Advanced Therapy Medicinal Products: EAEU GMP Update and What Your Russian Buyer Will Now Ask You For

What changed in the rules and who it applies to

The EAEU Good Manufacturing Practice Rules were approved by EEC Council Decision No. 77 of 3 November 2016. They now include a block of requirements for the manufacture of advanced therapy medicinal products — the group in which the active substance is not a conventional chemical substance but cells, tissues or genetic material. The document was drafted taking international experience and current manufacturing technologies into account, and its main practical purpose is to remove the differences in how pharmaceutical inspectorates of the member states assess manufacturing, and to harmonise approaches to qualification and validation.

For an exporter this matters in one very specific way. Until now, a difference in interpretation between the inspectorates of different Union countries turned into an argument about whether your documents were sufficient — and that argument usually happened when the batch had already arrived. Now all sides work to one standard. Mutual recognition of inspection assessments by member states and expert organisations when they analyse module 3 of the registration dossier remains in place: you do not have to go through a site inspection again because the country of import has changed.

Yaroslav Loginov — expert in logistics and customs clearance with 40 years of experience

Documents your buyer in Russia will now ask for

Medicinal products are declared under chapter 30 of the EAEU HS nomenclature, and almost everything that decides the fate of a consignment is settled before the declaration is filed. The inspector does not look at the packaging; they look at how the documents fit together: the marketing authorisation, details of the manufacturing site and confirmation that it complies with GMP requirements, module 3 quality data, and the transport and shipping documents with temperature data. Most of that set originates with you and not with the importer, which is why an inconsistent paper on your side turns into a delay at their border. And if the product travels not as a registered commercial good but for clinical research or as samples, the clearance route and the set of permits are different — that fork has to be taken before the flight is booked, not after the cargo has landed.

A consignment is rarely held because of what the product is. It is held because the details do not match: the name of the manufacturing site in the GMP compliance document differs from the name in the marketing authorisation and in your invoice by even a single word. For advanced therapy products such a mismatch costs more than usual — their shelf life is short, and a temporary storage warehouse is a difficult place to maintain the required storage conditions.

Customs regulation in this area rests on two levels at once: supranational acts of the Union, which include the GMP Rules, and the national rules of the country of import. Harmonisation at Union level does not cancel national government acts that approve lists of medicines, the import procedure and preferential rates — ask your buyer to confirm which of them apply to your product on the date of shipment. If ancillary items travel with the batch — consumables, media, devices for administering the product — agree the form of the compliance document and the certification body in advance: testing almost always takes longer than a purchasing department expects. Adjacent categories such as instruments and apparatus follow their own route; we have separate practice in customs clearance of medical equipment. Small shipments sent ahead of the main batch are handled as samples and catalogues and follow their own paperwork.

Logistics: cold chain, coolants and equipment shipments

Advanced therapy products almost always travel under controlled temperature — from a 2–8 °C regime to cryogenic conditions. That has two practical consequences for the shipper. First, the route is in practice an air route: sea freight is not considered for such consignments, and the rules for carrying dangerous goods by sea become relevant only for individual components and coolants, not for the product itself. Second, the coolant — dry ice, liquid nitrogen — is a dangerous good in its own right, and the airline will require the corresponding declaration and packaging. Reserve air freight capacity for this kind of cargo early rather than in the week of dispatch. A temperature logger in every box and continuous data recording are not a formality: they are the only way to prove that the regime was not broken, and your buyer will ask for the data itself, not for a statement.

The harmonised approach to qualification and validation also concerns companies that ship production equipment rather than the finished product. Qualification is documented proof that a specific unit of equipment works as declared, and it starts at the moment of delivery: passports, factory acceptance test protocols and completeness of supply all matter. If you ship bioreactors, cleanroom systems, freezing equipment or filling lines, send the technical file together with the goods and allow time for expert examination where it is required — customs clearance of equipment and machine tools in the EAEU relies on those papers, and what was not handed over at dispatch is hard to reconstruct afterwards.

