Article 72 of the Seventh National Development Plan: Regional Mutual Recognition

1. Key takeaways

Article 72, Chapter 14, of the Law on the Seventh National Development Plan of the Islamic Republic of Iran is the most important institutional change in Iranian medical device regulation in recent years. GRZAN’s assessment: Paragraph B writes regional mutual recognition into law as a statutory obligation of the Ministry of Health and Medical Education, with a deadline at the end of year 2 of the Plan. This means that Iranian registration is upgrading from single-country market access to a regional asset that can spill over outward. Companies with an intention to build a regional footprint should now organise their Iranian submission dossiers to the standard of being reviewable by a third party, because a dossier that can only be understood inside Iran cannot be exported to another regulator without being rebuilt from the ground up. The dossier standard, once set, also raises the quality of the Iranian submission itself.

2. Legal basis

1. Law on the Seventh National Development Plan of the Islamic Republic of Iran, in force for the Iranian calendar years 1403–1407 (AD 2024–2028), Chapter 14 on improving the health system, Article 72, Paragraph A: by the end of year 1 of the Plan, in cooperation with the Ministry of Industry, Mines and Trade and the Ministry of Agriculture, establish mechanisms to raise the self-sufficiency of active pharmaceutical ingredients, medicines, agricultural products, consumables and medical devices; export bans must be announced at least 1 year in advance. This paragraph is the domestic-production side of the same article.
2. Article 72, Paragraph B of the same law: by the end of year 2 of the Plan, the Ministry of Health and Medical Education must, through bilateral and multilateral negotiations (prioritising regional countries, countries of the shared civilisational sphere and members of the Eurasian Economic Union), work for these countries to accept Iranian-registered active pharmaceutical ingredients, medicines, consumables and medical devices, and to issue registration certificates, market access licences and joint production quality certificates. This paragraph is the mutual-recognition side, and it is the one that changes the external positioning of an Iranian registration.
3. Preamble to Article 72 of the same law: the annual export target for medicines and vaccines is to exceed 1 billion euros, and the annual export target for medical devices is to exceed 1 billion euros. The targets signal that the outward orientation is intended to be measurable, not declaratory.

3. Expert insights

Insight one: this is the first time Iran has written the goal of having other countries accept its registrations into a national development law. Until now the Iranian registration system was purely inward-looking. Article 72, Paragraph B changes that positioning, assigns responsibility explicitly to the Ministry of Health and Medical Education, and attaches a deadline — the end of year 2 of the Plan — which makes the obligation verifiable rather than aspirational. An obligation with a named owner and a date is a different kind of commitment from a policy direction, and companies should read it as such.

Insight two: the priority directions are already written down — regional countries, countries of the shared civilisational sphere, and the Eurasian Economic Union. These three categories give companies a concrete list of markets. For companies that are simultaneously building a presence in Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan, the strategic value of an Iranian registration is systematically raised, because the same dossier may later open doors that previously required separate filings, and the preparation cost of those filings falls accordingly.

Insight three: the self-sufficiency goal of Paragraph A and import restrictions are two sides of the same coin. Raising the domestic self-sufficiency rate and restricting comparable imports are two expressions of the same policy. While companies look at the benefits of Paragraph B, they must also face the tightening of access that Paragraph A brings — a pair of hedged variables that need to be managed at the same time, not one after the other, since both move on the same statutory timetable.

4. Practical recommendations

1. Organise the dossier to a reviewable standard: adopt the STED structure and internationally accepted evidence chains, leaving an interface for future mutual recognition so the dossier can be reviewed by a third party without reconstruction, and so the same file supports both the Iranian submission and later regional ones.
2. Draw a regional footprint map: measure Iranian registration against the three priority directions — regional countries, the civilisational sphere and the Eurasian Economic Union — to assess the spillover target markets, and keep the map updated as negotiations progress so the picture never goes stale.
3. Track the joint production quality certificate: Paragraph B explicitly mentions this certificate; companies localising production should follow its implementing details closely as they emerge, since it is the instrument that connects local manufacturing to regional recognition, and what has already been published should be recorded so the tracking does not depend on memory.
4. Hedge the tightening effect of Paragraph A: carry out the comparison with domestic like products at the same time, so that export benefits and import obstacles do not arrive together unmanaged and the company is never surprised by the second half of the same statute, with the two analyses filed side by side so they can be read together.

5. Verification checklist

• □ The full text of Paragraphs A and B of Article 72 has been obtained and archived
• □ The Iranian submission dossier has been organised according to the STED structure and internationally accepted evidence chains
• □ A map of regional spillover target markets has been drawn (regional countries, civilisational sphere, Eurasian Economic Union)
• □ The implementing details of the joint production quality certificate are on the tracking list
• □ The comparison with domestic like products has been completed in parallel, hedging the tightening effect of Paragraph A

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Iranian market. Our team manages adverse event reporting and recall coordination with IFDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com