Checklist for hospitals working with an access coordinator
For hospital pharmacy, procurement and quality teams handling a request for a non-registered medicine.
Reviewed by the Reserve Meds clinical operations team on 18 October 2026. Sources accessed 18 October 2026.
The short answer
Before a hospital works with a coordinator on a non-registered medicine, it should confirm that the permit is in place before any purchase order, that the supplier is licensed and named, that product documents such as the certificate of pharmaceutical product and GMP certificate are available, that labelling meets local rules, and that the cold chain is documented end to end.
- Permit first: regulator permission before the purchase order.
- Supplier: named, licensed and checkable.
- Product documents: CPP or registration certificate, GMP certificate, labelling.
- Custody: transport and storage per the manufacturer's conditions.
Regulatory permission
Using Bahrain as an example, NHRA Circular 41 of 2020 requires the hospital to obtain the authority's permission before issuing a purchase order for a non-registered medicine, and expects that there is no registered alternative in the country.[1]
The same circular lists, among the conditions, registration with the Gulf Health Council, a GCC state or a reference regulator such as the US FDA, and that the product is marketed in its country of origin, with exceptions for some rare, emergency and oncology medicines.[1]
Other countries apply their own procedures; confirm the current requirements with your regulator.
Product documents to request
- A copy of the certificate of pharmaceutical product (CPP) or the registration certificate from the reference country.[1]
- A copy of the manufacturer's good manufacturing practice (GMP) certificate.[1]
- Outer packs labelled with trade name, scientific name, strength, storage conditions, batch number, dosage form, production and expiry dates, and the manufacturer's name and address.[1]
Supplier and chain of custody
US wholesale drug distributors and third-party logistics providers must be appropriately licensed and must report their licensure to the FDA every year to count as authorized trading partners under that law. The FDA publishes the reports in a searchable database that is updated every business day. A listing is not an FDA licence or approval in itself: the licence is issued by the state, and the database helps you see that a company has reported one.[2]
In the United States, the Drug Supply Chain Security Act sets out an electronic, interoperable way to identify and trace certain prescription medicines at the package level as they move through the supply chain, to keep harmful products out and to find and remove them quickly if they get in.[3]
The same Bahrain circular requires transport and storage in containers that follow the manufacturer's recommended conditions.[1]
WHO's good storage and distribution practices note that medical products face risks at every stage, from purchasing and storage to repackaging, relabelling, transport and distribution, and that many different people and organizations handle them along the way.[4]
Coordinator responsibilities to agree in writing
- Who prepares and who files each document.
- Who receives the shipment, checks the temperature record and signs for it.
- Who handles a temperature deviation or customs hold, and how fast the hospital is told.
- How patient data is shared, with the patient's consent, and stored.
- How quotes, invoices and timelines are given to the hospital and the family.
Clinical responsibility
The treating physician prescribes and remains responsible for the patient's care. A coordinator supports documentation and logistics; it should not take part in clinical decisions.
How Reserve Meds helps
Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We coordinate the route with your treating doctor and hospital, prepare the paperwork the regulator or hospital asks for, and arrange supply once approval is in place. Your doctor prescribes and makes every medical decision. You can ask us for our wholesale partner's licence details, and you get your quote and timeline estimate in writing before you commit.
We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them. Your coordination fee is quoted in writing for your case before you commit. No hidden charges. We give you a written timeline estimate for your case before you commit.
Ask us about a medicine
Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.
Frequently asked questions
Does the permit come before the purchase order?
In Bahrain, yes: NHRA Circular 41 of 2020 requires the authority's permission before the purchase order. Check your own regulator's rules.
Which product documents are usually requested?
In Bahrain, the CPP or registration certificate from a reference country and the manufacturer's GMP certificate, with an application form.
How can we check a US wholesale supplier?
Ask for its name and state licence; US wholesale distributors report licensure to the FDA annually, and the FDA publishes a searchable database.
Is Reserve Meds the supplier?
No. Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner, whose licence details we share on request.
Sources for these answers: [1, 2]
Sources
All sources were opened and checked on 18 October 2026. Rules and labels change, so the treating hospital or regulator confirms the current position before anything is filed.
- NHRA Bahrain: Circular No. (41) of 2020, procedures for importing non-registered medicines (accessed 18 October 2026)
- US FDA: Annual Licensure Reporting by Wholesale Drug Distributors and Third-Party Logistics Providers (accessed 18 October 2026)
- US FDA: Drug Supply Chain Security Act (DSCSA) (content current as of 16 October 2025) (accessed 18 October 2026)
- World Health Organization: TRS 1025, Annex 7, Good storage and distribution practices for medical products (17 June 2020) (accessed 18 October 2026)
Related
- For hospitals
- Hospital ethics approval
- Questions to ask before you start
- Checklist for patients and families
- Reserve Meds vs Everyone.org: which fits a Gulf family?
- Answers to common access questions
This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.