How to prepare a medicine sourcing request

Most delays in sourcing a specialty or unregistered medicine start with an incomplete request. A message that only names a medicine leaves the exporter to guess the strength, the market version, the destination rules and the timing, and each guess needs another round of email. A complete request lets a supplier in India check availability, batches, documents, shipping and the legal route in one pass.

This guide lists the fields a sourcing request should contain and explains why each one matters. The same fields appear in the quote request form, so it can also be read as a guide to filling that in.

What a complete request contains

The example values are for illustration only and do not describe any real order.

Product identity

Name and brand

WHO describes international non-proprietary names as unique, globally recognised names that belong to the public domain. Using the INN avoids confusion between local brand names, which can differ from one country to the next. Add the brand and the manufacturer when a specific product is required. That is normal for biologics, where EU law expects adverse reaction reports to identify the product by name and batch under Directive 2010/84/EU, and for trial comparators, where the protocol may name one market version. The guide on biosimilars and reference biologics explains why.

Strength, form and pack

Give the strength exactly as prescribed, the dosage form, the pack size and, for injectables, the presentation. A request for a medicine in vials when the prescriber expects a pen will not pass the hospital's check on arrival.

Market of origin and alternatives

Say which market versions are acceptable, for example an EU pack, an Indian pack or any version approved in a named country. If the prescriber, sponsor or tender allows alternatives, list them and attach the decision. If not, say that no substitution is allowed.

Destination, consignee and permit status

The destination country decides the legal route, and the consignee decides who holds the permit. In the United Kingdom, for example, an unlicensed import is notified to MHRA by a licensed wholesaler or specials manufacturer, not by the patient. In Mexico, the COFEPRIS sanitary import permit has separate modalities for institutions, personal use, donations and research. The country import guides set out each route.

State the permit status in one of three ways:

1. Not yet filed. The exporter will prepare the proforma invoice and product documents the application needs.
2. Pending. Give the filing date and the regulator, so the exporter can hold stock if possible.
3. Issued. Give the permit number, the product and quantity it covers and its validity. Mexican permits, for example, are valid for 180 days, and Kazakh conclusions lapse at the end of the calendar year.

Patients and families should route the request through the treating physician or hospital. The first request does not need the patient's name or identity documents. Those are shared later, only as the route requires.

Quantity, shelf life and timing

Quantity, shelf life and date work together. A supplier may hold enough stock across several batches but not in one batch with the shelf life needed. State:

• the total quantity and whether a single batch is required, as trial sponsors may ask
• the minimum remaining shelf life on arrival, as covered in shelf-life requirements in medicine supply
• the date the goods are needed at the destination, not the date the request is sent

For trials, ICH E6(R3) asks sponsors to make sure investigational products are used only within their current shelf life, so the remaining shelf life has to cover the whole dosing period. The lead-time estimator shows whether the date is realistic once permit, export and transit time are added.

Commercial and logistics terms

Incoterm and delivery point

The Incoterms 2020 rules published by the International Chamber of Commerce set out how cost, risk and obligations are split between seller and buyer. For permit-based imports, CIP or DAP to the hospital or its customs broker are common, and FCA suits importers with their own forwarder. DDP is rarely practical when the local permit holder must be importer of record. The Incoterms guide covers each choice.

Temperature and mode

State the labelled storage condition. Room-temperature parcels often go by courier, while cold-chain and larger lots may need air cargo with qualified packaging. The guides on courier versus air cargo and cold-chain shipping of biologics explain the trade-offs, and the cold-chain transit checker tests a lane.

Currency and payment

Say which currency you will pay in and how, for example by bank transfer or letter of credit, and whether payment terms depend on the permit being issued. The options are covered in how to pay for an international medicine order. The landed cost calculator estimates duty and tax at the destination.

Attachments and document requests

Attach what proves the buyer can lawfully receive the goods:

• the consignee's licence, such as a hospital, pharmacy, wholesale or import licence
• the permit, notification or application, where one exists
• the trial protocol reference and sponsor details for comparators
• the tender reference and quality clause for donor-funded supply

In the same message, list the documents you need from the supplier, for example the certificate of analysis, the certificate of pharmaceutical product, the GMP certificate and a proforma invoice in the permit holder's name. The document checklist builds the list for each country, and pharma export documents explained describes each one.

Common gaps that slow a quote

The same omissions come up again and again. Checking for them before sending saves a round of questions:

• Strength without units or volume. For injectables, give both the amount and the volume, for example per vial.
• A brand name only. Local brand names differ between countries, so always add the INN.
• No consignee type. The exporter cannot tell whether a hospital, importer or physician will hold the permit.
• No shelf-life minimum. The first quote may offer a batch that is too short for the treatment or trial.
• No date or an unrealistic date. Permit, export and transit time add up, and the request should say what happens if the date cannot be met.
• Patient identity in the first email. It is not needed to check availability and should be shared only through the proper route.

Step by step: sending the request

1. Confirm the product details with the prescriber, sponsor or tender document.
2. Check the destination route and the consignee in the country guide.
3. Fill in every field in the table above, marking anything not yet known.
4. Attach the licence and permit papers, without patient identity data.
5. List the documents you need from the supplier.
6. Send the request and keep its reference for the permit application.
7. When the quote arrives, check that the product, batch, shelf life, Incoterm and lead time match the request before accepting it.

Before trusting any reply, check who is answering. The guide on how to verify a medicine supplier lists the licences and records to ask for.