Requirements on documents legislation

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Requirements on documents legislation

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:

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 copy)	Notarization (or the original copy) 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			Minsk Convention
Australia		Х
Austria		Х
Azerbaijan	Х			Minsk Convention
Bahamas		Х
Bahrain		X
Barbados		Х
Belarus		X		Despite provisions of the Minsk Convention, apostille is required. More details –in Ukrainian.
Belgium		Х
Belize		Х
Bolivia		X
Bosnia and Herzegovina		Х
Botswana		Х
Brazil		X
Brunei		Х
Bulgaria	Х			Bilateral treaty
Burundi		X
Cape Verde		X
China (PRC, except Hong Kong and Macau)		Х
Chile		X
Colombia		Х
Cook Islands		Х
Costa Rica		X
Croatia		Х
Cyprus		Х
Czech Republic	Х			Bilateral treaty
Denmark (except Greenland and Faroe Islands)		X
North Korea (DPRK)			X
Dominican Republic		Х
Ecuador		Х
Egypt			X
El Salvador		Х
Estonia	Х			Bilateral treaty
Fiji		Х
Finland		Х
France		Х
Georgia	Х			Bilateral treaty. Documents issued by tax authorities require apostille.
Germany		X
Greece		Х
Grenada		Х
Guatemala		Х
Guyana		X
Honduras		Х
Hong Kong		Х
Hungary		Х
Iceland		Х
India		Х
Iran			X
Ireland		Х
Israel		Х
Italy		Х
Japan		Х
Kazakhstan	Х			Minsk Convention
South Korea		X
Kyrgyzstan	Х
Latvia	Х			Bilateral treaty
Lesotho		Х
Liberia		Х
Liechtenstein		Х
Lithuania	Х			Bilateral treaty
Luxembourg		Х
Macau		X
Malawi		Х
Malta		Х
Marshall Islands		Х
Mauritius		Х
Mexico		Х
Moldova	Х			Minsk Convention
Monaco		Х
Mongolia		X
Montenegro		X		Bilateral treaty
Morocco		Х
Namibia		Х
New Zealand		Х
Netherlands		Х
Nicaragua		Х
Niue		Х
North Macedonia	Х			Bilateral treaty. Documents issued by tax authorities require apostille.
Norway		Х
Oman		X
Palau		Х (from 23 June 2020)	Х (before 23 June 2020)
Panama		Х
Paraguay		Х
Peru		Х
Philippines		X
Poland	Х			Bilateral treaty
Portugal		Х
Republic of South Africa		Х
Romania	Х			Bilateral treaty
Russia	Х			Minsk Convention
Saint Kitts and Nevis		Х
Saint Lucia		Х
Saint Vincent and the Grenadines		Х
Samoa		Х
San Marino		Х
São Tomé and Príncipe		Х
Serbia		Х
Seychelles		Х
Slovakia		Х
Slovenia		Х
Spain		Х
Surinam		Х
Swaziland		Х
Sweden		Х
Switzerland		Х
Tajikistan	Х			Minsk Convention
Tonga		Х
Trinidad and Tobago		Х
Tunisia		X
Turkey		Х
Turkmenistan	Х			Minsk Convention
United Kingdom of Great Britain and Northern Ireland		Х
United States of America USA		Х
Uzbekistan	Х			Bilateral treaty
Uruguay		X
Vanuatu		X
Venezuela		Х
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 copy) 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.

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.

We provide preliminary consultations free of charge, call us by phone +38 (068) 064-78-31, +38 (044) 223-61-67, or write to info@cratia.ua, or come to the meeting directly to our office.