Legalization requirements

Submittion of official documentation to the state authorities of Ukraine (MOH, State Expert Center, State Agency of Medicinal Products) requires presentation of such documents in the legalized form. Requirements for the legalization of document depend on the country of origin. 

Official documents mean documents that grant rights or obligations (such as Power of Attorney), specific certificates and licenses. For registration of medicinal products following documents are usually legalized: Power of Attorney, GMP certificate, Certificate of Pharmaceutical Product (CPP), Manufacturing License. For registration of medical devices following documents are usually legalized: Power of Attorney, Quality management system certificates (such as ISO), CE mark, Certificate of registration of legal entity. 

Document legalization means confirmation of authenticity (the original document or its copy, the authenticity of the signature) in compliance with international law. Different documents are legalized in different ways, namely:

Legalization requirements  | Cratia

Apostil is most common way of legalization

  • The Power of Attorney for representation of interests at state authorities of Ukraine shall be signed by the responsible person. Thus, the signature is notary certified for its authencity and legality. Further legalization of document (only notarization or apostille, or legalization at the Consulate) - depends on the country of origin.
  • Document copies must be certified by a notary; further legalization of a document depends on the country of origin.

To simplify the task, we have prepared table with the requirements set up in relation to the documentation of certain countries.

Country

Notarization only (or the original)

Notarization (or the original) and apostille

Notarization (or the original) and legalization at the Consulate of Ukraine

Notes or explanations

Albania

 

Х

 

 

Andorra

 

Х

 

 

Antigua and Barbuda

 

Х

 

 

Argentina

 

Х

 

 

Armenia

Х

 

 

The Minsk Convention

Australia

 

Х

 

 

Austria

 

Х

 

 

Azerbaijan

Х

 

 

The Minsk Convention

Bahamas

 

Х

 

 

Barbados

 

Х

 

 

Belarus

Х

 

 

The Minsk Convention

Belgium

 

Х

 

 

Belize

 

Х

 

 

Bosnia and Herzegovina

 

Х

 

 

Botswana

 

Х

 

 

Brunei

 

Х

 

 

Bulgaria

Х

 

 

Bilateral agreement

China, Hong Kong

 

Х

 

 

China, Macao

 

Х

 

 

China

 

 

Х

Council leglization is required. More details.

Colombia

 

Х

 

 

Cook Islands

 

Х

 

 

Croatia

 

Х

 

 

Cuba

Х

 

 

Bilateral agreement

Cyprus

 

Х

 

For some types of documents Apostil is required. More details.

Czech Republic

Х

 

 

Bilateral agreement

Democratic People's Republic of Korea (DPRK)

Х

 

 

Bilateral agreement

Dominican Republic

 

Х

 

 

Ecuador

 

Х

 

 

Egypt

 

X

 

Apostil is required. More details.

El Salvador

 

Х

 

 

Estonia

Х

 

 

Bilateral agreement

Fiji

 

Х

 

 

Finland

 

Х

 

 

France

 

Х

 

 

Georgia

Х

 

 

The Minsk Convention

Germany

 

X

 

Starting from 22.07.2010 necessity of legalization at Council has been cancelled. More details.

Greece

 

Х

 

For some types of documents Apostil is required. More details.

Grenada

 

Х

 

 

Honduras

 

Х

 

 

Hungary

 

Х

 

For some types of documents Apostil is required. More details.

Iceland

 

Х

 

 

India

 

Х

 

 

Iran

 

Х

 

For some types of documents Apostil is required. More details.

Ireland

 

Х

 

 

Israel

 

Х

 

 

Italy

 

Х

 

 

Japan

 

Х

 

 

Kazakhstan

Х

 

 

The Minsk Convention

Korea (South)

 

X

 

 

Kyrgyzstan

Х

 

 

 

Latvia

Х

 

 

Bilateral agreement

Lesotho

 

Х

 

 

Liberia

 

Х

 

 

Liechtenstein

 

Х

 

 

Lithuania

Х

 

 

Bilateral agreement

Luxembourg

 

Х

 

 

Malawi

 

Х

 

 

Macedonia

Х

 

 

Bilateral agreement

Malta

 

Х

 

 

Marshall Islands

 

Х

 

 

Mauritius

 

Х

 

 

Mexico

 

Х

 

 

Moldova

Х

 

 

The Minsk Convention

Monaco

 

Х

 

 

Mongolia

Х

 

 

Bilateral agreement

Namibia

 

Х

 

 

New Zealand

 

Х

 

 

Netherlands

 

Х

 

 

Niue

 

Х

 

 

Norway

 

Х

 

 

Panama

 

Х

 

 

Poland

Х

 

 

Bilateral agreement

Portugal

 

Х

 

 

Republic of South Africa

 

Х

 

 

Romania

Х

 

 

Bilateral agreement

Russian Federation

Х

 

 

The Minsk Convention

Saint Kitts and Nevis

 

Х

 

 

Saint Lucia

 

Х

 

 

Saint Vincent Grenadines

 

Х

 

 

Samoa

 

Х

 

 

San Marino

 

Х

 

 

Serbia and Montenegro

 

Х

 

 

Seychelles

 

Х

 

 

Slovakia

 

Х

 

 

Slovenia

 

Х

 

 

Spain

 

Х

 

 

Surinam

 

Х

 

 

Swaziland

 

Х

 

 

Sweden

 

Х

 

 

Switzerland

 

Х

 

 

Syria

Х

 

 

Bilateral agreement

Tajikistan

Х

 

 

The Minsk Convention

Tonga

 

Х

 

 

Trinidad and Tobago

 

Х

 

 

Turkey

 

Х

 

For some types of documents Apostil is required. More details.

Turkmenistan

Х

 

 

The Minsk Convention

United Kingdom of Great Britain and Northern Ireland

 

Х

 

 

USA

 

Х

 

For documents from the U.S.,  Apostille is required

Uzbekistan

Х

 

 

Bilateral agreement

Venezuela

 

Х

 

 

Viet Nam

 

Х

 

For some types of documents Apostil is required. More details.

Other countries not listed above

 

 

Х

For all countries that are not the parties of the Hague and the Minsk Convention and have not signed a treaty on mutual legal assistance with Ukraine – notarization (or original) and legalization at the Consulate of Ukraine are required.

Contact information of the Consulates of Ukraine is available on www.mfa.gov.ua; for the customers of Cratia Ltd this information is provided in the course of cooperation.

If you have any questions or suggestions, please e-mail us at info@cratia.ua, call us +38 044 332-42-94 or visit our office.

P.S: Cratia Ltd. provides assistance in the registration of medicinal products, medical devices and medical equipment, food supplements and cosmetics, and performs excellent translations of medical documentation of any complexity.