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BOE-A-2026-8700 ·21 April 2026 ·Royal Decree Medium impact
Tax

Pharmaceutical companies: 3 months to adapt Annex 1 of R.D. 2829/1977 to Directive (EU) 2025/2062

Order SND/362/2026 partially amends Annex 1 of R.D. 2829/1977 to align with Directive (EU) 2025/2062 following the transposition of the 1971 Convention. The change affects psychotropic substances and narcotic products, establishing a 3-month adaptation period from the date of entry into force (Art. 2).

In 2 key points

  1. Annex 1 of R.D. 2829/1977 is amended to align with Directive (EU) 2025/2062 (art. 2)
  2. A 3-month deadline is set to adapt control and registration processes (art. 2)

How it affects those involved

Pharmaceutical companies must update their records and control processes to comply with the new regulations on psychotropic substances. Laboratories and distributors face non-compliance risks if they fail to act. Advisors must review their monitoring procedures and ensure that records are updated in accordance with the new annex.

Lifecycle

2026-04-21PublishedPublished in the BOE
2026-04-22Into forceComes into force (fecha_vigencia (indice oficial del 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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