Turkmenistan Registration Exemptions: Four Statutory Categories

1. Key takeaways

Law No. 319-V provides for four categories of medicines and medical devices imported into Turkmenistan that are exempt from national registration:

1. Samples imported for national registration purposes — in quantities not exceeding 10 packages;
2. Products used for preclinical research and clinical research;
3. Exhibition items — which must be not intended for sale or subsequent use;
4. Products for personal use.

These four categories are not a matter of applying for a waiver; they are statutory exemption situations. Each of them, however, has strict boundary conditions, and crossing the boundary brings the product back under the mandatory registration red line described in Article 04. Each category attaches to the declared purpose of the import rather than to the type of product, so the same device may be exempt in one scenario and fully subject to registration in another.

2. Legal basis

3. Expert insights

Insight 1: the 10-package limit is a quantitative ceiling and the only quantified exemption condition.

Of the four exemptions, only the first carries a clear number: not more than 10 packages. The same figure appears in both the national registration regime and the exemption clauses of the mandatory certification regime, showing that the two regimes treat registration samples consistently. The practical implication: the number of samples submitted must be kept within 10 packages, and any excess requires a separate statement of reasons.

Insight 2: the second exemption is for research, not for trial use.

Products used for preclinical research and clinical research are exempt from registration. The key qualifier is research — market trial use, clinical demonstration and hospital trial use do not fall under this category. If trial use is disguised as research and is found to constitute sale or use, the red line of Article 04 is triggered. A hospital demonstration arranged under the label of a study is therefore outside the exemption, and the product would need a registration certificate before any such activity takes place.

Insight 3: the third exemption stands or falls on the condition of no intention to sell or use subsequently.

For exhibition items to be exempt from registration, the subjective-purpose condition of no intention to sell and no subsequent use must be satisfied. Therefore exhibition descriptions, customs purpose declarations, and post-exhibition disposal records should all be archived — they are the only evidence available to demonstrate the absence of intent to sell or use.

Insight 4: the fourth exemption, personal use, is of little relevance to business operations but matters for business travel.

The personal-use exemption addresses natural persons carrying devices for their own use across the border. Its value for B2B business is limited, but it applies to service engineers entering the country with tools and spare parts; attention must be paid to the boundary between personal use and use in commercial activity. The quantity and the nature of the items carried still matter, and the exemption does not extend to goods imported for sale, rental or display to potential customers.

Insight 5: none of the four exemptions waives the review logic of mandatory TDS certification.

Under the Law on Certification, similar exemption situations are also provided (laboratory and research samples, exhibition items, and goods of diplomatic missions and international organizations). The two exemption lists are highly similar but not fully congruent, so exemption from national registration must not be read as exemption from mandatory certification — the two must be confirmed separately.

4. Practical recommendations

1. Keep the number of samples within 10 packages, and state the purpose of the samples in the accompanying documents.
2. Maintain a separate file for research imports, documenting the study protocol and ethics basis, to avoid confusion with commercial trial use.
3. Prepare written declarations and disposal records for exhibition items, demonstrating no intention to sell or use subsequently.
4. Confirm with both the State Registration Center and the certification body whether each exemption applies on both tracks.
5. State the exemption category in the import documents, so that verification at the border can classify the shipment quickly.

5. Verification checklist

• □ The number of registration samples is not more than 10 packages.
• □ The accompanying documents state that the purpose of the samples is national registration.
• □ Research imports are filed with a study protocol and ethics basis.
• □ Exhibition items are covered by a declaration and disposal records of no intention to sell or use subsequently.
• □ Exemption applicability has been confirmed separately on the national registration and TDS certification tracks.
• □ The import documents state the exemption category.

Regulatory information verified as of October 30, 2026. The content cited in this document was checked against the provisions of Law No. 319-V on Drug Provision (January 12, 2016) on the four categories exempt from national registration; the 10-package ceiling is the quantitative limit stated in that law. Exemption situations on the mandatory certification (TDS) side follow the Law on Certification and do not fully coincide with the national registration exemption list, so the two must be confirmed separately.

GRZAN support in Turkmenistan: GRZAN provides registration support to manufacturers, importers and authorized representatives for this market. Local resources can be coordinated, including licensed importing entities and authorized representative arrangements, covering national registration submission, the consular legalization chain for documents, delivery of samples, alignment with mandatory TDS certification, and customs clearance support. Service capabilities include classification judgment, selection of the registration pathway, preparation of dossiers in the national format, notarization and consular legalization, preparation of testing and stability documentation, organization of GMP and ISO 13485 evidence, variations and renewal, and vigilance and post-market maintenance. Contact: info@grzanglobal.com.