Is it legal to sell contact lenses in pharmacies in Spain? What the current regulations (RD 192/2023) state

With the entry into force of Royal Decree 192/2023 and the appearance of new contact lens brands in pharmacies, many are asking:
Can pharmacies sell contact lenses in Spain? What exactly does the law say?

The answer is clear: yes, it is legal , although with specific conditions.

1. Contact lenses are medical devices

Contact lenses are classified as class IIa medical devices , regulated by Regulation (EU) 2017/745 (MDR) and developed in Spain through RD 192/2023 .
This means that they require special security, storage and traceability control .

2. Initial adaptation vs. reruns

The regulations distinguish between two situations:

• Initial fitting : This can only be performed by a qualified professional (optician-optometrist or ophthalmologist) in an authorized establishment with an optical section.

• Replacements : Once the user has been fitted, pharmacies can dispense contact lenses as replacements.

3. Sale of contact lenses in pharmacies

Royal Decree 192/2023 recognizes pharmacies as authorized points of sale for medical devices and grants them certain administrative exemptions (for example, they do not have to register in marketing registries like other distributors).

For contact lenses to be sold in pharmacies, three basic requirements must be met:

1. The client must have been previously fitted by a competent professional.

2. The pharmacy must perform a reasonable verification before dispensing the product.

3. A minimum traceability record must be kept (product, batch, date and supplier).

4. Conclusion

By 2025, the law is clear: pharmacies can sell contact lenses in Spain as long as they are replacements for already adapted users.
Opticians maintain their role in initial adaptation , while pharmacies consolidate themselves as a complementary and accessible channel for dispensing and restocking .

The current legal framework guarantees user safety and opens the door to new purchasing channels, both in physical pharmacies and online platforms.