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BOE-A-2026-4175 ·23 February 2026 ·Resolution Low impact
Tax

Companies with pharmaceutical business purposes: registration prohibited if they fail to meet Law on Guarantees requirements

The Directorate General for Legal Certainty and Public Faith has confirmed the refusal to register a company whose corporate purpose included the trade of pharmaceutical products without proof of prior administrative authorisation (Art. 68 RDL 1/2015). The resolution emphasises that the trade of medicines is restricted to legally authorised pharmacies and hospital pharmacy services (Art. 3.6 RDL 1/2015). Furthermore, it notes the requirement to register in the Registry of manufacturers, importers or distributors for importation purposes (Art. 76 RDL 1/2015).

In 3 key points

  1. The trade of medicines is limited to pharmacies and hospital pharmacy services (Art. 3.6 RDL 1/2015). (art. 3.6 RDL 1/2015)
  2. The distribution of medicines requires prior administrative authorisation (Art. 68 RDL 1/2015). (art. 68 RDL 1/2015)
  3. Importation requires registration in the Registry of manufacturers, importers or distributors (Art. 76 RDL 1/2015). (art. 76 RDL 1/2015)

How it affects those involved

For entrepreneurs and companies intending to operate in the pharmaceutical sector, the resolution establishes that incorporation alone is insufficient; it is imperative to prove administrative authorisation and compliance with distribution and importation requirements to achieve registration (Arts. 68 and 76 RDL 1/2015). Companies attempting to register corporate purposes involving the trade of medicines without such proof will face negative assessments from the Mercantile Registry.

Lifecycle

2026-02-23PublishedPublished in the BOE
Official text Based on BOE data (boe.es). Information, not advice.

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This analysis is informational only and does not constitute legal advice or create a client-adviser relationship. BM Consulting.
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