25 May 2017 EMA/102302/2005 v. 6.8 Human Medicines Evaluation Division

Member states contact points for translations review The e-mail should include at least the following information: E-mail subject: Post-opinion review – Day <…> – – Deadline for comments: <…> E-mail text: Please find attached the product information for in your national language. - > [only for generics/hybrids/biosimilars – delete if not applicable] Comments in Word must be sent directly to with copy to the Agency . Deadline for the linguistic review is: <...>

Renewals, variations, referrals, annual re-assessments Translations sent by Applicant/MAH and handled by Procedure secretary/Vet e-mail address Member states

Human

Austria

Translations reviewed by Germany

Veterinary Translations reviewed by Germany

Translations reviewed by France,

Translations reviewed by France,

Germany and the Netherlands

Germany and the Netherlands

Bulgaria

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[email protected]

Croatia

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[email protected]

Czech Republic

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[email protected]

Cyprus

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Translations reviewed by Greece

Denmark

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[email protected]

Belgium

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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

Member states

Human

Veterinary

Estonia

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Finland

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[email protected]

France

[email protected]; [email protected]

Germany BfArM* Germany PEI*

[email protected]; [email protected]; [email protected]

[email protected]

-

[email protected];

[email protected];

[email protected]

[email protected]

Germany BVL*

-

[email protected]

Greece

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Hungary

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Iceland

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Italy

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Lithuania

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[email protected]

Latvia

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Translations reviewed by France and

Translations reviewed by France

Germany

and Germany

Malta

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Netherlands

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[email protected]

Norway

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Poland

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Portugal

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Romania

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Slovak Republic

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Slovenia

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Spain

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Sweden

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Luxembourg

*German translations to be sent to both BfArM and PEI (Human) and to PEI and BVL (Veterinary)

Member states contact points for translations review EMA/102302/2005

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