Prescription Only Medicine or a medicine on the General Sale List. Please refer to the lists of substances, which provide exemptions for pharmacy supply, for further information.
4. How do I submit a 'me-too' reclassification application?
The variation change code C.I.5 may be used for a “me-too” reclassification. The variation may be a Type IB or Type II, depending on the data supporting the application, and grouping may be used where appropriate. The timelines would be as published, 30 days for a Type IB and 90 days for a Type II. Please note that as a Type IB application has very short deadlines, it is important that any application is fully consistent with the analogous, currently authorised cross reference product, particularly in terms of the Summary of Product Characteristics (SPC).
5. What is an analogous product?
For these purposes, an analogous medicinal product is a medicinal product, which has a United Kingdom marketing authorisation and which:
- has the same active ingredient, route of administration and use
- has the same strength or a higher strength
- has the same dosage or daily dosage, or a higher dosage or daily dosage
- is for sale or supply at the same quantity or a greater quantity
as the medicinal product in relation to which the application is made.
The pharmaceutical form is not listed in the above points and for an application where this is the only difference between the proposed and analogous products, it would be for the applicant to justify that there are no significant differences between the two pharmaceutical forms.
6. Is it possible to apply for two different legal statuses (eg POM and P or P and GSL) on a single marketing authorisation?
No, there should only be one legal status on any marketing authorisation (MA). Therefore, if a MA holder requires more than one legal status for a product there are two options:
- submit a simple abridged application to obtain a duplicate MA, then submit a reclassification variation application
- submit a standard abridged application, which will essentially combine both the assessment of the simple abridged application together with incorporating the proposed legal status into one application.
For further information on fees please refer to the pages on fees for licence applications and fees for reclassifications.
7. Is it necessary to submit a risk-management plan?
For a complex or standard procedures it is necessary to submit a risk-management plan. This should include details of measures incorporated to ensure correct self-diagnosis/self-treatment together with any essential safeguards required in order to prevent incorrect usage. This information will include changes such as, but not limited to, additional advice or warning statements, any restrictions on indications, contraindications, dose, pack, length of treatment and clear statements about circumstances requiring physician intervention and the action needed if symptoms do not respond or if an adverse reaction occurs. It may also include reference to availability of suitable educational materials for pharmacists and pharmacy staff.
8. Is it possible to submit a national reclassification application for a marketing authorisation that has been approved via the Decentralised Procedure (DCP) or the Mutual Recognition Procedure (MRP)?
For products authorised via the DCP or MRP the legal status is decided at a national level. As such, it is possible that a product may be available without a prescription in some Member States while remaining prescription only in others. The SPC should remain harmonised across the Member States involved in the procedure. It is recommended that you seek a scientific advice meeting if you wish to submit an application of this kind.
