Russia extends the foreign packaging regime for registered medicines to 2027

What changed

Russia's President signed Federal Law 483-FZ of 15 December 2025, which extends to 31 December 2027 the special regime that lets registered medicines in packaging made for other markets be imported and circulated in Russia. The regime sits in Article 47 of the federal law on the circulation of medicines and applies when there is a shortage of a medicine, or a risk of one, linked to sanctions. Pharmvestnik reported the signing on 16 December 2025 and gives 1 January 2026 as the date of entry into force.

The regime was first introduced by a government resolution in April 2022. Federal Law 494-FZ of December 2024 had carried it to 31 December 2025, so the new law adds two more years.

According to Pharmvestnik, an interdepartmental commission identified about 200 medicines as in shortage or at risk between 2022 and 2025, and foreign packaging was already allowed for 14 of them.

The text of the law was not read for this update. These details come from the Pharmvestnik report and the Konsu Group review, both secondary sources.

Who it affects

• Russian importers and wholesalers of registered medicines.
• Manufacturers, including Indian companies, that hold a Russian registration and also produce packs for other markets.
• Hospitals and distributors facing shortages of registered products.

What it means for buyers

For a medicine already registered in Russia, the extension keeps open a way to bring in stock packed for another market while a shortage lasts. For a manufacturer in India, a batch in export packaging for another country may be usable in Russia, subject to the conditions set for that product.

The regime does not help medicines that are not registered in Russia. Those still need a Ministry of Health conclusion for a specific patient under Government Decree 853, whose rules apply until 1 September 2027. A replacement for those rules was in draft when this update was written.

Banking for Russia trade can still be slow, so the payment route matters as much as the regulatory route.

What to do now

1. Ask the Russian importer whether the product has been cleared for import in foreign packaging, rather than assuming every registered product qualifies.
2. Check that the batch matches the Russian registration in everything except packaging.
3. For unregistered medicines, use the patient-specific procedure under Decree 853 and plan for its 2027 replacement.
4. Agree the bank and payment route before production starts.

For the full import picture, see the Russia import guide.