Medical warehouse licence and GSP: staffing pharmacists and device engineers

1. Key takeaways

The medical warehouse appears twice in this volume: once as a licensed applicant that can act as the rights holder under Article 6(1)(a), and once as the physical node in the import and storage chain. The first role decides who holds the certificate; the second decides whether the goods can be stored. The EDE import permit service page states expressly that imports from a bonded free zone require a GSP certificate issued by EDE, while the implementation of good storage and distribution practice depends on staffing. On whether the technical responsible person may be a pharmacist or a medical device engineer, and on headcount and how qualifications are retained, the position is a practical estimate with no EDE official text behind it, and it must follow the written reply of the competent authority.

• The medical warehouse is both a licence-holding applicant category and the physical storage node of the import chain.
• A medical store licence cannot substitute for a medical warehouse licence; the two licensed activities are distinct.
• An EDE-issued GSP certificate is an express condition for imports from bonded free zones.
• Technical responsible person qualifications are a practical estimate and require written confirmation from the competent authority.

2. Legal basis

The table below gathers the provisions relevant to the medical warehouse in both of its roles, together with the GSP condition published on the EDE import permit service page.

3. Expert insights

Insight 1: a medical warehouse and a medical store are not the same thing, and their licensed activities must not be mixed. The two licences are parallel and distinct licensed activities in the UAE, and a medical store has no authority to perform the storage and distribution functions of a medical warehouse. We have encountered multiple cases of rejection because the partner presented a medical store licence yet was written into the submission as the storage node. When verifying, read the licensed activity description on the face of the licence itself, rather than relying on the partner’s own account of its business capability.

Insight 2: the GSP certificate is an express official condition, and the certificate itself is not a one-off asset. The EDE service page lists the GSP certificate as one of the necessary conditions for bonded free zone imports, and requires it to be issued by EDE. In our judgement, the holder must continuously meet operational requirements concerning temperature, humidity, zoning, traceability and recall drills throughout the life of the certificate; any deviation found in a single on-site inspection can ripple into the pace at which import permits are issued. We recommend turning the GSP operating status into a monthly self-check item, rather than rushing remediation before a renewal or an inspection.

Insight 3: staffing is a practical estimate, and the competent authority must be consulted before the establishment plan is fixed. The position that the technical responsible person may be a pharmacist or a medical device engineer derives from prevailing industry practice; Article 6(1)(a) and Article 21 of Federal Decree-Law No. 38/2024 do not prescribe the qualifications for the role. Our recommendation is to front-load the confirmation: before site selection and recruitment, obtain a written reply from EDE or the competent emirate-level authority, clarifying the degree requirements, registration status and form of in-post evidence, so that the establishment plan does not have to be redone because the qualifications are later not recognised.

4. Practical recommendations

• Verify the face of the licence of the proposed warehousing partner, confirming the licensed activity is a medical warehouse and not a medical store, and retain a verification record.
• If the bonded free zone route is used, obtain the EDE-issued GSP certificate first, and check the certificate’s coverage and validity at the same time.
• Establish a monthly GSP self-check covering temperature and humidity records, zoned storage, traceability ledgers and recall drills, with executable evidence retained.
• Before site selection and recruitment, confirm in writing with the competent authority the position on technical responsible person qualifications, including degree, registration and in-post evidence requirements (practical estimate).
• Bring storage node changes under change management: a change of warehouse or responsible person should trigger re-verification of qualifications and a review of any impact on the Article 22 architecture.
• Agree with the Article 22 lead establishment on information transfer paths, so that storage anomalies, returns and recall information can be returned promptly to the rights holder.

5. Verification checklist

• □ The licensed activity on the warehousing partner’s licence has been confirmed as a medical warehouse, with no substitution by a medical store
• □ The EDE GSP certificate required for the bonded free zone route has been obtained, with coverage and validity checked
• □ Execution records for temperature and humidity, zoning, traceability ledgers and recall drills are complete and traceable month by month
• □ The technical responsible person position has been confirmed in writing by the competent authority and staffed to its requirements (practical estimate)
• □ A re-verification process exists for warehouse and responsible person changes, with the impact on the Article 22 architecture assessed
• □ The information transfer paths with the lead establishment for storage anomalies, returns and recalls are agreed in writing
• □ Warehouse inbound and outbound records are aligned with the Article 66 database registration requirement, with batches traceable in both directions

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the United Arab Emirates. Our team coordinates local authorised representative and importer arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com