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Regulatory Information

Strategic Oakmont Medical Services Ltd operates within the regulatory framework of the Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom.

1. Wholesale Dealer’s Authorisation (WDA)

Licence Status

Strategic Oakmont Medical Services Ltd is in the process of obtaining its Wholesale Dealer's Authorisation (WDA(H)) from the MHRA. Our licence number and full authorisation scope will be published here upon grant. All operations are conducted in compliance with applicable UK pharmaceutical regulations.

A Wholesale Dealer's Authorisation is required under the Human Medicines Regulations 2012 (SI 2012/1916) for any company engaged in wholesale distribution of medicinal products in the United Kingdom. The issuing authority is:

  • MHRA — Medicines and Healthcare products Regulatory Agency
  • 10 South Colonnade, Canary Wharf, London E14 4PU
  • gov.uk/mhra

2. GDP Compliance

All wholesale distribution activities at Strategic Oakmont Medical Services are conducted in accordance with the Guidelines on Good Distribution Practice (GDP) for medicinal products for human use, as published in the Official Journal of the European Union (2013/C 343/01) and adopted under UK law post-Brexit.

GDP compliance ensures:

  • Products are stored, handled, and transported in conditions that maintain their quality and integrity
  • Full traceability of all products through the supply chain
  • Qualified personnel with clearly defined responsibilities
  • Documented procedures and deviation management
  • Regular audits and self-inspections

3. Falsified Medicines Directive (FMD) Compliance

Strategic Oakmont Medical Services is committed to compliance with anti-falsification measures as required by the Falsified Medicines Directive (2011/62/EU) and its UK equivalents post-Brexit. This includes:

  • Verification of the unique identifier (serialisation) on all applicable products
  • Checking tamper-evident features on packaging
  • Participation in national medicines verification systems where applicable
  • Immediate quarantine and reporting of any suspected falsified product

4. Pharmacovigilance & Adverse Event Reporting

Important — Adverse Event Reporting:
If you suspect a product supplied by us has caused or may cause harm to a patient, or if you identify a quality defect, please contact us immediately at info@strategicoakmont.com and report directly to the MHRA Yellow Card scheme.

Healthcare professionals and patients can report suspected adverse reactions directly to the MHRA via:

5. Qualified Person for Pharmacovigilance (QPPV)

As a wholesale distributor, we maintain appropriate pharmacovigilance procedures and cooperate fully with the QPPV obligations of the Marketing Authorisation Holders (MAHs) of the products we distribute. For pharmacovigilance matters, please contact: info@strategicoakmont.com

6. Regulatory Contact

For regulatory enquiries, compliance matters, or to verify our licence status, please contact us at info@strategicoakmont.com or write to our registered address in the United Kingdom.