At the counter four ideas get blurred together, EFP, OTC, reimbursed medicine and PVP, and most shelf-price mistakes start in that blur. It helps to pull them apart and follow an invented price euro by euro, from the manufacturer to the receipt, to see how much of it the pharmacy can actually touch (not much). The pricing and advertising rules guide gives the full map; here we stay with the anatomy of the price.
EFP, OTC, "no prescription": three words, one map
"EFP" comes from Royal Decree 1416/1994 on medicine advertising. Its preamble describes these products as specialties excluded from public funding and from the authorised-price regime, and recalls that the 1990 law let manufacturers set their price freely. The 2015 consolidated text, which is the law in force, no longer contains the word "publicitaria". It speaks of medicines not subject to medical prescription, and article 80 lists three conditions for a medicine to be advertised to the public:
- It is not publicly funded.
- By its composition and purpose it is designed to be used without a doctor's diagnosis, prescription or follow-up, even if a pharmacist's intervention is needed.
- It is not a psychotropic or narcotic substance under international conventions.
So "EFP" survives as a common label for anything that meets those three conditions. It is still part of the trade's vocabulary and, judging by the search form of the Ministry's nomenclátor, "medicamento publicitario" still appears among its filters. "OTC" is the English over the counter: it is used loosely as a synonym for a medicine sold without a prescription, with the caveat that not everything dispensed without a prescription is an EFP, and not everything advertised is sold without one.
Two separate axes explain the confusion. One is prescription: whether a prescription is needed. The other is reimbursement: whether the National Health System (SNS) pays for it. They combine like this:
| Reimbursed by the SNS | Not reimbursed | |
|---|---|---|
| Prescription-only | Reimbursement price set by the CIPM (pricing commission); PVP = maximum ex-factory price + margins | Notified price, which the Ministry may object to; cannot be advertised to the public |
| No prescription | Price set by the authorities under the same rules as reimbursed products; cannot be advertised to the public | The EFP territory: notified price, advertising allowed under conditions |
The bottom-right cell is the one you see on TV and on posters. In the other three, the price is conditioned by the authorities or by the notification regime, and advertising to the public is not possible.
Where the PVP of a reimbursed medicine comes from
Article 94.10 of the consolidated text puts it in one sentence: the Ministry sets the PVP by adding the authorised ex-factory price, which is a maximum, and the wholesale distribution and dispensing margins. The ex-factory price is in turn set by the Interministerial Medicines Pricing Commission (CIPM) when the medicine enters reimbursement (art. 94.5). As a general rule, the reimbursed price is lower than or equal to what it would be outside the SNS (art. 94.7).
The margins are set by Royal Decree 823/2008. In its consolidated text as of November 2022:
- Wholesaler: 7.6 % of the distributor's selling price before taxes, if the manufacturer's selling price is 91.63 euros or less; EUR 7.54 per pack if it is higher.
- Pharmacy: 27.9 % of the PVP before taxes up to an ex-factory price of 91.63 euros. Above that, a fixed amount per pack: EUR 38.37 up to 200 euros, EUR 43.37 up to 500 and EUR 48.37 above.
- VAT: 4 % for human medicines, under article 91.Dos.1.3.º of Law 37/1992.
A worked example
Take a fictional medicine with an ex-factory price of EUR 10.00. Reading the margins as written, the path would be:
| Step | Calculation | Result |
|---|---|---|
| Ex-factory price (manufacturer) | starting figure | EUR 10.00 |
| Wholesaler's price | 10.00 / (1 − 0.076) | EUR 10.82 |
| PVP before tax | 10.82 / (1 − 0.279) | EUR 15.01 |
| PVP with 4 % VAT | 15.01 × 1.04 | EUR 15.61 |
On those figures the pharmacy keeps about EUR 4.19 of gross margin (27.9 % of 15.01), and more than a third of the PVP (EUR 5.61 of 15.61) is not ex-factory price but margins and VAT. This is an illustration: the medicine is made up, official rounding may differ by a few cents and the margins are reviewed, so it is not a way to audit a real label. Its use is different. It shows why the PVP can never move "a little" at the pharmacy's discretion: every euro is already allocated.
