Since 2006, when the Medicines Code was approved in Portugal, marketing authorisation holders had to include the retail selling price of medicines on the labelling of the secondary packaging of medicines or, if non-existent, on the primary packaging.
The scope of this obligation was successively amended from 2006 to 2023, which marks its elimination from the Portuguese legal system.
Whilst in 2006 reference was made to the retail selling price, the first revision – dated 2010 – developed the obligation to the indication of the retail selling price using a printout, label, or stamp, except in the case of reimbursed prescription medicines, when the patient benefitted from reimbursement. In 2011, reference to reimbursement was removed, and the obligation to include the retail price merely concerned the means to provide this information: print, label, or stamp.
On 26/12/2023, through Decree-Law no. 128/2023 (in force from 27/12/2023 and taking effect from 02/01/2024), the obligation to include the retail selling price of medicines on their labelling, as defined in 2011, was repealed.
According to the explanatory statement of Decree-Law no. 128/2023, the retail selling price, as it appears on the packaging of medicines, does not, as a rule, correspond to the cost of the medicine to the citizen. This cost is influenced by the possible co-payment, which depends partly on the citizen's economic condition, particularly in the case of pensioners, and the application of the reference price system to medicines for which there are generics. In the latter case, the co-payment is not on the retail price of the medicine, but on a reference price that varies according to the medicines available for each active substance and their price.
Additionally, it is the Government's opinion that pricing information on the packaging of medicines is not relevant or even difficult to interpret. Moreover, the price of medicines is subject to change, particularly as part of the annual price revision, which increases the risk of the information on the packaging being out of date.
For these reasons, to allow for transparency of information and to guarantee compliance with the applicable pricing rules, from 02.01.2024 information on the retail selling price of medicines must be provided to patients when the medicine is dispensed by pharmacies. This information should also be accessible on the Infomed database and the Poupe na Receita app, both available on Infarmed’s website.
The impact of this change on marketing authorisations, placement on the market and marketing of medicines has been subject to Infarmed’s clarification, issued on 05.01.2023 through Information no. 003/CD/100.20.200.
Specifically, Infarmed has determined that:
- New marketing authorisation applications approved from 02.01.2024 will not contain a mention of the retail sale price in the labelling, so there is no need to submit new labelling;
- Any changes that are underway and affect the content of the labelling will be approved without mentioning the retail sale price, there being no need to submit new labelling;
- For medicines that have already been authorised, the implementation of the new requirement does not require the submission of a request for amendment; The removal of the retail price can be executed on the next amendment affecting labelling;
- Since 02.01.2024, packaging placed on the market does not need to be marked with a price. However, packages of the same medicine with and without the respective price may coexist temporarily on the national market.