30 November 2016 EMA/95063/2016 rev. 3
Human Medicines Evaluation
Contact details of national competent authorities for requests of translation exemption falling under Art. 63.3 of Directive 2001/83/EC and cases of shortages
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Member State
Contact point
Austria
[email protected]
Belgium
[For cases of shortages]
[email protected] [For all other request]
[email protected]
Bulgaria
[email protected] (FAO Ms Rozalina Kulaksazova)
Croatia
[email protected] (FAO Mrs Anela Kraljević)
Czech Republic
[email protected] (FAO Marcela Beková)
Cyprus
[email protected] (FAO Mrs. Marlen Avraamidou)
Denmark
[Request to be addressed to the Head of Unit at]
[email protected] (FAO Deirdre Mannion, Head of Unit)
Estonia
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Finland
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France
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Germany
[email protected] [For vaccines/biological medicinal products]:
[email protected] (FAO Ms Dominique Westphal) and CC to
[email protected]
Greece
[email protected] (FAO Theoni Kousteni)
Hungary
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Ireland
[email protected] (FAO Tara Kelly)
Iceland
[email protected] [email protected]
Italy
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Latvia
[email protected] (FAO Maija Cirkina)
Lithuania
[email protected] (FAO Vaida Ribokaite)
Malta
[email protected] (FAO Ms Helen Vella) [or as alternate contact]
[email protected] (FAO Ms Emma Cassar Buontempo)
Netherlands
[email protected]
Norway
[email protected] (FAO Nina Malvik)
Contact details of national competent authorities for requests of translation exemption falling under Art. 63.3 of Directive 2001/83/EC and cases of shortages EMA/95063/2016 rev 3
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Member State
Contact point
Poland
[Request to be addressed to the Head of Agency at]
[email protected] [or alternatively to] Łukasz Burda –
[email protected] Anna Wachnik-Święcicka –
[email protected]
Portugal
[email protected]
Romania
[email protected] (FAO Ms Alexandrina Preda)
Slovak Republic
[email protected] (FAO Petra Dočolomanská)
Slovenia
[email protected] (FAO Marjeta Jordan)
Spain
[email protected] [or directly to] Blanca GARCÍA-OCHOA MARTÍN
[email protected]
Sweden
[email protected]
United Kingdom
[email protected] (FAO Ms Jan McDonald)
Contact details of national competent authorities for requests of translation exemption falling under Art. 63.3 of Directive 2001/83/EC and cases of shortages EMA/95063/2016 rev 3
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