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BOE-A-2026-8700 ·21 April 2026 ·orden Low impact
Tax

Pharmaceutical companies: 3-month deadline to update Annex 1 of Royal Decree 2829/1977

Order SND/362/2026 partially amends Annex 1 of Royal Decree 2829/1977 to align with EU Directive 2025/2062, following the implementation of the 1971 Convention. The changes affect psychotropic substances and narcotics, with a 3-month adaptation period from the date of entry into force (Article 2).

In 2 key points

  1. The annex 1 of Royal Decree 2829/1977 is amended to align with Directive (EU) 2025/2062 (art. 2)
  2. A 3-month period to adapt control and record-keeping processes (art. 2)

How it affects those involved

Pharmaceutical companies must update their records and control procedures to comply with the new regulations on psychoactive substances. Laboratories and distributors face non-compliance risks if they do not take action. Advisors must review their inspection procedures and ensure that records are updated in line with the new annex.

Lifecycle

2026-04-21PublishedPublished in the BOE
2026-05-21Into forceComes into force (disposicion final)
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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