Reference prices: the ceiling for each set
On top of the individual PVP there is a second mechanism. Article 98 defines the reference price as the maximum amount at which presentations of the same set are reimbursed, as long as they are prescribed and dispensed at public expense. A set groups presentations with the same ATC level 5 and the same route of administration, among which there is at least one generic or biosimilar. The reference price is calculated from the lowest cost per treatment-day in the group, and no medicine in the set may exceed it (art. 98.4).
Review runs at two speeds (art. 98.5): the sets and their prices are reviewed once a year, and the lowest prices within groups every quarter. This year's update is Order SND/1053/2026 of 1 October, published in BOE no. 249 on 7 October and in force from the next day. It creates sets F514 to F528 for medicines dispensed in pharmacies and P206 to P216 for hospital use, and Annex 1 lists, for each presentation, the reference ex-factory price and the "PVPIVA de referencia" (reference retail price including VAT). Anyone who wants to see a specific reference price should check that annex rather than a second-hand table: the order runs to almost eight hundred pages of the BOE.
That cadence has a practical consequence at the counter. An order published on 7 October does not change the till on the 8th: the price reaches the nomenclátor of the corresponding month and from there the pharmacy management software. The whole journey, with timings and the points where the chain breaks, is in how to change prices automatically.
And the EFP: who sets its price?
For non-reimbursed medicines, article 94.4 provides for the notified price regime: the marketing authorisation holder reports the price to the Ministry, which may object on public-interest grounds. Article 94.3 adds a safeguard: in an exceptional public-health situation, the CIPM may set the maximum retail amount for medicines not subject to prescription.
So "free price" is not the right expression. There is a starting price coming from the manufacturer, a ceiling printed on the pack, and a Ministry able to object or, in an emergency, to cap.
What the pharmacy can change (and what it cannot)
- Reimbursed medicines: nothing. The price is the one in the nomenclátor. Showing a different amount on a shelf, label or screen is a mistake, not a commercial decision.
- EFP: it cannot exceed the price printed on the pack or the receipt, which article 4 of RD 823/2008 treats as the maximum. The same article contemplates discounts of up to 10 % on the PVP including taxes for the medicines it calls "publicitarios". Which medicines that article reaches today, and how it sits alongside the ban on bonuses, gifts and rebates tied to selling these medicines (art. 80.5 of the consolidated text), is a question for the pharmacist-owner or the professional college before running any promotion. It is listed among this page's open validation items.
- Advertising: only medicines meeting the three conditions of article 80.1 may be advertised to the public, and the message must include the name of the medicine, an invitation to read the leaflet and a recommendation to consult the pharmacist. How this applies to a poster or a screen is developed in which medicines a pharmacy may advertise and in the digital signage guide.
- Parapharmacy: here the pharmacy does decide, under the general retail rules. It is outside this article.
Why it matters for the shelf
The costliest error usually comes from where nobody looks: a parallel spreadsheet with the prices "that were already there". The PVP of a reimbursed medicine changes through the nomenclátor, that of an EFP changes when the manufacturer notifies a new price, and the till is right because the management software updates. If the poster or shelf label reads from another source, sooner or later it shows a different amount from the one charged. For electronic shelf labels, the pharmacy ESL guide explains what has to happen for the label to read the same data as the till, and the integrations cover the technical side.
What this article does not cover
It does not replace review by a registered pharmacist or the criteria of each autonomous community or professional college. The margins quoted are those of the BOE consolidated text as of November 2022, and the wording in force must be checked in the BOE before using them in any calculation. Nor does it cover patient co-payments or how a reference set is dispensed, which are a different conversation.
Sources
- Real Decreto Legislativo 1/2015, texto refundido de la Ley de garantías y uso racional de los medicamentos y productos sanitarios, arts. 80, 94 y 98 (BOE)
- Real Decreto 1416/1994, por el que se regula la publicidad de los medicamentos de uso humano (BOE)
- Real Decreto 823/2008, márgenes, deducciones y descuentos de distribución y dispensación de medicamentos de uso humano (BOE, texto consolidado)
- Orden SND/1053/2026, de 1 de octubre, de actualización en 2026 del sistema de precios de referencia (BOE-A-2026-20825)
- Ley 37/1992 del Impuesto sobre el Valor Añadido, art. 91.Dos.1.3.º (BOE)
- Ministerio de Sanidad. Nomenclátor de facturación de medicamentos
- Real Decreto 177/2014, sistema de precios de referencia y agrupaciones homogéneas (BOE-A-2014-3189)