One accepted site, five markets: Russia and the CIS

Mutual recognition of inspection assessments has one consequence of direct commercial value to an exporter: a site accepted for supplies to Russia does not have to be inspected again when the same product goes to Armenia, Belarus, Kazakhstan or Kyrgyzstan. It also means your product is compared against goods already circulating inside the Union, where suppliers move without customs formalities at all.

If your buyer distributes the goods onward within the Union, that movement follows its own procedure: no customs declaration is filed, but VAT becomes payable in the country of import and reporting has to be submitted to the tax authority. The indirect tax return is filed for the month in which the goods were taken onto the books, together with the import and indirect tax payment application, the contract and the transport and shipping documents. That part is your buyer's responsibility, not yours — but it is built on your figures. Two mistakes are typical here. The first is assuming that where customs is not involved the permit side disappears: the marketing authorisation and confirmation of the site's status are required regardless of the direction of supply. The second is a discrepancy between the data in the application and the actual value or quantity in your documents — correcting it takes an amended application, and by then the counterparty in the other Union country has usually closed the period. Issue the invoice and packing data once and do not reissue them informally after dispatch.

What to do before you ship

1. Establish whether your product falls into the advanced therapy category: gene therapy, somatic cell and tissue-engineered products are now assessed against a separate block of GMP requirements.
2. Send the buyer the current documents on the manufacturing site and check the name, the address and the list of dosage forms produced against the marketing authorisation and the invoice — character by character. The invoice is issued by you, so the mismatch is yours to prevent.
3. Make sure module 3 data corresponds to what is actually manufactured and shipped: a change in the process that has not been reflected in the dossier is the most frequent reason for a dispute with the supervising authority.
4. Agree the HS code, the duty rate and the tax treatment with the buyer before dispatch; preferential rates apply according to lists that are approved and amended separately.
5. Agree the temperature regime and the coolant with the carrier, budget for temperature loggers and have a fallback plan for a delayed flight.
6. Decide the status of the shipment in advance: a registered commercial product, material for clinical research or samples follow different clearance routes and different sets of permits.
7. If you also supply equipment, hand over passports, factory test protocols and completeness lists before dispatch — qualification starts with them and they cannot be supplied retroactively.
8. Ask the buyer to keep track of national acts on the circulation and import of medicines: supranational rules operate in parallel with national ones, and it is the national ones that change the required document set at short notice.

Frequently asked questions

Do we have to go through inspection again if we start supplying the product to another Union country?
No. Mutual recognition of inspection assessments by member states and expert organisations when analysing module 3 of the registration dossier remains in force.

We ship conventional dosage forms — does this affect us?
Not directly: the additions relate to advanced therapy products. But the uniform approaches to qualification and validation gradually set the documentation standard for the whole industry, and inspectors' questions are becoming more specific.

What happens if the logger shows the temperature went outside the range?
The consignee must not open the packaging or take the goods onto their books until the manufacturer has decided: the conclusion on whether the batch is fit for use is given by the marketing authorisation holder on the basis of the temperature record. You will need to provide that decision in writing — it becomes part of the batch file.

Can the product be imported before registration is complete?
Only in specific cases provided for by the rules — for example for clinical research or on named-patient grounds — and under their own procedure with a separate set of permits. A commercial supply cannot be planned on that basis.

Summary

Adding advanced therapy requirements to the EAEU GMP Rules removes the differences in interpretation between the inspectorates of the Union countries and keeps mutual recognition of assessments under module 3 of the dossier. For an exporter that means a more predictable procedure at the border — and a stricter look at the documents you provide: the site, the dossier, the temperature regime and identical details in every paper. One accepted site covers Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan; onward movement inside the Union adds a tax part for your buyer — the import application and the indirect tax return within the set deadline. Send us a request and we will go through your specific consignment. See also our full range of logistics and customs clearance services.

We will check the HS code and the permit set for your pharmaceutical consignment before it leaves your warehouse.

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