Buying aesthetic medicine products may seem to be a question of price, but it ultimately comes down to a question of responsibility. A dermal filler purchased from an unauthorised distributor, a botulinum toxin without a documented cold chain, or a product without a CE mark could leave you without insurance cover, unable to trace the product in the event of an adverse reaction, and facing problems with an inspection. This guide explains what to expect from a supplier, how to distinguish between a medicinal product and a medical device, what documentation must accompany each purchase, and what records to keep in your practice.
Medicines and medical devices are not purchased in the same way
Botulinum toxin is a medicinal product. It may only be obtained through the legal pharmaceutical channel: a laboratory, an authorised wholesaler or a pharmacy, depending on the circumstances and the form of supply, and always with a prescription or order in the name of the doctor or the healthcare centre. The distribution of medicines is regulated by Royal Decree 782/2013, and purchasing them through any other channel is illegal.
Hyaluronic acid fillers, thread lifts, most biostimulators and medical devices are CE-marked medical devices, regulated by Regulation (EU) 2017/745. They are purchased from manufacturers or distributors who must be registered with the AEMPS, and come with labelling, instructions and a batch number. The distributor is responsible for verifying the product’s conformity before placing it on the market, and you are responsible for purchasing it from a supplier who fulfils this obligation.
What to look for in a distributor
- It must be identified by: company name, tax registration number, address and, for medical devices, the licence or notification of activity with the AEMPS.
- Invoice and delivery note made out to the doctor or the clinic, stating the description, quantity and batch number of each product.
- Product bearing the CE mark and labelled in Spanish, with instructions for use.
- For products requiring temperature control, documentation of the cold chain during transport.
- Accessible technical data sheet or instructions for use (IFU), and a contact for reporting incidents.
- Clear pricing and terms and conditions, with no freebies, bonuses or discounts linked to the volume of medicines purchased, which are restricted by promotional regulations.
Warning signs
- Prices well below market rates, particularly for botulinum toxin or fillers from well-known brands.
- Sales via social media, messaging apps or online marketplaces, without an invoice.
- Products without a CE mark, without a batch number, labelled only in another language, or with a tampered-with use-by date.
- Suppliers who sell botulinum toxin without requiring proof of medical qualification.
- Parallel imports without proof of origin.
Traceability in the surgery
Every procedure must be recorded, stating the product used, its batch number and the quantity. Keep a record of incoming supplies (delivery note, date, batch number, expiry date) and outgoing supplies (patient, date, batch number, quantity). Keep the batch label in the medical record or note it down in the informed consent. If a manufacturer recalls a batch or a patient experiences an adverse reaction, it is that traceability that enables you to take action and that the insurer requires of you, as we explain in the guide on the third-party liability insurance.
Conservation
Botulinum toxin is stored refrigerated in accordance with the product information leaflet, with the fridge temperature recorded. Fillers are usually stored at room temperature, away from light and heat. A product stored outside the specified conditions is no longer covered by the manufacturer’s warranty. If you work in a private practice, specify where your product is stored and who has access to it.
Incident reporting
Adverse reactions to medicines are reported to the pharmacovigilance system; incidents involving medical devices are reported to the AEMPS via its surveillance system. Reporting does not imply an admission of fault; it is simply part of standard practice. The distributor or manufacturer should provide you with the relevant reporting channel.
Compare suppliers without wasting hours
A large part of a new doctor’s time is spent requesting quotes, checking distributors and working out which product is best suited to each area. In the Medars Shop Distributors are verified before they join; each product comes with its own user guide and you speak directly to the representative; Medars does not sell anything nor does it influence the price, which is the same recommended retail price for all members. Basic membership is free for life and is activated once your professional registration has been verified, with no membership card required. Request access.
Related guides
- How much does it cost to open an aesthetic medicine clinic?
- Advertising in aesthetic medicine: what the regulations permit and what they prohibit
- Requirements for setting up a cosmetic medicine practice in Spain
- Dermal filler training courses for doctors: how to choose and what to look for
Continue exploring Medars
- Training for doctors: masterclasses on botulinum toxin, hyaluronic acid fillers and facial contouring, delivered by practising doctors.
- Memberships: Basic is free forever, and Gold and Black are available if you want more access.
- The Lounge: clinical cases with colleagues, direct messages and clinic rooms to rent.
- The Shop: verified laboratories and distributors.
- Teach at Medars: publish your masterclass and keep 70% from each sale.
- Frequently asked questions: verification, access and memberships.